| NCT ID | NCT06846411 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Seoul National University Bundang Hospital |
| Condition | Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2025-09-30 |
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 46 participants in total. It began in 2024-01-01 with a primary completion date of 2025-09-30.
⚠ 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
This multicenter, open-label, prospective study randomized 46 drug-naïve adults with T2D (HbA1c 6.5%-10.0%) to receive empagliflozin (10 mg/day) or metformin (1,000 mg/day) for 12 weeks.
Eligibility Criteria
Inclusion Criteria: * Participants were eligible if they had T2D with an HbA1c between 6.5% and 10.0%, were between 20 and 75 years of age, and had not received any anti-diabetic medications for at least eight weeks prior to screening. Exclusion Criteria: * individuals with a body mass index (BMI) \<18.5 kg/m² or ≥40 kg/m², clinically significant hepatic impairment (e.g., hepatic cirrhosis, portal hypertension, chronic active hepatitis), or a history of acute cardiovascular events (e.g., coronary artery disease, cerebrovascular disease, peripheral arterial disease) within two months prior to enrollment. Participants with CKD (eGFR \<60 mL/min/1.73 m²) or end-stage renal disease (eGFR \<15 mL/min/1.73 m² or on dialysis) were also excluded. Additional exclusion criteria included uncontrolled hypertension (BP ≥160/100 mmHg), New York Heart Association (NYHA) class III or IV heart failure, chronic oral corticosteroid use (\>30 consecutive days), a history of cancer (except basal cell carcinoma) within the past five years, or significant dyslipidemia (triglycerides \>1,000 mg/dL or LDL cholesterol \>250 mg/dL).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06846411 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Diabetes. 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 NCT06846411 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 NCT06846411 currently recruiting?
Yes, NCT06846411 is actively recruiting participants. Contact the research team at 65423@snubh.org for enrollment information.
Where is the NCT06846411 trial being conducted?
This trial is being conducted at Seongnam, South Korea.
Who is sponsoring the NCT06846411 clinical trial?
NCT06846411 is sponsored by Seoul National University Bundang Hospital. The trial plans to enroll 46 participants.
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