Effect of Efpeglenatide on Cardiovascular Outcomes
3期
提前终止
NCT03496298
| 适应症 | Type 2 Diabetes Mellitus |
|---|
| 分期 | 3期 |
|---|
| 申办方 | Sanofi |
|---|
| 状态 | 提前终止 |
|---|
| 受试者人数 | 4,076 人 |
|---|
| 干预（药物） | Efpeglenatide (SAR439977) |
|---|
| 开始日期 | 2018年4月27日 |
|---|
| 完成日期 | 2020年12月10日 |
|---|
| 结果公布日 | 2021年10月15日 |
|---|
摘要
Primary Objective: To demonstrate that efpeglenatide 4 and 6 mg was noninferior to placebo on 3-point major adverse cardiac events (MACE) in Type 2 diabetes mellitus (T2DM) participants at high cardiovascular (CV) risk. Secondary Objectives: To demonstrate that efpeglenatide 4 and 6 mg was superior to placebo in T2DM participants with high CV risk on the following parameters: * 3-point MACE. * Expanded CV outcome. * Composite outcome of new or worsening nephropathy. To assess the safety and tolerability of efpeglenatide 4 and 6 mg, both added to standard of care in T2DM participants at high CV risk.
Time to First Occurrence of Major Adverse Cardiovascular Events (MACE): Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular (CV) Event - Non-Inferiority Analysis
From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months) · events per 100 participant-years
| Efpeglenatide 4 mg+6 mg | 3.9 events per 100 participant-years |
|---|
| Placebo | 5.3 events per 100 participant-years |
|---|
| p-value | <.0001 |
|---|
| Hazard Ratio (HR) | 0.732 (95% CI 0.583–0.918) |
|---|
在 BENITIONS 中查看
查看 ClinicalTrials.gov 原文
全部试验
本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。