Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL). A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly in Patients With Type 2 Diabetes Mellitus.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 14,752
- 试验地点
- 1
- 主要终点
- Primary Efficacy Outcome MACE Events
研究概览
简要总结
This study will compare the impact of including exenatide once weekly in addition to usual care vs. usual care without exenatide on major cardiovascular outcomes as measured by the primary composite endpoint of cardiovascular-related death, nonfatal myocardial infarction (MI), or nonfatal stroke.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has type 2 diabetes mellitus
- •Patient has an HbA1c of ≥ 6.5 % and ≤ 10.0% and is currently using one of the following treatment regimens: A) Treatment with 0-3 oral antihyperglycemic agents B) Insulin therapy, either alone or in combination with up to two oral agents
- •Female patients must not be breast feeding and agree to use an effective method of contraception or must not otherwise be at risk of becoming pregnant.
排除标准
- •Patient has a diagnosis of type 1 diabetes mellitus, or a history of ketoacidosis.
- •Patient has ever been treated with an approved or investigational GLP-1 receptor agonist.
- •Patient is enrolled in another experimental protocol which involves the use of an investigational drug or device, or an intervention that would interfere with the conduct of the trial.
- •Patient has a planned or anticipated revascularization procedure.
- •Pregnancy or planned pregnancy during the trial period.
- •Patient has end-stage renal disease or an estimated glomerular filtration rate (eGFR) of <30 mL/min/1.73m
- •Patient has a history of gastroparesis or pancreatitis.
- •Personal or family history of medullary thyroid cancer or MEN2 (Multiple EndocrineNeoplasia Type 2) or calcitonin level of >40 ng/L at baseline.
研究组 & 干预措施
Exenatide Once Weekly
干预措施: Exenatide Once Weekly (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Primary Efficacy Outcome MACE Events
时间窗: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
The primary efficacy outcome variable is defined as the composite endpoint of cardiovascular death, nonfatal MI, or nonfatal stroke. The number of participants who had an event is reported in the results. The primary efficacy endpoint is the same as the primary safety endpoint, and the statistical analysis tests the superiority of exenatide against the placebo.
Primary Safety Outcome MACE Events
时间窗: Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
The primary safety outcome variable is defined as the composite endpoint of cardiovascular death, nonfatal MI, or nonfatal stroke. The number of participants who had an event is reported in the results. The primary safety endpoint is the same as the primary efficacy endpoints, and the statistical analysis tests the non-inferiority of exenatide against placebo.
次要结局
- Secondary Efficacy Outcome All-Cause Mortality(Time to first event. Information collected during study period (anticipated to be up to 7.5 years).)
- Secondary Efficacy Outcome CV Death(Time to first event. Information collected during study period (anticipated to be up to 7.5 years).)
- Secondary Efficacy Outcome Hospitalization for HF(Time to first event. Information collected during study period (anticipated to be up to 7.5 years).)
- Secondary Efficacy Outcome MI(Time to first event. Information collected during study period (anticipated to be up to 7.5 years).)
- Secondary Efficacy Outcome Stroke(Time to first event. Information collected during study period (anticipated to be up to 7.5 years).)
- Secondary Efficacy Outcome Hospitalization for ACS(Time to first event. Information collected during study period (anticipated to be up to 7.5 years).)