A 24-week, Randomized, Double-blind, Active-controlled, Parallel Group Trial to Assess the Superiority of Oral Linagliptin and Metformin Compared to Linagliptin Monotherapy in Newly Diagnosed, Treatment-naïve, Uncontrolled Type 2 Diabetes Mellitus Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 316
- 试验地点
- 82
- 主要终点
- Change From Baseline in HbA1c After 24 Weeks
研究概览
简要总结
The purpose of this trial is to determine whether a initial combination of linagliptin and metformin compared to linagliptin alone for 24 weeks is effective in newly diagnosed, treatment-naïve patients with Type 2 Diabetes.
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 —（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
linagliptin
patients receive linagliptin tablet once daily
干预措施: linagliptin (Drug)
linagliptin
patients receive linagliptin tablet once daily
干预措施: metformin placebo (Drug)
linagliptin plus metformin
patients receive linagliptin tablet once daily and metformin tablets twice daily
干预措施: metformin (Drug)
linagliptin plus metformin
patients receive linagliptin tablet once daily and metformin tablets twice daily
干预措施: linagliptin (Drug)
linagliptin plus metformin
patients receive linagliptin tablet once daily and metformin tablets twice daily
干预措施: metformin placebo (Drug)
结局指标
主要结局
Change From Baseline in HbA1c After 24 Weeks
时间窗: Baseline and 24 weeks
HbA1c is measured as a percentage. The change from baseline is the Week 24 HbA1c minus the baseline HbA1c. Means are adjusted for treatment and continuous baseline HbA1c
次要结局
- Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment(Baseline and 24 weeks)
- Change From Baseline in HbA1c by Visit Over Time(Baseline, 6, 12, 18 and 24 weeks)
- Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment)(Baseline and 24 weeks)
- Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 1.0% After 24 Weeks of Treatment)(Baseline and 24 weeks)
- Occurrence of Treat to Target Efficacy Response (HbA1c <7.0%) After 24 Weeks of Treatment(Baseline and 24 weeks)
- Change From Baseline in FPG by Visit Over Time(Baseline, 6, 12, 18 and 24 weeks)