NCT01167881已完成3 期
A Phase III Randomised, Double-blind, Active-controlled Parallel Group Efficacy and Safety Study of BI 10773 Compared to Glimepiride Administered Orally During 104 Weeks With a 104 Week Extension Period in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Metformin Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,549
- 试验地点
- 182
- 主要终点
- The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment.
研究概览
简要总结
This is a pivotal phase III study, mandatory to seek approval by regulatory authorities for BI 10773 as an anti-diabetic agent compared to an active comparator in patients with type 2 diabetes mellitus and 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
Glimepiride 1-4 mg plus metformin
Active Comparator
Patients receive one glimepiride capsule and one placebo tablet Bi 10773 once daily.
干预措施: Placebo (Drug)
BI 10773 dose plus metformin
Experimental
Patients receive one BI10773 tablet and one placebo Glimepiride capsule once daily
干预措施: BI 10773 (Drug)
BI 10773 dose plus metformin
Experimental
Patients receive one BI10773 tablet and one placebo Glimepiride capsule once daily
干预措施: Placebo (Drug)
Glimepiride 1-4 mg plus metformin
Active Comparator
Patients receive one glimepiride capsule and one placebo tablet Bi 10773 once daily.
干预措施: Glimepiride (Drug)
结局指标
主要结局
The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment.
时间窗: Baseline and 104 weeks
次要结局
- The Change From Baseline in HbA1c After 52 Weeks of Treatment.(baseline and 52 weeks)
- The Change in Body Weight From Baseline After 104 Weeks of Treatment.(baseline and 104 weeks)
- The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment.(baseline and 104 weeks)
- The Occurrence of Confirmed Hypoglycaemic Events During 52 Weeks of Treatment.(baseline and 52 weeks)
- The Change in Diastolic Blood Pressure (DBP) From Baseline After 52 Weeks of Treatment.(baseline and 52 weeks)
- The Change in Systolic Blood Pressure (SBP) From Baseline After 104 Weeks of Treatment.(baseline and 104 weeks)
- The Change in Diastolic Blood Pressure (DBP) From Baseline After 104 Weeks of Treatment.(baseline and 104 weeks)
- The Change in Body Weight From Baseline After 52 Weeks of Treatment.(baseline and 52 weeks)
- The Change in Systolic Blood Pressure (SBP) From Baseline After 52 Weeks of Treatment.(baseline and 52 weeks)
研究者
研究点 (182)
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