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

Sponsor
Yonsei University
Study ID
NCT06642623
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Enavogliflozin — DRUG
    The dosage and administration method are determined according to the investigator's judgment, considering the drug's approval requirements and the medical condition of the study participants.
  • Dapagliflozin or Empagliflozin — DRUG
    The dosage and administration method are determined according to the investigator's judgment, considering the drug's approval requirements and the medical condition of the study participants.

Study Details

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. However, its long-term clinical benefits concerning cardiovascular and renal outcomes have yet to be thoroughly studied. This study is an investigator-initiated, multicenter, randomized, pragmatic, open-label, active-controlled, non-inferiority trial. Eligible participants are adults aged 19 or older with type 2 diabetes who have a history of, or are at risk for, cardiovascular disease. A total of 2,862 participants will be randomly assigned to receive either enavogliflozin or other SGLT2 inhibitors with proven cardiorenal benefits, such as dapagliflozin or empagliflozin. The primary endpoint is the time to the first occurrence of a composite of major adverse cardiovascular and renal events. This trial aims to determine whether enavogliflozin is non-inferior to dapagliflozin or empagliflozin in terms of cardiorenal outcomes in patients with type 2 diabetes and cardiovascular risk factors. It will also clarify role of enavogliflozin in preventing vascular complications in this patient population.

Key Dates

Start date
Jan 22, 2024
Status verified
Oct 2024
Primary completion
Sep 30, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
2,862 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Enavogliflozin Group
    Subjects will take Enavogliflozin according to the investigator's judgment.
  • Active Comparator: Dapagliflozin, Empagliflozin Group
    Subjects will take Dapagliflozin or Empagliflozin according to the investigator's judgment.

Primary Outcome Measure

Time from randomization to first onset of cardiorenal composite outcome event [ Time Frame: 6 months, 12 months, 24 months, 36 months and 48 month ]

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