NCT02769481

Safety and Efficacy of Bexagliflozin Compared to Glimepiride as Add-on Therapy to Metformin in Type 2 Diabetes Subjects

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 426 (actual)
• Sponsor: Theracos · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Approximately 420 subjects with inadequately controlled T2DM on metformin will be recruited from North America and Europe. Subjects will be randomly assigned to receive bexagliflozin tablets, 20 mg, or glimepiride capsules, 2, 4 or 6 mg, in a ratio of 1:1 once daily for 96 weeks. Subjects will continue to take metformin for the duration of the study.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Bexagliflozin	20 mg, tablet
DRUG	Placebo for Bexagliflozin	inactive tablet to match active comparator bexagliflozin
DRUG	Glimepiride	2, 4 or 6 mg, capsule
DRUG	Placebo for Glimepiride	inactive capsules to match active comparator glimepiride

Timeline

• Start date: 2016-08-15
• Primary completion: 2019-06-14
• Completion: 2019-06-14
• First posted: 2016-05-11
• Last updated: 2021-05-27
• Results posted: 2021-05-27

Locations

45 sites across 4 countries: United States, Germany, Poland, Spain

Regulatory

• FDA-regulated drug study