None listed
Conditions
Interventions
Drug : This study was designed as a pragmatic clinical trial(pracmatic RCT), which demonstrates the real-world effectiveness of the intervention in broad patient groups.
1. Enavogliflozin Group
The do
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from randomization to first onset of cardiorenal composite outcome event | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Korea, Republic of
Contacts
Public ContactBong Soo Cha
Yonsei University Health System, Severance Hospital
Outcome results
None listed