Status:
RECRUITING
Pioglitazone and Empagliflozin for Fatty Liver Disease in Type 2 Diabetes
Lead Sponsor:
Seoul National University Bundang Hospital
Collaborating Sponsors:
Celltrion
Conditions:
Type 2 Diabetes
Fatty Liver
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief 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 d...
Eligibility Criteria
Inclusion
- Adults aged 20 years or older.
- Patients with inadequately controlled type 2 diabetes mellitus, defined as HbA1c between 7% and 10%, who are currently treated with either:
- Combination therapy of metformin and a sulfonylurea, or
- Combination therapy of metformin and a DPP-4 inhibitor, or
- Metformin monotherapy, or
- Triple therapy (including metformin) provided that sulfonylurea will be discontinued upon study enrollment.
- Evidence of hepatic steatosis within the past 3 months, confirmed by Fibroscan with a controlled attenuation parameter (CAP) ≥ 268 dB/m (consistent with S2 or greater \[≥10% hepatocyte steatosis\] according to the 2024 EASL-EASD-EASO guidelines).
- Presence of at least one of the following metabolic abnormalities:
- 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 (Homeostatic Model Assessment of Insulin Resistance) ≥2.5.
- Serum C-reactive protein (CRP) ≥2 mg/L.
- No changes in anti-diabetic or metabolic medications within the past 3 months, unless the changes are deemed by the investigator not to affect study outcomes.
Exclusion
- 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.
- Severe organ failure, defined as:
- Liver failure: AST or ALT \> 5 times the upper normal limit (UNL), serum albumin \< 3.2 g/dL, platelet count \< 60,000/µL, or Child-Pugh-Turcotte stage B or C.
- Renal failure: Serum creatinine ≥ 2.0 mg/dL, estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m² (CKD-EPI formula), or patients with end-stage renal disease or on dialysis.
- Presence of hepatocellular carcinoma, active malignancy, or metastatic cancer.
- History of or active bladder cancer.
- History of heart failure or current diagnosis of heart failure.
- Presence of terminal illnesses.
- History of gallstone disease, chronic pancreatitis, or acute pancreatitis.
- Underweight patients (body mass index \[BMI\] \< 18.5 kg/m²).
- Pregnant women or women planning to become pregnant.
- Known hypersensitivity to the active ingredients or excipients of the study medications.
- History of diabetic ketoacidosis.
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06989723
Start Date
January 1 2025
End Date
June 30 2027
Last Update
May 25 2025
Active Locations (1)
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1
Seoul National University Bundang Hospital
Seongnam-si, South Korea