Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 377
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Exenatide suspension 2 mg weekly subcutaneous injection arm 2: Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks

Interventions: intervention 1: Exenatide once weekly suspension intervention 2: Exenatide twice daily
Intervention descriptions: intervention 1: Exenatide suspension 2 mg weekly subcutaneous injection intervention 2: 5 mcg twice daily for 4 weeks followed by 10 mcg twice daily for 24 weeks

Protocol document: