FDA Approves Januvia for Type 2 Diabetes : FDA Approves Januvia for Type 2 Diabetes

FDA Approves Januvia for Type 2 Diabetes

Posted by dlife on Tue, Oct 17, 06, 10:10 AM 162 Comments

October 17, 2006 (FDA) - The Food and Drug Administration (FDA) announced today the approval of Januvia (sitagliptin phosphate) Tablets, the first diabetes treatment approved in a new class of drugs known as DDP-4 inhibitors that enhances the body's own ability to lower elevated blood sugar. FDA approved Januvia for use in addition to diet and exercise to improve blood sugar levels in patients with type 2 diabetes, alone or in combination with two other commonly prescribed oral diabetes medications, metformin or a PPAR (peroxisome proliferator-activated receptor gamma) agonist, when either of these drugs alone, along with diet and exercise, don't provide adequate blood sugar control.

"For the millions of Americans with type 2 diabetes, who continue to have inadequate blood sugar control, the approval of Januvia marks an important advance in the fight against diabetes," said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research. "We now have another new option that treats the disease in an entirely new way that can be added to existing treatment regimens to help patients gain more control over their blood sugar levels."

Type 2 diabetes is the most common form of the disease, accounting for about 90 percent to 95 percent of all diagnosed cases of diabetes (20.8 million in 2005). In type 2 diabetes, the body does not produce enough insulin or the cells ignore the insulin. Insulin is necessary to take sugar, the basic fuel for cells, from the blood into the cells. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness, nerve damage, and kidney damage.

Januvia prolongs the activity of proteins that increase the release of insulin after blood sugar rises, such as after a meal. Januvia does this by blocking an enzyme (dipeptidyl peptidase IV or DPP-IV) which breaks down these proteins, leading to better blood sugar control.

Januvia was examined in a total of 2,719 patients with type 2 diabetes, in studies lasting from 12 weeks to more than a year. These studies demonstrated improved blood sugar control when Januvia was used alone or in patients not satisfactorily managed with metformin or a PPAR agonist.

The most common side effects in clinical studies were upper respiratory tract infection, sore throat, and diarrhea.

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Tue, 10/31/2006 - 00:37 — thomas l schinskey (not verified)

Can I TAKE JANUVIA AND IN

Can I TAKE JANUVIA AND INSULIN ?

Wed, 10/18/2006 - 17:45 — Cheryl (not verified)

When will it be available

When will it be available for public use?

Thu, 10/19/2006 - 01:04 — Sara Jones (not verified)

I have been a diabetic fo

I have been a diabetic for 8 years now and I have been on several diffrent type of insulin to lower it. When I heard about this I was happy. I can't wait to try this and get back to somewhat of a normal life again.

Thu, 10/19/2006 - 02:01 — David Adan (not verified)

This is great news. Thank

This is great news. Thanks to all who are seeking a cure for this desease.

Tue, 11/07/2006 - 03:14 — Ruth Hathaway (not verified)

I am interest in this new

I am interest in this new drug for Diabetes Januvia. I take mediformin and glibride now. I walk every day and try to eat right, my sugar is still to high in the morning

Thu, 10/19/2006 - 13:13 — Regina Ransome (not verified)

I am so GLAD...........th

I am so GLAD...........that now there is a pill that can control high sugar. I was scare to death if I had to start taking the shots. I am frighten of the needles. Thank you guys for all the research you are doing to help control this illness.

Thu, 10/19/2006 - 14:11 — rosemarie bartus (not verified)

would like to find out mo

would like to find out more about januvia, since my doctor is in the process of changing my meds for diabetes, or adding to them,

Thu, 10/19/2006 - 15:22 — CATALINA BAHAMON (not verified)

I THINK THAT THIS MEDICIN

I THINK THAT THIS MEDICINE HELP TO THE PATIENTS THAT NOT HAVE BEEN CONTROLED THIS DIABETES TYPE II AND AVOID DAMAGE AND COMPLICATIONS IN THIS PATIENTS. THE JANUVIA IS A GOOD OPTIONS.

Thu, 10/19/2006 - 04:38 — sissy (not verified)

How does this Januvis wor

How does this Januvis work with people that have kidney problems?

Fri, 10/20/2006 - 13:59 — Beth McMurtry (not verified)

What will be the cost of

What will be the cost of this medication ? Any specific lab follow up required with this drug other than the usual diabetic labs?

Fri, 10/20/2006 - 15:14 — ginger (not verified)

I often wonder if its wor

I often wonder if its worth trying this new drug. Look, upper respiratory infections is one thing but diarrhea. come on. How can you go on your daily routine with having this. Let alone going out and getting stuck somewhere, where you have to stay near a bathroom all the time.....

Fri, 10/20/2006 - 15:24 — FRANK YEADON (not verified)

GREAT NEWS RE JUNUVIA HOW

GREAT NEWS RE JUNUVIA HOWEVER THE ARTICLE DOES NOT ADDRESS HOW OR IF THIS NEW DRUG CAN BE USED BY DIABETICS THAT ARE INSULIN DEPENDENT.

Fri, 10/20/2006 - 17:30 — lilliane ferrer,M.D. (not verified)

Keep me informed

Fri, 10/20/2006 - 17:52 — Sheila Ford (not verified)

When will janivus be avai

When will janivus be available for public use

Fri, 10/20/2006 - 18:58 — Steve Burns (not verified)

would like future reports

would like future reports on the performance of diabetes drugs

Fri, 10/20/2006 - 19:00 — Joan Fairservice (not verified)

Has the new drug Januvia

Has the new drug Januvia been approved in Canada yet. if so could you tell me when?

Fri, 10/20/2006 - 20:04 — Kathy Mayes (not verified)

Thank God that they final

Thank God that they finally came up with a new
drug for type 2 diabetics. I was diagnosed about
5 years ago and it has been tough. My sugar is high, then low. I have been on almost everything
there is for diabetes. I take Actos, Amaryl, Metformin and Apidra Insulin when needed. I have
also taken Byetta and only God knows what else. My
weigh is 246lbs. I never weighted this much in my
life, also the steroids did not help my weigh either. I am excited about the new medicine.

Fri, 10/20/2006 - 21:37 — richard (not verified)

ya its for people who hav

ya its for people who have. money,insurance,they say its a pricey drug now. iwonder is there really money to be made in the cure for this disease,or is it a cash cow in the products being sold

Fri, 10/20/2006 - 22:58 — Penny (not verified)

This and other new drugs

This and other new drugs (Byetta) do they only work on type 2 Diabetics on a pill? I'm type 2 but on shots. Why can't these new products work on people on shots?

Fri, 10/20/2006 - 23:44 — elia gonzales (not verified)

Can januvia be used if yo

Can januvia be used if you take insulin shots. I want something that will help me lose the weight.

Wed, 10/25/2006 - 17:48 — nettie g. bair (not verified)

My physician wants me to

My physician wants me to try Januvia along with metformin. I have tried Byetta which gave me really good control, however, it caused some sever reactions such as muscle cramps in my neck and arms, so I had to stop using it. Now I am hopeful that your new drug will work for me. I have medicare, but opt to take the Humana plan with drug coverage. I have been unable to find Januvia on their drug list and am wondering if it will be covered. Do you have any information on what medicare drug plans will pay on Januvia? Before I try this new therapy I will need to know this information, or at least know what cost will be if I have to pay for it myself. thanks. Nettie g. Bair.

Sat, 10/21/2006 - 00:00 — Cindy (not verified)

When will our Drs get the

When will our Drs get the info to perscribe it. Can it be used in conjunction with Byetta and Amaryl?

Sat, 10/21/2006 - 01:05 — Stallyn (not verified)

I think that is a great t

I think that is a great thing, however is it going to induce weight loss & if or when will insurances cover it since its within the $3-5 range per pill.

Sat, 10/21/2006 - 02:28 — Debby (not verified)

am very interested in lea

am very interested in learning more about this new drug.

Sat, 10/21/2006 - 02:57 — Ann Curtis (not verified)

Thanks for the info. How

Thanks for the info. However, I doubt belonging to the HMO that I belong to that people there will be able to have the new medication. They don't even allow you to have the pens ...that other insurances have...unless you can afford to pay the full price...a shame....but then that is the way of the insurance companies....

Sat, 10/21/2006 - 12:15 — vickie (not verified)

I HOPE THIS REALLY WORKS

I HOPE THIS REALLY WORKS, I HAVE BEEN PRAYING FOR SOMETHING NEW TO COME ALONG SO I WOULD NOT HAVE TO TAKE SHOTS, I HAVE HAD LIVER PROBLEMS DUE TO USING LIPITOR ,SO WILL THIS NEW PRODUCT HARM MY LIVER ? I HOPE NOT, FOR I REALLY WOULD LOVE TO TRY IT , THANKS FOR THE INFO. VICKIE

Sat, 10/21/2006 - 12:42 — mary (not verified)

Am I correct in assuming

Am I correct in assuming that this medication is not for type 11 diabetics on insulin already? And if so, am I correct in understanding that if you are eventually put on insulin it is because your pancreas has either decreased or stopped producing insulin? In other words this is for people newly dx or only on orals? Thanks for your time! Mary

Sat, 10/21/2006 - 15:35 — GEORGE SHAW (not verified)

IS THIS NEW DRUG AVAILABL

IS THIS NEW DRUG AVAILABLE FOR RETAIL PURCHASE
AND I ASSUME UNDER DOCTORS PRESCRIPTION?IF SO WHAT WOULD BE THE DOSAGE AND COST?
GEORGE SHAW

Sat, 10/21/2006 - 19:15 — Cindy Buell (not verified)

I have type 2 and take La

I have type 2 and take Lantus and Humalog. Can this drug be taken with insulin? I also take Byetta but am still having trouble with my morning sugars. I will be 70-100 at bedtime and wake up with 150-200. I am also having trouble losing weight since I've been on insulin. I have had a 40 pound weight gain in about 5 years

Wed, 11/08/2006 - 19:32 — Rena Rider (not verified)

Does this drug cause birt

Does this drug cause birth control pills to be less effective?

Sun, 10/22/2006 - 14:32 — Steve Rhodus (not verified)

This is all fine & great,

This is all fine & great, but what about all of us with type I? I have had type I Diabetes for 29 years and it is getting more difficult to control. How about a cure? I guess if they cured type I, the pharmaceutical companies would lose so much money on strips, lancets, syringes and insulin. What was I thinking?

Sun, 10/22/2006 - 14:52 — rhonda crider (not verified)

my son has been in the ho

my son has been in the honeymoon stage of diabetes for more than a year now. would Januvia benefit him. he is on insulin, but at times blood sugar runs so low he can't take his insulin. it's really frustrating for him....and me. thanks

Mon, 10/23/2006 - 01:49 — pat (not verified)

Can this medication be ta

Can this medication be taken with Byetta?

Mon, 10/23/2006 - 02:05 — John (not verified)

Januvia sounds great...Wh

Januvia sounds great...When will HMO's provide it to patients. Im a new diabetic and Im on Actos and Guberide.

Mon, 10/23/2006 - 14:18 — carol (not verified)

I have been on all the or

I have been on all the oral meds at one time or another. I have tried Byetta, except it would lower my sugar after meals too much. Now, for the past six months, I have been on Levemir. I have had to increase to 93 units so far. I was doing well with it for the first couple of months. My sugars are 240's in the morning and somethins 160's. They are increasingly going up. Do these medications stop working after awhile? I have always had high morning sugars. I have gotten up in the middle of the night and they are up around 200 or better. Do OTC herbal remedies help at all? My sugar right now is 313 one hour after eating breakfast. I have been Type 2 for 15 years. My A1C is currently 7.2 down from 8. since months' ago.

Mon, 10/23/2006 - 15:37 — Stan (not verified)

Can Januvia be taken by s

Can Januvia be taken by someone who uses inulin?

Fri, 10/20/2006 - 14:03 — Larry (not verified)

Isn't Merck the maker of

Isn't Merck the maker of Vioxx, helloooo! I also heard one of the side effects are severe joint pain.

I am Type 2 insulin dependent, and I have found after being on Actos, metaformin, avandia and avandament, An Insulin cocktail of 70/30 really isn't so bad. Inconveneient, at time yes. Side effects, minimal.

Mon, 10/23/2006 - 18:18 — Sheylla Ortiz (not verified)

When will this medicine b

When will this medicine be available to the doctors. I live in Kissimmee, Fl and would like to know when it will be on the market. Thank you..

Wed, 11/01/2006 - 17:15 — Ken Wilson (not verified)

My DR. has started me on

My DR. has started me on Januvia and I am concerned about the upper respitory tract infections. How big a problem is this?

Wed, 10/25/2006 - 22:25 — DARLENE JOBE (not verified)

I HAVE BEEN ON INSULIN FO

I HAVE BEEN ON INSULIN FOR 2 YRS NOW, I TAKE 70 UNITS IN AM AND 50 U AT NIGHT, WOULD LOVE TO BE ABLE TO CHECK MORE INTO THE JANUVIA PILL. ANYONE THAT HAS BEEN ON INSULIN AND ARE NOW USING JANUVIA I WOULD LIKE TO HEAR FROM.

Thu, 10/26/2006 - 01:24 — Jerri Hardin (not verified)

After reading of the side

After reading of the side effects above of the new diabetes drug, Januvia, I am afraid to take the medication! I am predisposed to upper respiratory tract infections & diarrhea, & I certainly don't need these things. My doctor gave me samples of the medication to try, in lieu of what I have been taking for several years, Glucophage XR 500 mgs. How common are these side effects, or does anyone know yet? Help!

Thu, 11/02/2006 - 01:27 — ARMSTRONG (not verified)

November 1, I started tak

November 1, I started taking januvia. Actos caused extreme weight gain. I would like to hear how others with type 2 are responding to this medicine. I am also on hypertensive medications.

How does stress fit in?

FDA Approves Januvia for Type 2 Diabetes

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