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RecruitingPhase 4NCT06846411

The EMPA-FIT Study

Empagliflozin Versus Metformin for Glucose Variability and Metabolic Outcomes in Drug-Naïve Type 2 Diabetes

Sponsor

Seoul National University Bundang Hospital

Enrollment

46 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

DiabetesDiabetes Mellitus, Type II

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

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study — called the EMPA-FIT Study — is testing whether a medication called empagliflozin (a drug that helps kidneys remove excess sugar from the blood) can improve blood sugar control, body composition, and metabolic health in people with newly diagnosed Type 2 diabetes who are not yet on medication. **You may be eligible if...** - You have Type 2 diabetes with an HbA1c between 6.5% and 10.0% - You are between 20 and 75 years old - You have not taken any diabetes medication in the past 8 weeks - Your BMI is between 18.5 and 40 **You may NOT be eligible if...** - You have had a recent heart attack, stroke, or significant cardiovascular event (within 2 months) - You have serious liver disease - You are pregnant or breastfeeding - You have Type 1 diabetes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEmpagliflozin 10 mg

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.

DRUGMetformin

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.

Locations(1)

SNUBH

Seongnam, South Korea

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NCT06846411

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