Halvorsen Yuan-Di, Lock John Paul, Frias Juan P, Tinahones Francisco José, Dahl Dominik, Conery Annie L, Freeman Mason W
Translational Medicine Group, Center for Computational and Integrative Biology, Massachusetts General Hospital, Boston, Massachusetts.
Theracos Sub, LLC, Marlborough, Massachusetts.
Diabetes Obes Metab. 2023 Jan;25(1):293-301. doi: 10.1111/dom.14875. Epub 2022 Oct 23.
To compare the effects of bexagliflozin tablets 20 mg, with those of optimally titrated glimepiride when used to treat adults with type 2 diabetes mellitus (T2DM) inadequately controlled by metformin.
Adults with type 2 diabetes (n = 426) taking metformin, and with a glycated haemoglobin (HbA1c) level between 53 and 91 mmol/mol [7.0% and 10.5%], were randomized to receive bexagliflozin tablets 20 mg or titrated glimepiride. The primary endpoint was the intergroup difference in the change from baseline to Week 60 in percent HbA1c. Secondary endpoints included changes from baseline in body mass and systolic blood pressure (SBP), and proportion of subjects experiencing severe or documented symptomatic hypoglycaemia.
The intergroup difference in percent HbA1c (bexagliflozin minus glimepiride) from baseline to Week 60 was -0.55 mmol/mol (95% confidence interval [CI] -2.30, 1.20)-[-0.05% (-0.21, 0.11)], establishing noninferiority of bexagliflozin to glimepiride by the prespecified margin of 3.83 mmol/mol [0.35%]. Prespecified tests gave, in order, a difference in body mass of -4.31 kg (95% CI -5.10, -3.52; P < 0.0001), a difference in SBP of -6.53 mm Hg (95% CI -10.56, -2.51; P = 0.0008), and an odds ratio of 0.12 (95% CI 0.05, 0.28; P < 0.0001) for severe or documented symptomatic hypoglycaemia. At the follow-up visit the mean difference in estimated glomerular filtration rate (eGFR) between arms was 6.05 mL min per 1.73 m (95% CI, 3.24, 8.87; P < 0.0001).
Bexagliflozin was noninferior to glimepiride in lowering HbA1c, was superior to glimepiride for decreases in body mass and SBP, and was associated with significantly fewer hypoglycaemic events than glimepiride. A favourable effect on eGFR was observed.
比较20毫克贝西格列净片与优化滴定剂量的格列美脲用于治疗二甲双胍控制不佳的2型糖尿病（T2DM）成人患者时的疗效。
426例服用二甲双胍且糖化血红蛋白（HbA1c）水平在53至91毫摩尔/摩尔[7.0%至10.5%]之间的2型糖尿病成人患者，被随机分配接受20毫克贝西格列净片或滴定剂量的格列美脲。主要终点是从基线到第60周HbA1c百分比变化的组间差异。次要终点包括体重和收缩压（SBP）相对于基线的变化，以及发生严重或有记录的症状性低血糖的受试者比例。
从基线到第60周，HbA1c百分比的组间差异（贝西格列净减去格列美脲）为-0.55毫摩尔/摩尔（95%置信区间[CI]-2.30，1.20）-[-0.05%（-0.21，0.11）]，按照预先设定的3.83毫摩尔/摩尔[0.35%]的非劣效界值，确定贝西格列净不劣于格列美脲。预先设定的检验依次得出，体重差异为-4.31千克（95%CI-5.10，-3.52；P<0.0001），SBP差异为-6.53毫米汞柱（95%CI-10.56，-2.51；P=0.0008），严重或有记录的症状性低血糖的比值比为0.12（95%CI0.05，0.28；P<0.0001）。在随访时，两组间估计肾小球滤过率（eGFR）的平均差异为每1.73平方米6.05毫升/分钟（95%CI，3.24，8.87；P<0.0001）。
在降低HbA1c方面，贝西格列净不劣于格列美脲，在降低体重和SBP方面优于格列美脲，且与格列美脲相比，低血糖事件显著减少。观察到对eGFR有有利影响。
