Assessing the Efficacy, Safety, and Tolerability of Met DR in Subjects With T2DM Over 12 Weeks

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).

Timeline

Start

2013-04

Primary completion

2013-09

Completion

2013-09

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs 800 mg DR; p = 0.0057; Hodges-Lehmann Estimation -14.0 (95% CI -22.0 to -4.0) NCT01819272 ↗

Publications

• Background Buse JB, DeFronzo RA, Rosenstock J, Kim T, Burns C, Skare S, Baron A, Fineman M. The Primary Glucose-Lowering Effect of Metformin Resides in the Gut, Not the Circulation: Results From Short-term Pharmacokinetic and 12-Week Dose-Ranging Studies. Diabetes Care. 2016 Feb;39(2):198-205. doi: 10.2337/dc15-0488. Epub 2015 Aug 18.

Drugs

Indications