Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 11:57 PM
Study NCT ID:
NCT07258394
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-02
First Post:
2025-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study for Dimethyl Fumarate in Preserving Islet β-Cell Function in Type 1 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-30', 'studyFirstSubmitDate': '2025-07-28', 'studyFirstSubmitQcDate': '2025-11-30', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Geometric mean area under the serum C-peptide curve (AUC-C-peptide), adjusted for baseline, during a 2-hour Mixed-Meal Tolerance Test (MMTT)', 'timeFrame': 'Intervention Week 24, and Post-intervention Weeks 24 and 52', 'description': 'Participants will consume a standardized liquid meal containing fixed amounts of carbohydrate, fat, and protein. Following consumption, blood glucose, C-peptide, and glucagon levels will be measured at 0-, 30-, 60-, 90-, and 120-minute time points over a 2-hour period.'}], 'secondaryOutcomes': [{'measure': 'Number of participants who remain C-peptide positive (peak C-peptide concentration ≥200 pmol/L after a 2-hour MMTT).', 'timeFrame': 'Post-intervention Week 52', 'description': 'Participants will consume a standardized liquid meal containing fixed amounts of carbohydrate, fat, and protein. Following consumption, blood glucose, C-peptide, and glucagon levels will be measured at 0-, 30-, 60-, 90-, and 120-minute time points over a 2-hour period.'}, {'measure': 'Changes from baseline in the geometric mean area under the C-peptide curve (AUC-C-peptide) during the 2-hour Mixed-Meal Tolerance Test (MMTT) at Intervention Week 24 and at Weeks 24 and 52 after the end of the intervention.', 'timeFrame': 'Intervention Week 24, and Post-intervention Weeks 24 and 52', 'description': 'Participants will consume a standardized liquid meal containing fixed amounts of carbohydrate, fat, and protein. Following consumption, blood glucose, C-peptide, and glucagon levels will be measured at 0-, 30-, 60-, 90-, and 120-minute time points over a 2-hour period.'}, {'measure': 'Glycemic Control Status', 'timeFrame': 'Intervention Week 24, and Post-intervention Weeks 24 and 52', 'description': 'Hemoglobin A1c (HbA1c) levels and changes from baseline; Number of participants with poor glycemic control (HbA1c \\> 9%); Number of participants with good glycemic control (HbA1c \\< 6.5%).'}, {'measure': 'Mean Daily Dose of Exogenous Insulin Used During the 7 Days Preceding Each Study Visit', 'timeFrame': 'Intervention Week 24, and Post-intervention Weeks 24 and 52'}, {'measure': 'Incidence Rates of Hypoglycemia/Severe Hypoglycemia and Ketosis/Diabetic Ketoacidosis (DKA)', 'timeFrame': 'Baseline, Weeks4, 8, 12, 16, 20 and 24 During Intervention, and 12, 24, 36, and 52 Weeks After Intervention'}, {'measure': 'Incidence Rates of Flushing, Abdominal Pain, Diarrhea, Nausea, Vomiting, Pruritus, Rash, Proteinuria, Erythema, and Dyspepsia', 'timeFrame': 'Week 4, 8, 12, 16, and 24 During Intervention'}, {'measure': 'Serum Profiles of Pro-Inflammatory and Regulatory Cytokines, Along with Other Immunological Mediators', 'timeFrame': 'Baseline, Week 24 During Intervention, and 24,52 Weeks After Intervention'}, {'measure': 'Number, Specificities, and Titers of Islet Autoantibodies', 'timeFrame': 'Baseline, Weeks 24 During Intervention, and 12, 24, 36, and 52 Weeks After Intervention'}, {'measure': 'White Blood Cell (WBC) Subpopulation Differentiation', 'timeFrame': 'Baseline, Week 24 During Intervention, and 24,52 Weeks After Intervention', 'description': 'including the quantity, phenotype, and functional characteristics of T cells, B cells, and natural killer (NK) cells'}, {'measure': 'Incidence Rates of Elevated Aspartate Aminotransferase (AST), Elevated Total Bilirubin (TBIL), and Lymphocytopenia', 'timeFrame': 'Week 4, 8, 12, 16, and 24 During Intervention'}, {'measure': 'Incidence Rates of Anaphylaxis, Angioedema, and Opportunistic Infections', 'timeFrame': 'Week 4, 8, 12, 16, and 24 During Intervention'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 1 Diabetes', 'Immunotherapy', 'Pancreatic Beta-Cell Function'], 'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'Purpose of the Clinical Trial:\n\nThis clinical trial aims to investigate whether dimethyl fumarate can treat adults with newly diagnosed type 1 diabetes and to evaluate the safety profile of dimethyl fumarate.\n\nPrimary Research Questions:\n\nDoes dimethyl fumarate protect pancreatic beta-cell function in adults with newly diagnosed type 1 diabetes? What medical issues may arise in individuals taking dimethyl fumarate?\n\nStudy Design:\n\nResearchers will compare dimethyl fumarate with a placebo (an identical substance without active ingredients) to determine whether Dimethyl fumarate can effectively treat type 1 diabetes.\n\nParticipant Activities:\n\nTake dimethyl fumarate orally twice daily for 24 weeks. Attend on-site visits every 4 weeks during the intervention period and every 12 weeks after the intervention for examinations and assessments.\n\nRecord symptoms, blood glucose control, islet function, and insulin usage throughout the trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects who provide written informed consent.\n2. Aged 18-65 years.\n3. Diagnosed with Type 1 Diabetes Mellitus (per ADA 2024 criteria).\n4. Positive for ≥2 autoantibodies: Insulin autoantibody (IAA) Glutamic acid decarboxylase autoantibody (GADA) Protein tyrosine phosphatase antibody (IA-2A) Islet cell antibody (ICA) Zinc transporter 8 autoantibody (ZnT8A) Note: For IAA-positive subjects with insulin use \\>14 days, ≥2 additional autoantibodies must be positive.\n5. Disease duration ≤100 days post-T1DM diagnosis.\n6. Random C-peptide ≥ 200 pmol/L.\n\nExclusion Criteria:\n\n1. Pregnancy, lactation, or women of childbearing potential not using contraception.\n2. Well-controlled glycemia with oral hypoglycemic agents alone.\n3. Participation in other diabetes/immune-modulating trials.\n4. ALT/AST \\>3× upper limit of normal (ULN).\n5. History of malignancy, uncontrolled autoimmune disorders, or active infections.\n6. Alcohol/drug abuse, psychiatric disorders, or conditions unsuitable for trial participation.\n7. Use of immunosuppressants within 12 weeks prior.\n8. Participation in other drug trials within 12 weeks prior.\n9. History of drug allergies, hypersensitivity, or drug addiction.\n10. Any condition deemed by investigators to compromise study integrity.'}, 'identificationModule': {'nctId': 'NCT07258394', 'briefTitle': 'Clinical Study for Dimethyl Fumarate in Preserving Islet β-Cell Function in Type 1 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing Medical University'}, 'officialTitle': 'A Single-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Evaluating the Efficacy and Safety of Dimethyl Fumarate in Preserving Islet β-Cell Function in Patients With Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '2025-SR-439'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dimethyl fumarate Arm', 'description': 'The dosing regimen for Dimethyl fumarate enteric-coated capsules initiates at 120 mg twice daily (bid). After 7 days, the dose should be escalated to the maintenance level of 240 mg bid. This investigational product is administered concurrently with standard insulin therapy for glycemic control in Type 1 Diabetes Mellitus (T1DM).', 'interventionNames': ['Drug: Dimethyl Fumarate Enteric-coated Capsules']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Arm', 'description': 'The placebo capsules initiate at a dosage of 120 mg twice daily (bid). After 7 days, the dose should be increased to the maintenance level of 240 mg bid, administered concomitantly with standard insulin-based antihyperglycemic therapy for Type 1 Diabetes Mellitus (T1DM).', 'interventionNames': ['Drug: Matching placebo capsules']}], 'interventions': [{'name': 'Dimethyl Fumarate Enteric-coated Capsules', 'type': 'DRUG', 'description': 'The dosing regimen for Dimethyl fumarate enteric-coated capsules initiates at 120 mg twice daily (bid). After 7 days, the dose should be escalated to the maintenance level of 240 mg bid. This investigational product is administered concurrently with standard insulin therapy for glycemic control in Type 1 Diabetes Mellitus (T1DM).', 'armGroupLabels': ['Dimethyl fumarate Arm']}, {'name': 'Matching placebo capsules', 'type': 'DRUG', 'description': 'The placebo capsules initiate at a dosage of 120 mg twice daily (bid). After 7 days, the dose should be increased to the maintenance level of 240 mg bid, administered concomitantly with standard insulin-based antihyperglycemic therapy for Type 1 Diabetes Mellitus (T1DM).', 'armGroupLabels': ['Placebo Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Deparement of Endocrinology and Metabolism, The First Affiliated Hospital with Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Yong Gu', 'role': 'CONTACT', 'email': 'yong.gu@njmu.edu.cn', 'phone': '+86 13814084876'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, {'name': 'Qilu Pharmaceutical (Hainan) Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Director of Endocrinology Dept.; Associate Chief Physician; Associate Professor; Principal Investigator, The First Affiliated Hospital with Nanjing Medical University', 'investigatorFullName': 'Yong Gu', 'investigatorAffiliation': 'Nanjing Medical University'}}}}