Vildagliptin Effective in Previously Untreated People with Diabetes

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Efficacy and tolerability of vildagliptin monotherapy in drug-naïve patients with type 2 diabetes, by F.X. Pi-Sunyer and colleagues. Diab Res Clin Pract 76:132-138, 2007.

What is the problem and what is known about it so far?

Drug therapy for diabetes can help control high blood glucose levels, but no medication is perfect. Insulin requires regular injections, and many anti-diabetes drugs cause weight gain.

A drug that is taken less often and has fewer side effects than older therapies would be an advance in the treatment of diabetes. Vildagliptin (Galvus, Novartis) is a drug that increases the function of cells in the pancreas that produce insulin and helps control levels of insulin and blood glucose.

Why did the researchers do this particular study?

The researchers wanted to see how well vildagliptin worked in people with diabetes who had not previously taken any medication. Also, they wanted to see if there are differences between people who take the drug once a day and those who take divided doses twice a day.

Who was studied?

The study included 354 people with type 2 diabetes who had not previously been treated with anti-diabetes drugs.

How was the study done?

Participants underwent a physical exam and had blood drawn for lab tests. They were randomly assigned into groups to receive 50 milligrams of vildagliptin once a day, 50 milligrams of drug twice a day, 100 milligrams of drug once a day, or a placebo. Participants were followed for 24 weeks.

What did the researchers find?

Vildagliptin controlled blood glucose levels without causing participants who took the drug to gain weight. The effect was the same whether participants took the drug once or twice a day. There were few reports of adverse effects.

What were the limitations of the study?

The study only included people who had not previously been treated with anti-diabetes drugs. The results may not apply to other groups of people.

At the time this article was published, the Food and Drug Administration had not yet approved vildagliptin for the treatment of diabetes.

What are the implications of the study?

Vildagliptin is safe and effective for treating type 2 diabetes. Taking the drug once a day is just as good as taking half of the dosage twice a day, so vildagliptin may benefit people who have trouble taking medication.