Pioglitazone and Empagliflozin for Fatty Liver Disease in Type 2 Diabetes

ConditionsType 2 Diabetes Fatty Liver

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

120 Participants

are divided into 3 treatment groups

Group A: PioglitazoneExperimental treatment 1 intervention

Group B: EmpagliflozinExperimental treatment 1 intervention

Group C: Pioglitazone & EmpagliflozinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Proportion of Participants Achieving HbA1c Treatment Targets

Percentage of participants who achieve the predefined HbA1c treatment goal at 24 weeks.

Time frame

24 weeks

Change in Fibroscan Controlled Attenuation Parameter (CAP) Score

Assessment of changes in hepatic steatosis as measured by the controlled attenuation parameter (CAP) score using Fibroscan technology over a 24-week period.

Time frame

24 weeks

Secondary outcomes

Change in HbA1c Levels

Change in glycated hemoglobin (HbA1c) from baseline after 24 weeks of treatment.

Time frame

24 weeks

Change in Liver Stiffness Measurement

Change in liver stiffness measurement (LSM) assessed using Fibroscan

Time frame

24 weeks

Change in Non-Invasive Blood-Based Fibrosis Markers

Change in NAFLD score, Fibrosis-4 (FIB-4) index, and AST to Platelet Ratio Index (APRI) over 12 and 24 weeks.

Time frame

12 weeks, 24 weeks

Change in Anthropometric Measures

Changes in metabolic parameters including body weight, body mass index (BMI), waist circumference

Time frame

12 weeks, 24 weeks

Other outcomes

Change in Other Blood Biomarkers

Change in ketone body levels

Time frame

24 weeks

Change in Proteinuria

Change in urinary albumin-to-creatinine ratio, protein-to-creatinine ratio

Time frame

24 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Bundang Hospital

Lead sponsor

Celltrion

Collaborator

Source ClinicalTrials.gov

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