NCT03259789

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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Bexagliflozin in Subjects With Type 2 Diabetes Mellitus Who Are Not Adequately Controlled by Metformin Alone

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 351 (actual)
• Sponsor: Theracos · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the effect of bexagliflozin compared to placebo as an add-on therapy to metformin in lowering hemoglobin A1c (HbA1c) levels in subjects with type 2 diabetes mellitus (T2DM).

Detailed description

Approximately 300 subjects with inadequately controlled T2DM on metformin were to be recruited from the United States and Japan. Subjects were randomly assigned to receive bexagliflozin tablets, 20 mg, or bexagliflozin tablets, placebo, in a ratio of 1:1 once daily for 24 weeks. Subjects were to continue taking metformin for the duration of the study. The study also enrolled 50 subjects with extremely poorly controlled T2DM on metformin to receive open-label bexagliflozin tablets, 20 mg, for 24 weeks.

Conditions

• Type2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Bexagliflozin tablets, 20 mg	Each subject will receive bexagliflozin, 20 mg once daily for the duration of the study.
DRUG	Bexagliflozin tablets, placebo	Each subject will receive placebo (inactive tablet) once daily for the duration of the study.
DRUG	Bexagliflozin tablets, 20 mg	Each subject will receive bexagliflozin, 20 mg once daily for the duration of the study.

Timeline

• Start date: 2017-11-28
• Primary completion: 2019-01-23
• Completion: 2019-01-23
• First posted: 2017-08-24
• Last updated: 2021-07-07
• Results posted: 2021-07-07

Locations

43 sites across 2 countries: United States, Japan

Regulatory

• FDA-regulated drug study