A prospective trial of Enavogliflozin to evaluate cardio-renal outcome in type 2 diabetes mellitus patients
- Conditions
- Endocrine, nutritional and metabolic diseases
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 2862
1. Male and female adults aged 19 years and older at screening
2. Subjects diagnosed with T2D at screening
3. Subjects on treatment with or requiring treatment with enavogliflozin, dapagliflozin, or empagliflozin within the scope of label and reimbursement criteria
1. Subjects with different types of diabetes mellitus other than T2D
2. Subjects with moderate to severe hepatic impairment
3. 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
4. Subjects with major comorbidities
5. Subjects with a history of hypersensitivity to enavogliflozin, dapagliflozin, or empagliflozin and any of its components
6. Pregnant or breastfeeding women
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time from randomization to first onset of cardiorenal composite outcome event
- Secondary Outcome Measures
Name Time Method Time from randomization to the first onset of 3-point MACE and proportion of the patients;death from any cause;death from cardiovascular causes;hospitalization due to unstable angina;hospitalization due to HF;coronary or peripheral revascularization;major renal events;progression of macroalbuminuria