[Translation] A multicenter, randomized, double-blind study of metformin hydrochloride in combination with Bexagliflozin (20 mg) tablets or dapagliflozin (10 mg) tablets in patients with type 2 diabetes who were poorly controlled after metformin hydrochloride monotherapy , parallel, positive control phase III clinical study
主要目的: 在接受二甲双胍≥1500mg/天单药治疗,糖化血红蛋白(HbA1c)控制不佳的2型糖尿病(T2DM)患者中,评估Bexagliflozin或达格列净治疗24周后HbA1c较基线水平的降低,证明Bexagliflozin的疗效非劣于达格列净。
次要目的:
比较Bexagliflozin和达格列净治疗组之间,第24周较基线的体重变化 比较Bexagliflozin与达格列净治疗组之间,第24周空腹血糖(FPG)较基线的变化
比较Bexagliflozin和达格列净治疗组之间,第24周达到血糖疗效反应(定义为HbA1c<7.0%和<6.5%)的受试者比例
比较Bexagliflozin和达格列净治疗组之间,第24周较基线的血压变化
比较Bexagliflozin和达格列净治疗组之间,第24周餐后2h血糖(MTT试验2h点)相对基线的变化
安全性目的:
比较Bexagliflozin和达格列净治疗组之间对相关不良事件(AE)发生率的影响
比较Bexagliflozin和达格列净治疗组之间对一般安全性评估的影响
[Translation] Main objective: To assess the reduction in HbA1c from baseline after 24 weeks of treatment with Bexagliflozin or dapagliflozin in patients with type 2 diabetes mellitus (T2DM) who received metformin ≥1500 mg/day monotherapy and whose glycated hemoglobin (HbA1c) was poorly controlled, Demonstrated that Bexagliflozin is non-inferior to dapagliflozin.
Secondary purpose:
Comparison of weight change from baseline at Week 24 between Bexagliflozin and dapagliflozin-treated groups
To compare the proportion of subjects who achieved a glycemic response (defined as HbA1c <7.0% and <6.5%) at Week 24 between the Bexagliflozin and Dapagliflozin treatment groups
Comparison of blood pressure change from baseline at Week 24 between Bexagliflozin and Dapagliflozin treatment groups
Comparison of changes from baseline in 2h postprandial blood glucose (MTT test 2h point) at week 24 between Bexagliflozin and dapagliflozin treatment groups
Security Purpose:
To compare the effects of Bexagliflozin and Dapagliflozin treatment groups on the incidence of related adverse events (AEs)
Comparison of effects on general safety assessment between Bexagliflozin and dapagliflozin treatment groups