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Exenatide Once Monthly Showed Positive Results in Phase 2 Study
Date:3/10/2011

emic control," said Christian Weyer, M.D., senior vice president, research and development, Amylin Pharmaceuticals. "Based on the encouraging results of this study, we plan to proceed with regulatory interactions to outline the next steps for this important program."

More than 90 percent of patients overall completed the study. The most common adverse events among the exenatide once monthly treatment groups were headache and nausea. Headache and diarrhea were most common among the once-weekly BYDUREON group. No major or minor hypoglycemia was reported in the study.

Exenatide once monthly is a new, extended-release formulation of exenatide, the active ingredient in BYETTA® (exenatide) injection, which is given twice daily. Exenatide once monthly is based on the same Medisorb® microsphere technology used in BYDUREON.

Study Design

This phase 2, randomized, open-label study included 121 adults with type 2 diabetes who were not achieving adequate glucose control using diet and exercise alone or with a stable regimen of metformin, Actos® (pioglitazone), or both.  Subjects were randomized to receive either 2 mg weekly subcutaneous injections of BYDUREON or subcutaneous injections of exenatide once monthly at a low, medium or high dose, each administered once every four weeks, for a total of 20 weeks.

About Diabetes

Diabetes affects nearly 26 million people in the U.S. and an estimated 285 million adults worldwide.(i, ii)  Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes costs approximately $174 billion per year in direct and indirect medical expenses.(iii)

According to the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey, approximately 60 percent of people with diabetes do not achieve their target blood sugar levels with their current treatment regimen.(iv) In addition, 85 percent of type 2 diabetes patients are
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SOURCE Amylin Pharmaceuticals, Inc.
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