A Phase III Randomised, Double-blind, Double-dummy, Parallel Group Study to Compare the Efficacy and Safety of Twice Daily Administration of the Fix Dose Combination of Linagliptin 2.5 mg + Metformin 500 mg, or of Linagliptin 2.5 mg + Metformin 1000 mg, With the Individual Components of Metformin (500 mg or 1000 mg, Twice Daily), and Linagliptin (5.0 mg, Once Daily) Over 24 Weeks in Treatment naïve Type 2 Diabetic Patients With Insufficient Glycaemic Control
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 876
- 试验地点
- 56
- 主要终点
- The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group - FAS (OC)
研究概览
简要总结
Reduced factorial design study with 24 week randomized treatment of initial combination therapy with linagliptin and metformin in T2DM patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
linagliptin2.5mg / metformin500mg BID
patient to receive a tablet containing linagliptin 2.5mg and metformin 500mg BID
干预措施: linagliptin 5mg (Drug)
linagliptin2.5mg / metformin500mg BID
patient to receive a tablet containing linagliptin 2.5mg and metformin 500mg BID
干预措施: Metformin 500mg (Drug)
linagliptin2.5mg / metformin1000mg BID
patient to receive a tablet containing linagliptin 2.5mg and metformin 1000mg BID
干预措施: linagliptin 5mg (Drug)
linagliptin2.5mg / metformin1000mg BID
patient to receive a tablet containing linagliptin 2.5mg and metformin 1000mg BID
干预措施: Metformin 1000mg (Drug)
metformin 500mg BID
patient to receive a tablet containing metformin 500mg BID
干预措施: linagliptin2.5mg/metformin500mg (Drug)
metformin 1000mg BID
patient to receive a tablet containing metformin 1000mg BID
干预措施: linagliptin2.5mg/metformin1000mg (Drug)
linagliptin 5 mg QD
patient to receive a tablet containing linagliptin 5mg once daily
干预措施: linagliptin2.5mg/metformin1000mg (Drug)
linagliptin 5 mg QD
patient to receive a tablet containing linagliptin 5mg once daily
干预措施: linagliptin2.5mg/metformin500mg (Drug)
结局指标
主要结局
The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group - FAS (OC)
时间窗: Baseline and week 24
The change from baseline in HbA1c after 24 weeks of treatment in main group. Only subjects from the FAS with measured HbA1c values (observed cases \[OC\]) were considered. The mean was adjusted by treatment, baseline HbA1c, week and treatment\*week. The sensitivity analysis was added as the primary analysis failed with borderline results.
The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group
时间窗: Baseline and week 24
The change from baseline in HbA1c after 24 weeks of treatment in main group. The mean was adjusted by baseline HbA1c and treatment group.
The Change From Baseline in HbA1c After 12 Weeks of Treatment in APG
时间窗: Baseline and week 12
The change from baseline in HbA1c after 12 weeks of treatment in additional parallel group (APG) The mean was adjusted by baseline HbA1c and treatment group.
次要结局
- The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 7.0 % After 12 Weeks of Treatment in APG(Week 12 (after first drug administration))
- The Occurrence of Relative Efficacy Response in Main Group(From baseline until week 24)
- The Change in Fasting Plasma Glucose (FPG) From Baseline After 12 Weeks of Treatment in APG(Baseline and week 12)
- The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 7.0 % After 24 Weeks of Treatment in Main Group(Week 24 (after first drug administration))
- The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 6.5% After 24 Weeks of Treatment in Main Group(Week 24 (after first drug administration))
- The Frequency of Patients With Use of Rescue Therapy During 12 Week Treatment Period in APG(From baseline until week 12)
- The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 6.5% After 12 Weeks of Treatment in APG(Week 12 (after first drug administration))
- The Occurrence of Relative Efficacy Response in APG(From baseline until week 12)
- The Change in Fasting Plasma Glucose (FPG) From Baseline After 24 Weeks of Treatment in Main Group(Baseline and week 24)
- The Frequency of Patients With Use of Rescue Therapy During 24 Week Treatment Period in Main Group(From baseline until week 24)