At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 1,736 enrolled
Drug / intervention
Metformin XR +3 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 24-Week International, Multi-center, Randomized, Parallel-group, Double-blind Trial to Evaluate Metformin Extended Release Monotherapy Compared to Metformin Immediate Release Monotherapy in Adults Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise
In Brief
A Phase 4 clinical trial evaluating Metformin XR, Metformin IR, and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 1,736 participants across 156 sites in 10 countries.
Detailed Summary
The purpose of this study is determine if Metformin XR monotherapy in subjects with type 2 diabetes is non-inferior to Metformin IR monotherapy
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesCanada, Czechia, Germany, Hungary, Poland, Puerto Rico, Romania, South Africa, United Kingdom, United States
Collaborators--
Timeline
Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 2013
Enrollment StartJun 2013
Primary CompletionJun 2016
TodayJul 2026
First PostedMay 29, 2013
Enrollment StartJun 20, 2013
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 13.1 years ago
Interventions
Metformin XRdrug
Metformin IRdrug
Placebo matching with Metformin XRdrug
Placebo matching with Metformin IRdrug