Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes exenatide Byetta Amylin Lilly
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 494
Healthy volunteers: no

Brief summary:
This study in Germany is designed to compare the effects of twice-daily exenatide plus metformin and twice-daily premixed human insulin aspart plus metformin with respect to glycemic control, as measured by HbA1c, combined with the percentage of patients with at least one treatment-emergent hypoglycemic episode. Patients will be treated with study therapy for approximately 26 weeks.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: exenatide twice daily (BID) intervention 2: premixed insulin aspart twice daily (BID)
Intervention descriptions: intervention 1: subcutaneous injection (5 mcg or 10 mcg), twice a day intervention 2: subcutaneous injection (titrated appropriately), twice a day

Protocol document: