The Effect of Dulaglutide on Major Cardiovascular Events in Patients With Type 2 Diabetes: Researching Cardiovascular Events With a Weekly INcretin in Diabetes (REWIND)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 9,901
- 试验地点
- 1
- 主要终点
- Number of Participants Who Experienced an Event For Time, From Randomization 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
The purpose of this trial is to assess whether dulaglutide can reduce major cardiovascular events and other serious outcomes in persons with type 2 diabetes, when added to their anti-hyperglycemic regimen.
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 with Hemoglobin A1c equal to or less than 9.5% (equal to or less than 81 mmol/mol)
- •Anti-hyperglycemic drug naive or treated with up to 2 oral hyperglycemic drugs with or without a glucagon-like peptide-1analog or basal insulin, or basal insulin alone
- •On stable antihyperglycemic regimen for at least 3 months
- •Age equal to or greater than 50 years with established clinical vascular disease, or age equal to or greater than 55 years and subclinical vascular disease or age equal to or greater than 60 years and at least 2 or more cardiovascular risk factors
排除标准
- •Uncontrolled diabetes requiring immediate therapy
- •History of severe hypoglycemia in past year
- •Acute coronary or cerebrovascular event within past 2 months
- •Planned or anticipated revascularization procedure
- •History of pancreatitis, hepatic insufficiency , chronic renal failure or of C-cell thyroid disorder
- •Pregnancy or planned pregnancy during the trial period
- •Completed or withdrawn from any study investigating dulaglutide
研究组 & 干预措施
1.5 mg Dulaglutide
Administered once weekly, subcutaneously
干预措施: Dulaglutide (Drug)
Placebo
Administered once weekly, subcutaneously
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Who Experienced an Event For Time, From Randomization to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)
时间窗: From randomization to first occurrence or death from any cause or study completion (Median Follow-Up of 5.4 Years)
The time from randomization to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite endpoint) was evaluated using time-to-event analysis. The primary analysis model was a Cox proportional hazards regression model for the time to the first occurrence of a primary endpoint event, with treatment as a fixed effect using the intent-to-treat population. The number of participants who experienced a primary cardiovascular (CV) endpoint event is presented.
次要结局
- Number of Participants Who Experienced an Event for Time to All-cause Mortality(From randomization to study completion (Median Follow-Up of 5.4 Years))
- Number of Participants Who Experienced An Event for Time to First Occurrence After Randomization of Heart Failure Requiring Hospitalization or an Urgent Heart Failure Clinic Visit(From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years))
- Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of First Hospitalization for Unstable Angina(From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years))
- Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke, Individually(From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years))
- Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of the Composite Microvascular Endpoint(From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years))