At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 386 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 Sitagliptin in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control by Metformin
In Brief
A Phase 3 clinical trial evaluating Bexagliflozin, Sitagliptin, and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 386 participants across 56 sites in 6 countries.
Detailed Summary
The purpose of this study is to investigate the effect of bexagliflozin compared to sitagliptin 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
CountriesCzechia, Hungary, Japan, Poland, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedApr 2017
Enrollment StartOct 2017
Primary CompletionOct 2018
TodayJul 2026
First PostedApr 14, 2017
Enrollment StartOct 12, 2017
Primary CompletionOct 31, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.2 years ago
Interventions
Bexagliflozindrug
tablets containing 20 mg bexagliflozin
Sitagliptindrug
tablets containing 100 mg sitagliptin
Placebo for sitagliptindrug
inactive tablets to match the appearance of sitagliptin tablets
Placebo for bexagliflozindrug
inactive tablets to match the appearance of bexagliflozin tablets