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DOI: 10.2337/dc06-2375
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Original Research |
Effects of Once-Weekly Dosing of a Long-Acting Release Formulation of Exenatide on Glucose Control and Body Weight in Subjects With Type 2 Diabetes
1Amylin Pharmaceuticals, Inc., San Diego, CA
2Eli Lilly and Company, Indianapolis, IN
3Eli Lilly and Company, Hamburg, Germany
dkim{at}amylin.com
ABSTRACT
Objective:: In patients with type 2 diabetes, exenatide reduces HbA1c (A1C), postprandial and fasting glucose, and weight. This study investigated the effects of continuous exenatide administration from a long-acting release (LAR) formulation.
Research and Design Methods:: In this randomized, placebo-controlled phase 2 study, exenatide LAR (0.8 or 2.0 mg) was administered subcutaneously once weekly for 15 weeks to subjects with type 2 diabetes (N=45) suboptimally controlled with metformin (60%) and/or diet and exercise (40%): 40% female, A1C 8.5±1.2%, fasting plasma glucose 9.9±2.3 mmol/L, weight 106±20 kg, diabetes duration 5±4 years, mean±SD.
Results:: From baseline to Week 15, exenatide LAR reduced mean±SE A1C by -1.4±0.3% (0.8 mg) and -1.7±0.3% (2.0 mg), compared to +0.4±0.3% with placebo LAR (p <0.0001 for both). An A1C of 
7% was achieved by 36% and 86% of subjects receiving 0.8 and 2.0 mg exenatide LAR, respectively, compared to 0% of subjects receiving placebo LAR. Fasting plasma glucose was reduced by -2.4±0.9 mmol/L (0.8 mg) and -2.2±0.5 mmol/L (2.0 mg), compared to +1.0±0.7 mmol/L with placebo LAR (p <0.001 for both). Exenatide LAR reduced self-monitored postprandial hyperglycemia. Subjects receiving 2.0 mg exenatide LAR had body weight reductions (-3.8±1.4 kg) (p <0.05), while body weight was unchanged with both placebo LAR and the 0.8 mg dose. Mild nausea was the most frequent adverse event. No subjects treated with exenatide LAR withdrew from the study.
Conclusions:: Exenatide LAR offers the potential of 24-hour glycemic control and weight reduction with a novel once-weekly treatment for type 2 diabetes.
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