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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enavogliflozin Group | Experimental | Subjects will take Enavogliflozin according to the investigator's judgment. |
|
| Dapagliflozin, Empagliflozin Group | Active Comparator | Subjects will take Dapagliflozin or Empagliflozin according to the investigator's judgment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time from randomization to first onset of cardiorenal composite outcome event | 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. | 6 months, 12 months, 24 months, 36 months and 48 month |
| Measure | Description | Time Frame |
|---|---|---|
| Time from randomization to the first onset of 3-point MACE and proportion of the patients | Time to first event of a composite of key major adverse cardiovascular events (non-fatal MI, non-fatal stroke, and death from cardiovascular causes) | 6 months, 12 months, 24 months, 36 months and 48 months |
| death from any cause |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea | Recruiting | Seoul | 03722 | South Korea |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D002318 | Cardiovascular Diseases |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000729921 | Enavogliflozin |
| C529054 | dapagliflozin |
| C570240 | empagliflozin |
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his study was designed as a pragmatic clinical trial(pracmatic RCT), which demonstrates the real-world effectiveness of the intervention in broad patient groups.
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| 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. |
|
Time to death from any cause |
| 6 months, 12 months, 24 months, 36 months and 48 months |
| death from cardiovascular causes | Time to death from cardiovascular cause | 6 months, 12 months, 24 months, 36 months and 48 months |
| hospitalization due to unstable angina | Time to first event of hospitalization due to unstable angina | 6 months, 12 months, 24 months, 36 months and 48 months |
| hospitalization due to heart failure | Time to first event of hospitalization due to heart failure | 6 months, 12 months, 24 months, 36 months and 48 months |
| coronary or peripheral revascularization | Time to first event of coronary or peripheral revascularization | 6 months, 12 months, 24 months, 36 months and 48 months |
| major renal events | Time to first event of a composite of major kidney events | 6 months, 12 months, 24 months, 36 months and 48 months |
| progression of macroalbuminuria | Time to development of macroalbuminuria | 6 months, 12 months, 24 months, 36 months and 48 months |
|
| D004700 | Endocrine System Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |