Actively Recruiting
The EMPA-FIT Study
Led by Seoul National University Bundang Hospital · Updated on 2025-02-26
46
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The EMPA-FIT Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have type 2 diabetes with HbA1c between 6.5% and 10.0%
- Are between 20 and 75 years old
- Have not taken any anti-diabetic medications for at least 8 weeks prior to screening
You will not qualify if you...
- Body mass index (BMI) less than 18.5 kg/m² or 40 kg/m² or higher
- Clinically significant liver problems such as cirrhosis, portal hypertension, or chronic active hepatitis
- History of acute cardiovascular events, including coronary artery disease, stroke, or peripheral arterial disease, within 2 months before enrollment
- Chronic kidney disease with eGFR less than 60 mL/min/1.73 m² or end-stage renal disease with eGFR less than 15 mL/min/1.73 m² or on dialysis
- Uncontrolled high blood pressure (160/100 mmHg or higher)
- New York Heart Association class III or IV heart failure
- Use of oral corticosteroids for more than 30 consecutive days
- History of cancer (except basal cell carcinoma) within the past 5 years
- Very high blood fat levels (triglycerides over 1000 mg/dL or LDL cholesterol over 250 mg/dL)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
SNUBH
Seongnam, South Korea
Actively Recruiting
Research Team
J
Ji Young Byun Administrative staff, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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