Pioglitazone and Empagliflozin for Fatty Liver Disease in Type 2 Diabetes

Sponsor
Seoul National University Bundang Hospital
Study ID
NCT06989723
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Pioglitazone 15 MG [Actos] — DRUG
    Participants will receive pioglitazone 15 mg, administered orally once daily. The tablet may be taken with or without food.
  • Empagliflozin 10 MG [Jardiance] — DRUG
    Participants will receive empagliflozin 10 mg, administered orally once daily. The tablet may be taken with or without food.
  • Empagliflozin 10 MG [Jardiance] + Pioglitazone 15 MG [Actos] — DRUG
    Participants will receive one tablet of pioglitazone 15 mg and one tablet of empagliflozin 10 mg, administered orally once daily. Both tablets may be taken with or without food.

Study Details

This exploratory study will assess the efficacy of combined pioglitazone and empagliflozin therapy in improving hepatic and metabolic outcomes in patients with type 2 diabetes mellitus and metabolic dysfunction-associated fatty liver disease (MAFLD). Although each agent has shown beneficial effects individually, evidence on their combined impact on liver health is scarce. This study seeks to determine whether the combination therapy yields additive improvements in hepatic steatosis, inflammation, and fibrosis, potentially offering a new therapeutic strategy for diabetic patients with fatty liver disease.

Key Dates

Start date
Jan 1, 2025
Status verified
May 2025
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

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

Arms

  • Experimental: Pioglitazone
    Pioglitazone 15mg
  • Experimental: Empagliflozin
    Empagliflozin 10mg
  • Experimental: Pioglitazone & Empagliflozin
    Pioglitazone 15mg + Empagliflozin 10mg

Primary Outcome Measure

Proportion of Participants Achieving HbA1c Treatment Targets [ Time Frame: 24 weeks ]

Central Contacts

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