NCT06642623 A Prospective Trial of Enavogliflozin to Evaluate Cardio-renal Outcome in Type 2 Diabetes Mellitus Patients
| NCT ID | NCT06642623 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Yonsei University |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,862 participants |
| Start Date | 2024-01-22 |
| Primary Completion | 2029-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 2,862 participants in total. It began in 2024-01-22 with a primary completion date of 2029-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Frequently Asked Questions
Who can join the NCT06642623 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Diabetes Mellitus, Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06642623 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06642623 currently recruiting?
Yes, NCT06642623 is actively recruiting participants. Visit ClinicalTrials.gov or contact Yonsei University to inquire about joining.
Where is the NCT06642623 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06642623 clinical trial?
NCT06642623 is sponsored by Yonsei University. The trial plans to enroll 2,862 participants.
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