This study compared two common diabetes medications—empagliflozin and metformin—in people newly diagnosed with type 2 diabetes over a 12-week period. Researchers wanted to see how well each medication worked and how it affected patients' fitness and overall health. The study included 46 adults whose blood sugar levels indicated they had type 2 diabetes.
Key Objective: This trial tested whether empagliflozin could be an effective first-line treatment for type 2 diabetes, potentially offering an alternative to the standard metformin treatment.
Who to Consider: Adults recently diagnosed with type 2 diabetes who have never taken diabetes medication and want to compare how different treatment options might work for their condition should consider enrolling.
Trial Parameters
Brief 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 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 carci