Byetta gains expanded indication for first-line treatment for type 2 diabetes

The FDA has approved Byetta (exenatide injection, from Amylin and Lilly), a GLP-1 receptor agonist, for use as monotherapy along with diet and exercise to improve glycemic control in adults with type 2 diabetes. This approval was based on a clinical study of patients with type 2 diabetes who were unable to achieve glycemic control through diet and exercise alone. Study results showed that patients treated with Byetta 5mcg or 10mcg as monotherapy reduced their A1C by 0.7 percentage points and 0.9 percentage points, respectively, and lost 6 pounds and 6.4 pounds, respectively.

Byetta is already indicated as an adjunct to metformin, a sulfonylurea, a thiazolidinedione, or in combination with metformin and a sulfonylurea or with metformin and a thiazolidinedione in adults with type 2 diabetes without adequate glycemic control.

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