Actively Recruiting
A Prospective Trial of Enavogliflozin to Evaluate Cardio-renal Outcome in Type 2 Diabetes Mellitus Patients
Led by Yonsei University · Updated on 2024-10-15
2862
Participants Needed
1
Research Sites
362 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Prospective Trial of Enavogliflozin to Evaluate Cardio-renal Outcome in Type 2 Diabetes Mellitus Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 19 years and older at screening
- Diagnosed with type 2 diabetes at screening
- Currently treated with or requiring treatment with enavogliflozin, dapagliflozin, or empagliflozin within approved label and reimbursement criteria
You will not qualify if you...
- Diagnosed with types of diabetes other than type 2 diabetes
- Moderate to severe liver impairment
- Kidney problems including estimated glomerular filtration rate below 60 mL/min/1.73 m2, end stage renal disease, or on dialysis
- Major other medical conditions
- History of allergic reaction to enavogliflozin, dapagliflozin, empagliflozin or their components
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Internal Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea
Seoul, South Korea, 03722
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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