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Clinical Trial Details

Trial ID: L4638
Source ID: NCT06642623
Associated Drug: Enavogliflozin
Title: A Prospective Trial of Enavogliflozin to Evaluate Cardio-renal Outcome in Type 2 Diabetes Mellitus Patients
Acronym: ENVELOP
Status: RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2|Cardiovascular Diseases|Kidney Diseases
Interventions: DRUG: Enavogliflozin|DRUG: Dapagliflozin or Empagliflozin
Outcome Measures: Primary: Time from randomization to first onset of cardiorenal composite outcome event, 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., 6 months, 12 months, 24 months, 36 months and 48 month | Secondary: Time from randomization to the first onset of 3-point MACE and proportion of the patients, Time to first event of a composite of key major adverse cardiovascular events (non-fatal MI, non-fatal stroke, and death from cardiovascular causes), 6 months, 12 months, 24 months, 36 months and 48 months|death from any cause, Time to death from any cause, 6 months, 12 months, 24 months, 36 months and 48 months|death from cardiovascular causes, Time to death from cardiovascular cause, 6 months, 12 months, 24 months, 36 months and 48 months|hospitalization due to unstable angina, Time to first event of hospitalization due to unstable angina, 6 months, 12 months, 24 months, 36 months and 48 months|hospitalization due to heart failure, Time to first event of hospitalization due to heart failure, 6 months, 12 months, 24 months, 36 months and 48 months|coronary or peripheral revascularization, Time to first event of coronary or peripheral revascularization, 6 months, 12 months, 24 months, 36 months and 48 months|major renal events, Time to first event of a composite of major kidney events, 6 months, 12 months, 24 months, 36 months and 48 months|progression of macroalbuminuria, Time to development of macroalbuminuria, 6 months, 12 months, 24 months, 36 months and 48 months
Sponsor/Collaborators: Sponsor: Yonsei University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 2862
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-01-22
Completion Date: 2030-12-31
Results First Posted:
Last Update Posted: 2024-10-15
Locations: Department of Internal Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea, Seoul, 03722, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT06642623