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Monotherapy BYETTA(R) (exenatide) Injection Study Results Presented at ADA 2008 Showed Adults with Type 2 Diabetes Experienced Improved Glycemic Control and Weight Loss
Date:6/7/2008

Submitted to FDA for Stand-Alone Therapy in Q1 2008

SAN FRANCISCO, June 7 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced additional results from a study of patients with type 2 diabetes who were unable to achieve glycemic control through diet and exercise alone and were treated with either monotherapy (stand-alone) BYETTA(R) (exenatide) injection taken twice daily or placebo. Study findings showed that patients treated with monotherapy exenatide showed statistically significant improvement in both A1C and weight loss with a lower incidence of nausea than in previous exenatide studies. Exenatide is indicated as adjunctive therapy to improve glycemic control in patients with type 2 diabetes mellitus who are taking metformin, a sulfonylurea, a thiazolidinedione, a combination of metformin and a sulfonylurea, or a combination of metformin and a thiazolidinedione, but have not achieved adequate glycemic control. These findings were presented at the 68th Annual Scientific Sessions of the American Diabetes Association (ADA) in San Francisco.

In this 24-week randomized, double-blind, placebo-controlled, parallel study of 232 drug-naive patients (N=77 exenatide 5 mcg, N=78 exenatide 10 mcg, N=77 placebo) with type 2 diabetes who were treated with 5 mcg and 10 mcg of exenatide as a monotherapy reduced their A1C (a measure of average blood sugar over three months) by 0.7 percentage points and 0.9 percentage points, respectively, fro
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SOURCE Eli Lilly and Company
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