A 24‐week, randomized, double‐blind, active‐controlled clinical trial comparing bexagliflozin with sitagliptin as an adjunct to metformin for the treatment of type 2 diabetes in adults

• Published in: Diabetes, obesity & metabolism obesity & metabolism, 2019-10, Vol.21 (10), p.2248-2256
• Main Authors: Halvorsen, Yuan‐Di, Lock, John P., Zhou, Wenjiong, Zhu, Fang, Freeman, Mason W.
• Format: Article
• Language: English
• Subjects: Antidiabetics; bexagliflozin; Blood pressure; body mass; Body mass index; Diabetes; Diabetes mellitus; Diabetes mellitus (non-insulin dependent); Double-blind studies; fasting plasma glucose; Glucose; HbA1c; Hemoglobin; Metformin; safety; sodium‐glucose co‐transporter‐2 inhibitor; systolic blood pressure; tolerability
• ISSN: 1462-8902; 1463-1326
• DOI: 10.1111/dom.13801

Aim To compare the relative safety and effectiveness of bexagliflozin and sitagliptin as adjuncts to metformin for the treatment of adults with type 2 diabetes. Methods Participants (n = 386) were randomized to receive bexagliflozin (20 mg) or sitagliptin (100 mg) in addition to their existing doses of metformin. The primary endpoint was the non‐inferiority of bexagliflozin to sitagliptin for change in HbA1c from baseline to week 24. Changes from baseline to week 24 in fasting plasma glucose (FPG), body mass (in subjects with baseline body mass index ≥25 kg m−2) and systolic blood pressure (SBP) were secondary endpoints. Results The mean change from baseline to week 24 in HbA1c was −0.74 (95% CI −0.86%, −0.62%) in the bexagliflozin arm and −0.82% (95% CI −0.93%, −0.71%) in the sitagliptin arm, establishing non‐inferiority. The changes from baseline FPG, body mass and SBP were −1.82 mmol L−1, −3.35 kg and −4.23 mmHg in the bexagliflozin arm and −1.45 mmol L−1, −0.81 kg and −1.90 mmHg in the sitagliptin arm, respectively. These differences were significant for the first two measures (one‐sided P = 0.0123, P