Status:
RECRUITING
A Prospective Trial of Enavogliflozin to Evaluate Cardio-renal Outcome in Type 2 Diabetes Mellitus Patients
Lead Sponsor:
Yonsei University
Conditions:
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief 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...
Detailed Description
The ENVELOP study aims to assess cardiorenal outcomes following enavogliflozin administration compared with dapagliflozin or empagliflozin in Korean patients with type 2 diabetes, representing the fir...
Eligibility Criteria
Inclusion Criteria:
- Male and female adults aged 19 years and older at screening
- Subjects diagnosed with T2D at screening
- Subjects on treatment with or requiring treatment with enavogliflozin, dapagliflozin, or empagliflozin within the scope of label and reimbursement criteria
Exclusion Criteria:
- Subjects with different types of diabetes mellitus other than T2D
- Subjects with moderate to severe hepatic impairment
- 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
- Subjects with major comorbidities
- Subjects with a history of hypersensitivity to enavogliflozin, dapagliflozin, or empagliflozin and any of its components
- Pregnant or breastfeeding women
Key Trial Info
Start Date :
January 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
2862 Patients enrolled
Trial Details
Trial ID
NCT06642623
Start Date
January 22 2024
End Date
December 31 2030
Last Update
October 15 2024
Active Locations (1)
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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