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After One Year, Type 2 Diabetes Patients Taking Exenatide Once Weekly Sustained Improvements in Glycemic Control and Weight; DURATION-1 Presented at ADA 2008
Date:6/9/2008

Following the 30-week comparison period, patients (evaluable population N=241) who continued on exenatide once weekly showed sustained improvements in A1C and fasting plasma glucose levels at week 52 [A1C: -2.0%+/-0.1; FPG -47+/-3 mg/dL (LS mean+/-SE)]. Patients who switched from BYETTA to exenatide once weekly had further improvements in glycemic control [A1C: -2.0% +/-0.1; FPG - 43+/-3 mg/dL] that were consistent with those of patients receiving exenatide once weekly for 52 weeks. These data suggested the additional impact of continuous exenatide levels on glycemic control.

In both groups, A1C reduction was similar at 52 weeks. Seventy-two percent of patients treated with exenatide once weekly achieved an endpoint A1C of 7 percent or less, and 54 percent achieved an A1C of 6.5 percent or less. In patients who switched from BYETTA to exenatide once weekly, 75 percent of patients achieved an endpoint A1C of 7 percent or less and 53 percent achieved an A1C of 6.5 percent or less. An A1C of below 7 percent is the target for good glucose control as recommended by the ADA. Unlike the weight gain that is commonly associated with insulin therapy and many oral diabetes medications, exenatide once weekly was associated with an average weight loss of 9.5 pounds over 52 weeks.

Exenatide once weekly uses a proprietary technology for long-acting medications developed by Alkermes. The technology encapsulates active medication into polymer-based microspheres that are injected into the body where they degrade slowly, gradually releasing the drug in a controlled manner to provide continuous therapeutic exenatide levels in plasma.

Safety Profile

Exenatide once weekly was well tolerated during the first 30 weeks of treatment and the following 22-week, open-ended treatment period with overall tolerability improving over the course of the study. No major hypoglycemia events regardless of background therapy, were observed with exenatide once weekly. Ca
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SOURCE Eli Lilly and Company
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