A Double-blind, Randomised, Parallel Group Efficacy and Safety Study of BI 10773 (5 mg, 10 mg, 25 mg, and 50 mg) Compared to Placebo When Administered Orally Once Daily Over 12 Weeks, as Monotherapy, in Patients With Type 2 Diabetes and Insufficient Glycaemic Control Despite Diet and Exercise, Followed by a 40 Week Randomised Extension Study to Assess Long Term Safety of BI 10773 (10 mg and 25 mg)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 547
- 试验地点
- 32
- 主要终点
- Change From Baseline in HbA1c After 12 Weeks of Treatment.
研究概览
简要总结
This study is conducted to determine the most appropriate therapeutic doses of BI 10773 in Japanese patients with T2DM at first treatment period. The second treatment period is required to obtain sufficient safety data (one-year exposure to BI 10773) in Japanese patients with T2DM according to the ICH E1 guideline.
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
- 20 Years 至 80 Years（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 QD
BI 10773 tablets low dose once a day
干预措施: Placebo (mid dose) (Drug)
BI 10773 low dose QD
BI 10773 tablets low dose once a day
干预措施: Placebo (high dose) (Drug)
BI 10773 low dose QD
BI 10773 tablets low dose once a day
干预措施: BI 10773 (Drug)
BI 10773 mid-low dose QD
BI 10773 tablets mid-low dose once a day
干预措施: Placebo (high dose) (Drug)
BI 10773 mid-low dose QD
BI 10773 tablets mid-low dose once a day
干预措施: Placebo (low dose) (Drug)
BI 10773 mid-low dose QD
BI 10773 tablets mid-low dose once a day
干预措施: BI 10773 (Drug)
BI 10773 mid-high dose QD
BI 10773 tablets mid-high dose once a day
干预措施: BI 10773 (Drug)
BI 10773 mid-high dose QD
BI 10773 tablets mid-high dose once a day
干预措施: Placebo (high dose) (Drug)
BI 10773 mid-high dose QD
BI 10773 tablets mid-high dose once a day
干预措施: Placebo (low dose) (Drug)
BI 10773 mid-high dose QD
BI 10773 tablets mid-high dose once a day
干预措施: Placebo (mid dose) (Drug)
BI 10773 high dose QD
BI 10773 tablets high dose once a day
干预措施: Placebo (low dose) (Drug)
BI 10773 high dose QD
BI 10773 tablets high dose once a day
干预措施: Placebo (mid dose) (Drug)
BI 10773 high dose QD
BI 10773 tablets high dose once a day
干预措施: BI 10773 (Drug)
Placebo
Placebo tablets once a day
干预措施: Placebo (low dose) (Drug)
Placebo
Placebo tablets once a day
干预措施: Placebo (high dose) (Drug)
Placebo
Placebo tablets once a day
干预措施: Placebo (mid dose) (Drug)
结局指标
主要结局
Change From Baseline in HbA1c After 12 Weeks of Treatment.
时间窗: baseline and 12 weeks
The primary endpoint in this study is the change from baseline in HbA1c after 12 weeks of treatment.
次要结局
- Occurrence of Treat to Target Efficacy Response(baseline and 12 weeks)
- Change From Baseline in FPG(baseline and 12 weeks)