Actively Recruiting
Pioglitazone and Empagliflozin for Fatty Liver Disease in Type 2 Diabetes
Led by Seoul National University Bundang Hospital · Updated on 2025-05-25
120
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
Sponsors
S
Seoul National University Bundang Hospital
Lead Sponsor
C
Celltrion
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pioglitazone and Empagliflozin for Fatty Liver Disease in Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 20 years or older.
- Patients with inadequately controlled type 2 diabetes mellitus, with HbA1c between 7% and 10%, currently treated with either metformin and a sulfonylurea combination, metformin and a DPP-4 inhibitor combination, metformin alone, or triple therapy including metformin (with sulfonylurea to be discontinued upon enrollment).
- Evidence of hepatic steatosis within the past 3 months confirmed by Fibroscan with CAP score of 268 dB/m or higher.
- Presence of at least one metabolic abnormality: waist circumference ≥90 cm for men or ≥85 cm for women; blood pressure ≥130 mmHg systolic or ≥85 mmHg diastolic or use of antihypertensive medication; serum triglycerides ≥150 mg/dL or current use of lipid-lowering agents; HDL-cholesterol <45 mg/dL for men or <50 mg/dL for women; HOMA-IR ≥2.5; or serum C-reactive protein ≥2 mg/L.
- No changes in anti-diabetic or metabolic medications in the past 3 months unless deemed not to affect study outcomes.
You will not qualify if you...
- Patients receiving insulin therapy or diagnosed with type 1 diabetes mellitus.
- Use of GLP-1 receptor agonists, SGLT2 inhibitors, rosiglitazone, vitamin E, or ursodeoxycholic acid within the past 3 months.
- Secondary causes of hepatic steatosis unrelated to metabolic dysfunction, such as hepatitis B, hepatitis C, or alcoholic fatty liver disease.
- Use of medications that induce hepatic steatosis including valproic acid, estrogen, tamoxifen, amiodarone, or chloroquine.
- Severe organ failure: liver failure with AST or ALT >5 times upper normal limit, serum albumin <3.2 g/dL, platelet count <60,000/µL, or Child-Pugh-Turcotte stage B or C; renal failure with serum creatinine ≥2.0 mg/dL, eGFR <30 mL/min/1.73 m², end-stage renal disease, or dialysis.
- Presence of hepatocellular carcinoma, active malignancy, or metastatic cancer.
- History or active bladder cancer.
- History or current heart failure.
- Terminal illness.
- History of gallstone disease, chronic or acute pancreatitis.
- Underweight patients with BMI <18.5 kg/m².
- Pregnant women or women planning pregnancy.
- Known hypersensitivity to study medications.
- History of diabetic ketoacidosis.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Actively Recruiting
Research Team
S
Soo Lim Dr, MD PhD
CONTACT
M
Minji Sohn Dr, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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