NCT02526524

Dose-Ranging Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Metformin Delayed Release in Subjects With T2DM

Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo-Controlled, Dose-Ranging Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Metformin Delayed Release In Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 571 (actual)
• Sponsor: Elcelyx Therapeutics, Inc. · Industry
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to compare the glycemic effects of delayed-release metformin (Met DR) to placebo in subjects with type 2 diabetes mellitus (T2DM) over 16 weeks. The study is designed to evaluate several doses of Met DR (600 to 1500 mg once daily in the morning \[qAM\]) compared to placebo. A single-blind reference treatment of 2000 mg metformin immediate-release (Met IR) per day administered as equal divided doses (1000 mg Met IR BID) will also be included.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Met DR	metformin delayed-release tablets
DRUG	Met IR	metformin immediate-release tablets
DRUG	Placebo

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2015-08-18
• Last updated: 2018-04-27
• Results posted: 2018-04-27

Locations

137 sites across 2 countries: United States, Puerto Rico