CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 39 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/NCT01658514
NCT01658514Phase 2Completed
CompareCT.gov

A Randomized, Crossover Study Assessing the Single Dose Pharmacokinetics of Delayed-Release Metformin in Subjects With Renal Dysfunction

Elcelyx Therapeutics, Inc.·interventional·Posted Aug 7, 2012·Updated Dec 30, 2015

In Brief

A Phase 2 clinical trial evaluating Met DR, Met XR, and 1 other intervention for Renal Insufficiency. Completed, enrolled 39 participants.

Detailed Summary

This study evaluated how a single dose of delayed-release metformin (Met DR) behaves in subjects with normal kidney function, mild kidney dysfunction, moderate kidney dysfunction, or severe kidney dysfunction. The safety and tolerability of Met DR was also examined. In addition, this study compared the behavior of a single dose of Met DR with that of extended-release metformin (Met XR) and placebo in subjects with the varying levels of kidney function described above.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Insufficiency
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 7, 2012
Enrollment StartJan 1, 2014
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 13.9 years ago

Interventions

Met DRdrug

metformin delayed-release tablets

Met XRdrug

metformin extended-release tablets

Placebodrug