CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 571 enrolled
Drug / intervention
Met DR +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02526524
NCT02526524Phase 2Completed
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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

Elcelyx Therapeutics, Inc.·interventional·Posted Aug 18, 2015·Updated Apr 27, 2018

In Brief

A Phase 2 clinical trial evaluating Met DR, Met IR, and 1 other intervention for Type 2 Diabetes Mellitus. Completed, enrolled 571 participants across 137 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 18, 2015
Enrollment StartSep 1, 2015
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 10.9 years ago

Interventions

Met DRdrug

metformin delayed-release tablets

Met IRdrug

metformin immediate-release tablets

Placebodrug