I8F-MC-GPGN: The Effect of Tirzepatide versus Dulaglutide on Major Adverse Cardiovascular Events in Patients with Type 2 Diabetes (SURPASS-CVOT)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4,301
- 试验地点
- 224
- 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
To assess efficacy of maximally tolerated tirzepatide dose up to 15 mg QW compared to QW dulaglutide 1.5 mg on time to first occurrence of the composite endpoint of death from CV causes, MI, or stroke (MACE-3) when both are added to standard of care in patients with T2DM and high CV risk. Primary analysis will be an assessment of NI of tirzepatide to dulaglutide for MACE-3. After establishing NI, superiority of tirzepatide compared to dulaglutide for MACE-3 will be evaluated.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
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 a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- •Have had a blood transfusion or severe blood loss within 90 days prior to screening or have known hematological conditions that may interfere with HbA1c measurement
- •Have type 1 diabetes mellitus
- •Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the last 6 months
- •Are currently planning treatment for diabetic retinopathy and/or macular edema
- •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 currently planning any gastric outlet obstruction, or have undergone or currently planning any gastric bypass (bariatric) surgery or restrictive bariatric surgery
- •Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years
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)
Time to First Occurrence of Death from Cardiovascular (CV) Causes, Myocardial Infarction (MI), or Stroke (MACE-3)
Time to First Occurrence of a component event of MACE-3
Time to First Occurrence of a component event of MACE-3
次要结局
未报告次要终点
研究者
Lilly Clinical Trials information desk
Scientific
Eli Lilly & Co.