Who is sponsoring NCT02526524?

NCT02526524 is sponsored by Elcelyx Therapeutics, Inc..

What condition does NCT02526524 study?

NCT02526524 studies Type 2 Diabetes Mellitus.

What drugs are being tested in NCT02526524?

Interventions: Met DR, Met IR, Placebo.

What is the status of NCT02526524?

NCT02526524 is currently COMPLETED.

Last reviewed 2018-03-27 · How we verify

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

NCT02526524 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	Elcelyx Therapeutics, Inc.
Phase	Phase 2
Status	COMPLETED
Enrolment	571
Start date	2015-09
Completion	2016-09

Conditions

Type 2 Diabetes Mellitus

Interventions

Met DR
Met IR
Placebo

Primary outcomes

Change in HbA1c (%) at 16 Weeks — Baseline and 16 weeks after the first dose of study medication

Countries

United States, Puerto Rico