The EMPA-FIT Study

Sponsor
Seoul National University Bundang Hospital
Study ID
NCT06846411
Phase
PHASE4
Status
Recruiting
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Conditions

  • Diabetes
  • Diabetes Mellitus, Type II

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jan 1, 2024
Status verified
Feb 2025
Primary completion
Sep 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
46 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard
    Metformin therapy
  • Experimental: Experimental
    Empagliflozin therapy

Primary Outcome Measure

mean amplitude of glucose excursion (MAGE) [ Time Frame: 24 weeks ]

Central Contacts

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