At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 240 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.
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
In Brief
A Phase 2 clinical trial evaluating Met DR, Met XR, and 1 other intervention for Type 2 Diabetes Mellitus. Completed, enrolled 240 participants.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 2013
Enrollment StartApr 2013
Primary CompletionSep 2013
TodayJul 2026
First PostedMar 27, 2013
Enrollment StartApr 1, 2013
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 13.3 years ago
Interventions
Met DRdrug
metformin delayed-release tablets
Met XRdrug
metformin extended-release tablets
Placebodrug
placebo delayed-release tablets