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Exenatide Once Weekly Provided Superior Glucose Control Compared to BYETTA(R) in DURATION-5 Study
Date:12/15/2009

trol as measured by A1C, and build upon other successful DURATION trials," said Orville G. Kolterman, M.D., senior vice president of research and development, Amylin Pharmaceuticals. "More importantly, these results continue to suggest that if approved, exenatide once weekly could play an important role in advancing the treatment of type 2 diabetes by providing patients the opportunity for improved A1C control and weight loss with just one dose per week."

Approximately 80 percent of patients completed the study. Consistent with previous DURATION trials, the most frequently reported adverse event in both groups was nausea, reported less frequently by exenatide once weekly users (14 percent) than by BYETTA users (35 percent). There were no major hypoglycemic events. Cases of minor hypoglycemia in both groups were limited to patients using background sulfonylurea therapy.

The 24-week, open-label superiority study included approximately 250 participants with type 2 diabetes who were not achieving adequate glucose control using background therapies that included diet and exercise, metformin, sulfonylurea, thiazolidinediones or a combination of the agents. Patients were randomized to receive either exenatide once weekly or BYETTA. Patients in the exenatide once weekly treatment arm received 2 milligrams once a week, while patients in the BYETTA arm received 5 micrograms twice a day for the first four weeks and 10 micrograms twice a day for the remaining 20 weeks. The primary endpoint was reduction in A1C; secondary endpoints included change in body weight and fasting plasma glucose, safety and tolerability.

Amylin, Lilly and Alkermes submitted a new drug application (NDA) for exenatide once weekly to the U.S. Food and Drug Administration (FDA) in May 2009; the NDA was accepted for review in July 2009. Lilly will be responsible for marketing exenatide once weekly outside the U.S. and expects to submit a marketing application to the Europea
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SOURCE Amylin Pharmaceuticals, Inc.; Eli Lilly and Company
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4. Meta-Analysis of Clinical Data Showed No Increased Risk of Cardiovascular Events Associated With Exenatide Use: Data Presented at ADA 2009
5. Exenatide Once Weekly Provided Sustained Improvements in Glycemic Control With Weight Loss Over Two Years: DURATION-1 Interim Long-Term Data Presented at ADA 2009
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9. After One Year, Type 2 Diabetes Patients Taking Exenatide Once Weekly Sustained Improvements in Glycemic Control and Weight; DURATION-1 Presented at ADA 2008
10. Type 2 Diabetes Patients Taking Exenatide Once Weekly, a Phase 3 Investigational Diabetes Therapy, Showed Improvements in Glycemic Control, Weight
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