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Once-Monthly Exenatide Improved Glucose Control in Patients with Type 2 Diabetes: Phase 2 Study Results Presented at ADA 2011
Date:6/24/2011

SAN DIEGO, June 24, 2011 /PRNewswire/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced additional results from a phase 2 study of an investigational, once-monthly injectable suspension formulation of exenatide which showed substantial improvements in glycemic control, including reductions in A1C and fasting plasma glucose, with modest weight loss. These findings will be presented in a late breaking poster session at the 71st Scientific Sessions of the American Diabetes Association on Sunday, June 26 from 12-2 p.m. PDT.

The 121-patient study assessed the efficacy, safety and tolerability of three different doses (5 mg, 8 mg and 11 mg) of exenatide once monthly, a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist. After 20 weeks of treatment (total of five injections), patients receiving exenatide once monthly experienced average improvements in A1C (a measure of average blood sugar over three months) from baseline of 1.3 percentage points for the 5 mg and 8 mg doses and 1.5 percentage points for the 11 mg dose. In addition, 50 percent of those treated with the 5 mg dose, 57 percent treated with the 8 mg dose and 70 percent treated with the 11 mg dose achieved an A1C of less than 7 percent, the ADA-recommended target for good glucose control. Patients also lost a modest amount of weight (0.9 pounds with the 8 mg dose and 2.4 pounds with the 5 mg and 11 mg doses), although exenatide once monthly is not being studied as a weight-loss product. Fasting plasma glucose was improved with all doses, with reductions of 25 mg/dL with the 5 mg dose, 30 mg/dL with the 8 mg dose and 49 mg/dL with the 11 mg dose. The mean pharmacokinetic p
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SOURCE Amylin Pharmaceuticals, Inc.; Eli Lilly and Company; Alkermes, Inc.
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