Conditions: Diabetes Mellitus Type 2
Keywords: diabetes type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 442
Healthy volunteers: no

Brief summary:
The purpose of this study is to examine the effectiveness and safety of insulin lispro protamine suspension (ILPS) as compared to insulin detemir as basal insulin therapy in adults with type 2 diabetes. A gatekeeper strategy will be employed for sequentially testing the secondary objectives.

Detailed description:

Arms:
arm 1: Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks. arm 2: Detemir: Patient specific dose administered subcutaneously once or twice daily x 24 weeks.

Interventions: intervention 1: Insulin Lispro Protamine Suspension intervention 2: Detemir
Intervention descriptions: intervention 1: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks. intervention 2: Patient specific dose administered subcutaneously once or twice daily x 24 weeks.

Protocol document: