Coffee Intake Linked to Lower Diabetes Risk

June 26, 2006 (Eurekalert) - Drinking coffee, especially when it is decaffeinated, may be associated with a reduced risk of type 2 diabetes, according to a report in the June 26 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

Previous studies in the United States and Europe have linked coffee to a reduced risk of type 2 diabetes, according to background information in the article. The link between coffee and diabetes risk appears to be consistent across different ages and body weights; in addition, most research has found that the more coffee an individual generally drinks, the lower his or her risk for diabetes. However, it remains unclear whether it is the caffeine or another ingredient in coffee that may confer a protective effect.

Mark A. Pereira, Ph.D., and colleagues at the University of Minnesota, Minneapolis, studied coffee intake and diabetes risk in 28,812 postmenopausal women in Iowa over an 11-year period. At the beginning of the study, in 1986, the women answered questions about their risk factors for diabetes, including age, body mass index, physical activity, alcohol consumption and smoking history. They also reported how often they consumed a variety of foods and beverages over the previous year, including regular and decaffeinated coffee.

Based on information reported in the initial questionnaire, about half of the women (14,224) drank one to three cups of coffee per day; 2,875 drank more than six cups; 5,554 four to five cups; 3,231 less than one cup; and 2,928 none. Over the following 11 years, 1,418 of the women reported on surveys that they had been newly diagnosed with type 2 diabetes. After adjusting the data for some of the other diabetes risk factors, women who drank more than six cups of any type of coffee per day were 22 percent less likely than those who drank no coffee to be diagnosed with diabetes; those who drank more than six cups of decaffeinated coffee per day had a 33 percent reduction in risk compared with those who drank none.

Overall caffeine intake did not appear to be related to diabetes risk, further suggesting that some other ingredient in coffee was responsible. "Magnesium, for which coffee is a good source, could explain some of the inverse association between coffee intake and risk of type 2 diabetes mellitus through known beneficial effects on carbohydrate metabolism," the authors write. However, the study found no association between this mineral and diabetes risk. Other minerals and nutrients found in the coffee bean--including compounds known as polyphenols that have also been shown to help the body process carbohydrates and antioxidants that may protect cells in the insulin-producing pancreas--may contribute to its beneficial effects and should be examined in future studies.

"In summary, we observed an inverse association between coffee consumption, especially decaffeinated coffee consumption, and the risk of type 2 diabetes mellitus over an 11-year period in postmenopausal women residing in the state of Iowa," the authors conclude. "Although the first line of prevention for diabetes is exercise and diet, in light of the popularity of coffee consumption and high rates of type 2 diabetes mellitus in older adults, these findings may carry high public health significance."

Posted by dlife at 02:40 PM | Comments (0)

One-Third of Adults with Diabetes Still Don’t Know They Have It

May 25, 2006 - The prevalence of diagnosed diabetes in U.S. adults age 20 and older has risen from about 5.1 percent to 6.5 percent, according to researchers at the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC), who analyzed national survey data from two periods — 1988 to 1994 and 1999 to 2002. However, the percentage of adults with undiagnosed diabetes did not change significantly over the years studied. About 2.8 percent of U.S. adults — one-third of those with diabetes — still don’t know they have it.

The study, published in the June 2006 issue of Diabetes Care, notes that type 2 diabetes accounts for up to 95 percent of all diabetes cases and virtually all undiagnosed diabetes cases. Diabetes is a group of diseases marked by high levels of blood glucose resulting from defects in insulin production, insulin action, or both. It is the most common cause of blindness, kidney failure, and amputations in adults and a major cause of heart disease and stroke.

Over the years studied, about 26 percent of adults age 20 and older continued to have impaired fasting glucose (IFG), a form of pre-diabetes. IFG, in which blood glucose measured after an overnight fast is high but not yet diagnostic of diabetes, increases the risk of heart disease as well as the risk of developing type 2 diabetes.

“It’s important to know if you have pre-diabetes or undiagnosed type 2 diabetes,” said Dr. Larry Blonde, chair of the National Diabetes Education Program (NDEP), jointly sponsored by the NIH, CDC, and 200 partner organizations. “You should talk to your health care professional about your risk. If your blood glucose is high but not high enough to be diagnosed as diabetes, losing weight and increasing physical activity will greatly lower your risk of getting type 2 diabetes. If you have diabetes, controlling your blood glucose, blood pressure, and cholesterol will prevent or delay the complications of diabetes.”

The researchers also found that:

nearly 22 percent of people age 65 and older had diabetes.
about 13 percent of non-Hispanic blacks age 20 and older had diabetes. Diabetes was twice as common in non-Hispanic blacks compared to non-Hispanic whites.
about 13 percent of non-Hispanic blacks age 20 and older had diabetes. Diabetes was twice as common in non-Hispanic blacks compared to non-Hispanic whites.
about 8 percent of Mexican Americans age 20 and older had diabetes. Because the average age of Mexican Americans is younger than for other groups, the age-and sex-adjusted prevalence of diabetes in Mexican Americans is twice that of non-Hispanic whites and about equal to that of non-Hispanic blacks.
IFG and undiagnosed diabetes were about 70 percent more common in men than in women, especially in non-Hispanic white men.
nearly 40 percent of people age 65 and older had IFG, which becomes more common with age.

In the study, the researchers compared two slices of data, one from 1988 to 1994 and the other from 1999 to 2002. The data were derived from a national sample of U.S. adults age 20 years and older who took part in the National Health and Nutrition Examination Survey (NHANES) conducted by the CDC’s National Center for Health Statistics. Survey participants were interviewed in their homes and received a physical exam with a blood test, which included a glucose reading taken after an overnight fast. The NHANES is unique because it includes a blood test that detects undiagnosed diabetes and IFG.

“This study updates and generally corroborates earlier analyses that were based on 2 years of NHANES data,” said lead author Catherine Cowie, Ph.D., of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). “We’re seeing a rising prevalence of diagnosed diabetes that is not substantially offset by a drop in the rate of undiagnosed — about one-third of adults with diabetes still don’t know they have it. Another 26 percent of adults have a form of pre-diabetes.”

Pre-diabetes, which usually causes no symptoms, is serious because many people with the condition develop type 2 diabetes in the next 10 years. Also, pre-diabetes substantially raises the risk of a heart attack or stroke even if type 2 diabetes does not develop.

People with pre-diabetes may have IFG or impaired glucose tolerance (IGT) or both.

In IFG, blood glucose is high (100 to 125 milligrams per deciliter or mg/dL) after an overnight fast but not high enough to be diagnostic of diabetes.
In IGT, blood glucose is high (140 to 199 mg/dL) 2 hours after drinking a sugary drink in an oral glucose tolerance test but not high enough to be diagnostic of diabetes.
In the current study, researchers did not assess the prevalence of IGT because an oral glucose tolerance test was not a part of the survey.

People with pre-diabetes can often prevent or delay diabetes if they lose a modest amount of weight by cutting calories in their diet and increasing physical activity (for example, walking 30 minutes a day 5 days a week). A major study of people with IGT has shown that lifestyle changes leading to a 5 to 7 percent weight loss lowered diabetes onset by 58 percent.

If you are over age 45, you should consult your health care provider about testing for pre-diabetes or diabetes. If you are younger than 45, overweight, and have another risk factor, you should ask about testing. You are at greater risk of developing pre-diabetes and type 2 diabetes if you:

are age 45 or older
have a family history of diabetes
are overweight
have an inactive lifestyle (exercise less than three times a week)
are members of a high-risk ethnic population (e.g., African American, Hispanic/Latino American, American Indian and Alaska Native, Asian American, Pacific Islander)
have high blood pressure: 140/90 mm/Hg or higher
have an HDL cholesterol less than 35 mg/dL or a triglyceride level 250 mg/dL or higher
have had diabetes that developed during pregnancy (gestational diabetes) or have given birth to a baby weighing more than 9 pounds
have polycystic ovary syndrome, a metabolic disorder that affects the female reproductive system
have acanthosis nigricans (dark, thickened skin around neck or armpits)
have a history of disease of the blood vessels to the heart, brain, or legs
have had IFG or IGT on previous testing.

In its “Small Steps. Big Rewards. Prevent Type 2 Diabetes” campaign, the NDEP (www.ndep.nih.gov/) is reaching out to people at risk for type 2 diabetes with the message that they have the power to turn the tide against this disease. The NDEP campaign, “Control Your Diabetes for Life,” encourages people with diabetes to control their blood glucose as well as their blood pressure and cholesterol. By keeping all three as close to normal as possible, people with diabetes can prevent or delay the development and progression of diabetes complications, which affect the heart, eyes, nerves, kidneys, and blood vessels.

For more diabetes statistics, http://diabetes.niddk.nih.gov/dm/pubs/statistics/index.htm

Posted by dlife at 02:43 PM | Comments (0)

Studies Reveal Generational Cycle of Mother's Early Puberty Driving Child's Obesity Risk and Early Puberty

Other Pediatric Studies at ENDO 2006 Address Short Stature and Insulin Pumps

BOSTON, June 25 /PRNewswire/ -- A new study not only confirms the link between childhood obesity and early onset of puberty but also demonstrate that a mother's age at her first period is linked to her children's risk for obesity. Taken together, the results suggest a spiraling generational link between obesity and early puberty.

This study, as well as two others on treatment of diabetes in children, will be discussed at a media roundtable on Sunday, June 25th at 2:00 P.M. EDT during ENDO 2006, the 88th Annual Meeting of The Endocrine Society at the Boston Convention & Exhibition Center.

Early Puberty for Mother Predicts Rapid Infant Growth and Childhood Obesity

A related study by Dr. Ken Ong of the UK Medical Research Council and University of Cambridge set out to find possible inherited reasons for such findings, that larger girls are more likely to mature earlier. Ong found that mothers who had completed their own puberty early were shorter and fatter than other mother. They gave birth to offspring who grew rapidly during infancy, became more overweight during childhood, and themselves had earlier puberty.

In the ALSPAC birth cohort study from Bristol UK, Ong looked at the body mass index (BMI) for more than 6,000 children at age 9. The children of mothers who had periods before the age of 11 were far more likely to have larger BMI measurements and body fat than children whose mother's did not go through puberty until 15 or later. In addition, a more detailed review of childhood growth for more than 900 of the children revealed that offspring of mothers with early puberty grew more rapidly than the others only during the first two years of life and they then remained taller and fatter as children.

"We have identified a remarkable but common inherited growth pattern, starting with rapid infancy growth and weight gain, taller childhood stature, but earlier maturation and completion of growth resulting in slightly shorter adult stature" said Ong. "We knew that age when girls have their first period is an inherited trait, transmitted from mother to child. Now it appears that this trans-generational trait also has important influences on infancy and childhood growth rates and on obesity risks throughout life."

Insulin Pump Therapy in Very Young Children with Diabetes

While the use of insulin infusion pumps in young diabetic children is increasing, there is little information about the long-term effectiveness of this treatment. A study by Dr. Linda DiMeglio of Indiana University compared two groups of preschool children, one that used intensive insulin injection therapy for the first six months before switching to the pump and one that used the pump throughout the study time.

The study measured the level of hemoglobin A1c as well as the body mass index (BMI) at the time of enrollment, time of pump start and at six, 12, 18 and 24 months after pump start. Despite the potential to have a more liberalized diet once the pump was in place, there were no significant increases in BMI for age and hemoglobin A1c levels remained improved.

"The persistent reduction of hemoglobin A1c, during a time when children are transitioning into school and receiving some care outside of the home, is encouraging for the continued use of this technology in very young children," said DiMeglio.

Evaluation and Treatment Patterns for Pediatric type 2 Diabetes

With the prevalence of Type 2 diabetes increasing in children, it is important to understand the impact of current patterns of treatment and their relationship to controlling symptoms before complications occur. Doctors at the University of Florida in Gainesville, the University of Texas in Houston, the University of Colorado Medical School, the University of South Carolina Medical School, Children's Hospital of Philadelphia, Driscoll Children's Hospital in Corpus Christi, TX and Akron Children's Hospital in Akron, OH joined together to review data on nearly 600 young patients with type 2 diabetes.

The results were sobering: Most children had either worsening or no change in their blood glucose levels over time; this could be attributed to either poor compliance with treatment or simply worsening of the disease following its natural course. In addition, elevations in blood cholesterol or triglycerides were seen in almost one third of patients, and a few of these young patients were already showing signs of nerve and eye damage related to diabetes.

"Despite early onset of complications in patients with type 2 diabetes, a significant number of young patients are not evaluated for complications and cardiovascular risk factors by pediatric endocrinologists," said Dr. Vanessa Davis, one of the researchers for the study. "Such screening will be particularly important to prevent heart disease, diabetes-related complications and to improve long term quality of life for these children".

Posted by dlife at 02:38 PM | Comments (0)

New Perspective Emerges on Metabolic Syndrome

Leaders of the American Diabetes Association and the American Heart Association Announce Joint Letter at ENDO 2006, Annual Meeting of The Endocrine Society

BOSTON, June 25 (PRNewswire) - Though they have markedly different opinions on the controversial Metabolic Syndrome, leaders of the American Heart Association and the American Diabetes Association announced at the annual meeting of The Endocrine Society that they will co-publish a statement on Monday expressing a desire for the organizations to work together on the topic of "cardio-metabolic risk."

Despite their differences of opinion, both organizations are working together to prevent heart disease, stroke and diabetes, said Robert H. Eckel, president of the American Heart Association, a physician and professor at the University of Colorado.

Eckel presented alongside John Buse, vice president of the American Diabetes Association in a debate at The Endocrine Society annual meeting entitled "Controversies in Endocrinology: Impact and Management of the Metabolic Syndrome."

The two organizations represented by Buse and Eckel clearly still have differing viewpoints on the Metabolic Syndrome, as articulated last year in a paper published by the American Diabetes Association, "The Metabolic Syndrome: Time for a Critical Appraisal."

The Metabolic Syndrome is loosely defined as a cluster of medical conditions -- including obesity, high blood pressure, high LDL cholesterol (and low HDL) -- that increase the risks of diabetes and cardio-vascular disease.

The American Heart Association, according to Eckel, supports identifying and treating the syndrome through lifestyle modifications and other treatments.

But the American Diabetes Association, Buse said, believes that the definition of the syndrome is poor, and that risk prediction of cardiovascular disease is also poor. Further, he said there is little benefit to treating the syndrome as a whole rather than identifying and treating the various components.

The letter, to be released Monday, uses the term "cardio-metabolic risk," new terminology which Buse said may signify a new way of describing and therefore treating the condition known as Metabolic Syndrome.

The debate also included representatives of the FDA and the pharmaceutical industry.

Founded in 1916, The Endocrine Society is the world's oldest, largest, and most active organization devoted to research on hormones, and the clinical practice of endocrinology. Today, The Endocrine Society's membership consists of over 12,000 scientists, physicians, educators, nurses and students in more than 80 countries. Together, these members represent all basic, applied, and clinical interests in endocrinology. The Endocrine Society is based in Chevy Chase, Maryland. To learn more about the Society, and the field of endocrinology, visit our web site at http://www.endo-society.org/.

Posted by dlife at 02:36 PM | Comments (0)

Diabetes, heart disease can herald early GI cancers

LOS ANGELES (May 23, 2006) – Heart disease and diabetes are among the most common conditions plaguing Americans today, and they are related to a host of other diseases. Research presented today at Digestive Disease Week® 2006 (DDW) now also demonstrates that these conditions can be warning signs for some types of digestive cancers, and may lead to early screening and interventions that may help prevent the onset of cancer or lead to earlier detection and treatment. Furthermore, certain treatments for these diseases may actually reduce digestive cancer risk. DDW is the largest international gathering of physicians and researchers in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.

"The presence of diabetes or heart disease can be a signal for clinicians to evaluate patients' risk for digestive cancers," said Randall W. Burt, M.D., professor of medicine, University of Utah School of Medicine and Interim Executive Director, Huntsman Cancer Institute at the University of Utah. "The associations between these two diseases and cancer, as shown in these studies, provide a critical tool to diagnose cancer early when patients might benefit most from treatment. These studies also suggest that certain treatments for heart disease, in particular ACE inhibitors, may reduce the risk of colon, pancreatic and esophageal cancers."

Resectability of Pre-Symptomatic Pancreatic Cancer and its Relationship to Onset of Diabetes: A Retrospective Review of CT Scans and Fasting Glucose Values Prior to Diagnosis [Abstract 952]

Pancreatic cancer is one of the deadliest forms of cancer, claiming the lives of nearly 32,000 people in the United States each year. With few visible symptoms, pancreatic cancer is often difficult to catch early and many patients are not diagnosed until the cancer is too advanced for surgery.

Up to 80 percent of pancreatic cancer patients are diabetic and research now suggests that a recent diagnosis of diabetes may be a marker of early pancreatic cancer. This study looked at CT scans of pancreatic cancer patients who were also diabetic to determine if a new diabetes diagnosis indeed signals early pancreatic cancer, hoping that it would help with asymptomatic detection and a better chance of successful treatment with surgery.

Mario Pelaez-Luna, M.D., and study partners at the Mayo Clinic in Rochester, Minn. examined the CT scans of 20 patients who had at least one abdominal scan prior to being diagnosed with pancreatic cancer. These initial scans were reviewed to determine the condition of the patient's pancreas – no changes, some pancreatic duct narrowing or blockage, early, small tumors, or advanced tumors.

The 20 patients had undergone a total of 23 CT scans six or more months prior to their diagnosis of pancreatic cancer. All scans done more than six months prior to diagnosis showed no definite evidence of cancer. At the time of cancer diagnosis, 80 percent of the cancers were too advanced to be treated with surgery. With regard to the relationship to diabetes, all scans prior to the onset of diabetes were found normal. When patients first showed high blood sugar levels suggestive of diabetes, 85 percent still had a normal-appearing pancreas or showed early cancer; only 15 percent of cancers were advanced. The cancer was diagnosed, on average, five months after the diabetes first developed.

The research suggests that the number of pancreatic cancers amenable to surgical treatment can be greatly increased if the diagnosis is made even six months earlier. Diabetes associated with pancreatic cancer occurs at a time when the tumor is still treatable by surgery. Thus, a new diabetes diagnosis can be a warning sign that pancreatic cancer may be present, leading to an early cancer diagnosis with potentially better outcomes.

"Pancreatic cancer is difficult to treat. By the time patients develop symptoms, the cancer is already at an advanced stage" said Mario Pelaez-Luna, M.D., lead author of the study. "However, discovering new links between pancreatic cancer and other conditions such as diabetes is helping us identify clues to early diagnosis. The only hope of offering surgical treatment to more patients with pancreatic cancer is diagnosing the disease before symptoms develop."

Type 2 Diabetes Mellitus: The Impact on Colorectal Adenoma Risk in Women [Abstract S1245]

Having Type 2 Diabetes Mellitus raises a person's risk for developing colorectal cancer, and while there have been several studies linking insulin resistance to colorectal cancer risk, there is little data on whether women with diabetes are more at risk for colorectal adenomas, or polyps, which can become cancerous.

In this study, researchers from Washington University in St. Louis, MO., selected 600 women undergoing screening colonoscopies – 100 had Type 2 (adult onset) diabetes and 500 were non-diabetic. Both groups were similar in terms of age, race, having a first-degree relative with colorectal cancer and body mass index.

Results showed that diabetics had increased rates of adenoma than non-diabetics (37 percent versus 24 percent) and advanced adenoma, larger adenomas and/or with more abnormal cells (14 percent versus 6 percent). Researchers compared 245 obese women with 321 non-obese women and found that the obese women had a higher rate of adenoma (32 percent versus 22 percent). Obese diabetics compared with non-obese, non-diabetics had increased rates of any adenoma (42 percent versus 23 percent) and advanced adenoma (19 percent versus 7 percent). A multivariate analysis that took into account age, race, diabetes, hypertension, cholesterol levels, body mass index, and NSAID use showed that diabetes was a risk factor for both adenomas and advanced adenomas and increased age was a risk factor for adenomas.

"This study took a careful look at women with diabetes to determine how gender might impact the diabetes-colorectal cancer connection, and results show colon cancer is indeed a concern for diabetic women," said Jill E. Elwing, M.D., of Washington University and lead study author. "Colorectal cancer screening is critical for this population, as their diabetic condition raises their risk of colorectal cancer."

Patients With Coronary Artery Disease Are At High Risk For Developing Colorectal Cancer and Adenoma: An Interim Analysis of a Prospective Study [Abstract 208]

Colorectal cancer is one of the most common but curable cancers, when caught early. This underscores the importance of identifying high risk patients and screening them to ensure early detection and treatment. Investigators from the University of Hong Kong conducted a prospective study to evaluate potential risk factors for colorectal cancer and found that patients with coronary artery disease (CAD) were also prone to colorectal cancer and adenoma, most likely as a result of common risk factors for both diseases. Both conditions share risk factors including male sex, old age, diabetes, smoking, high fat diet, sedentary life style and high body mass index (BMI).

Researchers administered coronary exams in 307 patients, diagnosing coronary artery disease (CAD) in those who had at least 50 percent blockage in one of the main heart arteries. The group of patients with CAD (46.3 percent) showed a higher incidence of adenomas and cancer than the patients who did not have CAD (30.3 percent versus 19.4 percent), including having larger adenomas with abnormal cells (16.9 percent versus 6.7 percent). Five cases of colorectal cancers were detected in the CAD group (3.5 percent) and none were detected in the group that did not have CAD. Analysis of the data showed a strong association between colorectal cancer and adenomas and CAD, with male smokers most at risk to have both diseases.

"Patients with CAD are at high risk of developing colorectal adenomas," said Annie On On Chan, M.D., University of Hong Kong and lead study author. "The two diseases share risk factors, and screening by colonoscopy of these patients should be mandatory to help prevent the disease and, if necessary, encourage early treatment."

Posted by dlife at 03:02 PM | Comments (1)

Less Sleep Linked to Weight Gain

Newswise — Women who sleep 5 hours or less per night weigh more on average than those who sleep 7 hours, according to a study to be presented at the American Thoracic Society International Conference on May 23rd.

The study found that women who slept for 5 hours per night were 32% more likely to experience major weight gain (defined as an increase of 33 pounds or more) and 15% more likely to become obese over the course of the 16-year study compared with women who slept 7 hours. Women who slept for 6 hours were 12% more likely to have major weight gain and 6% more likely to become obese compared with women who slept 7 hours a night.

The study included 68,183 middle-aged women who were enrolled in the Nurses Health Study. They were asked in 1986 about their typical night’s sleep, and were then asked to report their weight every 2 years for 16 years.

On average, women who slept 5 hours or less per night weighed 5.4 pounds more at the beginning of the study than those sleeping 7 hours and gained an additional 1.6 pounds more over the next 10 years.

“That may not sound like much, but it is an average amount—some women gained much more than that, and even a small difference in weight can increase a person’s risk of health problems such as diabetes and hypertension,” said lead researcher Sanjay Patel, M.D., Assistant Professor of Medicine at Case Western Reserve University in Cleveland, OH.

Dr. Patel noted that this is by far the largest study to track the effect of sleep habits on weight gain over time. “There have been a number of studies that have shown that at one point in time, people who sleep less weigh more, but this is one of the first studies to show reduced sleep increases the risk of gaining weight over time.”

The researchers looked at the women’s diets and exercise habits to see if they could account for part of the findings. “Prior studies have shown that after just a few days of sleep restriction, the hormones that control appetite cause people to become hungrier, so we thought that women who slept less might eat more. But in fact they ate less,” Dr. Patel said. “That suggests that appetite and diet are not accounting for the weight gain in women who sleep less.”

The researchers also asked women about how much they participated in exercise activities such as running, jogging or playing tennis. But they didn’t find any differences in physical activity that could explain why women who slept less weighed more.

“We don’t have an answer from this study about why reduced sleep causes weight gain, but there are some possibilities that deserve further study,” Dr. Patel said. “Sleeping less may affect changes in a person’s basal metabolic rate (the number of calories you burn when you rest). Another contributor to weight regulation that has recently been discovered is called non-exercise associated thermogenesis, or NEAT, which refers to involuntary activity, such as fidgeting or standing instead of sitting. It may be that if you sleep less, you move around less, too, and therefore burn up fewer calories.”

Posted by dlife at 02:55 PM | Comments (0)

Joslin Researcher Available to Comment on New Study Showing Adults With Two Parents with Type 2 Diabetes Show Early Signs of Cardiovascular Disease

BOSTON, June 23, 2006 (Joslin) - Joslin Diabetes Center's Allison M. Goldfine, M.D., has just published an interesting study in the Journal for the American College of Cardiology that found adults with two parents who have type 2 diabetes show early signs of atherosclerosis (plaque building up in the arteries) even when the adult children themselves do not have diabetes.

The study examined 38 adults without diabetes in their mid-to-late 30s. Nineteen of the adults had two parents with type 2 diabetes and were found to have impaired blood vessel responsiveness. Please refer to the American College of Cardiology's press release below for more details.

Dr. Goldfine is an Investigator in Joslin's Section on Cellular and Molecular Physiology, Assistant Director of Clinical Research at Joslin, Associate Physician at Brigham and Women's Hospital and Assistant Professor of Medicine at Harvard Medical School.

If you would like to interview Dr. Goldfine about this study, please contact Marge Dwyer or Jenny Eriksen from Joslin's Communications Office at 617-732-2415 or via email at marjorie.dwyer@joslin.harvard.edu or jenny.eriksen@joslin.harvard.edu.

Posted by dlife at 02:34 PM | Comments (0)

Children of Diabetics Show Signs of Atherosclerosis

Impaired blood vessel responses seen even though study participants did not have diabetes

BETHESDA, MD, June 23, 2006 (Joslin) - The blood vessels of people whose parents both have type 2 diabetes do not respond as well to changes in blood flow as those of people without a family history of diabetes, even if they do not have diabetes themselves, according to a new study in the June 20, 2006, issue of the Journal of the American College of Cardiology.

"We find that offspring of type 2 diabetic parents have endothelial dysfunction, even when they do not have diabetes. If early treatment can prevent progression of atherosclerosis, then identifying groups of persons at risk for diabetes in whom early atherosclerosis may be present is clinically important," said Allison B. Goldfine, M.D. from the Joslin Diabetes Center and Brigham and Women's Hospital in Boston, Massachusetts.

None of the 38 adults (mid- to late-30s) in this study had diabetes, but half of them were the offspring of two diabetic parents. The researchers restricted blood flow in the arms of the participants using a blood pressure cuff. Then, using ultrasound, they compared how blood vessels in the arms of participants responded to the surge in blood flow when the cuff was released. Blood vessel responsiveness was impaired in all 19 participants (9 men and 10 women) whose parents had diabetes.

Diabetes is a leading cause of heart disease. Other studies have linked higher blood sugar levels to impaired responsiveness of the lining of blood vessels (endothelial dysfunction); but this is the first study to demonstrate that even when blood sugar is below the diabetic range, modest increases in blood sugar can contribute to endothelial dysfunction. Endothelial dysfunction in this population shows a predisposition to atherosclerosis.

Type 2 diabetes, also known as adult-onset diabetes, is linked to overweight and obesity. However, obesity and other common risk factors, including age, gender, ethnicity, cholesterol, blood pressure and insulin resistance did not explain the differences observed between participants who had a family history of diabetes and those who did not.

"Persons whose parents both have type 2 diabetes have endothelial dysfunction. This predisposition to atherosclerosis is present even when the offspring do not have diabetes themselves. Insulin resistance has been suggested to be important to both the development of diabetes and cardiovascular disease in large populations. However, in this high-risk group, even the most insulin sensitive offspring had diminished endothelial function," Dr. Goldfine said.

The problem seems to be related to the availability of nitric oxide, a key signaling chemical that triggers blood vessel dilation. The researchers reported that there was no difference between the two groups of participants in how much their blood vessels dilated after treatment with nitroglycerin, which boosts nitric oxide levels in the blood.

While physicians already are told to aggressively combat heart disease risk factors in patients with diabetes, the results of this study suggest even apparently healthy people may have blood vessel problems, if they have a strong family history of diabetes. The researchers did not perform genetic analyses of the participants. In this case, family history includes both genetic inheritance and environmental factors.

"Persons with a strong family history of diabetes are at increased risk of atherosclerosis in addition to risk of diabetes. They may benefit from aggressive cardiovascular risk factor modification, including blood pressure and lipid control, weight management and smoking cessation to reduce their risk of heart attack and stroke," Dr. Goldfine said. "Blood sugar levels, even in the non-diabetic range contribute importantly to endothelial dysfunction and thus the atherosclerotic process. This raises the question of when doctors should recommend interventions to lower glucose levels and what should be the appropriate level of glucose recommended to patients with diabetes."

Dr. Goldfine noted that this study included only a small number of participants. However, she said it did a better job than earlier studies of matching the offspring of diabetics to control subjects; so that the effects of family history could be distinguished from the effects of risk factors such as insulin resistance, obesity, cholesterol and blood pressure.

Ann Marie Schmidt, M.D. from Columbia University Medical Center in New York, NY, who was not connected with this study, said the study was "quite informative," particularly the finding that the participants with a family history of diabetes showed signs of impaired endothelial function in their blood vessels even when they were not only free of diabetes itself, but even when they lacked any insulin resistance, which is one key early sign of a type of diabetes.

"These studies point out that genetic, and perhaps environmental, influences, as the groups were all first-degree relatives, critically impact on endothelial function. Although it is tempting to strictly predict genetic differences underlie this finding, the influence of dietary habits, exercise patterns and perhaps environmental exposures cannot be discounted," Dr. Schmidt said. "Taken together, this fascinating study suggests that irrespective of family history, efforts to limit factors leading to insulin resistance may have frank benefits in enhancing endothelial health and integrity."

Dr. Schmidt noted that the study had only a small number of participants. She also pointed out that the participants with a family history of diabetes had higher fasting glucose levels than the participants without a family history of diabetes.

Posted by dlife at 02:32 PM | Comments (0)

New Gene Therapy Technique for Potential Treatment of Type I Diabetes

Newswise (May 22, 2006) — Researchers at Baylor University Medical Center at Dallas and the Baylor Research Institute have developed a novel technique to deliver insulin genes to the pancreas, the organ that produces the body’s insulin. This approach is a major step in the potential treatment of Type I diabetes since patients with the disease do not produce enough insulin on their own. The research results were published in the May 2006 issue of the Proceedings of the National Academy of Sciences.

Insulin is a hormone that allows blood glucose (blood sugar) to enter the cells of the body to be used for energy. The technique, known as ultrasound-targeted microbubble destruction (UTMD), delivers these insulin genes to the organ via microscopic “bubbles.” Once the bubbles reach their target, they are burst with ultrasound releasing the insulin genes into the pancreas.

Using UTMD, researchers delivered the bubbles containing human insulin genes into the pancreas of rats and later found that the rat’s blood sugar had been subsequently lowered. Another gene that regulates insulin production, known as hexokinase I, was successfully delivered using UTMD as well, and resulted in increased blood insulin and decreased blood sugar in the rats.

“Not only was their blood sugar lowered, but there was no evidence of any damage to the pancreas,” says Paul Grayburn, M.D., principal investigator of the study. “Other forms of gene therapy are usually invasive and unlike the UTMD technique, do not target the tissues and organs specifically.”

Currently, patients with Type I (juvenile onset) diabetes must inject themselves with insulin daily to keep their blood sugar levels balanced in addition to following strict nutritional guidelines. Dr. Grayburn says that the UTMD technique is one of the most important steps in the development of a successful treatment of diabetes without the need for daily insulin injections.

“Now that we have successfully delivered insulin genes to the pancreas, our ultimate goal is to research the regeneration of insulin-producing cells in patients with Type I diabetes,” says Dr. Grayburn.

In the future, Dr. Grayburn says that the UTMD technique for gene delivery can be used to deliver therapeutic agents to other organs as well.

Nationwide, more than one million people have Type 1 (juvenile onset) diabetes. Diabetes – the fifth deadliest disease in the United States – affects the body’s ability to produce or respond to insulin. People with Type 1 diabetes are at increased risk for many serious complications, including heart disease, blindness, nerve damage and kidney damage.

Dr. Grayburn’s research was supported by a grant from the National Institutes of Health and by the Mary Alice M. and Mark Shepherd, Jr. Endowment Fund in Cardiology and Cardiovascular Surgery and Research. The study was also held in conjunction with researchers from Duke University and UT Southwestern Medical Center.

Baylor University Medical Center at Dallas, a 997-bed not-for-profit academic hospital, is a major patient care and research center in the southwest. In 2005, U.S. News & World Report recognized Baylor Dallas for the 13th consecutive year in its “America’s Best Hospitals” guide in several medical specialties. Baylor Dallas serves as the flagship hospital of Baylor Health Care System.

The Baylor Research Institute, an affiliate of Baylor Health Care System, promotes and supports clinically relevant research, bringing innovative treatments from the laboratory workbench to the patient bedside. Investigators at Baylor are conducting more than 500 active research protocols spanning more than 20 medical specialties.

Posted by dlife at 03:06 PM | Comments (0)

Metabolic Syndrome Significantly Boosts Risk of Heart Failure in Middle Age

May 22, 2006 (British Medical Journal) — Metabolic syndrome significantly boosts the chances of heart failure in middle age, suggests research published ahead of print in Heart.

Metabolic syndrome refers to a cluster of conditions, including obesity, high blood pressure, unfavourable blood fat levels, and diabetes.

The researchers base their findings on regular monitoring of more than 2,300 men who were aged 50 between 1970 and 1974 and who were tracked until the age of 70.

The presence of metabolic syndrome at the start of the study was strongly associated with the subsequent development of heart failure. Men with the syndrome were almost twice as likely to develop heart failure as those without.

This was independent of any other established risk factors for heart failure, such as coronary artery disease, a heart attack, smoking, and poorly working heart valves.

The authors suggest that metabolic syndrome may directly affect the heart itself as well as boosting the build up of fatty deposits in the arteries.

The likely mechanism is insulin resistance and the subsequent excess insulin circulating in the blood, say the authors. Insulin may excessively enlarge the heart muscle (myocardium), so impairing its capacity.

High circulating levels of insulin also stimulate the sympathetic nervous system, thought to be a risk factor in heart failure, and cause heart muscle cells to wither and/or stiffen.

Click here to view the paper in full: http://press.psprings.co.uk/heart/june/ht89011.pdf.

Posted by dlife at 03:04 PM | Comments (0)

RBP4 Predicts Type 2 Diabetes

BOSTON, June 14, 2006 (Newswise) – A study in the June 15 issue of The New England Journal of Medicine (NEJM) reveals that elevated levels of a molecule called RBP4 (retinol binding protein 4) can foretell early stages in the development of insulin resistance, a major cause of type 2 diabetes as well as cardiovascular disease.

The new findings, led by researchers at Beth Israel Deaconess Medical Center (BIDMC), offer a potential new target for the development of anti-diabetic therapies to lower serum RBP4 levels as well as an early means of identifying individuals who are at risk of developing diabetes – before the onset of overt disease.

“Type 2 diabetes is a rapidly increasing epidemic in the Western world,” explains senior author Barbara Kahn, MD, Chief of the Division of Diabetes, Endocrinology and Metabolism at BIDMC and Professor of Medicine at Harvard Medical School. “Since it is now occurring even in childhood, predictions indicate that it could shorten lifespan in the U.S. for the first time in more than a century.”

Insulin resistance develops when the body’s muscles, fat and liver cells lose the ability to respond to the hormone insulin. Because insulin is necessary to enable the body to take up sugar from blood and convert it into energy, this impairment results in a buildup of glucose in the bloodstream.

“Insulin resistance not only predisposes individuals to type 2 diabetes, it is also a major risk factor for cardiovascular disease,” adds co-lead author Timothy Graham, MD, an investigator in the Kahn laboratory. “Unfortunately, in the clinical setting, it is often difficult to distinguish individuals with and without insulin resistance.”

Last year, in a study conducted in animals, Kahn’s laboratory made the discovery that RBP4, a protein secreted from fat, can cause insulin resistance. Prior to this, the molecule was recognized only for its role in the transport of vitamin A.

In this new research, Graham, together with co-lead author Qin Yang, MD, PhD, set out to determine whether levels of RBP4, as measured in blood, correlate with the presence or absence of insulin resistance. (Study subjects represented three separate cohorts from San Diego, California; Goteberg, Sweden; and Leipzig, Germany.)

They first studied individuals with either obesity, impaired glucose tolerance (a “pre-diabetic” state), or with type 2 diabetes, comparing the blood levels of RBP4 in these insulin-resistant subjects with levels found in non-obese healthy subjects. Their results showed that not only were RBP4 levels higher in all cases in which insulin resistance was high, but that elevated serum RBP4 was also closely associated with components of the metabolic syndrome, including increased body mass index, waist-to-hip ratio, serum triglyceride levels, and systolic blood pressure, as well as decreased levels of high-density lipoprotein (HDL), or good, cholesterol.

The study was then extended to subjects with normal body weight and normal blood glucose, but with a strong family history of type 2 diabetes. “These are people who appear healthy, but have a high risk of developing diabetes due to their genetic background,” explains Ulf Smith, MD, PhD, of Sahlgrenska Hospital, Goteberg, Sweden, where this group of subjects was based. As predicted, the investigators found elevated RBP4 levels among this group as well.

Finally, the authors tested whether a therapeutic intervention – in this case, exercise – could lower RBP4 levels and increase insulin sensitivity. They found that all of the people who improved their insulin sensitivity with exercise also lowered their serum RBP4 levels. Among the one-third of the subjects who did not improve their insulin sensitivity, neither did RBP4 levels go down.

“Collectively, these findings tell us that RBP4 is a useful marker for therapeutic improvement and that this protein could play a causal role in insulin resistance in humans, just as our lab previously showed in mice,” says Kahn. Furthermore, she adds, because RBP4 levels consistently corresponded with insulin resistance -- even among lean subjects whose genetic risk for the development of diabetes might otherwise be overlooked -- this protein could be an important marker for type 2 diabetes among the general population.

“Being able to determine diabetes risk well before the onset of symptoms could provide an important opportunity for patients to take preventive measures,” she adds. “For those who are overweight or sedentary, this could mean making changes to their diet and fitness routines. For those who are lean and fit, but have a family history of type 2 diabetes, this could mean taking antidiabetic medication. Either way, these findings could help clinicians to better manage this growing epidemic.”

In addition to Kahn, Graham and Yang, study coauthors include Christopher Watson of BIDMC; Matthias Bluher, MD and Andreas Oberbach, MD, of the University of Leipzig Medical Center, Germany; Ann Hammarstedt, PhD, Per-Anders Jansson, MD, PhD, and Ulf Smith, MD, of Sahlgrenska University Hospital, Goteborg, Sweden; and Theodore Ciaraldi, PhD and Robert Henry, MD, of the Veterans Affairs San Diego Healthcare System.

This study was funded, in part, by grants from the National Institutes of Health, the American Diabetes Association, the Swedish Diabetes Association, and the Takeda Pharmaceutical Company, LTD.

Beth Israel Deaconess Medical Center is a patient care, research and teaching affiliate of Harvard Medical School and ranks fourth in National Institutes of Health funding among independent hospitals nationwide. BIDMC is clinically affiliated with the Joslin Diabetes Center and is a research partner of the Dana-Farber/Harvard Cancer Center. BIDMC is the official hospital of the Boston Red Sox. For more information, visit http://www.bidmc.harvard.edu.

Posted by dlife at 02:30 PM | Comments (0)

New Data On Renin Inhibitor SPP100 (Rasilez) Demonstrates Its Potential Use In Diabetic Patients

Robust efficacy and safety data presented at European Society of Hypertension meeting

BASEL, Switzerland and BRIDGEWATER, N.J., June 13, 2006 (PRNewswire-FirstCall) - Speedel (SWX: SPPN) is very pleased with the Phase III clinical data on SPP100 (Rasilez(1) in the treatment of hypertension in diabetic patients presented today by Novartis in Madrid at the 16th Meeting of the European Society of Hypertension (ESH). The data demonstrated the robust efficacy and good safety profile of SPP100 as a monotherapy and in co-administration with ramipril, an ACE(2) inhibitor. SPP100 is the first-in-class once daily oral renin inhibitor that Speedel successfully developed through Phase I and II clinical trials before Novartis exercised its license-back option in 2002. The U.S. Food and Drug Administration (FDA) in April 2006 accepted for review Novartis' new drug application (NDA) for SPP100 as a treatment for hypertension both as monotherapy and in co-administration with other anti-hypertensives.

Dr. Jessica Mann, Speedel Medical Director, said: "This new data underlines the potential of SPP100 in diabetic hypertensives, a segment of the hypertension population which is at a higher risk of having cardiovascular events than those hypertensive patients without diabetes. SPP100 offers additional blood pressure control and is well tolerated when co-administered with ramipril -- this is critical given that so many patients, especially those with hypertension and diabetes, are taking combination treatments in order to reach blood pressure targets."

The ESH meeting in Madrid is the first time that this data on SPP100 (Rasilez) has been presented in a scientific forum in Europe. The data presented today were from a clinical trial in 837 patients with diabetes and hypertension. Such patients are at an increased cardiovascular risk and the American Diabetes Association (ADA) recommends a lower blood pressure (BP) goal (< 130/80 mmHg) than patients with hypertension but without diabetes. In order to achieve such BP targets, most patients require therapy with multiple antihypertensive therapies. The use of SPP100 together with the ACE inhibitor ramipril (a first line therapy recommended by the ADA), not only decreases blood pressure further than ramipril alone through its additive effects, but also shows sustained 24-hour blood pressure control in these patients.

The number of adults with diabetes in the world is estimated to increase from 135 million in 1995 to 300 million in the year 2025(3).

The data from the Phase III clinical trial was presented today by investigators in the format of two posters:

SPP100 has greater BP lowering effect than ramipril and additional BP lowering effect when combined with ramipril in patients with diabetes and hypertension(4):

* After 8 weeks treatment, co-administration therapy with SPP100 and
ramipril provided superior reductions in MSDBP(5) from baseline compared
with either monotherapy

* By week 8, MSSBP(6) reductions from baseline were significantly greater
with both SPP100 monotherapy and SPP100/ramipril co-administration
therapy compared with ramipril monotherapy

* By the end of the study significantly more patients had responded to
SPP100 monotherapy and to SPP100/ramipril co-administration therapy than
ramipril monotherapy

* Co-administration therapy provided a clinically relevant additional BP
reduction of 4.6/2.1 mmHg over that achieved with standard ACE-I
treatment

* All treatments were well tolerated. As expected, the incidence of cough
was lower with SPP100 as a monotherapy than with ramipril. With
co-administration therapy the incidence of cough was lower than with
ramipril alone -- an unanticipated result that suggests an attenuation
of ACE-I induced cough

Adding SPP100 to ramipril improves 24-hour BP control compared to ramipril alone in patients with diabetes and hypertension(7):

* All treatments provided effective 24-hour BP lowering from baseline,
with SPP100/ramipril co-administration therapy providing significantly
greater ADBP(8) lowering than ramipril monotherapy

* Smoothness indices indicate that SPP100 monotherapy and SPP100/ramipril
co-administration therapy provide BP lowering from baseline with less
variability over the 24 hour period than ramipril alone

* Reductions from baseline in BP during the early morning BP surge were
greater with SPP100 monotherapy and SPP100/ramipril co-administration
therapy than with ramipril alone, suggesting that SPP100 based regimens
may provide greater protection for patients during the early morning
period of increased cardiovascular risk

Speedel believes that SPP100 has a five year lead over the next generation of renin inhibitors being developed in the industry. Speedel's own family of renin inhibitors includes SPP635 currently in Phase I with results due in the second half of 2006, followed by the SPP1100 series currently in toxicology testing with a compound due for entry into man before the end of 2006, and the SPP800 series currently in late-stage pre-clinical profiling.

About SPP100 (aliskiren, Rasilez(9)

SPP100 (aliskiren, Rasilez) is the first-in-class oral renin inhibitor. The development of SPP100 is the result of over 20 years of research on renin. Renin is the key enzyme at the top of the Renin Angiotensin System (RAS), one of the key regulators of blood pressure. The RAS is a cascade, starting with renin, leading to angiotensin I and finally to angiotensin II. Angiotensin-converting enzyme inhibitors (ACE-Is) and angiotensin II receptor antagonists (ARBs) have been developed to block this system "down stream" and have shown clinical efficacy in patients with hypertension and other cardiovascular diseases.

Inhibition of renin, articulated as Plasma Renin Activity (PRA) is believed to be very important in end-organ protection (e.g. heart and kidney). PRA is a surrogate marker for several cardio-renal diseases, such as myocardial infarction and chronic renal disease. A renin inhibitor can lower PRA efficiently whereas most current leading anti-hypertensive drug classes such as diuretics, ACE-Is and ARBs increase PRA levels.

Speedel in-licensed SPP100 from Novartis in 1999, and successfully completed 18 clinical trials through Phase I and II in about 500 patients and healthy volunteers. Based on the results generated during this programme, Novartis exercised a license-back option in 2002, and in March 2004 Novartis started trials with SPP100 in Phase III as monotherapy for hypertension and in Phase IIb as combination therapy. Phase III trials are ongoing in the US, EU, and Japan, with first regulatory submission in the US already filed in Q1 2006 and planned in the EU during 2006.

Speedel believes that it is the first company to establish successfully a clinical proof of concept in Phase II and to have developed and filed for patent protection a commercially viable manufacturing process for a renin inhibitor, an area of industry research for over 20 years. In a Phase II study of 200 patients conducted by Speedel, it was demonstrated that SPP100 achieves dose-dependent blood pressure reduction. The study also showed that 150mg and 300mg SPP100 once daily were comparable to Losartan 100mg, which is double the starting dose of this ARB (Stanton, Jensen, Nussberger, O'Brien, Hypertension.2003; 42: 1137-1143).

About Hypertension

Hypertension is a major risk factor for heart disease and the main risk factor for stroke and heart attack, and can also lead to heart and kidney failure, so-called "end-organ damage". This disease is estimated to affect approximately 190 million people in the seven key markets (United States, Japan, Germany, France, United Kingdom, Italy and Spain), representing the largest indication for prescription pharmaceuticals worldwide, with approximately USD 39 billion in global annual sales in 2004, according to Datamonitor, IMS Health and Business Insights.

Hypertension is a common disorder in which blood pressure is abnormally high, placing undue stress on the heart, blood vessels and other organs such as the kidney and the brain. Blood pressure is determined in two phases as the heart contracts and relaxes. Systolic blood pressure represents the force that blood exerts on the walls of arteries as the heart contracts to pump out blood. Diastolic blood pressure represents the force as the heart relaxes to allow the blood to flow into the heart.

Due to its wide prevalence and impact on cardiovascular health, hypertension is a major cause of disease and death in Europe and North America. More than one in three Europeans and North Americans over the age of 35 suffers from hypertension -- but for the vast majority of patients who undergo hypertension treatment, the causes of high blood pressure are unknown. More than 40 % of patients undergoing treatment with current therapies do not reach targeted blood pressure levels, and so there is a considerable unmet medical need.

The latest potential therapeutic agents for hypertension are renin inhibitors. Renin is an enzyme produced in the kidneys in response to reduced renal perfusion. Through a cascade of biological events, renin acts to bring about sodium retention, an increase in blood pressure, and restoration of renal perfusion, which shuts off the signal for renin release. For hypertensive individuals, renin inhibitors are currently being investigated as a therapy that may provide benefits over current therapies to reduce blood pressure, decrease salt retention and may protect end organs such as the kidney, heart and brain.

About Speedel

Speedel is a public biopharmaceutical company that seeks to create value for patients, partners and investors by developing innovative therapies for cardiovascular and metabolic diseases. Speedel is a world leader in renin inhibition, a promising new approach with significant potential for treating cardiovascular diseases. Our lead compound SPP100 (Rasilez), the first-in-class renin inhibitor, is partnered with Novartis for development and commercialisation in hypertension, and the NDA was filed with the FDA in the US in Q12006. Our pipeline covers three different modes of action, and in addition to SPP100, includes SPP301 in Phase III, SPP200 in Phase II, SPP635 in Phase I, and several pre-clinical projects.

Speedel develops novel product candidates through focused innovation and smart drug development from lead identification to the end of Phase II. We either partner with big pharma for Phase III and commercialisation in primary-care indications, or we may ourselves complete Phase III development in specialist indications. Candidate compounds for development and the company's intellectual property come from our late-stage research unit Speedel Experimenta and from in-licensing. Our team of approximately 70 employees, including over 30 experienced pharmaceutical scientists, is located at our headquarters and laboratories in Basel, Switzerland and at offices in New Jersey, USA and Tokyo, Japan.

In March 2006 the company raised gross proceeds of CHF 83.95 million (approximately EUR 53m or USD 64m) through the public offering of 500,000 treasury shares. As a private company, we have previously raised gross proceeds of CHF 239 million (approximately EUR 154 million or USD 183 million) from private placements of equity securities and two convertible loans and we have had total revenues, principally from milestone payments, of CHF 57.7 million (approximately EUR 37 million or USD 44 million). The company's shares were listed on the SWX Swiss Exchange under the symbol SPPN on 08 September 2005.

Posted by dlife at 02:27 PM | Comments (0)

Liraglutide Phase 2 Study Shows Increased Insulin Secretion and Improved Blood Glucose Control in People with Type 2 Diabetes

WASHINGTON, June 13, 2006 (PRNewswire) - Liraglutide, an investigational treatment for type 2 diabetes under development by Novo Nordisk, improved the ability of pancreatic beta cells to secrete insulin in people with type 2 diabetes, according to findings from a late-breaking presentation today at the 66th annual meeting of the American Diabetes Association (ADA).(1)

The findings from the study, part of a larger, double-blind, placebo-controlled, randomized trial conducted over 14 weeks,(2) specifically showed that liraglutide increased the maximum capacity of beta cells to secrete insulin. In addition, insulin secretion was increased in the so-called "first phase" insulin response, which is typically diminished in patients with type 2 diabetes.

The larger trial showed that liraglutide reduced levels of A1C, the primary endpoint and a measure of a person's average blood glucose level over the past two to three months. Additionally, participants on the highest dose of liraglutide lost significantly more weight than did those on placebo by the end of the 14-week study.

"The prevalence of type 2 diabetes continues to increase, and we need to research and develop new therapies for the condition," said study investigator Sten Madsbad, M.D., DMSc., Department of Endocrinology, Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark. "We are excited by these results as they demonstrate that liraglutide monotherapy significantly improves blood glucose control without risk of major or minor hypoglycemia, is well tolerated, lowers body weight and may help improve the body's ability to produce insulin."

Pancreatic beta cells are responsible for producing insulin, a hormone that helps transport glucose from the bloodstream into body cells, providing them an important source of energy and preventing blood glucose from becoming dangerously high. People with type 2 diabetes, the most common form of the condition, do not produce enough insulin or their body cells are less sensitive to it. While diet, exercise and weight loss may initially maintain control of blood glucose levels (glycemic control), beta cell function declines over time, necessitating therapy with one or more oral antidiabetic (OAD) agents that boost insulin secretion or heighten insulin sensitivity. As beta cell function further declines and OAD therapy eventually fails, insulin therapy is required.

One problem with insulin and some OAD therapies is that they can reduce blood glucose levels too low (hypoglycemia), which can also be dangerous. Liraglutide acts to lower blood glucose only when levels become too high,(3,4) and studies show it is associated with a low risk of hypoglycemia.(5,6) Furthermore, in animal models, liraglutide has been shown to decrease beta-cell apoptosis (programmed cell death) and increase beta-cell mass.(7,8,9,10,11)

Studies and findings

The larger study was a double-blind, placebo-controlled, randomized trial conducted over 14 weeks and included 165 patients with type 2 diabetes who were previously treated with diet or a single oral antidiabetic agent. After an initial four-week washout period, patients were randomized to one of three once-daily doses of liraglutide (0.65 mg, 1.25 mg and 1.9 mg) or placebo.

Improved blood glucose control was achieved with liraglutide monotherapy. Levels of A1C, the primary endpoint, were significantly reduced compared to placebo in all liraglutide treatment groups (p<0.0001). At the highest dose, the average reduction of A1C vs. placebo was 1.74 percent. Between 43 and 50 percent of patients who received liraglutide and 8 percent on placebo reached an A1C level of less than or equal to 7 percent. The improved glycemic control was achieved with no major or minor hypoglycemic episodes. In addition, patients on liraglutide had a reduction in bodyweight, with those on the highest dose losing approximately three kg (6.6 pounds) vs baseline and 1.2 kg (2.5 pounds) vs placebo after 14 weeks.

Liraglutide was well tolerated by participants in all groups, with the main adverse events being related to the gastrointestinal (GI) system. Nausea, which was experienced by 10 percent of participants in the high-dose group, and diarrhea, were the most common adverse events; however, the frequency of all GI events declined over time.

The late-breaking findings were from a subgroup of 39 participants who were also part of the larger trial. At baseline and after 14 weeks, these participants underwent standard tests to assess first-phase insulin secretion and maximal beta cell insulin secretory capacity. Of 39 participants who began the study, 28 completed the 14 weeks of treatment. The two higher doses of liraglutide (1.25 mg and 1.9 mg) significantly increased maximal beta cell insulin secretory capacity compared to placebo by 114 percent and 97 percent, respectively (p<0.05 for both doses), and first-phase insulin secretion by 124 percent and 107 percent, respectively (p<0.05).

Posted by dlife at 12:00 PM | Comments (0)

New Study Assesses Accuracy of Abbott's Investigational FreeStyle Navigator(TM) Continuous Glucose Monitoring System

Clinical Results Presented at ADA Scientific Sessions Suggest Accuracy and Stability Over Five Days of Wear

WASHINGTON, June 13, 2006 (PRNewswire-FirstCall) - Abbott announced today the presentation of results from a new study designed to assess the accuracy of the FreeStyle Navigator(TM) Continuous Glucose Monitoring System for people with diabetes. The study met its primary endpoint of demonstrated accuracy and stability over five days of wear.

Study results were discussed by William L. Clarke, M.D., professor of pediatrics at the University of Virginia Health System, in a presentation today during the 66th annual Scientific Sessions of the American Diabetes Association.

FreeStyle Navigator Continuous Glucose Monitoring System is an investigational device under FDA review. The system includes a five-day sensor, a transmitter, and a wireless receiver with a built-in FreeStyle(R) blood glucose monitoring system. The system is designed to provide glucose readings once per minute, high / low glucose alarms and projected glucose alarms.

The accuracy of FreeStyle Navigator was assessed in 58 subjects ranging in age from 18 to 64. Comparison of the FreeStyle Navigator system measurements (n=20,362) with a laboratory reference method (YSI) gave a mean absolute relative difference of 12.8% and a median absolute relative difference of 9.3%. On the Clarke Error Grid (CEG), 81.7% (n=16627) of measurements were in zone A, and 16.7% (n=3398) were in zone B (as compared to YSI). The Clarke Error Grid compares readings from a lab reference to a reading from a glucose monitoring device at a specific point in time. The variance between the two readings is placed on a grid within clinical categories, also known as zones. Each zone is labeled A, B, C, D, or E. Points in the A zone are clinically accurate and most consistent with the lab reference value. B zone readings are clinically acceptable. Points in the C, D, and E zones are progressively less accurate.

"Frequent and accurate glucose monitoring is an essential element of achieving tight glycemic control. The accuracy, particularly in the A zone, of continuous glucose monitoring sensors is critical to assessing the benefits that patients can derive from the technology," said Dr. Clarke. "In clinical studies presented by Abbott earlier this week, the FreeStyle Navigator system, under development, has set a new threshold for point glucose accuracy in a continuous glucose monitoring system."

"We look forward to making FreeStyle Navigator available to people with diabetes and we're very pleased that the system continues to demonstrate excellent accuracy in clinical studies," said Ed Fiorentino, president, Abbott Diabetes Care.

Posted by dlife at 11:58 AM | Comments (0)

Testosterone Levels Correlate with Insulin Resistance and Insulin Sensitivity in Type 2 Diabetes Patients

Findings from this analysis of diabetic patients call for more research to evaluate benefits of testosterone replacement therapy in Type 2 diabetes patients

MALVERN, Pa., June 12, 2006 (PRNewswire-FirstCall) - Auxilium Pharmaceuticals, Inc. , a specialty pharmaceutical company, announced that new findings presented today at the American Diabetes Association's 66th Annual Scientific Sessions suggest that abnormally low testosterone levels may be linked to progression of type 2 diabetes. The data are obtained from patient screening for a prospective study and include 568 men with type 2 diabetes. Researchers found a general increase in insulin resistance in patients with type 2 diabetes who have low total testosterone levels, compared to Type 2 diabetes patients with normal total testosterone levels. Recent studies have highlighted the potential importance of androgen concentrations in relation to insulin sensitivity. This latest cohort analysis provides evidence of the need for additional investigation into the effects that testosterone replacement therapy has on insulin resistance, glucose regulation and progression of type 2 diabetes. Data were presented today in a poster titled, "Comparison of Indices of Insulin Resistance and Insulin Secretion between Hypogonadal and Non-Hypogonadal type 2 Diabetic Patients" (Abstract #606-P), at the American Diabetes Association's 66th Annual Scientific Sessions in Washington, DC. The study was sponsored by Auxilium Pharmaceuticals, Inc.

The objective of the analysis was to characterize possible differences in insulin resistance (IR) and insulin secretion (IS) between hypogonadal (total testosterone < 300 ng/dL) and non-hypogonadal type 2 diabetic participants. Of the subjects in the analysis, 252 (44.4%) were classified as hypogonadal and 316 subjects (55.6%) were classified non-hypogonadal. The homeostatic model assessment (HOMA) method was used in this study to assess beta cell function and insulin resistance from basal (fasting) glucose and insulin or C-peptide concentrations. The HOMA IR for hypogonadal subjects was 7.6 and 5.1 for the non-hypogonadal subjects (P < 0.0001). The HOMA IS was 113.3 and 93.3 for hypogonadal and non-hypogonadal subjects, respectively (P = 0.018). The comparison of these index values suggests a generalized increase in insulin resistance in Type 2 diabetes patients with low total testosterone levels.

"Given that insulin resistance is an important indicator for diabetes progression and a common cause of mortality in diabetic patients, these findings naturally raise the question of the effect that testosterone supplementation has on insulin resistance and whether it may help counter the progression of type 2 diabetes," said Marc S. Rendell, M.D., Creighton Diabetes Center, an Investigator in this study. "Our data suggest that it is important to assess testosterone levels in male patients with diabetes and to treat low levels as part of the overall plan of therapy"

Testosterone is an androgen hormone that is primarily responsible for normal growth and development of male sex organs. The normal range for total testosterone in men is generally 300 to 1,000 nanograms per deciliter (ng/dL), depending on the lab performing the test and the methodology used.

A decrease in testosterone production, when testosterone levels drop below the normal range, is known medically as hypogonadism. A simple blood test conducted by a physician can determine if a man has low testosterone.

Researchers are accumulating clinical evidence that links low testosterone levels to long-term medical conditions such as metabolic syndrome, Type 2 diabetes, coronary heart disease, osteoporosis and depression. Additionally, studies have shown that men who suffer from obesity, diabetes or hypertension may be twice as likely to have low testosterone levels. Several published studies have shown the beneficial effects on men's health by normalizing testosterone levels with testosterone replacement therapy.

Posted by dlife at 12:22 PM | Comments (0)

Novocell Presents Phase I/II Data on Safety and Response to Encapsulated Islets at the American Diabetes Association's 66th Annual Scientific Session

Novocell's Chief Scientific Officer Speaks in a Symposium on Engineering Stem Cells to Endoderm the First Step to Producing Unlimited Numbers of Insulin-Producing Islet Cells

WASHINGTON, June 12 (PRNewswire) - Novocell, Inc., a stem cell engineering company, presented preliminary data from its phase I/II proof-of-principle clinical trial for encapsulated primary human islet allografts in a late-breaking poster presentation today at the American Diabetes Association's 66th Scientific Session.

The poster entitled "Encapsulated Human Islet Allografts -- Phase I/II Clinical Trial" described safety and efficacy results following subcutaneous implants of encapsulated human islet allografts into patients with type I diabetes of long standing duration. The first two partially implanted patients are showing early evidence of encapsulated islet function. The recipients are not showing evidence of encapsulated islet destruction by autoimmune reactions or allograft rejection to date. The patients only received transient low dose cyclosporine (50-100 ng/ml 12hr trough) and do not receive cyclosporine long term or any other form of immunosuppression.

"Patients are free of any safety concerns or adverse events to date," commented David Scharp, M.D., Chief Medical Officer. "We hope to see additional efficacy as these recipients receive increasing doses of encapsulated islets."

The single site study is being conducted in San Antonio, Texas, with Co-Principal Investigators, Sherwyn Schwartz, MD, Director of the Diabetes and Glandular Disease Center and Paraic Mulgrew, MD, of the Transplant Institute at the Christus Santa Rosa Hospital. The study is partially funded by the Juvenile Diabetes Research Foundation.

Novocell believes its proof of principle study is important to demonstrate the safety and efficacy of the encapsulation technology that can be used with the unlimited source of insulin-producing cells developed from stem cells to treat patients with diabetes.

Toward this goal, Chief Scientific Officer Emmanuel Baetge, Ph.D. will discuss engineering stem cells into definitive endoderm, the gatekeeper cells that are required to produce unlimited quantities of human islet cells, in a symposium entitled "First Steps in Making Beta-Cells from Stem Cells" on Tuesday, June 13th from 8 a.m. to 10 a.m. at this same meeting. Dr. Baetge's work in this area was published in Nature Biotechnology in December of 2005 and reviewed in the New England Journal of Medicine in February 2006. He will also address the importance of the endoderm in the creation of insulin-producing islet cells.

The combination of stem cell engineering and cell encapsulation addresses the two primary issues currently limiting islet implant therapy for the treatment of diabetes: chronic immunosuppression and islet cell supply. Novocell is currently engineering stem cell derived endoderm for the production of insulin-producing islet cells as a solution to the limited islet supply for implantation in people with diabetes.

Posted by dlife at 12:13 PM | Comments (0)

Joslin Scientists Discover Surprising Signs of Residual Islet Cell Functioning in People with Type 1 Diabetes in the 50-Year Medalist Study

Study to be presented June 12 at the American Diabetes Association's 66th Scientific Sessions in Washington, D.C.

BOSTON, June 12, 2006 - Scientists at Joslin Diabetes Center have discovered that a surprisingly high percentage of people with type 1 diabetes (insulin-dependent) who have had the disease for 50 years or longer (The Joslin Medalists) may still have residual functioning, insulin-producing islet cells and/or islet cell antibodies. The findings will be presented June 12 at the American Diabetes Association (ADA) 66th Annual Scientific Sessions in Washington, D.C.

"It is surprising that some Medalists still have c-peptide secretion, a sign of insulin production, and some are positive for antibodies to the islets, another sign that some islet function or mass still is present. The significance of these findings is that even after such a prolonged period of diabetes, some patients still have residual islet function," said George L. King, M.D., the study's lead author. Dr. King is Joslin's Research Director, Head of the Section on Vascular Cell Biology, head of Joslin's 50-Year Medalist Study and a Professor of Medicine at Harvard Medical School.

In addition, the researchers found 48 percent of the total participants reported no or very little microvascular complications, such as kidney and eye problems, which demonstrates that long duration of diabetes does not always progress to complications. There also was no significant difference in age, duration, age of onset or long-term glucose control measured by A1C (glycated hemoglobin) levels between those with or without complications.

This talk is one of nearly 80 presentations to be delivered by Joslin scientists at the ADA's Scientific Sessions, Friday, June 9, through Tuesday, June 13. Some 15,000 scientists, physicians and health professionals will attend the conference, to be held at the Washington Convention Center. The talk, "Immune Tolerance and Other Treatment Approaches for Type 1 Diabetes," is scheduled for June 12 at an 8-10 a.m. EST session on Immunology/Transplantation. [Abstract Number 278-OR: "Positivity of C-peptide, GADA and IA2 antibodies in Type 1 Diabetic Patients with Extreme Duration"]

Since 1970, Joslin Diabetes Center in Boston has awarded medals or certificates to people with type 1 diabetes who have been insulin-dependent continuously for at least 25 years. To date there have been approximately 2,400 50-Year Medals awarded and 17 distinctive 75-Year Medals. The Medalist Study began in April 2005 to identify physiological, clinical, genetic and other factors shared by the Medalists.

The study being presented at the ADA meeting is part of the second phase of the Joslin 50-Year Medalist Study that is assessing these factors in 326 patients with more than 50 years of insulin-dependent diabetes. It evaluated a subset of 125 people with type 1 diabetes for biomarkers of insulin function. Of this group, 12.7 percent had a c-peptide level greater than 0.3 ng/mL, which indicates active islet cells and some residual insulin production. Most of the Medalists have the characteristics associated with type 1 diabetes with or without the presence of c-peptide.

In addition, 23.2 percent of the c-peptide positive participants produced either of two antibodies, GADA and IA2, which attack islet cells. The study also found that 17 percent of participants who were not c-peptide positive produced GADA or IA2 antibodies to the islet cells, another indication that a small amount of islet cells may still be present and/or functioning.

"The findings are phenomenal," said Hillary Keenan, Ph.D., research associate at Joslin and co-investigator on the 50-Year Medalist Study, who will present the findings. "This is the first study to look at the specific biomarkers for islet cell presence in people with a 50-year duration of insulin-dependent diabetes." Other Joslin investigators in the study included Alessandro Doria, M.D., Ph.D., Lloyd Paul Aiello, M.D., Ph.D., Korey Hood, Ph.D., and Jennifer Sun, M.D.

The group also was tested for other clinical parameters, such as cholesterol, triglycerides, body mass index and daily insulin dose. The data shows no significant difference in clinical parameters for participants with or without c-peptide. For example, the average total cholesterol of the c-peptide positive participants was 146 compared to 162 for the participants who did not produce c-peptide.

"If we could find out the reason for their lack of complications, we could perhaps prevent kidney or eye disease," said Dr. King. The study has been investigating whether other factors, such as lifestyle or longevity genes, play a role in the development of complications, reported Dr. Keenan.

Overall, the study opens new avenues for research and treatment of type 1 diabetes. "The findings suggest that many patients, even after many years of diabetes, may still have some residual islet function. If a way can be found to stimulate islet growth, we could improve their diabetes and reduce insulin usage or better control blood glucose levels. If islets were returned to normal levels, they wouldn't need to take insulin," said Dr. King.

Of the 326 Joslin 50-Year Medalist Study respondents who have completed an extensive health questionnaire, 175 were female and 151 were male, with an average age of 70 years. The average age of diabetes onset was 13 years and average duration of type 1 diabetes 57 years. The data collected so far show that individuals who have survived 50 years or more have a greatly reduced risk of nephropathy and retinopathy.

Funding for the study was provided by the Juvenile Diabetes Research Foundation.

About Joslin Diabetes Center
Joslin Diabetes Center, dedicated to conquering diabetes in all of its forms, is the global leader in diabetes research, care and education. Founded in 1898, Joslin is an independent nonprofit institution affiliated with Harvard Medical School. Joslin research is a team of more than 300 people at the forefront of discovery aimed at preventing and curing diabetes. Joslin Clinic, affiliated with Beth Israel Deaconess Medical Center in Boston, the nationwide network of Joslin Affiliated Programs, and the hundreds of Joslin educational programs offered each year for clinicians, researchers and patients, enable Joslin to develop, implement and share innovations that immeasurably improve the lives of people with diabetes. As a nonprofit, Joslin benefits from the generosity of donors in advancing its mission. For more information on Joslin, call 1-800-JOSLIN-1 or visit www.joslin.org.

Posted by dlife at 12:08 PM | Comments (0)

Study Shows New Non-Invasive Device Screens Diabetes Better Than Fasting Plasma Diabetes Biomarkers Found in Skin Shown to Correlate Well With Diabetes Risk

WASHINGTON, June 12, 2006 (PRNewswire) - Researchers reported a new non-invasive technology that uses fluorescent light to detect the presence of abnormal concentrations of diabetes-related biological markers found in skin was able to significantly outperform fasting plasma glucose (FPG) as a screening test for pre-diabetes and type 2 diabetes. Results from a clinical study presented at the 66th annual Scientific Sessions of the American Diabetes Association, held here, showed a prototype medical device using the technology was able to identify 20 percent more patients with type 2 diabetes or its precursor. The study was conducted by researchers from the University of New Mexico School of Medicine, TriCore Reference Labs, InLight Solutions and VeraLight -- the developer of the non-invasive diabetes screening device it calls, "Scout."

Skin AGEs Predict Diabetes and Its Complications

Previous studies have shown that the presence of so-called "advanced glycation endproducts," or AGEs, found in skin correlate well with diabetes and are a predictor of the disease's serious complications. Analogous to a "diabetes odometer," AGEs are a sensitive metric for the cumulative damage the body has endured due to the effects of abnormally high blood sugar. They affect the proteins that make up blood vessels, connective tissue and skin, and are thought to be major factors in aging and age-related chronic diseases. According to medical experts, non-invasive skin detection of AGEs could replace the fasting plasma glucose test as the medical workhorse for screening people suspected of having diabetes.

"AGEs have been well-recognized as a diabetes biomarker and as a predictor of complications that may lead to blindness and kidney disease," said Robert E. Ratner, M.D., vice president of scientific affairs at Medstar Research Institute, Baltimore-Washington area's largest healthcare delivery system. "Until the advent of VeraLight's technology and the Scout system, a skin biopsy was the only way to detect AGEs which made them impractical for clinical use. With a simple, non-invasive technology, skin AGEs will be a valuable tool for identifying people with sub-clinical disease. Lack of a fasting requirement, overall convenience and superior accuracy may make this the technology of choice for diabetes and pre-diabetes screening."

Scout Technology More Sensitive Than Fasting Glucose Test

The study was undertaken in 328 subjects at risk for diabetes or pre-diabetes to evaluate VeraLight's non-invasive Scout technology against the FPG test, which measures a patient's blood sugar after a 12-hour fast. The oral glucose tolerance test, which measures blood glucose two hours after oral administration of a 75-gram glucose load, was used as a confirmatory test. The subjects in the study ranged in age from 21 to 88 years old. The results were analyzed to compare each test's "receiver-operator characteristics" -- a statistical measure that graphically illustrates a test's false-positive relationship to sensitivity (a measure of true positives). At the lower, impaired fasting glucose threshold of 100 milligrams per deciliter (mg/dl), the FPG sensitivity was 57.5 percent with a specificity (a measure of true normals) of 78 percent. At that specificity, the Scout sensitivity was 68.9 percent, showing the ability to detect 20 percent more individuals with diabetes or its precursor.

VeraLight Scout

Weighting about 10 pounds, the VeraLight Scout utilizes proprietary fluorescence spectroscopic technology that does not require patient fasting. The subject inserts the palm-side of the forearm into the system, which resembles a drug-store blood-pressure monitor. In about a minute the Scout shines various wavelengths of light on the skin to stimulate fluorescence that is measured by the machine to provide an indication of diabetes risk based on the presence of AGEs. The instrument optically calibrates for skin pigmentation so that performance is not diminished by skin coloration. A specially designed fiber-optic probe couples the excitation light to the subject and relays resulting skin fluorescence to a detection module. The system's software utilizes multivariate statistical techniques that are applied to the spectra to obtain a diabetes risk score.

Need for Early and More Accurate Diabetes Screening

More than 73 million Americans -- one third of the adult population -- now have diabetes or may be on their way to getting it, according to a NIDDK study published in the June issue of Diabetes Care. The study showed 9.3 percent of adults age 20 and older (19.3 million people) had diabetes in 1999-2002. While the prevalence of undiagnosed diabetes has remained essentially stable since 1988-1994 at 2.8 percent, the prevalence of diagnosed diabetes rose sharply during the same period -- from 5.1 percent to 6.5 percent of the population.

Another 26 percent of Americans had impaired fasting glucose, a form of pre-diabetes. In pre-diabetes, glucose levels are higher than normal, even though they are not yet high enough for a diagnosis of diabetes. Pre-diabetes often leads to diabetes if steps are not taken to prevent it.

Due to their inaccuracy and inconvenience, current screening methods for diabetes are grossly inadequate. The result is that 50% of diabetics are not identified until they present 5-to-9 years into the disease with one or more (often irreversible) complications. A more accurate and convenient screening method could dramatically reduce the costs and morbidity associated with such complications, allowing patients to halt or reverse disease progression.

In 2002 the United States spent $132 billion on diabetes treatment and complications, or approximately 10 percent of all national healthcare expenditures. Most of this was for complications -- yet numerous clinical studies have demonstrated the effectiveness of early therapeutic intervention in preventing the disease or mitigating these complications.

About VeraLight

VeraLight, based in Albuquerque, N. M., is a privately held medical instrumentation company that was established in 2004 as an independent spinout of InLight Solutions to focus on a comprehensive approach to non-invasive diabetes screening. The company's mission is to help stem the tide of the world wide diabetes epidemic through early diabetes detection, thus enabling initiation of therapies that can prevent diabetes or reduce its complications. VeraLight develops and acquires intellectual property, products, and services that contribute to this mission. For more information see http://www.veralight.com.

Posted by dlife at 12:06 PM | Comments (0)

Levemir(R) Helps Patients Significantly and Safely Improve Control in a Real World Study

Study supports evidence of improved control while maintaining weight neutrality in actual clinical practice - in one of the largest worldwide observational diabetes studies to date - with data from more than 10,000 patients

WASHINGTON, June 12, 2006 (PRNewswire-FirstCall) - Novo Nordisk today announced results from the German cohort of 10,276 patients enrolled in the observational PREDICTIVE(TM) trial, which found Levemir(R) (insulin detemir [rDNA origin] injection) improved blood sugar control (A1C) and reduced episodes of major hypoglycemia (low blood sugar) with no weight gain in actual clinical practice. The primary endpoint was safety. These results and the findings of a separate sub-group analysis were presented at the 66th Scientific Sessions of the American Diabetes Association in Washington, D.C.

In PREDICTIVE, Levemir demonstrated significant improvement in blood sugar control - A1C levels were reduced significantly in both type 1 and type 2 diabetes patients. In addition, patients with type 2 diabetes lost weight, while type 1 patients maintained their weight while using Levemir. Weight gain is a common side effect of insulin therapy(1) and Levemir is the first insulin to show less weight gain versus other basal insulins in 12 of 12 controlled clinical trials. Among people with diabetes, 90 to 95 percent have type 2 diabetes(2) and 80 percent of people with diabetes are overweight or obese(3).

Additionally, an analysis of a sub-group of this study of type 2 diabetes patients (n=511) focused on patients who switched from NPH or glargine to Levemir. These patients experienced significant improvement in A1C, and reduced episodes of major hypoglycemia. Both patient groups also experienced weight reduction.

"Novo Nordisk continues to make a difference by bringing innovative treatments to meet the individual needs of the growing number of people living with diabetes," said Alan Moses, Associate Vice President of Clinical Research and Medical Affairs at Novo Nordisk. "The recent addition of Levemir to our robust diabetes portfolio should not only help patients reach recommended A1C levels, but may also help physicians break down barriers to initiating insulin therapy."

PREDICTIVE Study Key Findings (Poster# 511-P)

PREDICTIVE (Predictable Results and Experience in Diabetes through Intensification and Control to Target: An International Variability Evaluation), a multi-center observational study, is assessing the safety and efficacy of Levemir and providing insights into different treatment patterns and blood sugar control. The primary endpoint of the study was safety, including the incidence of major hypoglycemic events. The findings are from the German cohort of 10,276 patients (26 percent type 1, 73
percent type 2, 1 percent other classification), with a mean follow-up period of 14.5 weeks after initiation of Levemir:

-- Levemir reduced mean A1C levels by 0.54 percent for type 1 and 0.89
percent for type 2 diabetes patients (P<0.001 for both)

-- Episodes of major hypoglycemia were significantly reduced in type 1
patients and as well as type 2 patients. In type 1 patients, major
hypoglycemic episodes dropped from 1.08 per patient year in the four
weeks prior to study start to 0.12 per patient year in the four weeks
before follow-up (P<0.001). In type 2 patients, major episodes dropped
from 0.3 to 0.06 per patient year (P<0.001)

-- Twenty eight serious adverse drug reactions were reported during the
follow up period of 14.5 weeks, the majority of which were hypoglycemic
episodes

-- Type 1 patients gained no weight and type 2 patients experienced a
slight reduction in body weight during the study (-0.6kg, P<0.001)

-- 73 percent of type 2 patients used Levemir once daily

"With the prevalence of diabetes expected to exceed 333 million by 2025(4), this study not only provides us with an opportunity to validate the benefits of Levemir in clinical practice but it will also provide valuable information about diabetes treatment patterns and glycemic control," said Dr. Hans-Joachim Luddeke, an investigator in the PREDICTIVE study in Munich, Germany. "This will help to inform further improvements in the management of this potential pandemic."

In the sub-group analysis of patients with type 2 diabetes who switched from NPH (n=251) or glargine (n=260) to Levemir (Poster# 614-P), A1C was reduced by 0.57 percent and 0.58 percent, respectively. In these patients, no major hypoglycemia was observed for Levemir (NPH insulin switches decreased from 0.4 to 0/patient years, insulin glargine switches decreased from 0.3 to 0/patients years). Furthermore, patients in both groups switching from NPH and glargine experienced slight weight reduction (-0.9 kg and -0.8 kg, respectively).

Novo Nordisk recently initiated the PREDICTIVE 303 study in the U.S. to investigate a simple self-titration algorithm to help patients achieve their A1C targets with Levemir.

Posted by dlife at 12:03 PM | Comments (0)

Glucon Announces New Clinical Study Results of Aprise(TM) in a Poster Presentation at the American Diabetes Association's 66th Scientific Sessions, in Washington, D.C.

BOULDER, Colo, June 12, 2006 (BUSINESS WIRE) - Aprise is a Non-Invasive, Continuous Blood Glucose Monitoring Device Glucon Inc., developer of innovative continual blood glucose monitoring devices, announced the complete results of its recent clinical study of Aprise at the American Diabetes Association's 66th Scientific Sessions, in Washington, D.C., June 9-13, 06 The data are also published in the Scientific Sessions Abstract Book, the June supplement to the journal Diabetes.

Dr. Ram Weiss presented Glucon's poster, titled Non Invasive Continuous Glucose Monitoring - Results from the First 62 Subjects. The presentation is part of the Clinical Therapeutics/New Technology Glucose Monitoring and Sensing category, number 408-P in the Poster Session in the Exhibit Hall. Dr. Weiss is a senior pediatric endocrinologist at Hadassah - Hebrew University School of Medicine in Jerusalem.

"Of the personal, non-invasive, continual blood glucose technologies currently in development, Glucon's Aprise is the most advanced in the clinical investigation process," noted Glucon's CEO Dan Goldberger.

The analysis of the data generated by the 62 subjects included 979 pairs of reference values and prospective, sensor derived glucose determinations. The mean absolute relative difference (RAD) of the sample was 19.9% with a median RAD of 13.2%. The mean and median differences were both around -5 -6 mg/dl (0.28 - 0.33 mmol/l)indicating a slight over estimation of the sensor. When all of the results were plotted using the Clarke error grid (figure 1), 66.5%, 28.1%, 1%,4.4% and 0% were within the A, B, C, D and E ranges respectively.

"When the three study protocols were analyzed separately, the mean RAD for the oral glucose tolerance tests and the meal tolerance tests was superior to the mean RAD of the glucose infusion studies (17% vs. 19% vs. 22% respectively). Similarly, the prevalence of range D errors in the Clark error grid was smaller in OGTTs vs. meal tolerance tests and glucose infusion studies (2.1% vs. 5% vs. 8.6% respectively)," said Dr. Weiss.

Aprise(TM) is intended for self monitoring diabetic patients. It is the only device able to read blood glucose levels directly from a blood vessel, without puncturing the skin, through the use of a novel Photoacoustic (optical and sound-based) technology, proven to be superior to optics alone. The reading can be updated every five minutes or faster, allowing patients to respond to real time information. Aprise also signals when glucose levels rise or fall beyond acceptable levels.

"The study data further supports earlier findings that Aprise performs favorably in comparison to conventional finger stick glucose monitoring devices. We are currently developing the next generation of Aprise, which will be even smaller, lighter weight and comfortable to wear," said Glucon President Ron Nagar.

About Glucon

Glucon (www.glucon.com) is developing a pipeline of automated, continual, blood glucose (sugar) monitoring devices for home and clinical use. Glucon was founded in 2000 by Israeli scientists including Company President Ron Nagar. The company's flagship product, Aprise, is currently undergoing extensive clinical trials. Seed financing was provided by InnoMed Ventures. Additional investors include Giza Venture Capital, Infinity Venture Capital Fund, Ascend Technology Ventures, and several others.

Posted by dlife at 12:00 PM | Comments (2)

Meditation May Improve Cardiac Risk Factors in Patients With Coronary Heart Disease

June 12, 2006 (Eurekalert) - A relaxation technique known as transcendental meditation may decrease blood pressure and reduce insulin resistance among patients with coronary heart disease, according to a report in the June 12 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

Transcendental meditation, derived from the ancient Vedic tradition in India, is taught through a standard protocol involving lectures, personal instruction and group meetings, according to background information in the article. It has previously been shown to lower blood pressure but its effect on other risk factors associated with coronary heart disease, including those linked to the metabolic syndrome, has not been thoroughly examined. The metabolic syndrome refers to a cluster of symptoms that increase cardiac risk, including high blood pressure (hypertension), abdominal obesity, high cholesterol and insulin resistance, which occurs when the body is unable to use the insulin produced by the pancreas to process sugar into energy.

Maura Paul-Labrador, M.P.H., Cedars-Sinai Medical Center, Los Angeles, and colleagues conducted a 16-week trial of transcendental meditation in patients with coronary heart disease. Fifty-two participants (average age 67.7 years) were instructed in transcendental meditation and 51 control patients (average age 67.1 years) received health education. At the beginning and end of the trial, the patients fasted overnight and then gave a blood sample, participated in a medical history review and underwent tests of blood vessel function and heart rate variability. Heart rate variability testing assesses the functioning of the autonomic nervous system, which controls the heart and other involuntary muscles.

Overall, of the 103 participants who were enrolled, 84 (82 percent) completed the study. At the end of the trial, patients in the transcendental meditation group had significantly lower blood pressure; improved fasting blood glucose and insulin levels, which signify reduced insulin resistance; and more stable functioning of the autonomic nervous system. "These physiological effects were accomplished without changes in body weight, medication or psychosocial variables and despite a marginally statistically significant increase in physical activity in the health education group," the authors write.

"These current results also expand our causal understanding of the role of stress in the rising epidemic of the metabolic syndrome," they continue. "Although current low levels of physical activity, unhealthy eating habits and resultant obesity are triggers for this epidemic, the demands of modern society may also be responsible for higher levels of chronic stress." Such stress causes the release of cortisol and other hormones and neurotransmitters, which over time damage the cardiovascular system.

"Our results, demonstrating beneficial physiological effects of transcendental meditation in the absence of effects on psychosocial variables, suggest that transcendental meditation may modulate response to stress rather than alter the stress itself, similar to the physiological impact of exercise conditioning," the authors write. This method of controlling the body's response to stress may provide a new target for the treatment and prevention of coronary heart disease, warranting further study, they conclude.

Posted by dlife at 11:58 AM |