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A 12‐week, randomized, double‐blind, placebo‐controlled, four‐arm dose‐finding phase 2 study evaluating bexagliflozin as monotherapy for adults with type 2 diabetes
Author(s) -
Halvorsen YuanDi,
Walford Geoffrey,
Thurber Tara,
Russell Heidy,
Massaro Monica,
Freeman Mason W.
Publication year - 2020
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.13928
Subject(s) - medicine , placebo , type 2 diabetes , blood pressure , clinical endpoint , adverse effect , diabetes mellitus , randomized controlled trial , body mass index , abstinence , endocrinology , alternative medicine , pathology , psychiatry
Aim To compare the safety and efficacy of bexagliflozin administered as monotherapy at three dosage strengths over a 12‐week period to patients with type 2 diabetes who were either naïve to pharmacotherapy or were previously prescribed one oral hypoglycaemic agent and underwent a 6‐week period of medication abstinence. Methods Adults with type 2 diabetes (n = 292) having an HbA1c of between 7.0% and 8.5% were randomized to receive one of three dosage strengths of bexagliflozin (5, 10 or 20 mg) or placebo. The primary endpoint was the change from baseline to week 12 in the %HbA1c. Secondary endpoints included the changes from baseline in fasting plasma glucose (FPG), systolic blood pressure and diastolic blood pressure, body mass and fraction of patients achieving an HbA1c of <7%. Results The mixed model repeated measure estimates of the placebo‐adjusted change in %HbA1c from baseline to week 12 for the 5, 10 and 20 mg groups were −0.55% (95% CI: −0.76%, −0.34%, P < 0.0001), −0.68% (95% CI: −0.89%, −0.47%, P < 0.0001) and −0.80% (95% CI: −1.01%, −0.59%, P < 0.0001), respectively. Significant and dose‐dependent placebo‐adjusted mean reductions from baseline to week 12 in FPG and body mass were observed. The fraction of subjects achieving an HbA1c of <7% was significantly greater in the 20 mg bexagliflozin group. The incidence of adverse events was similar for participants in all active arms (42.3%) compared with the rate measured in those receiving placebo (40.3%). Conclusions Bexagliflozin confers substantial and dose‐dependent benefits on subjects with type 2 diabetes and has an acceptable safety profile. Further evaluation of bexagliflozin for the control of type 2 diabetes in adults is warranted.