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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

¹ Amylin Pharmaceuticals, Inc., San Diego, California
² Eli Lilly and Company, Indianapolis, Indiana
³ Eli Lilly and Company, Hamburg, Germany

Address correspondence and reprint requests to Dennis Kim, MD, Amylin Pharmaceuticals, Inc., 9360 Towne Centre Dr., Suite 110, San Diego, CA 92121. E-mail: dkim{at}amylin.com

OBJECTIVE—In patients with type 2 diabetes, exenatide reduces A1C, postprandial and fasting glucose, and weight. In this study we investigated the effects of continuous exenatide administration from a long-acting release (LAR) formulation.

RESEARCH DESIGN AND 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 (mean ± SD) 8.5 ± 1.2%, fasting plasma glucose 9.9 ± 2.3 mmol/l, weight 106 ± 20 kg, and diabetes duration 5 ± 4 years.

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 with +0.4 ± 0.3% with placebo LAR (P < 0.0001 for both). A1C of 7% was achieved by 36 and 86% of subjects receiving 0.8 and 2.0 mg exenatide LAR, respectively, compared with 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 with +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), whereas 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-h glycemic control and weight reduction with a novel once-weekly treatment for type 2 diabetes.

Abbreviations: BID, twice daily • GLP-1, glucagon-like peptide-1 • ITT, intention to treat • LAR, long-acting release

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