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.