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A 96-week multinational randomized double-blind parallel-group clinical trial evaluating the safety and effectiveness of bexagliflozin as a monotherapy for adults with type 2 diabetes

Diabetes, Obesity and Metabolism Jul 18, 2019

Halvorsen YD, et al. - The present analysis was conducted to assess the efficacy and safety of extended exposure to bexagliflozin as a monotherapy for type 2 diabetes. Two hundred eighty-eight diabetic adults from the U.S., Colombia and Mexico were randomized 1:1 to receive bexagliflozin (20 mg) or placebo for 96 weeks. A further 72 weeks of dosing were continued to assess the safety and durability of the treatment effect. According to findings, bexagliflozin at 20 mg/d was well tolerated and provided participants in this phase 2 trial with a lasting, clinically significant improvement in glycemic control over 96 weeks. Bexagliflozin produced a significant reduction in weight and blood pressure, with no increase in the rates of significant adverse events.
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