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:

  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:

  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

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

A Prospective Trial of Enavogliflozin to Evaluate Cardio-renal Outcome in Type 2 Diabetes Mellitus Patients | DecenTrialz