Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 20 and up

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.

More Diabetes trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages20 Years and up
SexAll
Enrollment46 (estimated)
SponsorSeoul National University Bundang Hospital
Academic / other
Locations1 site (Seongnam)
StatusRecruiting
StartedJanuary 1, 2024
Main results expectedSeptember 30, 2025
Study endsDecember 31, 2025
Registry record updatedFebruary 26, 2025
Trial IDNCT06846411 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.