New Diabetes Drug Januvia Approved by FDA

The U.S. Food and Drug Administration (FDA) approved a new oral diabetes drug on Tuesday, October 17. The drug, sitagliptin (brand name Januvia), is manufactured by the pharmaceutical company Merck & Co., Inc., and is meant for use in people with Type 2 diabetes. Januvia is the first drug in a new class called dipeptidyl peptidase IV (or DPP-4) inhibitors to be approved.

DPP-4 inhibitors work by enhancing the body’s levels of a protein called GLP-1. This protein, in turn, stimulates the pancreas to produce more insulin and prevents the liver from producing glucose—but only when blood glucose levels are already elevated. This selectivity makes DPP-4 inhibitors much less likely to cause hypoglycemia (low blood glucose) than some older diabetes drugs.

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Januvia is meant to be taken once a day and can be taken on its own or in addition to certain other diabetes medicines, namely metformin (Glucophage and other brand names), pioglitazone (Actos), and rosiglitazone (Avandia). One of its chief selling points will likely be that, according to clinical trials, it does not cause weight gain or severe side effects like hypoglycemia. In a study of over 2,000 people, the most common side effects were sore throat, diarrhea, and colds. This study also showed that Januvia lowered HbA1c (a measure of blood glucose control) by an average of 0.67%, the same amount as the older diabetes drug glipizide (Glucotrol and other brand names), which does tend to cause weight gain and hypoglycemia.

Januvia’s chief drawback for many people will likely be its price, which is $4.86 per day, or about $145 per month.

Merck is planning to ship Januvia to pharmacies and send free samples to doctors quickly, meaning that the drug should be available to people with diabetes very soon. A survey of 60 doctors conducted by Reuters showed that 90% plan to begin prescribing the drug right away.

Another drug in the DPP-4 class, called vildagliptin (Galvus), is expected to be approved later this year, possibly as soon as next month. Galvus is manufactured by the pharmaceutical company Novartis AG. Merck is also applying for FDA approval for a drug that combines Januvia with metformin.

  • Darla Bononi

    It’s very hard for me to see that light orange color on some words that you want to stand out. Bold Black with parenthesies would be better. Also blue on blue is hard to read too. Please forgive any mispelled words.
    Darla Bononi

  • michelle

    do we have any idea how soon it will be available? my doctor perscribed it today 10/30 and I can’t seem to get it filled anywhere. you would think doctors would know this. I was very excited to try it.

  • Tara Dairman, Web Editor

    Hi Michelle,

    While Merck claims that Januvia should be available soon, you can visit http://www.januvia.com to request more information about the drug. You can also find contact information for Merck at http://www.merck.com/contact.

  • janis

    I went on Januvia (Janument, actually) at Thanksgving and by New Years I had lost 28 pounds. I followed the diabetic diet and exercised, so I did my part. But that amount of weight loss just floored me. My A1c went from 7.8 in October to 6 by January. I don’t know what they put in this drug, but it’s a miracle for me. My total weight loss now is 32 pounds. I feel great.

  • judy

    Janis, may I ask what your diet and exercise plan was? When I see my doctor in two weeks I am going to find out about the drug Januvia, as what I am taking now is not working and I have gained 40 pounds in the last 2yrs.

  • Jacquie Moore

    My Dr. already tried me on Januvia, and it had the side affect of giving me a stuffy nose and then a sore throate. It helped reduce my diabetic numbers by 5 points. Since I am an ashmatic I was steered away from this med. Avandia, is now under suspcican as it is supposed to be bad for one’s heart. I don’t honestly see what Metformin is really doing for me except give me diarehea. Sp? Well that is it for now.