NCT01179048已完成3 期
A Long-term, Multi-centre, International, Randomised Double-blind, Placebo-controlled Trial to Determine Liraglutide Effects on Cardiovascular Events
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 9,341
- 试验地点
- 1
- 主要终点
- Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)
研究概览
简要总结
This trial is conducted in Africa, Asia, Europe, and North and South America. The aim of this trial is to determine the long term effect of liraglutide on cardiovascular events in subjects 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 (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes - Age min. 50 years at screening and concomitant cardiovascular, cerebrovascular or peripheral vascular disease or chronic renal failure or chronic heart failure OR age min. 60 years at screening and other specified risk factors of cardiovascular disease - HbA1c: 7.0% or above - Anti-diabetic drug naive or treated with one or more oral anti-diabetic drugs (OADs) or treated with human NPH insulin or long-acting insulin analogue or premixed insulin, alone or in combination with OAD(s)
排除标准
- •Type 1 diabetes - Use of a glucagon-like peptide-1 (GLP-1) receptor agonist (exenatide, liraglutide or other) or pramlintide or any dipeptidyl peptidase 4 (DPP-4) inhibitor within the 3 months prior to screening (trial start) - Use of insulin other than human NPH insulin or long-acting insulin analogue or premixed insulin within 3 months prior to screening. Short-term use of other insulin during this period in connection with intercurrent illness is allowed, at Investigator's discretion
研究组 & 干预措施
Liraglutide
Experimental
干预措施: liraglutide (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)
时间窗: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)
Time from randomisation to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome). The percentage of subjects experiencing a first event of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome) is presented.
次要结局
- Time From Randomisation to All Cause Death(from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days))
- Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome(from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days))
- Time From Rand. to First Occurrence of an Expanded Composite Cardiovascular Outcome Defined as Either Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, Revascularisation, Hospitalisation for Unstable Angina or for Heart Failure.(from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days))
- Time From Randomisation to First Occurrence of a Composite Microvascular Outcome(from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days))
- Time From Randomisation to Each Individual Component of the Composite Microvascular Outcome and to the Retinopathy and Nephropathy Composite Outcomes Separately.(from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Efficacy and Safety of Activated Recombinant Human Factor VII in Severely Injured Trauma PatientsAcquired Bleeding DisorderTraumaNCT01563523Novo Nordisk A/S283
已完成
4 期
Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT00469092Novo Nordisk A/S480
已完成
2 期
Haemophilia Patients With Inhibitors Being Treated for Acute Joint BleedsCongenital Bleeding DisorderHaemophilia AHaemophilia BNCT00486278Novo Nordisk A/S51
已完成
2 期
Safety and Efficacy of 3 Different Doses of Long Acting Factor VII in Haemophilia A or B Patients With InhibitorsCongenital Bleeding DisorderHaemophilia A With InhibitorsHaemophilia B With InhibitorsNCT00951405Novo Nordisk A/S23
已完成
2 期
Efficacy of NovoSeven® in Bleeding Prophylaxis in HemophiliaCongenital Bleeding DisorderHaemophilia A With InhibitorsHaemophilia B With InhibitorsNCT00108758Novo Nordisk A/S23