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.

中文翻译：

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一项为期12周，随机，双盲，安慰剂对照，四臂剂量寻找2期研究评估贝沙格列净作为2型糖尿病成人的单药治疗。

目的比较贝沙列净以三种剂量强度在12周期间内对未接受药物治疗或先前已处方一种口服降糖药并接受6周口服治疗的2型糖尿病患者的安全性和有效性。禁药。方法将HbA1c在7.0％至8.5％之间的2型糖尿病成年人（n = 292）随机接受贝格列净（5、10或20 mg）或安慰剂的三种剂量之一。主要终点是％HbA1c从基线到第12周的变化。次要终点包括空腹血糖（FPG），收缩压和舒张压，体重和HbA1c <7％的患者比例的基线变化。结果对于5、10和20 mg组，从基线到第12周，安慰剂调整后％HbA1c的混合模型重复测量估计值为-0.55％（95％CI：-0.76％，-0.34％，P <0.0001 ），-0.68％（95％CI：-0.89％，-0.47％，P <0.0001）和-0.80％（95％CI：-1.01％，-0.59％，P <0.0001）。观察到FPG和体重从基线到第12周的安慰剂调整后均值显着降低。在20 mg贝格列净组中，达到HbA1c <7％的受试者比例显着更高。与接受安慰剂者（40.3％）相比，所有活动组参与者的不良事件发生率相似（42.3％）。结论贝格列净对2型糖尿病患者具有实质性和剂量依赖性的益处，并且具有可接受的安全性。