Pioglitazone and Empagliflozin for Fatty Liver Disease in Type 2 Diabetes

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20+
SponsorSeoul National University Bundang Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Adults aged 20 years or older.

Combination therapy of metformin and a sulfonylurea, or

Combination therapy of metformin and a DPP-4 inhibitor, or

Metformin monotherapy, or

Disqualifiers

Patients receiving insulin therapy or diagnosed with type 1 diabetes mellitus.

Use of the following medications within the past 3 months: GLP-1 receptor agonists, SGLT2 inhibitors, rosiglitazone (TZD), vitamin E, or ursodeoxycholic acid (UDCA).

Presence of secondary causes of hepatic steatosis unrelated to metabolic dysfunction, such as hepatitis B, hepatitis C, or alcoholic fatty liver disease.

Use of medications known to induce hepatic steatosis, including valproic acid, estrogen, tamoxifen, amiodarone, or chloroquine.

Trial design

Treatments tested in this trial

  • Pioglitazone 15 MG [Actos]
  • Empagliflozin 10 MG [Jardiance]
  • Empagliflozin 10 MG [Jardiance] + Pioglitazone 15 MG [Actos]

Treatment groups

120 Participants
are divided into 3 treatment groups

Sponsors and collaborators