Extension Study Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid Versus Metformin 1000 mg Bid
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 567
- 试验地点
- 112
- 主要终点
- Frequency of Patients With Adverse Events (AEs)
研究概览
简要总结
A phase III randomised, double-blind parallel group extension study to investigate the efficacy and safety of twice daily administration of the free combination of linagliptin 2.5 mg + metformin 500 mg or of linagliptin 2.5 mg + metformin 1000 mg versus monotherapy with metformin 1000 mg twice daily over 54 weeks in type 2 diabetic patients previously completing the double-blind part of study 1218.46
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
Linagliptin + metformin bid
Linagliptin low dose + metformin 500 mg, bid
干预措施: Linagliptin + metformin (Drug)
Linagliptin+ metformin bid
Linagliptin low dose + metformin 1000 mg bid
干预措施: Linagliptin+metformin (Drug)
Metformin bid
Metformin 1000 mg bid
干预措施: Metformin (Drug)
结局指标
主要结局
Frequency of Patients With Adverse Events (AEs)
时间窗: 54 weeks
This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.
Change From Baseline at Week 54 in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
时间窗: 54 weeks
Baseline is defined as Visit 1 of 1218.52.
Change From Baseline at Week 54 in Pulse Rate
时间窗: 54 weeks
Baseline is defined as Visit 1 of 1218.52.
Frequency of Patients With Possibly Clinically Significant Abnormal Laboratory Parameters: Haematology
时间窗: 54 weeks
Possibly Clinically Significant Abnormal Laboratory Parameters: Clinical Chemistry
时间窗: 54 weeks
ULN means upper limit of normal
Clinical Relevant Drug-related Abnormal Findings in Physical Examination and ECG as Reported as AE
时间窗: Baseline and drug stop (up to 54 weeks) + 7 days
Frequency of patients with adverse events by treatment, primary system organ class and preferred term
次要结局
- Change in HbA1c From Baseline Over Time(78 weeks)
- Number of Patients With HbA1c <7.0% After 54 Weeks(54 weeks)
- Number of Patients With HbA1c <6.5% Over Time(54 weeks)
- Number of Patients With HbA1c of at Least <0.5% Over Time(54 weeks)
- Change in FPG From Baseline Over Time(54 weeks)
- Number of Patients With Rescue Therapy(54 weeks)