Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2 Metformin XR Metformin IR
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 532
Healthy volunteers: no

Brief summary:
This is a Phase 4, prospective, open label, randomized, parallel controlled multicenter trial in which metformin extended release (XR) will be compared with metformin immediate release (IR) for the gastrointestinal tolerability and efficacy in the newly diagnosed subjects with Type 2 diabetes who have glycosylated hemoglobin (HbA1c) value between 7.0 to 10.0 percent (%).

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Metformin IR intervention 2: Metformin XR
Intervention descriptions: intervention 1: Subjects will receive Metformin Immediate Release (IR) tablets, orally once daily at a dose of 500 milligram (mg) for 1 week, and then dose will increase with increments of 500 mg every week in first 2 weeks to 1500 mg. After that dose will increase up to maximum dose of 2000 mg for the next 2 weeks and will be maintained at 2000 mg until Week 16. intervention 2: Subjects will receive Metformin Extended Release (XR) tablets, orally once daily at a dose of 500 mg for 1 week, and then dose will increase with increments of 500 mg every week in first 2 weeks to 1500 mg. After that dose will increase up to maximum dose of 2000 mg for the next 2 weeks and will be maintained at 2000 mg until Week 16.

Protocol document: