At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,700 enrolled
Drug / intervention
Bexagliflozin +1 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 Double Blind Placebo Controlled Study to Evaluate the Effects of Bexagliflozin on Hemoglobin A1c in Patients With Type 2 Diabetes and Increased Risk of Cardiovascular Adverse Events
In Brief
A Phase 3 clinical trial evaluating Bexagliflozin and Placebo for Type 2 Diabetes Mellitus. Completed, enrolled 1,700 participants across 157 sites in 10 countries.
Detailed Summary
The purpose of this study is to investigate the effect of bexagliflozin in lowering hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM) and increased risk of cardiovascular adverse events. The data from this study will be combined with the data from other bexagliflozin studies in a meta-analysis of CV safety outcomes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesCanada, Czechia, Denmark, Mexico, Netherlands, Poland, Russia, South Korea, Taiwan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 2015
Enrollment StartOct 2015
Primary CompletionAug 2018
Study CompletionOct 2019
TodayJul 2026
First PostedSep 23, 2015
Enrollment StartOct 1, 2015
Primary CompletionAug 1, 2018
Study CompletionOct 23, 2019
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 10.8 years ago
Interventions
Bexagliflozindrug
20 mg, tablet
Placebodrug
20 mg tablet to match active comparator