CTRI/2020/04/024938进行中（未招募）3 期
Protocol I8F-MC-GPGN(a)The Effect of Tirzepatide versus Dulaglutide on MajorAdverse Cardiovascular Events in Patients with Type 2Diabetes (SURPASS-CVOT)
Eli Lilly and Company India Pvt Ltd18 个研究点 分布在 1 个国家目标入组 12,500 人开始时间: 2020年7月29日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12,500
- 试验地点
- 18
- 主要终点
- Time to First Occurrence of Death from Cardiovascular (CV) Causes, Myocardial Infarction (MI), or Stroke (MACE-3)
研究概览
简要总结
The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 40.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Have a diagnosis of type 2 diabetes
- •Have confirmed atherosclerotic cardiovascular disease
- •HbA1c ≥7.0% to ≤10.5%
- •Body mass index (BMI) ≥25 kilograms per meter squared (kg/m²).
排除标准
- •Have had a major cardiovascular event within the last 60 days
- •Have type 1 diabetes mellitus
- •Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the last 6 months
- •Have a history of proliferative diabetic retinopathy; or diabetic maculopathy; or non-proliferative diabetic retinopathy that requires acute treatment
- •Currently planning a coronary, carotid, or peripheral artery revascularization
- •Have a history of pancreatitis
- •Have a history of ketoacidosis or hyperosmolar state/coma
- •Have a known clinically significant gastric emptying abnormality, have undergone or plan to have during the course of the study, or chronically take drugs that directly affect gastrointestinal (GI) motility
- •Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years
- •Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2).
结局指标
主要结局
Time to First Occurrence of Death from Cardiovascular (CV) Causes, Myocardial Infarction (MI), or Stroke (MACE-3)
时间窗: Randomization up to Study Completion (Approximate Maximum 54 Months)
次要结局
- Cumulative Number of Primary Composite Events of CV Death and Total (First and Recurrent) MI and/or Stroke(Cumulative Number of CV Deaths and Total (First and Recurrent) Heart Failure Events Requiring Hospitalization and/or Urgent Heart Failure Visits)
- Time to Death from Any Cause(Time to CV Death)
- Percentage of Participants with More than 10% Weight Loss(36 Months)
- Change from Baseline in Body Weight(Change from Baseline in Hemoglobin A1c (HbA1c))
- Time to First Occurrence of Revascularization(Time to First Occurrence of Hospitalization Due to Unstable Angina)
研究者
研究点 (18)
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