Actively Recruiting
A Prospective, Open, Registry-based Randomized, Controlled Trial of Enavogliflozin to Evaluate Cardio-renal Outcomes in Type 2 Diabetes Patients
Led by Yonsei University · Updated on 2024-10-15
2862
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term effects of enavogliflozin, a new sodium-glucose cotransporter-2 (SGLT2) inhibitor, in adults aged 19 and older with type 2 diabetes who have or are at risk for cardiovascular disease. This study aims to determine if enavogliflozin is not less effective than other SGLT2 inhibitors like dapagliflozin or empagliflozin in reducing major heart and kidney problems. The trial is a multicenter, randomized, open-label, active-controlled, non-inferiority study focusing on cardiorenal outcomes in the Korean population. Participants will be randomly assigned to receive enavogliflozin or either dapagliflozin or empagliflozin, with the dosing and administration guided by the investigator based on approved use and the participant's medical condition. The study includes an initial treatment period with follow-up assessments up to 48 months to monitor outcomes. The primary measurement is the time to the first major heart or kidney event, while secondary outcomes include rates of heart attacks, hospitalizations, deaths, kidney events, and progression of kidney damage. During the study, participants will have regular evaluations at 6, 12, 24, 36, and 48 months to assess cardiovascular and kidney health. Researchers will monitor hospitalizations, deaths, and kidney function changes using clinical records and laboratory tests. This long-term follow-up aims to clarify the role of enavogliflozin in preventing vascular complications in patients with type 2 diabetes and cardiovascular risk factors, with safety and outcomes carefully tracked throughout the study period.
CONDITIONS
Brief 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
- Diagnosed with type 2 diabetes at screening
- Currently on or need treatment with enavogliflozin, dapagliflozin, or empagliflozin within approved use and reimbursement criteria
You will not qualify if you...
- Diagnosis of diabetes types other than type 2 diabetes
- Moderate to severe liver impairment
- Kidney problems with eGFR less than 60 mL/min/1.73 m2, end stage renal disease, or dialysis treatment
- Major additional health conditions
- History of allergic reaction to enavogliflozin, dapagliflozin, empagliflozin, or their ingredients
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 months
Participants take enavogliflozin, dapagliflozin, or empagliflozin as directed by their investigator to evaluate cardiorenal outcomes.
Regular visits as scheduled by the investigator to monitor treatment
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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