A Multicentre, International, Randomised, Parallel Group, Double Blind Study to Evaluate Cardiovascular Safety of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes Mellitus at High Cardiovascular Risk.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 6,103
- 试验地点
- 607
- 主要终点
- The First 3-point Major Adverse Cardiovascular Events (3P-MACE)
研究概览
简要总结
The aim of the study is to investigate the longterm impact on cardiovascular morbidity and mortality, relevant efficacy parameters (e.g., glycaemic parameters) and safety (e.g., weight and hypoglycaemia) of treatment with linagliptin in patients with type 2 diabetes at elevated cardiovascular risk receiving usual care, and compare outcome against glimepiride.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 85 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
patient to receive linagliptin or glimepiride placebo over encapsulated tablet Quaque die (QD)
干预措施: linagliptin (Drug)
linagliptin
patient to receive linagliptin or glimepiride placebo over encapsulated tablet Quaque die (QD)
干预措施: glimepiride placebo (Drug)
glimepiride 1-4 mg QD
patient to receive glimepiride 1-4 mg or linagliptin placebo tablet Quaque die (QD)
干预措施: glimepiride (Drug)
glimepiride 1-4 mg QD
patient to receive glimepiride 1-4 mg or linagliptin placebo tablet Quaque die (QD)
干预措施: linagliptin placebo (Drug)
结局指标
主要结局
The First 3-point Major Adverse Cardiovascular Events (3P-MACE)
时间窗: From randomization until individual day of trial completion, up to 432 weeks
The first occurrence of any of the following Clinical Event Committee (CEC) confirmed adjudicated components of the primary composite endpoint: CV death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI (excluding silent MI), or nonfatal stroke is presented.
次要结局
- Time to First Occurrence of Any of the Components of the Composite Endpoint of All Adjudication-confirmed Events(From start of the treatment until 7 days after the end of treatment, up to 433 weeks)
- Change From Baseline to Final Visit Fasting Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol and High-density Lipoprotein (HDL) Cholesterol(Baseline and week 432)
- Change From Baseline to Final Visit in Triglycerides(Baseline and week 432)
- Change From Baseline to Final Visit in Creatinine(Baseline and week 432)
- Percentage of Participants With Occurrence of Any of the Components of the Composite Endpoint of All Adjudication-confirmed Events(From start of the treatment until 7 days after the end of treatment, up to 433 weeks)
- Change From Baseline to Final Visit in Estimated Glomerular Filtration Rate (eGFR)(Baseline and week 432)
- Change From Baseline to Final Visit in Urine Albumin Creatinine Ratio (UACR)(Baseline and week 432)
- Percentage of Participants Who Were on Trial Medication at Trial End, Maintained Glycaemic Control (HbA1c ≤7.0%) Without Need for Rescue Medication, and Without >2% Weight Gain During Maintenance Phase(From Visit 6 (Week 16) to Final visit (Week 432) (Maintenance Phase))
- Change From Baseline to Final Visit in Hemoglobin A1c (HbA1c)(Baseline and week 432)
- Percentage of Participants With Transition in Albuminuria Classes(Baseline and week 432)
- Percentage of Participants With Occurrence of Accelerated Cognitive Decline at End of Follow-up(433 weeks)
- Change From Baseline of Insulin Secretion Rate (ISR) at Fixed Glucose Concentration at 208 Weeks(Baseline and week 208)
- CGM Sub-study : Change From Baseline in the Inter-quartile Range of Diurnal Glucose Variability (Millimoles/ Litre) to End of Study(Baseline)
- Percentage of Participants Taking Trial Medication at Trial End, Maintained Glycaemic Control (HbA1c ≤7.0%) Without Need for Rescue Medication, Without >2% Weight Gain, and Without Moderate/Severe Hypoglycaemic Episodes During Maintenance Phase(From Visit 6 (Week 16) to Final visit (Week 432) (Maintenance Phase))
- Continuous Glucose Monitoring (CGM) Sub-study: Change From Baseline in the Inter-quartile Range of Diurnal Glucose Variability (Milligrams/ Deciliter) to End of Study(Baseline)
- The First 4-point (4P)- MACE(From randomization until individual day of trial completion, up to 432 weeks)
- Percentage of Participants With the Occurrence of at Least One Event of 3P-MACE(From randomization until individual day of trial completion, up to 432 weeks)
- Percentage of Participants With the Occurrence of at Least One Event of 4P -MACE(From randomization until individual day of trial completion, up to 432 weeks)
- Change From Baseline to Final Visit in Fasting Plasma Glucose (FPG)(Baseline and week 432)