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Exenatide Once Weekly Provided Superior Glucose Control Compared to Lantus(R) in Head-to-Head DURATION-3 Study
Date:7/20/2009

nts with type 2 diabetes taking stable doses of metformin alone or in combination with a sulfonylurea. Exenatide once weekly was administered once a week in a fixed dose while Lantus was administered daily in a variable dose determined by patient blood sugar levels.

"Exenatide once weekly outperformed Lantus in this superiority study by meeting its primary endpoint," stated Orville G. Kolterman, M.D., senior vice president of research and development, Amylin Pharmaceuticals. "Both treatment arms started with a baseline A1C of 8.3 percent and exenatide once weekly provided statistically significantly greater A1C reduction, weight loss versus weight gain and fewer episodes of hypoglycemia."

More than 90 percent of patients completed the study. During the 26-week treatment period, the most frequently reported adverse events were upper respiratory infection, including nasopharyngitis, in both treatment arms, as well as gastrointestinal events, including nausea, in the exenatide once weekly treatment group. Patients treated with exenatide once weekly experienced less confirmed hypoglycemia: the incidence of hypoglycemia was 4 percent with exenatide once weekly versus 19 percent with Lantus for patients on metformin background therapy, and 20 percent with exenatide once weekly versus 44 percent with Lantus for patients on metformin and a sulfonylurea background therapy, differences that are statistically significant in both treatment groups.

Study Design

The 26-week open-label, superiority study included 467 subjects with type 2 diabetes who were not achieving adequate glucose control using metformin therapy alone or in combination with a sulfonylurea. Subjects were randomized to receive exenatide once weekly 2 milligrams by subcutaneous injection weekly or insulin glargine injections administered daily in a variable dose determined by patient blood sugar levels. There was no lead-in or wash
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SOURCE Amylin Pharmaceuticals, Inc.; Eli Lilly and Company
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