NCT01819272

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

A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Delayed-Release Metformin in Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Elcelyx Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Met DR	metformin delayed-release tablets
DRUG	Met XR	metformin extended-release tablets
DRUG	Placebo	placebo delayed-release tablets

Timeline

• Start date: 2013-04-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2013-03-27
• Last updated: 2017-03-15
• Results posted: 2015-09-21