A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg, 25 mg) Administered Orally, Once Daily Over 24 Weeks in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite Treatment With Metformin Alone or Metformin in Combination With a Sulfonylurea
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,504
- 试验地点
- 148
- 主要终点
- HbA1c Change From Baseline
研究概览
简要总结
The objective of the current study is to investigate the efficacy, safety and tolerability of two doses of BI 10773 compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients with Typ 2 Diabetes Mellitus with insufficient glycaemic control.
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
- Double
入排标准
- 年龄范围
- 18 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
BI 10773 Arm 2
BI 10773 once daily high dose
干预措施: BI 10773 (Drug)
BI 10773 Arm 2
BI 10773 once daily high dose
干预措施: Placebo identical to BI 10773 low dose (Drug)
Placebo
Placebo matching BI 10773
干预措施: Placebo identical to BI 10773 low dose (Drug)
Placebo
Placebo matching BI 10773
干预措施: Placebo identical to BI 10773 high dose (Drug)
BI 10773 open-label
BI 10773 once daily high dose open label
干预措施: BI 10773 (Drug)
BI 10773 Arm 1
BI 10773 once daily low dose
干预措施: Placebo identical to BI 10773 high dose (Drug)
BI 10773 Arm 1
BI 10773 once daily low dose
干预措施: BI 10773 (Drug)
结局指标
主要结局
HbA1c Change From Baseline
时间窗: Baseline and 24 weeks
Change from baseline in HbA1c after 24 weeks. For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication.
次要结局
- Body Weight Change From Baseline(Baseline and 24 weeks)
- Mean Daily Plasma Glucose (MDG) Change From Baseline(Baseline and 24 weeks)