NCT06642623RecruitingPhase 4
A Prospective Trial of Enavogliflozin to Evaluate Cardio-renal Outcome in Type 2 Diabetes Mellitus Patients
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)
Source: ClinicalTrials.gov · Last updated 15 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 2862 (estimated)
- First submitted
- 13 Oct 2024
- Start date
- 22 Jan 2024
- Primary completion date
- 30 Sept 2029
- Lead sponsor
- Yonsei University
- Diseases
- Type 2 diabetes
- NCT number
- NCT06642623
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 2862
- From 22 Jan 2024 to the primary completion date, 30 Sept 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Subjects with different types of diabetes mellitus other than T2D
- Subjects with moderate to severe hepatic impairment
- Subjects with a history of hypersensitivity to enavogliflozin, dapagliflozin, or empagliflozin and any of its components
Lab values
- 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
Other
- Subjects with major comorbidities
- Pregnant or breastfeeding women
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Internal Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.