NCT02558296

Bexagliflozin Efficacy and Safety Trial

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,700 (actual)
• Sponsor: Theracos · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Approximately 130 investigative sites globally are planned to participate in this study. An estimated 1650 subjects with inadequately controlled T2DM and an elevated risk of cardiovascular adverse events will be randomized to bexagliflozin tablets, 20 mg, or placebo in a ratio of 2:1 in addition to the background anti-diabetic medications. The study is an event-driven trial. The treatment period will end when the last randomized subject has completed at least 52 weeks of treatment and a total of at least 134 subjects have experienced a cardiac event.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Bexagliflozin	20 mg, tablet
DRUG	Placebo	20 mg tablet to match active comparator

Timeline

• Start date: 2015-10-01
• Primary completion: 2018-08-01
• Completion: 2019-10-23
• First posted: 2015-09-23
• Last updated: 2021-07-14
• Results posted: 2021-07-07

Locations

157 sites across 10 countries: United States, Canada, Czechia, Denmark, Mexico, Netherlands, Poland, Russia, South Korea, Taiwan