A Prospective Trial of Enavogliflozin to Evaluate Cardio-renal Outcome in Type 2 Diabetes Mellitus Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Enavogliflozin, Dapagliflozin or Empagliflozin.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 2, Cardiovascular Diseases, Kidney Diseases. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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)
Overview
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.
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 first large-scale SGLT2 inhibitor outcome study targeting this population.
Interventions
- Drug Enavogliflozin
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. - Drug Dapagliflozin or Empagliflozin
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 outcome measures
- Time from randomization to first onset of cardiorenal composite outcome event [Time frame: 6 months, 12 months, 24 months, 36 months and 48 month]
Secondary outcome measures (8)
- 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]
- death from any cause [Time frame: 6 months, 12 months, 24 months, 36 months and 48 months]
- death from cardiovascular causes [Time frame: 6 months, 12 months, 24 months, 36 months and 48 months]
- hospitalization due to unstable angina [Time frame: 6 months, 12 months, 24 months, 36 months and 48 months]
- hospitalization due to heart failure [Time frame: 6 months, 12 months, 24 months, 36 months and 48 months]
- coronary or peripheral revascularization [Time frame: 6 months, 12 months, 24 months, 36 months and 48 months]
- major renal events [Time frame: 6 months, 12 months, 24 months, 36 months and 48 months]
- progression of macroalbuminuria [Time frame: 6 months, 12 months, 24 months, 36 months and 48 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Department of Internal Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Se — Seoul
Identifiers
NCT: NCT06642623 · 4-2023-1334