Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2026-01-20 @ 12:11 PM
Study NCT ID:
NCT07289750
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Alogliptin Combined With Actoplus Met on Glucose and Lipid Metabolism and Pancreatic Function in Patients With T2DM Complicated With MAFLD.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2025-12-04', 'studyFirstSubmitQcDate': '2025-12-04', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hemoglobin A1c', 'timeFrame': 'after 6 months of treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['T2DM', 'MAFLD'], 'conditions': ['T2DM', 'MAFLD']}, 'descriptionModule': {'briefSummary': 'To compare the efficacy and safety of the combination of alogliptin and actoplus met with that of actoplus met alone in improving the glucose and lipid metabolism and pancreatic function in T2DM patients complicated with MAFLD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1.Meet the T2DM diagnosis criteria of China's Diabetes Prevention and Control Guidelines (2024 Edition) 2.Meet the MAFLD diagnosis criteria of Guideline for the Prevention and Treatment of Metabolic Dysfunction-associated Fatty Liver Disease (Version 2024) 3.HbA1c: 6.5-9.5%，BMI: 19-35 kg/m2。 4.No hypoglycemic drugs or insulin have been used within half a year.\n\nExclusion Criteria:\n\n* 1.Severe infections, surgeries and other stressful situations. 2.Other types of diabetes. 3.Severe cardiovascular, brain, liver and kidney disorders. 4.Acute complications of diabetes. 5.Malignant tumor"}, 'identificationModule': {'nctId': 'NCT07289750', 'briefTitle': 'The Effect of Alogliptin Combined With Actoplus Met on Glucose and Lipid Metabolism and Pancreatic Function in Patients With T2DM Complicated With MAFLD.', 'organization': {'class': 'OTHER', 'fullName': 'The Fourth Affiliated Hospital of Zhejiang University School of Medicine'}, 'officialTitle': 'The Effect of Alogliptin Combined With Pioglitazone and Metformin Hydrochloride Tablets on Glucose and Lipid Metabolism and Islet Function in Patients With Type 2 Diabetes Mellitus Complicated With Metabolic Dysfunction-associated Fatty Liver Disease.', 'orgStudyIdInfo': {'id': 'KY-2025-242'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental group', 'interventionNames': ['Drug: combination treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'interventionNames': ['Drug: alone treatment']}], 'interventions': [{'name': 'combination treatment', 'type': 'DRUG', 'description': 'combination of alogliptin and actoplus met', 'armGroupLabels': ['experimental group']}, {'name': 'alone treatment', 'type': 'DRUG', 'description': 'actoplus met', 'armGroupLabels': ['control group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Fourth Affiliated Hospital of Zhejiang University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}