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NCT Number: NCT06642623

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Urogenital Diseases Urologic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Internal Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea

Seoul, 03722, South Korea

Location status: Recruiting

Location contact

Bong Soo Cha, MD, PhD

CONTACT

[email protected]

+82-2-2228-1962

About this study

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 first large-scale SGLT2 inhibitor outcome study targeting this population.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Time from randomization to first onset of cardiorenal composite outcome event

    Time frame: 6 months, 12 months, 24 months, 36 months and 48 month

    Major adverse cardiovascular events include nonfatal myocardial infarction (MI), nonfatal stroke, and hospitalization for unstable angina, hospitalization for heart failure, coronary or peripheral revascularization, and death from any cause. Renal events include a sustained decline in estimated glomerular filtration rate (GFR) calculated by means of the Chronic Kidney Disease Epidemiology Collaboration equation of ≥40% from baseline to <60 mL/min/1.73m2, onset of end-stage kidney disease (dialysis for ≥28 days, kidney transplantation, or an estimated GFR of <15 mL/min/1.73m2), development of macroalbuminuria, and death from renal causes.

Secondary outcomes

  1. Time from randomization to the first onset of 3-point MACE and proportion of the patients

    Time frame: 6 months, 12 months, 24 months, 36 months and 48 months

    Time to first event of a composite of key major adverse cardiovascular events (non-fatal MI, non-fatal stroke, and death from cardiovascular causes)

  2. death from any cause

    Time frame: 6 months, 12 months, 24 months, 36 months and 48 months

    Time to death from any cause

  3. death from cardiovascular causes

    Time frame: 6 months, 12 months, 24 months, 36 months and 48 months

    Time to death from cardiovascular cause

  4. hospitalization due to unstable angina

    Time frame: 6 months, 12 months, 24 months, 36 months and 48 months

    Time to first event of hospitalization due to unstable angina

  5. hospitalization due to heart failure

    Time frame: 6 months, 12 months, 24 months, 36 months and 48 months

    Time to first event of hospitalization due to heart failure

  6. coronary or peripheral revascularization

    Time frame: 6 months, 12 months, 24 months, 36 months and 48 months

    Time to first event of coronary or peripheral revascularization

  7. major renal events

    Time frame: 6 months, 12 months, 24 months, 36 months and 48 months

    Time to first event of a composite of major kidney events

  8. progression of macroalbuminuria

    Time frame: 6 months, 12 months, 24 months, 36 months and 48 months

    Time to development of macroalbuminuria

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

A Prospective, Open, Registry-based Randomized, Controlled, Investigator Initiated Trial of Enavogliflozin(ENVlo) to EvaLuate Cardio-renal Outcome in Type 2 Diabetes Mellitus Patients (ENVELOP Study)

Acronym: ENVELOP

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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