BCB118

A Randomized, Open-Label, Long-Term, Parallel-Group, Comparator-Controlled, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Exenatide Twice Daily in Subjects With Type 2 Diabetes Mellitus

BCB118 [NCT01652716]

Description:  To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus.

To examine the long-term (52 weeks of treatment) safety and effect on glucose control of exenatide suspension administered once weekly in subjects with type 2 diabetes mellitus.


Drug: Exenatide; Drug: Placebo

Primary Investigator: Kereiakes

Drug/Device Information
Compare the glycemic effects, safety, and tolerability of Exenatide once weekly suspension to Exenatide twice daily
Randomized (3:2) SQ 2-mg Exenatide once week or 10 mcg Exenatide twice day (BID, 5 mcg X 4 weeks then 10 mcg X 24 weeks)
Exenatide (BYETTA®) is a glucagon-like peptide-1 (GLP-1) receptor agonist FDA approved as a twice-daily injection
Amylin Pharmaceuticals, Inc.