Comparing empagliflozin and metformin for treating type 2 diabetes
Empagliflozin Versus Metformin for Glucose Variability and Metabolic Outcomes in Drug-Naïve Type 2 Diabetes
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 |
| Enrollment | 46 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Seoul National University Bundang Hospital Academic / other |
| Locations | 1 site (Seongnam) |
| Trial ID | NCT06846411 on ClinicalTrials.gov |
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.
Who should consider this trial
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%.
Not a fit: Patients with significant comorbidities such as severe obesity, uncontrolled hypertension, or recent cardiovascular events may not benefit from this study.
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 performed: Other studies have shown success with similar approaches in managing type 2 diabetes, indicating potential for positive outcomes.
Eligibility criteria
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 this trial is running
Seongnam
- Snubh — Seongnam, South Korea (Recruiting)
Study contacts
- Study coordinator: Ji Young Byun Administrative staff, MS
- Email: 65423@snubh.org
- Phone: 82-31-787-7035
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.