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New treatment option for Type 2 Diabetes
Official title Pioglitazone and Empagliflozin for Fatty Liver Disease in Type 2 Diabetes
ClinicalTrials.gov ID: NCT06989723
What this study is testing
What is Pioglitazone 15 MG [Actos]?
Pioglitazone 15 MG [Actos] is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for type 2 diabetes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Presence of secondary causes of hepatic steatosis unrelated to metabolic dysfunction, such as hepatitis B, hepatitis C, or alcoholic fatty liver...
- 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...
See the full eligibility criteria
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Seongnam-si, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seongnam-si, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.