The EMPA-FIT Study

Last updated: February 20, 2025
Sponsor: Seoul National University Bundang Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Diabetic Gastroparesis

Diabetic Vitreous Hemorrhage

Diabetes And Hypertension

Treatment

Metformin

Empagliflozin 10 mg

Clinical Study ID

NCT06846411
B-2201-732-003
2021-02251
  • Ages > 20
  • All Genders

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 Criteria

Inclusion

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-diabeticmedications for at least eight weeks prior to screening.

Exclusion

Exclusion Criteria:

  • individuals with a body mass index (BMI) <18.5 kg/m² or ≥40 kg/m², clinicallysignificant 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/1.73m²) or end-stage renal disease (eGFR <15 mL/min/1.73 m² or on dialysis) were alsoexcluded.

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

Total Participants: 46
Treatment Group(s): 2
Primary Treatment: Metformin
Phase: 4
Study Start date:
January 01, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • SNUBH

    Seongnam,
    Korea, Republic of

    Active - Recruiting

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