NCT02252965

Metformin Extended Release Versus Metformin Immediate Release in Subjects With Type 2 Diabetes

CONSENT - Comparison of metfOrmin XR to IR as moNotherapy in the Newly diagnoSed Type 2 diabEtes Patients for the gastroiNtestinal Tolerability and Efficacy: a Randomized, Parallel Control, Open-label and Multicenter Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 532 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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 (%).

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Metformin IR	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.
DRUG	Metformin XR	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.

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-11-01
• Completion: 2016-04-01
• First posted: 2014-09-30
• Last updated: 2017-01-24
• Results posted: 2017-01-24

Locations

1 site across 1 country: Germany