Exenatide Aids Glycemic Control in Diabetics

Addition of exenatide improves glycemic control in type 2 diabetic patients inadequately controlled on combined metformin-sulfonylurea. Dr. Alain D. Baron, senior investigator stated that, "exenatide, which is now approved for marketing under the name Byetta, is a first-in-class incretin mimetic shown to improve glucose control in patients with type 2 diabetes who exhibit a wide range of disease severity and (fail) to achieve adequate control on one or two of the most commonly used antidiabetic medications."

Dr. Baron of Amylin Pharmaceuticals, San Diego and colleagues note that a number of glucoregulatory peptides have shown promise as therapies for type 2 diabetics.

To investigate the effects of exenatide, the researchers conducted a double-blind, placebo-controlled study of 733 patients. The active treatment group injected 5 or 10 micrograms of exenatide twice daily. All patients continued with their metformin and were randomized to either maximally effective or minimum recommended doses of sulfonylurea.

At 30 weeks, the placebo-adjusted reduction in hemoglobin A1C was 1.0% in the 10 microgram exenatide group and 0.8% in the 5 microgram group. In addition, both exenatide groups showed significant weight loss.

Mild or moderate nausea was the most common side effect. The incidence of mild or moderate hypoglycemia was 28% in the 10 microgram exenatide group, 19% in the 5 microgram group and 13% in the placebo group.

There appeared to be a lower incidence of hypoglycemia in patients given the minimum recommended dose of sulfonylurea.
The agent "works through a set of unique modes of action, with restoration of first phase insulin secretion as the most characteristic, and thus represents a significant additional therapeutic tool to treat type 2 diabetes, an increasingly prevalent and difficult disease to get under control," Dr. Baron concluded.
Diabetes Care 2005;28:1083-1091.

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