RecruitingPhase 4NCT06989723

Pioglitazone and Empagliflozin for Fatty Liver Disease in Type 2 Diabetes

Evaluation of Pioglitazone and Empagliflozin Combination Therapy in Type 2 Diabetes Patients With Metabolic Dysfunction-Associated Fatty Liver Disease


Sponsor

Seoul National University Bundang Hospital

Enrollment

120 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two medications — pioglitazone and empagliflozin — to see which is more effective at treating fatty liver disease (excess fat in the liver) in people with type 2 diabetes who are not well controlled on their current medications. **You may be eligible if...** - You are 20 or older - You have type 2 diabetes with HbA1c between 7% and 10% (not well controlled) - You are currently on metformin with a sulfonylurea, a DPP-4 inhibitor, or metformin alone (or triple therapy where a sulfonylurea will be stopped) - You have confirmed fatty liver disease on a liver scan (FibroScan CAP score of 268 or above) - You have at least one metabolic abnormality (e.g., excess belly fat, high blood pressure, or abnormal cholesterol) **You may NOT be eligible if...** - Your blood sugar is too high or too low (outside the 7–10% HbA1c range) - You do not have confirmed fatty liver disease - You do not meet the medication criteria Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPioglitazone 15 MG [Actos]

Participants will receive pioglitazone 15 mg, administered orally once daily. The tablet may be taken with or without food.

DRUGEmpagliflozin 10 MG [Jardiance]

Participants will receive empagliflozin 10 mg, administered orally once daily. The tablet may be taken with or without food.

DRUGEmpagliflozin 10 MG [Jardiance] + Pioglitazone 15 MG [Actos]

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.


Locations(1)

Seoul National University Bundang Hospital

Seongnam-si, South Korea

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NCT06989723


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