A Randomised, Double-blind Parallel Group Study to Compare the Efficacy and Safety of Initial Combination Therapy With Linagliptin 5 mg + Pioglitazone 15 mg, 30 mg, or 45 mg, vs. Monotherapy With Pioglitazone (15 mg, 30 mg, or 45 mg) or Linagliptin 5 mg Once Daily for 30 Weeks, Followed by a Blinded Trial Period on Linagliptin 5 mg + Pioglitazone 30 or 45 mg Versus Pioglitazone Monotherapy 30 or 45 mg or Linagliptin 5 mg for up to 54 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control on Diet and Exercise
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 936
- 试验地点
- 132
- 主要终点
- Change From Baseline in HbA1c After 30 Weeks of Treatment.
研究概览
简要总结
The primary objective is to demonstrate superior glycaemic control (HbA1c reduction) after 30 weeks of linagliptin/pioglitazone (5/15, 5/30 and 5/45 mg) versus the respective individual monotherapies of pioglitazone (15 mg, 30 mg, or 45 mg, administered orally once daily), and linagliptin (5 mg, administered orally once daily). In addition, durability of treatment effect and safety under chronic treatment conditions will be investigated.
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
Pioglitazone 15 mg
Pioglitazone Capsules 15 mg once daily
干预措施: Pioglitazone 15 mg (Drug)
Pioglitazone 30 mg
Pioglitazone Capsules 30 mg once daily
干预措施: Pioglitazone 30 mg (Drug)
Pioglitazone 45 mg
Pioglitazone Capsules 45 mg once daily
干预措施: Pioglitazone 45 mg (Drug)
Linagliptin 5mg
Linagliptin 5mg Tablets once daily
干预措施: Linagliptin 5mg (Drug)
Linagliptin 5mg / Pioglitazone 15 mg
Linagliptin 5mg / Pioglitazone 15 mg Tablets once daily
干预措施: Linagliptin 5mg / Pioglitazone 15 mg FDC (Drug)
Linagliptin 5mg / Pioglitazone 30 mg
Linagliptin 5mg / Pioglitazone 30 mg Tablets once daily
干预措施: Linagliptin 5mg / Pioglitazone 30 mg FDC (Drug)
Linagliptin 5mg / Pioglitazone 45 mg
Linagliptin 5mg / Pioglitazone 45 mg Tablets once daily
干预措施: Linagliptin 5mg / Pioglitazone 45 mg FDC (Drug)
结局指标
主要结局
Change From Baseline in HbA1c After 30 Weeks of Treatment.
时间窗: Baseline and 30 weeks
HbA1c is measured as a percentage. The change from baseline is the Week 30 HbA1c minus the baseline HbA1c.
次要结局
- Fasting Plasma Glucose (FPG) Change From Baseline by Visit Over Time(Baseline, week 6, week 12, week 18, week 24, week 30)
- Time to First Use of Rescue Therapy(30 weeks)
- Incidence of Rescue Therapy During the First 30 Weeks of Treatment(30 weeks)
- Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 7.0% After 30 Weeks of Treatment(Baseline and 30 weeks)
- Two-hour Postprandial Glucose (2hPPG) Change From Baseline at Week 30 by Meal Tolerance Test (MTT)(Baseline and 30 weeks)
- Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 6.5% After 30 Weeks of Treatment(Baseline and 30 weeks)
- Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 30 Weeks of Treatment)(Baseline and 30 weeks)
- HbA1c Change From Baseline by Visit Over Time(Baseline, week 6, week 12, week 18, week 24, week 30)
- Fasting Plasma Glucose (FPG) Change From Baseline After 30 Weeks of Treatment(Baseline and 30 weeks)