A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Bexagliflozin in Subjects With Type 2 Diabetes Mellitus Who Are Not Adequately Controlled by Metformin Alone
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 351
- 试验地点
- 43
- 主要终点
- Change From Baseline in HbA1c at Week 24 for Double-blind Group
研究概览
简要总结
The purpose of this study is to investigate the effect of bexagliflozin compared to placebo as an add-on therapy to metformin in lowering hemoglobin A1c (HbA1c) levels in subjects with type 2 diabetes mellitus (T2DM).
详细描述
Approximately 300 subjects with inadequately controlled T2DM on metformin were to be recruited from the United States and Japan. Subjects were randomly assigned to receive bexagliflozin tablets, 20 mg, or bexagliflozin tablets, placebo, in a ratio of 1:1 once daily for 24 weeks. Subjects were to continue taking metformin for the duration of the study. The study also enrolled 50 subjects with extremely poorly controlled T2DM on metformin to receive open-label bexagliflozin tablets, 20 mg, for 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Bexagliflozin tablets, 20 mg; Double-Blind
干预措施: Bexagliflozin tablets, 20 mg (Drug)
Bexagliflozin tablets, Placebo; Double Blind
干预措施: Bexagliflozin tablets, placebo (Drug)
Bexagliflozin Tablets, 20 mg; High Glycemic Group
干预措施: Bexagliflozin tablets, 20 mg (Drug)
结局指标
主要结局
Change From Baseline in HbA1c at Week 24 for Double-blind Group
时间窗: Baseline to week 24
HbA1c was obtained at baseline and at Week 24. The model-adjusted change from baseline was calculated using mixed-effects repeated measures analysis.
Change From Baseline in HbA1c at Week 24 for High Glycemic Group
时间窗: Baseline to week 24
The change in HbA1c from baseline at Week 24 in High Glycemic Group was calculated by subtracting the mean HbA1c at baseline from the mean HbA1c at Week 24
次要结局
- Proportion of Subjects Achieving HbA1c < 7% Over Time for Double-blind Group(Baseline, up to 24 weeks)
- Proportion of Subjects Achieving HbA1c < 7% Over Time for High Glycemic Group(Baseline, up to 24 weeks)
- Change in Body Mass From Baseline to Week 24 in Subjects With a BMI ≥ 25 kg/m2 for Double-blind Group(Baseline to week 24)
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 for Double-blind Group(Baseline, up to 24 weeks)
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 for High Glycemic Group(Baseline, up to 24 weeks)
- Change From Baseline in Systolic Blood Pressure (SBP) at Week 24(Baseline to week 24)
- Change in Body Mass From Baseline to Week 24 in Subjects With a BMI ≥ 25 kg/m2 for High Glycemic Group(Baseline to week 24)
- Change From Baseline in HbA1c Over Time in Double-blind Treatment Group(Baseline, up to 24 weeks)
- Change in HbA1c Over Time Among Subjects Who Have Baseline HbA1c of > 10.5% and ≤ 12.0%(Baseline, up to 24 weeks)