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

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 (%).

Timeline

Start

2014-12

Primary completion

2015-11

Completion

2016-04

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Metformin IR vs Metformin XR; p = 0.674; Percentage difference -1.52 (95% CI -8.60 to 5.56); Mantel Haenszel NCT02252965 ↗

Drugs

Indications