At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 426 enrolled
Drug / intervention
Bexagliflozin +3 moredrug
Likely dose
Bexagliflozin 20 mgfrom 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 Phase 3, Randomized, Double-blind, Active-controlled Study to Evaluate the Effects of Bexagliflozin Versus Glimepiride in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control by Metformin
In Brief
A Phase 3 clinical trial evaluating Bexagliflozin, Placebo for Bexagliflozin, and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 426 participants across 45 sites in 4 countries.
Detailed Summary
The purpose of this study is to investigate the effect of bexagliflozin compared to glimepiride as an add-on therapy to metformin in lowering hemoglobin A1c (HbA1c) levels in subjects with type 2 diabetes mellitus (T2DM).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesGermany, Poland, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 2016
Enrollment StartAug 2016
Primary CompletionJun 2019
TodayJul 2026
First PostedMay 11, 2016
Enrollment StartAug 15, 2016
Primary CompletionJun 14, 2019
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 10.1 years ago
Interventions
Bexagliflozindrug
20 mg, tablet
Placebo for Bexagliflozindrug
inactive tablet to match active comparator bexagliflozin
Glimepiridedrug
2, 4 or 6 mg, capsule
Placebo for Glimepiridedrug
inactive capsules to match active comparator glimepiride