Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 240
Healthy volunteers: no

Brief summary:
This study compared the effect of delayed-release metformin (Met DR) to placebo and extended release metformin (Met XR) on glycemic control (fasting plasma glucose and HbA1c) and body weight, and assessed the safety and tolerability of a range of doses of Met DR when administered in subjects with type 2 diabetes mellitus (T2DM).

Detailed description:

Arms:
arm 1: 600 mg delayed-release metformin once daily in the morning arm 2: 800 mg delayed-release metformin once daily in the morning arm 3: 1000 mg delayed-release metformin once daily in the morning arm 4: 1000 mg extended-release metformin once daily in the evening arm 5: 2000 mg extended-release metformin once daily in the evening arm 6: Placebo once daily in the morning

Interventions: intervention 1: Met DR intervention 2: Met XR intervention 3: Placebo
Intervention descriptions: intervention 1: metformin delayed-release tablets intervention 2: metformin extended-release tablets intervention 3: placebo delayed-release tablets

Protocol document: