A Prospective, Open, Registry-based Randomized, Controlled, Investigator Initiated Trial of Enavogliflozin(ENVlo) to EvaLuate Cardio-renal Outcome in Type 2 Diabetes Mellitus Patients (ENVELOP Study)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 2,862
- 试验地点
- 1
- 主要终点
- Time from randomization to first onset of cardiorenal composite outcome event
研究概览
简要总结
The novel sodium-glucose cotransporter-2 (SGLT2) inhibitor, enavogliflozin, effectively reduces glycated hemoglobin (HbA1c) levels and body weight without increasing the risk of serious adverse events. However, its long-term clinical benefits concerning cardiovascular and renal outcomes have yet to be thoroughly studied. This study is an investigator-initiated, multicenter, randomized, pragmatic, open-label, active-controlled, non-inferiority trial. Eligible participants are adults aged 19 or older with type 2 diabetes who have a history of, or are at risk for, cardiovascular disease. A total of 2,862 participants will be randomly assigned to receive either enavogliflozin or other SGLT2 inhibitors with proven cardiorenal benefits, such as dapagliflozin or empagliflozin. The primary endpoint is the time to the first occurrence of a composite of major adverse cardiovascular and renal events. This trial aims to determine whether enavogliflozin is non-inferior to dapagliflozin or empagliflozin in terms of cardiorenal outcomes in patients with type 2 diabetes and cardiovascular risk factors. It will also clarify role of enavogliflozin in preventing vascular complications in this patient population.
详细描述
The ENVELOP study aims to assess cardiorenal outcomes following enavogliflozin administration compared with dapagliflozin or empagliflozin in Korean patients with type 2 diabetes, representing the first large-scale SGLT2 inhibitor outcome study targeting this population.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female adults aged 19 years and older at screening
- •Subjects diagnosed with T2D at screening
- •Subjects on treatment with or requiring treatment with enavogliflozin, dapagliflozin, or empagliflozin within the scope of label and reimbursement criteria
排除标准
- •Subjects with different types of diabetes mellitus other than T2D
- •Subjects with moderate to severe hepatic impairment
- •Subjects with contraindications to SGLT-2 inhibitors, i.e., kidney function disorders with estimated glomerular filtration (eGFR) <60 mL/min/1.73 m2, end stage renal disease (ESRD), or on dialysis
- •Subjects with major comorbidities
- •Subjects with a history of hypersensitivity to enavogliflozin, dapagliflozin, or empagliflozin and any of its components
- •Pregnant or breastfeeding women
研究组 & 干预措施
Enavogliflozin Group
Subjects will take Enavogliflozin according to the investigator's judgment.
干预措施: Enavogliflozin (Drug)
Dapagliflozin, Empagliflozin Group
Subjects will take Dapagliflozin or Empagliflozin according to the investigator's judgment.
干预措施: Dapagliflozin or Empagliflozin (Drug)
结局指标
主要结局
Time from randomization to first onset of cardiorenal composite outcome event
时间窗: 6 months, 12 months, 24 months, 36 months and 48 month
Major adverse cardiovascular events include nonfatal myocardial infarction (MI), nonfatal stroke, and hospitalization for unstable angina, hospitalization for heart failure, coronary or peripheral revascularization, and death from any cause. Renal events include a sustained decline in estimated glomerular filtration rate (GFR) calculated by means of the Chronic Kidney Disease Epidemiology Collaboration equation of ≥40% from baseline to \<60 mL/min/1.73m2, onset of end-stage kidney disease (dialysis for ≥28 days, kidney transplantation, or an estimated GFR of \<15 mL/min/1.73m2), development of macroalbuminuria, and death from renal causes.
次要结局
- Time from randomization to the first onset of 3-point MACE and proportion of the patients(6 months, 12 months, 24 months, 36 months and 48 months)
- death from any cause(6 months, 12 months, 24 months, 36 months and 48 months)
- death from cardiovascular causes(6 months, 12 months, 24 months, 36 months and 48 months)
- hospitalization due to unstable angina(6 months, 12 months, 24 months, 36 months and 48 months)
- hospitalization due to heart failure(6 months, 12 months, 24 months, 36 months and 48 months)
- coronary or peripheral revascularization(6 months, 12 months, 24 months, 36 months and 48 months)
- major renal events(6 months, 12 months, 24 months, 36 months and 48 months)
- progression of macroalbuminuria(6 months, 12 months, 24 months, 36 months and 48 months)