Evaluating Enavogliflozin for Heart and Kidney Health in Type 2 Diabetes
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)
This study is testing if a new diabetes medication called enavogliflozin can improve heart and kidney health in adults with type 2 diabetes compared to other similar medications.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 2862 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06642623 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of enavogliflozin, a sodium-glucose cotransporter-2 (SGLT2) inhibitor, on cardiovascular and renal outcomes in adults with type 2 diabetes. The study is a multicenter, randomized, open-label trial comparing enavogliflozin to other established SGLT2 inhibitors like dapagliflozin and empagliflozin. A total of 2,862 participants will be enrolled, and the primary goal is to assess the time to the first occurrence of major adverse cardiovascular and renal events. This research aims to provide insights into the long-term benefits of enavogliflozin in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 or older with type 2 diabetes who have a history of or are at risk for cardiovascular disease.
Not a fit: Patients with other types of diabetes, severe kidney issues, or major comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence for the long-term cardiovascular and renal benefits of enavogliflozin in patients with type 2 diabetes.
How similar studies have performed: Other studies have shown success with SGLT2 inhibitors in improving cardiovascular and renal outcomes, making this approach promising.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Department of Internal Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea — Seoul, South Korea (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.