Bexagliflozin as an adjunct to metformin for the treatment of type 2 diabetes in adults: A 24-week, randomized, double-blind, placebo-controlled trial.

Autor: Halvorsen YD; Translational Medicine Group, Center for Computational and Integrative Biology, Massachusetts General Hospital, Boston, Massachusetts, USA., Conery AL; Translational Medicine Group, Center for Computational and Integrative Biology, Massachusetts General Hospital, Boston, Massachusetts, USA., Lock JP; Diabetes Center of Excellence, Department of Medicine, University of Massachusetts, Worcester, Massachusetts, USA., Zhou W; Hopkins Consulting LLC, Philadelphia, Pennsylvania, USA., Freeman MW; Translational Medicine Group, Center for Computational and Integrative Biology, Massachusetts General Hospital, Boston, Massachusetts, USA.
Jazyk: angličtina
Zdroj: Diabetes, obesity & metabolism [Diabetes Obes Metab] 2023 Oct; Vol. 25 (10), pp. 2954-2962. Date of Electronic Publication: 2023 Jul 06.
DOI: 10.1111/dom.15192
Abstrakt: Aim: To evaluate the relative safety and effectiveness of bexagliflozin as an adjunct to metformin for the treatment of type 2 diabetes mellitus.
Methods: In total, 317 participants were randomized to receive bexagliflozin or placebo plus metformin. The primary endpoint was the change in glycated haemoglobin (HbA1c) from baseline to week 24, with secondary endpoints for systolic blood pressure (SBP), fasting plasma glucose and weight loss. An open label arm enrolled participants with HbA1c >10.5% and was analysed separately.
Results: The mean change in HbA1c was -1.09% (95% CI -1.24%, -0.94%) in the bexagliflozin arm and -0.56% (-0.71%, -0.41%) in the placebo arm, a difference of -0.53% (-0.74%, -0.32%; p < .0001). Excluding observations after rescue medication, the intergroup difference was -0.70% (-0.92, -0.48; p < .0001). The open label group change in HbA1c was -2.82% (-3.23%, -2.41%). Placebo-adjusted changes from baseline SBP, fasting plasma glucose and body mass were -7.07 mmHg (-9.83, -4.32; p < .0001), -1.35 mmol/L (-1.83, -0.86; p < .0001) and -2.51 kg (-3.45, -1.57; p < .0001). Adverse events affected 42.4% and 47.2% of subjects in the bexagliflozin and placebo arms, respectively; fewer subjects in the bexagliflozin arm experienced serious adverse events.
Conclusions: Bexagliflozin produced clinically meaningful improvement in glycaemic control, estimated glomerular filtration rate and SBP when added to metformin in a population of adults with diabetes.
(© 2023 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)
Databáze: MEDLINE
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