A Phase III, Randomized, Double-blind, Placebo-controlled, Parallel Group Safety and Efficacy Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) During 52 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycemic Control on MDI Insulin Regimen Alone or With Metformin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 566
- 试验地点
- 103
- 主要终点
- Change From Baseline in HbA1c After 18 Weeks of Treatment
研究概览
简要总结
This trial will evaluate use of BI 10773 as add-on to insulin regimen alone or with metformin in patients with typr 2 diabetes. Both lowering glucose and HbA1c and reducing the use of insulin in this population would provide significant new information for the BI 10773 use and would offer a potential new therapeutic option in this population.
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 low dose once daily
干预措施: Placebo (Drug)
BI 10773 low dose
BI 10773 low dose once daily
干预措施: BI 10773 (Drug)
BI 10773 high dose
BI 10733 high dose once daily
干预措施: Placebo (Drug)
BI 10773 high dose
BI 10733 high dose 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
Change From Baseline in HbA1c After 18 Weeks of Treatment
时间窗: Baseline and 18 weeks
The primary endpoint was the change from baseline in HbA1c after 18 weeks of treatment.
次要结局
- Change From Baseline in Insulin Dose After 52 Weeks of Treatment(Baseline and 52 weeks)
- Change From Baseline in Body Weight After 52 Weeks of Treatment(Baseline and 52 weeks)
- Change From Baseline in HbA1c After 52 Weeks of Treatment(Baseline and 52 weeks)