Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 571
Healthy volunteers: no

Brief summary:
The purpose of the study is to compare the glycemic effects of delayed-release metformin (Met DR) to placebo in subjects with type 2 diabetes mellitus (T2DM) over 16 weeks. The study is designed to evaluate several doses of Met DR (600 to 1500 mg once daily in the morning \[qAM\]) compared to placebo. A single-blind reference treatment of 2000 mg metformin immediate-release (Met IR) per day administered as equal divided doses (1000 mg Met IR BID) will also be included.

Detailed description:

Arms:
arm 1: 600 mg metformin delayed-release once daily in the morning arm 2: 900 mg metformin delayed-release once daily in the morning arm 3: 1200 mg metformin delayed-release once daily in the morning arm 4: 1500 mg metformin delayed-release once daily in the morning arm 5: placebo match for 600 and 1200 mg Met DR qAM treatment groups arm 6: placebo match for 900 and 1500 mg Met DR qAM treatment groups arm 7: 1000 mg metformin immediate-release twice daily

Interventions: intervention 1: Met DR intervention 2: Met IR intervention 3: Placebo
Intervention descriptions: intervention 1: metformin delayed-release tablets intervention 2: metformin immediate-release tablets intervention 3: None

Protocol document: