Effect of Empagliflozin and Dulaglutide on MAFLD in Patients With T2D

Sponsor
Seoul National University Bundang Hospital
Study ID
NCT05140694
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin — DRUG
    Empagliflozin 10 mg p.o. once daily (available to control over \~25mg)
  • Dulaglutide — DRUG
    Dulaglutide 0.75mg s.c. once a week (available to control over \~1.5mg)
  • Empagliflozin and Dulaglutide — DRUG
    Empagliflozin 10 mg p.o. once daily with Dulaglutide 0.75mg s.c. once weekly

Study Details

The co-administration of SGLT2 inhibitor and GLP-1 receptor agonist would be safe and effective on glycemic control in subjects with type 2 diabetes mellitus and MAFLD better than empagliflozin or dulaglutide alone. The SGLT2 inhibitor and GLP-1 receptor agonist would be safe and effective on fatty liver disease in subjects with type 2 diabetes mellitus and MAFLD.

Key Dates

Start date
Dec 1, 2023
Status verified
Oct 2022
Primary completion
Jun 30, 2024
Completion
Dec 31, 2025

Study Design

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

Arms

  • Experimental: Empagliflozin
    Empagliflozin 10mg p.o. once daily (available to control over \~25mg)
  • Experimental: Dulaglutide
    Dulaglutide 0.75mg s.c. once weekly (available to control over \~1.5mg)
  • Experimental: Empagliflozin and Dulagludie
    Empagliflozin 10mg p.o. once daily and dulaglutide 0.75mg s.c. once weekly

Primary Outcome Measure

Changes of HbA1c level [ Time Frame: baseline, week 12, week 24 ]

Central Contacts

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