A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg and 25 mg Administered Once Daily) as Add on to Pre-existing Antidiabetic Therapy Over 52 Weeks in Patients With Type 2 Diabetes Mellitus and Renal Impairment and Insufficient Glycaemic Control
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 741
- 试验地点
- 127
- 主要终点
- HbA1c Change From Baseline in Patients With Mild or Moderate Renal Impairment
研究概览
简要总结
This study will investigate the efficacy and safety of the BI 10773 in type 2 diabetic patients with renal impairment in order to provide these data for approval for BI 10773 as an antidiabetic agent by regulatory authorities.
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 low dose
BI 10773 tablets once daily
干预措施: BI 10773 (Drug)
BI 10773 low dose
BI 10773 tablets once daily
干预措施: Placebo (Drug)
BI 10773 high dose
BI 10773 tablets once daily
干预措施: Placebo (Drug)
BI 10773 high dose
BI 10773 tablets once daily
干预措施: BI 10773 (Drug)
Placebo
Placebo tablets matching BI 10773
干预措施: Placebo (Drug)
结局指标
主要结局
HbA1c Change From Baseline in Patients With Mild or Moderate Renal Impairment
时间窗: Baseline and 24 weeks
Change from baseline in HbA1c after 24 weeks, for patients with mild or moderate renal impairment. Note adjusted means are provided.
HbA1c Change From Baseline in Patients With Mild Renal Impairment
时间窗: Baseline and 24 weeks
Change from baseline in HbA1c after 24 weeks, for patients with mild renal impairment. Note adjusted means are provided.
HbA1c Change From Baseline in Patients With Moderate Renal Impairment
时间窗: Baseline and 24 weeks
Change from baseline in HbA1c after 24 weeks, for patients with moderate renal impairment. Note adjusted means are provided.
次要结局
未报告次要终点