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The EMPA-FIT Study

ConditionsDiabetesDiabetes Mellitus, Type II
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20+
SponsorSeoul National University Bundang Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Empagliflozin 10 mg

    Drug

    The primary objective was to evaluate the efficacy of early treatment with empagliflozin in reducing GV, as measured by the change in MAGE from baseline to Week 12, compared to metformin.

  • Metformin

    Drug

    The primary objective was to evaluate the efficacy of early treatment with empagliflozin in reducing GV, as measured by the change in MAGE from baseline to Week 12, compared to metformin.

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: StandardActive comparator 1 intervention
Group B: ExperimentalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

mean amplitude of glucose excursion (MAGE)

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

Time frame
24 weeks

Secondary outcomes

1

SD of glucose

Standard deviation of glucose obtained from continuous glucose monitoring (CGM)

Time frame
24 weeks
2

Time in range (TIR)

Time in range obtained from continuous glucose monitoring (CGM)

Time frame
24 weeks
3

Mean Blood Glucose (MBG)

Mean Blood Glucose (MBG) obtained from continuous glucose monitoring (CGM)

Time frame
24 weeks
4

Glucose Management Indicator (GMI)

Glucose Management Indicator (GMI) obtained from continuous glucose monitoring (CGM)

Time frame
24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Bundang Hospital

Lead sponsor

Source ClinicalTrials.gov
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