A 52-week, Randomised, Multi-centre, Parallel Group Study to Investigate the Safety and Efficacy of BI 10773 (10 mg or 25 mg Administered Orally Once Daily) as add-on Therapy to an Oral Antidiabetic Drug (Sulfonylurea, Biguanide, Thiazolidinedione, Alpha Glucosidase Inhibitor, DPP-IV Inhibitor, or Glinide) in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,162
- 试验地点
- 87
- 主要终点
- Number of Patients With Drug Related Adverse Events
研究概览
简要总结
The objective of the study is to investigate the long-term safety and efficacy of BI 10773 given for 52 weeks as add-on therapy to one oral antidiabetic drug in patients with type 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
- 20 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 tablet once daily
干预措施: BI 10773 (Drug)
BI 10773 low dose
BI 10773 low dose tablet once daily
干预措施: Placebo (high dose) (Drug)
BI 10773 high dose
BI 10773 high dose tablet once daily
干预措施: Placebo (low dose) (Drug)
Metformin
Metformin tablets 500-2250 mg a day (twice or three times per day)
干预措施: Metformin (Drug)
BI 10773 high dose
BI 10773 high dose tablet once daily
干预措施: BI 10773 (Drug)
结局指标
主要结局
Number of Patients With Drug Related Adverse Events
时间窗: After the first drug intake until 7 days after the last treatment administration, up to 383 days
Number of Patients With Drug Related Adverse Events after the first drug intake until 7 days after the last treatment administration, up to 383 days
次要结局
- Change From Baseline in HbA1c(Baseline and 52 weeks)