Conditions: Type 2 Diabetes
Keywords: Exenatide Amylin Lilly Byetta Exenatide Once Weekly
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 121
Healthy volunteers: no

Brief summary:
The purpose of Study BCB111 is to collect efficacy, pharmacokinetic, pharmacodynamic, safety, and tolerability data in patients with type 2 diabetes to assess the feasibility of once monthly dosing of the exenatide suspension formulation.

Detailed description:

Arms:
arm 1: 2 mg exenatide once weekly subcutaneous (SC). This arm is used as a reference arm in the study. arm 2: Low dose 5 mg exenatide once monthly suspension SC. arm 3: Medium dose 8 mg exenatide once monthly suspension SC. arm 4: High dose 11 mg exenatide once monthly suspension SC.

Interventions: intervention 1: exenatide once weekly intervention 2: exenatide once monthly suspension intervention 3: exenatide once monthly suspension intervention 4: exenatide once monthly suspension
Intervention descriptions: intervention 1: subcutaneous injection, 2 mg, once a week intervention 2: subcutaneous injection, low dose, once a month intervention 3: subcutaneous injection, medium dose, once a month intervention 4: subcutaneous injection, high dose, once a month

Protocol document: