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FDA Panel Weighs New Diabetes Drugs

FDA Advisory Committee Considers New Type 2 Diabetes Drugs Onglyza, Liraglutide
By
WebMD Health News
Reviewed by Louise Chang, MD

April 1, 2009 -- An FDA advisory panel is considering two new drugs to improve blood sugar control in people with type 2 diabetes.

Those drugs, named Onglyza (saxagliptin) and liraglutide, treat high blood sugar (hyperglycemia) in type 2 diabetes patients.

Onglyza, which is taken as a once-daily tablet and is in the same class of drugs as Januvia, is being discussed today by an FDA advisory committee.

In a clinical trial presented last year in Rome, Onglyza trumped a placebo at improving hemoglobin A1c (a gauge of blood sugar control) over the previous two to three months in type 2 diabetes patients who took Onglyza or the placebo along with other diabetes drugs for six months. 

The drug companies Bristol-Myers Squibb and AstraZeneca, which are collaborating on Onglyza, are seeking approval for Onglyza as a standalone drug as an adjunct to diet and exercise, and in combination with other diabetes drugs. 

Liraglutide, which is given once daily by injection and is in the same class of drugs as Byetta, will be on the advisory panel's agenda on April 2. Liraglutide is made by the drug company Novo Nordisk.

In September 2008, researchers reported in The Lancet that liraglutide was safe and effective, and also helped patients lose weight and lower their blood sugar.

The FDA advisory committee will review data from those trials and consider whether further data about cardiovascular safety are needed for either drug candidate.

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If the level is below 70 or you are experiencing symptoms such as shaking, sweating or difficulty thinking, you will need to raise the number immediately. A quick solution is to eat a few pieces of hard candy or 1 tablespoon of sugar or honey. Recheck your numbers again in 15 minutes to see if the number has gone up. If not, repeat the steps above or call your doctor.

People who experience hypoglycemia several times in a week should call their health care provider. It's important to monitor your levels each day so you can make sure your numbers are within the range. If you are pregnant always consult with your health care provider.

Congratulations on taking steps to manage your health.

However, it's important to continue to track your numbers so that you can make lifestyle changes if needed. If you are pregnant always consult with your physician.

Your level is high if this reading was taken before eating. Aim for 70-130 before meals and less than 180 two hours after meals.

Even if your number is high, it's not too late for you to take control of your health and lower your blood sugar.

One of the first steps is to monitor your levels each day. If you are pregnant always consult with your physician.

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