A Randomised Double-blind, Active-controlled Parallel Group Efficacy and Safety Study of BI 1356 ( 5.0 mg, Administered Orally Once Daily) Compared to Glimepiride Over Two Years in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,560
- 试验地点
- 221
- 主要终点
- HbA1c Change From Baseline at Week 52
研究概览
简要总结
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5.0 mg daily) compared to glimepiride given for 104 weeks as add-on therapy to preferably > 1500 mg metformin 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
- 18 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 1356 5mg, once daily
patient to receive a tablet containing 5mg BI 1356 plus one (two in US) inactive placebo capsule matching Glimepiride
干预措施: Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg (Drug)
BI 1356 5mg, once daily
patient to receive a tablet containing 5mg BI 1356 plus one (two in US) inactive placebo capsule matching Glimepiride
干预措施: BI 1356 (Drug)
Glimepiride
patient to receive 1mg or 2mg or 3mg (not in US) or 4mg Glimepiride capsule plus one inactive placebo tablet matching BI 1356 (plus one inactive placebo capsule in US)
干预措施: Placebo identical to BI 1356 5mg (Drug)
Glimepiride
patient to receive 1mg or 2mg or 3mg (not in US) or 4mg Glimepiride capsule plus one inactive placebo tablet matching BI 1356 (plus one inactive placebo capsule in US)
干预措施: Glimepiride (Drug)
结局指标
主要结局
HbA1c Change From Baseline at Week 52
时间窗: Baseline and week 52
This co-primary endpoint, change from baseline, reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.
HbA1c Change From Baseline at Week 104
时间窗: Baseline and week 104
This co-primary endpoint, change from baseline, reflects the Week 104 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.
次要结局
- HbA1c Change at Week 40(Baseline and week 40)
- HbA1c Change at Week 52(Baseline and week 52)
- HbA1c Change at Week 65(Baseline and week 65)
- HbA1c Change at Week 78(Baseline and week 78)
- HbA1c Change at Week 91(Baseline and week 91)
- Body Weight Change From Baseline at Week 52(Baseline and week 52)
- Body Weight Change From Baseline at Week 104(Baseline and week 104)
- Incidence of Hypoglycaemic Events up to 52 Weeks(Week 52)
- Incidence of Hypoglycaemic Events up to 104 Weeks(Week 104)
- Fasting Plasma Glucose (FPG) Change From Baseline at Week 52(Baseline and week 52)
- Fasting Plasma Glucose (FPG) Change From Baseline at Week 104(Baseline and week 104)
- Percentage of Patients With HbA1c <7.0% at Week 52(Week 52)
- Percentage of Patients With HbA1c <7.0% at Week 104(Week 104)
- Percentage of Patients With HbA1c <6.5% at Week 52(Week 52)
- Percentage of Patients With HbA1c <6.5% at Week 104(Week 104)
- Percentage of Patients With HbA1c Lowering by 0.5% at Week 104(Week 104)
- 2 hr Postprandial Glucose (PPG) Change From Baseline at Week 104(Baseline and week 104)
- HbA1c Change at Week 4(Baseline and week 4)
- HbA1c Change at Week 8(Baseline and week 8)
- HbA1c Change at Week 12(Baseline and week 12)
- HbA1c Change at Week 16(Baseline and week 16)
- HbA1c Change at Week 28(Baseline and week 28)
- HbA1c Change at Week 104(Baseline and week 104)
- Change in Baseline Lipid Parameter Cholesterol at Week 104(Baseline and week 104)
- Change in Baseline Lipid Parameter HDL at Week 104(Baseline and week 104)
- Change in Baseline Lipid Parameter Low Density Lipoprotein (LDL) at Week 104(Baseline and week 104)
- Change in Baseline Lipid Parameter Triglyceride at Week 104(Baseline and week 104)