Clinical trial NCT06642623: A Prospective Trial of Enavogliflozin to Evaluate Cardio-renal Outcome in Type 2 Diabetes Mellitus Patients
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Cardiovascular Diseases
Kidney Diseases
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 2862
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: his study was designed as a pragmatic clinical trial(pracmatic RCT), which demonstrates the real-world effectiveness of the intervention in broad patient groups.
Primary purpose: TREATMENT

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. 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.

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

Primary outcomes:
measure: Time from randomization to first onset of cardiorenal composite outcome event
timeFrame: 6 months, 12 months, 24 months, 36 months and 48 month
Secondary outcomes:
measure: Time from randomization to the first onset of 3-point MACE and proportion of the patients
timeFrame: 6 months, 12 months, 24 months, 36 months and 48 months
measure: death from any cause
timeFrame: 6 months, 12 months, 24 months, 36 months and 48 months
measure: death from cardiovascular causes
timeFrame: 6 months, 12 months, 24 months, 36 months and 48 months
measure: hospitalization due to unstable angina
timeFrame: 6 months, 12 months, 24 months, 36 months and 48 months
measure: hospitalization due to heart failure
timeFrame: 6 months, 12 months, 24 months, 36 months and 48 months
measure: coronary or peripheral revascularization
timeFrame: 6 months, 12 months, 24 months, 36 months and 48 months
measure: major renal events
timeFrame: 6 months, 12 months, 24 months, 36 months and 48 months
measure: progression of macroalbuminuria
timeFrame: 6 months, 12 months, 24 months, 36 months and 48 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Internal Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea
Study officials:
References: