Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1736
Healthy volunteers: no

Brief summary:
The purpose of this study is determine if Metformin XR monotherapy in subjects with type 2 diabetes is non-inferior to Metformin IR monotherapy

Detailed description:

Arms:
arm 1: Metformin Extended Release (XR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks

Placebo matching with Metformin XR 0 mg tablets by mouth twice daily (BID) for 24 weeks arm 2: Metformin Immediate Release (IR) 500 mg tablets (500-2000 mg per day) by mouth twice daily (BID) for 24 weeks

Placebo matching with Metformin IR 0 mg tablets by mouth twice daily (BID) for 24 weeks

Interventions: intervention 1: Metformin XR intervention 2: Metformin IR intervention 3: Placebo matching with Metformin XR intervention 4: Placebo matching with Metformin IR
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol document: