Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT05140694
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-10-04
First Post:
2021-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Empagliflozin and Dulaglutide on MAFLD in Patients With T2D
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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': 'C570240', 'term': 'empagliflozin'}, {'id': 'C555680', 'term': 'dulaglutide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 135}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-01', 'studyFirstSubmitDate': '2021-04-26', 'studyFirstSubmitQcDate': '2021-11-21', 'lastUpdatePostDateStruct': {'date': '2022-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes of urine markers', 'timeFrame': 'baseline, week 12, week 24', 'description': 'Urinalysis will be performed at all visit days'}, {'measure': 'Changes of bone health', 'timeFrame': 'baseline, week 12, week 24', 'description': 'parathyroid hormone, 25-hydroxylated vitamin will be measured at all visit days'}, {'measure': 'Changes of gut microbiota', 'timeFrame': 'baseline, week 24', 'description': 'gut microbiota composition, microbiota related to metabolic dysfunction'}], 'primaryOutcomes': [{'measure': 'Changes of HbA1c level', 'timeFrame': 'baseline, week 12, week 24', 'description': 'Patients achieving the target level'}, {'measure': 'Changes of CAP score', 'timeFrame': 'baseline, week 24', 'description': 'Controlled Attenuation Parameter (CAP) score by transient elastography'}], 'secondaryOutcomes': [{'measure': 'Changes of LSM score', 'timeFrame': 'baseline, week 24', 'description': 'Liver stiffness measurement (LSM) score by transient elastography'}, {'measure': 'Changes of noninvasive liver fibrosis markers', 'timeFrame': 'baseline, week 12, week 24', 'description': 'Noninvasive liver fibrosis markers will be calculated at baseline and at the end of the study'}, {'measure': 'Changes of body weight and body composition', 'timeFrame': 'baseline, week 24', 'description': 'Body composition by bioelectrical impedance will be measured at baseline and at the end of the study'}, {'measure': 'Changes of lipid levels', 'timeFrame': 'baseline, week 12, week 24', 'description': 'Cholesterol level will be measured at all visit days'}, {'measure': 'Changes of ketone levels', 'timeFrame': 'baseline, week 12, week 24', 'description': 'Ketone level will be measured at all visit days'}, {'measure': 'Changes of liver parenchyma by ultrasonography', 'timeFrame': 'baseline, week 24', 'description': 'improvement or deterioration'}, {'measure': 'Changes of liver function parameters', 'timeFrame': 'baseline, week 12, week 24', 'description': 'Liver enzymes, albumin will be measured at all visit days.'}, {'measure': 'Changes of liver fibrosis biomarkers', 'timeFrame': 'baseline, week 24', 'description': 'Type IV collagen'}, {'measure': 'Changes of inflammation biomarker', 'timeFrame': 'baseline, week 24', 'description': 'high-sensitivity CRP'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metabolic-associated Fatty Liver Disease', 'Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The co-administration of SGLT2 inhibitor and GLP-1 receptor agonist would be safe and effective on glycemic control in subjects with type 2 diabetes mellitus and MAFLD better than empagliflozin or dulaglutide alone.\n\nThe SGLT2 inhibitor and GLP-1 receptor agonist would be safe and effective on fatty liver disease in subjects with type 2 diabetes mellitus and MAFLD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. age 20 or over\n2. uncontrolled HbA1c (7\\~10%) with metformin and/or sulfonylurea\n3. Hepatic steatosis estimated by Fibroscan (CAP ≥258 dB/m)\n4. MAFLD: presence of any conditions\n\n 1. Overweight or obese: BMI ≥23 kg/m2 (Asian)\n 2. Metabolic dysregulation: at least of two of following criteria\n\n * Waist circumference: ≥90/80 cm in men and women (Asian)\n * Blood pressure ≥130/85 mmHg or drug treatment\n * Plasma triglycerides ≥150 mg/dL or drug treatment\n * Plasma HDL-cholesterol \\<40/50 mg/dL for men and women or drug treatment\n * Prediabetes (i.e. fasting glucose levels 100 to 125 mg/dL or 2-hour post-load glucose levels 140 to 199 mg/dL or HbA1c 5.7% to 6.4%\n * HOMA-insulin resistance score ≥2.5\n * Plasma high-sensitivity CRP \\>2 mg/L\n\nExclusion Criteria:\n\n1. Significant alcohol consumption\n2. Other competing causes for hepatic steatosis: viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha1 anti-trypsin deficiency, Celiac disease, Overt hypothyroidism, other secondary causes\n3. Type 1 diabetes mellitus\n4. medication usage within 3 months: vitamin E, PUFA, UDCA, fish oil, SGLT2 inhibitors, GLP1-RAs, TZDs\n5. Severe organ dysfunction\n\n 1. liver damage: AST/ALT \\>x5 UNL, albumin \\<3.2, platelet \\<60k, Child-Pugh-Turcotte stage B or C\n 2. kidney damage: serum creatinine ≥2.0 mg/dL or eGFR \\<50 mL/min/1.72m2\n6. Hepatocellular carcinoma, active tumor, or metastasis\n7. End-stage liver disease"}, 'identificationModule': {'nctId': 'NCT05140694', 'briefTitle': 'Effect of Empagliflozin and Dulaglutide on MAFLD in Patients With T2D', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'A Randomized, Active-comparator Controlled, Parallel-group Study, to Evaluate the Effect of Empagliflozin and Dulaglutide on MAFLD in Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'MAFLD_empa_dula'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Empagliflozin', 'description': 'Empagliflozin 10mg p.o. once daily (available to control over \\~25mg)', 'interventionNames': ['Drug: Empagliflozin']}, {'type': 'EXPERIMENTAL', 'label': 'Dulaglutide', 'description': 'Dulaglutide 0.75mg s.c. once weekly (available to control over \\~1.5mg)', 'interventionNames': ['Drug: Dulaglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Empagliflozin and Dulagludie', 'description': 'Empagliflozin 10mg p.o. once daily and dulaglutide 0.75mg s.c. once weekly', 'interventionNames': ['Drug: Empagliflozin and Dulaglutide']}], 'interventions': [{'name': 'Empagliflozin', 'type': 'DRUG', 'otherNames': ['Jardiance'], 'description': 'Empagliflozin 10 mg p.o. once daily (available to control over \\~25mg)', 'armGroupLabels': ['Empagliflozin']}, {'name': 'Dulaglutide', 'type': 'DRUG', 'otherNames': ['Trulicity'], 'description': 'Dulaglutide 0.75mg s.c. once a week (available to control over \\~1.5mg)', 'armGroupLabels': ['Dulaglutide']}, {'name': 'Empagliflozin and Dulaglutide', 'type': 'DRUG', 'otherNames': ['Jardiance and Trulicity'], 'description': 'Empagliflozin 10 mg p.o. once daily with Dulaglutide 0.75mg s.c. once weekly', 'armGroupLabels': ['Empagliflozin and Dulagludie']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Soo Lim, MD, PhD', 'role': 'CONTACT', 'email': 'limsoo@snu.ac.kr', 'phone': '+82-31-787-7035'}, {'name': 'Minji Sohn, PhD', 'role': 'CONTACT', 'email': 'rainbowmjs@naver.com', 'phone': '+82-31-787-8443'}], 'overallOfficials': [{'name': 'Soo Lim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Soo Lim', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}