The EMPA-FIT Study

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

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).

Conditions2

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