Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-02-20 @ 10:08 PM
Study NCT ID:
NCT03646292
Status:
COMPLETED
Last Update Posted:
2025-03-05
First Post:
2018-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antidiabetic Drugs for Steatotic Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077205', 'term': 'Pioglitazone'}, {'id': 'C570240', 'term': 'empagliflozin'}], 'ancestors': [{'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'open label'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study will evaluate the efficacy in lowering liver fat and the safety of empagliflozin 10mg, pioglitazone 15mg, alone or in combination (empagliflozin 10mg/pioglitazone 15mg), over a 24-week period.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-03', 'studyFirstSubmitDate': '2018-08-10', 'studyFirstSubmitQcDate': '2018-08-22', 'lastUpdatePostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in liver fat fraction (%) measured by MRI-PDFF in the largest possible polygonal region of interest encompassing both lobes of the liver', 'timeFrame': 'After 24 weeks of treatment', 'description': 'To measure the fat fraction, we drew the largest possible polygonal region of interest encompassing both lobes of the liver on a cross-sectional image, while avoiding blood vessels, bile ducts, and distinct hepatic lesions.'}], 'secondaryOutcomes': [{'measure': 'Liver fibrosis measured by magnetic resonance elastography', 'timeFrame': 'After 24 weeks of treatment', 'description': 'The secondary endpoint is to analyze the changes before and after drug administration for the following items: liver stiffness (kPa) measured by magnetic resonance elastography.'}, {'measure': 'The changes in lipid profile', 'timeFrame': 'After 24 weeks of treatment', 'description': 'The secondary endpoint is to analyze the changes before and after drug administration for the following items: The changes in lipid profile including total cholesterol (mg/dL), triglyceride (mg/dL), high-density lipoprotein-cholesterol (mg/dL), low-density lipoprotein-cholesterol (mg/dL), and free fatty acid (μEq/L).'}, {'measure': 'The changes in liver enzyme', 'timeFrame': 'After 24 weeks of treatment', 'description': 'he secondary endpoint is to analyze the changes before and after drug administration for the following items: The changes in liver enzyme including aspartate aminotransferase (IU/L), alanine aminotransferase (IU/L), alkaline phosphatase (IU/L), and gamma-glutamyl transferase (IU/L).'}, {'measure': 'The changes in glucose metabolism', 'timeFrame': 'After 24 weeks of treatment', 'description': 'The secondary endpoint is to analyze the changes before and after drug administration for the following items: The changes in glucose metabolism including fasting glucose (mg/dL), HbA1c (%), fasting insulin (μIU/mL), homeostatic model assessment for insulin resistance (mg/dL\\*μIU/mL), and homeostasis model assessment of β-cell function (%)'}, {'measure': 'The changes in cytokines', 'timeFrame': 'After 24 weeks of treatment', 'description': 'The secondary endpoint is to analyze the changes before and after drug administration for the following items: The changes in cytokines including high sensitivity C-reactive protein (mg/L), adiponectin (μg/mL), and leptin (ng/mL).'}, {'measure': 'The changes in other biochemical parameters', 'timeFrame': 'After 24 weeks of treatment', 'description': 'The secondary endpoint is to analyze the changes before and after drug administration for the following items: The changes in other biochemical parameters including complete blood count, platelet count (10³/μL), total protein (g/dL), albumin (g/dL), total bilirubin (mg/dL), blood urea nitrogen (mg/dL), creatinine (mg/dL), and uric acid (mg/dL).'}, {'measure': 'The changes in blood pressure and anthropometric parameters', 'timeFrame': 'After 24 weeks of treatment', 'description': 'The secondary endpoint is to analyze the changes before and after drug administration for the following items: The changes in blood pressure and anthropometric parameters including systolic and diastolic blood pressure (mmHg), body weight (kg), body mass index (kg/m², defined as weight \\[kg\\] divided by the square of the body height \\[m\\]), and waist circumference (cm).'}, {'measure': 'The changes in body composition', 'timeFrame': 'After 24 weeks of treatment', 'description': 'The secondary endpoint is to analyze the changes before and after drug administration for the following items: The changes in body composition including abdominal subcutaneous fat area (cm²) and abdominal visceral fat area (cm²).\n\nTo measure the body composition, abdominal fat content was assessed using a 3-mm thick cross-sectional abdominal fat CT scan at the midpoint of the L3 vertebra, with the participants in a supine position.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-alcoholic Fatty Liver Disease', 'Hypoglycemic Agents', 'Physiological Effects of Drugs', 'Sodium-Glucose Cotransporter 2 Inhibitors', 'Pioglitazone', 'Molecular Mechanisms of Pharmacological Action', 'Empagliflozin', 'Metabolic Dysfunction-Associated Steatotic Liver Disease', 'Type 2 Diabetes', 'Digestive System Disease', 'Liver Diseases', 'Fatty Liver', 'Thiazolidinediones'], 'conditions': ['MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease', 'Type 2 Diabetes', 'Digestive System Disease', 'Liver Diseases', 'Fatty Liver', 'Metabolic Dysfunction-Associated Steatotic Liver Disease', 'Non-Alcoholic Fatty Liver Disease', 'Hypoglycemic Agents', 'Physiological Effects of Drugs', 'Sodium-Glucose Cotransporter 2 Inhibitors', 'Pioglitazone', 'Molecular Mechanisms of Pharmacological Action', 'Empagliflozin', 'Thiazolidinediones']}, 'referencesModule': {'references': [{'pmid': '40336058', 'type': 'DERIVED', 'citation': 'Lee M, Hong S, Cho Y, Rhee H, Yu MH, Bae J, Lee YH, Lee BW, Kang ES, Cha BS. Synergistic benefit of thiazolidinedione and sodium-glucose cotransporter 2 inhibitor for metabolic dysfunction-associated steatotic liver disease in type 2 diabetes: a 24-week, open-label, randomized controlled trial. BMC Med. 2025 May 7;23(1):266. doi: 10.1186/s12916-025-04017-x.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the synergic therapeutic effect of thiazolidinediones and SGLT2 inhibitor on metabolic dysfunction-associated steatotic liver disease, the effect of empagliflozin 10mg, pioglitazone 15mg monotherapy and combination therapy in patients with type 2 diabetes and steatotic liver disease will be compared and analyzed.\n\nThis study was designed to include a total of 60 patients (20 per subgroup) for randomized controlled trials with prospective, open label, randomized, single-institution clinical trials.\n\nThe drug will be maintained for a total of 24 weeks. The primary endpoint is the difference of liver fat change measured by MRI-PDFF in the largest possible polygonal region of interest encompassing both lobes of the liver between three groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Men and women aged 19 to 75 years\n2. Individuals who are diagnosed with type 2 diabetes (HbA1c ≥ 7.5% and \\< 11.0%) and treated with antidiabetic drugs excluding TZD and SGLT2i over the previous 12 weeks\n3. Individuals diagnosed with steatotic liver disease as documented by abdominal ultrasonography within the previous year\n4. Individuals who have voluntarily agreed in written form to participate in the clinical trial after hearing the explanation of this clinical trial\n5. Individuals who understand the content of the clinical trial and are able to participate in the trial until the end of the clinical trial\n\nExclusion Criteria:\n\n1. Type 1 diabetes and gestational diabetes\n2. Highly uncontrolled diabetes (HbA1c ≥ 11.0%)\n3. Excessive alcohol intake (210 g and 140 g/week for men and women, respectively) within the previous 2 years\n4. A history of taking thiazolidinedione or sodium-glucose cotransporter 2 inhibitor class medications within the last 12 weeks, or a history of discontinuing these medications due to severe side effects\n5. Treatment with four or more classes of antidiabetic medications\n6. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma, within 24 weeks\n7. Intake of drugs that can cause steatotic liver disease (amiodarone, methotrexate, tamoxifen, valproate, etc.)\n8. Allergy or hypersensitivity to the study drugs or their constituents\n9. Oral or parenteral chronic corticosteroid therapy (more than 14 consecutive days) that requires continual adjustments in corticosteroid dose for therapeutic purposes within 8 weeks\n10. Galactosemia\n11. Genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption\n12. Malignant tumors currently undergoing treatment or progression\n13. A history of substance abuse or alcohol intoxication within 12 weeks\n14. Infection of human immunodeficiency virus\n15. Severe infection\n16. Pre- and post-operative status, or severe trauma\n17. Cardiac failure within 24 weeks (class III to IV in the NYHA classification)\n18. Acute cardiovascular event within 12 weeks (unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass grafting, or coronary intervention)\n19. AAcute and chronic renal disease (estimated glomerular filtration rate \\< 45 mL/min/1.73 m²) or dialysis\n20. Pregnant or lactating women\n21. Individuals whom the investigator determines to be unsuitable for participation in the clinical trial'}, 'identificationModule': {'nctId': 'NCT03646292', 'briefTitle': 'Antidiabetic Drugs for Steatotic Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Comparison of The Effects of Thiazolidinediones(TZD), Sodium- Glucose Cotransporter 2 Inhibitors(SGLT2i) Alone and TZD / SGLT2i Combination Therapy on Metabolic Dysfunction-Associated Steatotic Liver Disease in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '4-2018-0655'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pioglitazone monotherapy', 'description': 'Pioglitazone 15mg 1T daily for 24 weeks', 'interventionNames': ['Drug: Pioglitazone']}, {'type': 'EXPERIMENTAL', 'label': 'Empagliflozin monotherapy', 'description': 'Empagliflozin 10mg 1T daily for 24 weeks', 'interventionNames': ['Drug: Empagliflozin']}, {'type': 'EXPERIMENTAL', 'label': 'Pioglitazone + Empagliflozin combination therapy', 'description': 'Pioglitazone 15mg 1T + Empagliflozin 10mg 1T combination daily for 24 weeks', 'interventionNames': ['Drug: Combination of pioglitazone and empagliflozin']}], 'interventions': [{'name': 'Pioglitazone', 'type': 'DRUG', 'description': 'The investigators will compare the degree of liver fat before and after pioglitazone monotherapy.', 'armGroupLabels': ['Pioglitazone monotherapy']}, {'name': 'Empagliflozin', 'type': 'DRUG', 'description': 'The investigators will compare the degree of liver fat before and after empagliflozin monotherapy.', 'armGroupLabels': ['Empagliflozin monotherapy']}, {'name': 'Combination of pioglitazone and empagliflozin', 'type': 'DRUG', 'description': 'The investigators will compare the degree of liver fat before and after pioglitazone and empagliflozin combination therapy.', 'armGroupLabels': ['Pioglitazone + Empagliflozin combination therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Internal Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}