Initiation Of New DURATION-5 Clinical Study
The companies have initiated DURATION-5, a new phase 3b study in which patients with type 2 diabetes will use exenatide once weekly commercial-scale drug product in its final commercial configuration. This randomized, 26-week, open-label study in approximately 240 patients has broad utility and is designed to show superiority of exenatide once weekly compared to BYETTA, support regulatory submissions outside the United States and provide additional controlled clinical data on the commercially manufactured product.
"In the near-term, we are working to bring this important therapy to market as quickly as possible," said David Vondle, Lilly's global brand development leader for exenatide. "In the long-term, we are executing on a clinical trial program aimed to show superiority of exenatide once weekly over other diabetes medications."
Diabetes affects more than 23 million people in the United States and an estimated 246 million adults worldwide.(i,ii) Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes is the fifth leading cause of death by disease in the United States and costs approximately $132 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 overw
|SOURCE Amylin Pharmaceuticals, Inc.|
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