Comparing empagliflozin and metformin for treating type 2 diabetes
Official title: Empagliflozin Versus Metformin for Glucose Variability and Metabolic Outcomes in Drug-Naïve Type 2 Diabetes
Run by Seoul National University Bundang Hospital · NCT06846411 · Data updated 2026-11-12
This study is testing whether empagliflozin or metformin works better to help adults with type 2 diabetes manage their blood sugar levels over 12 weeks.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 20 Years and up |
| Sex | All |
| Enrollment | 46 (estimated) |
| Sponsor | Seoul National University Bundang Hospital Academic / other |
| Locations | 1 site (Seongnam) |
| Status | Recruiting |
| Started | January 1, 2024 |
| Main results expected | September 30, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | February 26, 2025 |
| Trial ID | NCT06846411 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 20 to 75 with drug-naïve type 2 diabetes and an HbA1c between 6.5% and 10.0%.
✕Probably not a fit
Patients with significant comorbidities such as severe obesity, uncontrolled hypertension, or recent cardiovascular events may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, open-label study involves 46 drug-naïve adults with type 2 diabetes (T2D) who are randomized to receive either empagliflozin (10 mg/day) or metformin (1,000 mg/day) for a duration of 12 weeks. Participants must have an HbA1c level between 6.5% and 10.0% and be aged between 20 and 75 years. The study aims to evaluate the effectiveness of these medications in managing glucose variability in T2D patients.
Why it matters
Potential benefit: If successful, this study could provide insights into more effective treatment options for managing type 2 diabetes.
How similar studies have gone: Other studies have shown success with similar approaches in managing type 2 diabetes, indicating potential for positive outcomes.
Who can join: the full rules
Show full inclusion / exclusion 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).
Where it's running
-
Snubh
Seongnam, South Korea Recruiting
Study contacts
- Study coordinator: Ji Young Byun Administrative staff, MS
- Email: 65423@snubh.org
- Phone: 82-31-787-7035
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.