A Double-blind Phase III Study to Evaluate the Efficacy of BI 1356 5 mg and 10 mg vs. Placebo for 12 Weeks and vs. Voglibose 0.6 mg for 26 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control, Followed by an Extension Study to 52 Weeks to Evaluate Long-term Safety
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 561
- 试验地点
- 47
- 主要终点
- Change From Baseline in HbA1c at Week 12
研究概览
简要总结
The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (BI 1356) (5 mg or 10 mg / once daily) compared to placebo given for 12 weeks and voglibose for 26 weeks as mono therapy in patients with type 2 diabetes mellitus with insufficient glycaemic control. Furthermore, long-term safety is evaluated with an extension treatment to 52 weeks.
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
voglibose 0.2 mg three times a day (TID)
patient to receive a tablet containing 0.2 mg voglibose TID plus 2 placebo tablets matching BI 1356
干预措施: voglibose (Drug)
BI 1356 low dose
patient to receive a tablet containing BI 1356 and matching placebo plus 3 placebo tablets matching voglibose
干预措施: BI 1356 (Drug)
BI 1356 high dose
patient to receive 2 tablets containing BI 1356 plus 3 placebo tablets matching voglibose
干预措施: BI 1356 (Drug)
placebo
patient to receive 2 placebo tablets matching BI 1356 plus 3 placebo tablets matching voglibose
干预措施: voglibose placebo (Drug)
placebo
patient to receive 2 placebo tablets matching BI 1356 plus 3 placebo tablets matching voglibose
干预措施: BI 1356 placebo (Drug)
结局指标
主要结局
Change From Baseline in HbA1c at Week 12
时间窗: 12 weeks
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Change From Baseline in HbA1c at Week 26
时间窗: 26 weeks
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Examination of Long-term Safety of Linagliptin (52-week Treatment)
时间窗: 52 weeks
The incidence of AEs (Preferred Terms) with a frequency of 5% or more in the patients with type 2 diabetes mellitus who received linagliptin (5 mg or 10 mg) once daily for 52 weeks
次要结局
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12(12 weeks)
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26(26 weeks)
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52(52 weeks)
- Relative Efficacy Response of HbA1c at Week 12(12 weeks)
- Relative Efficacy Response of HbA1c at Week 26(26 weeks)
- Relative Efficacy Response of HbA1c at Week 52(52 weeks)