The EMPA-FIT Study

Phase 4

Recruiting

• Conditions: Diabetes; Diabetes Mellitus, Type II
• Interventions: Drug: Metformin; Drug: Empagliflozin 10 mg

• Registration Number: NCT06846411
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2025-02
• Study First Submitted: 2025-02-20
• Study First Submitted QC: 2025-02-20
• Last Update Submitted: 2025-02-20
• Study First Posted: 2025-02-26
• Last Update Posted: 2025-02-26
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard	Metformin	Metformin therapy
Experimental	Empagliflozin 10 mg	Empagliflozin therapy

Primary Outcome Measures

Name	Time	Method
mean amplitude of glucose excursion (MAGE)	24 weeks	MAGE is a key glucose variability index that assesses the amplitude of clinically relevant glucose fluctuations and is calculated as the mean of the differences between consecutive glucose nadirs and peaks that exceed one standard deviation (SD) above or below the mean glucose level

Secondary Outcome Measures

Name	Time	Method
SD of glucose	24 weeks	Standard deviation of glucose obtained from continuous glucose monitoring (CGM)
Time in range (TIR)	24 weeks	Time in range obtained from continuous glucose monitoring (CGM)
Mean Blood Glucose (MBG)	24 weeks	Mean Blood Glucose (MBG) obtained from continuous glucose monitoring (CGM)
Glucose Management Indicator (GMI)	24 weeks	Glucose Management Indicator (GMI) obtained from continuous glucose monitoring (CGM)
Coefficient of Variation (CV)	24 weeks	Coefficient of Variation (CV) obtained from continuous glucose monitoring (CGM)

Trial Locations

Locations (1)

SNUBH; 🇰🇷 Seongnam, Korea, Republic of