Clinical Trial

A Prospective Trial of Enavogliflozin to Evaluate Cardio-renal Outcome in Type 2 Diabetes Mellitus Patients

Study acronym: ENVELOP
Recruiting Phase 4
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Summary
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.
Trial Details
NCT Number NCT06642623
Lead Sponsor Yonsei University
Conditions Diabetes Mellitus, Type 2, Cardiovascular Diseases, Kidney Diseases
Enrollment 2,862 participants
Start Date 2024-01-22
Primary Completion 2029-09-30 (estimated)
Study Completion 2030-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-10-15