[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612808":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":28,"studyPopulation":28,"armGroups":54,"interventions":67,"overallOfficials":28,"centralContacts":75,"locations":81,"responsibleParty":99,"collaborators":102,"id":108,"slug":28,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":28,"eligibilityCriteria":113,"healthyVolunteers":109,"sex":114,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":28,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":84,"whyStopped":28,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Nanjing Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"Baseline-adjusted geometric mean area under the serum C-peptide curve (C-peptide AUC) during a 2-hour mixed-meal tolerance test (MMTT) 24 weeks post-intervention.","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.","Post-intervention Weeks 24",[14,17,20,23,26,29,33,36,38,40],{"measure":15,"description":11,"timeFrame":16},"Baseline-adjusted geometric mean area under the curve (AUC) for serum C-peptide during a 2-hour mixed-meal tolerance test (MMTT) at 24 weeks of intervention and 52 weeks after the end of intervention.","Week 24 of intervention and 52 weeks post-intervention",{"measure":18,"description":11,"timeFrame":19},"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.","Intervention Week 24, and Post-intervention Weeks 24 and 52",{"measure":21,"description":11,"timeFrame":22},"The number of subjects who remained C-peptide positive at 52 weeks after the end of intervention (defined as a stimulated peak serum C-peptide concentration >= 200 pmol\u002FL during a 2-hour MMTT).","Post-intervention Week 52",{"measure":24,"description":25,"timeFrame":19},"Glycemic Control Status","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 \\\u003C 6.5%).",{"measure":27,"description":28,"timeFrame":19},"Mean Daily Dose of Exogenous Insulin Used During the 7 Days Preceding Each Study Visit",null,{"measure":30,"description":31,"timeFrame":32},"Immunological markers","Count, phenotype, and functional characteristics of white blood cell (WBC) subsets (including T cells, B cells, and natural killer \\[NK\\] cells); serum proinflammatory and regulatory cytokine profiles, along with other immune mediators; and the number of positive types, specific types, and titer levels of islet autoantibodies.","Baseline, Week 24 During Intervention, and 24,52 Weeks After Intervention",{"measure":34,"description":28,"timeFrame":35},"Incidence Rates of Flushing, Abdominal Pain, Diarrhea, Nausea, Vomiting, Pruritus, Rash, Proteinuria, Erythema, and Dyspepsia","Week 4, 8, 12, 16, and 24 During Intervention",{"measure":37,"description":28,"timeFrame":35},"Incidence Rates of Anaphylaxis, Angioedema, and Opportunistic Infections",{"measure":39,"description":28,"timeFrame":35},"Incidence Rates of Elevated Aspartate Aminotransferase (AST), Elevated Total Bilirubin (TBIL), and Lymphocytopenia",{"measure":41,"description":28,"timeFrame":42},"Incidence Rates of Hypoglycemia\u002FSevere Hypoglycemia and Ketosis\u002FDiabetic Ketoacidosis (DKA)","Baseline, Weeks4, 8, 12, 16, 20 and 24 During Intervention, and 12, 24, 36, and 52 Weeks After Intervention",{"allocation":44,"interventionModel":45,"interventionModelDescription":28,"primaryPurpose":46,"observationalModel":28,"timePerspective":28,"maskingInfo":47},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":48,"maskingDescription":28,"whoMasked":49},"QUADRUPLE",[50,51,52,53],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[55,61],{"label":56,"type":57,"description":58,"interventionNames":59},"Dimethyl fumarate Arm","EXPERIMENTAL","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).",[60],"Drug: Dimethyl Fumarate Enteric-coated Capsules",{"label":62,"type":63,"description":64,"interventionNames":65},"Placebo Arm","PLACEBO_COMPARATOR","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).",[66],"Drug: Matching placebo capsules",[68,72],{"type":69,"name":70,"description":58,"armGroupLabels":71,"otherNames":28},"DRUG","Dimethyl Fumarate Enteric-coated Capsules",[56],{"type":69,"name":73,"description":64,"armGroupLabels":74,"otherNames":28},"Matching placebo capsules",[62],[76],{"name":77,"role":78,"phone":79,"phoneExt":28,"email":80},"Yong Gu","CONTACT","+86 13814084876","yong.gu@njmu.edu.cn",[82],{"facility":83,"status":84,"city":85,"state":86,"zip":87,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":95,"contacts":96},"Deparement of Endocrinology and Metabolism, The First Affiliated Hospital with Nanjing Medical University","RECRUITING","Nanjing","Jiangsu","210029","China","CN",{"type":91,"coordinates":92},"Point",[93,94],118.77778,32.06167,{"lat":94,"lon":93},[97],{"name":77,"role":78,"phone":98,"phoneExt":28,"email":80},"+8613645148415",{"type":100,"investigatorFullName":77,"investigatorTitle":101,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","Deputy Director of Endocrinology Dept.; Associate Chief Physician; Associate Professor; Principal Investigator, The First Affiliated Hospital with Nanjing Medical University",[103,105],{"name":104,"class":6},"The First Affiliated Hospital with Nanjing Medical University",{"name":106,"class":107},"Qilu Pharmaceutical (Hainan) Co., Ltd.","INDUSTRY","100612808",false,"NCT07258394","Clinical Study for Dimethyl Fumarate in Preserving Islet β-Cell Function in Type 1 Diabetes Mellitus","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","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\u002FL.\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\u002Fimmune-modulating trials.\n4. ALT\u002FAST \\>3× upper limit of normal (ULN).\n5. History of malignancy, uncontrolled autoimmune disorders, or active infections.\n6. Alcohol\u002Fdrug 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.","ALL","18 Years","65 Years",{"count":118,"type":119},90,"ESTIMATED","INTERVENTIONAL",[122],"PHASE3","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 or placebo 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.",[125],"Type 1 Diabetes",[125,127,128],"Immunotherapy","Pancreatic Beta-Cell Function","2026-03-03",{"date":131,"type":132},"2026-03-05","ACTUAL",{"date":134,"type":132},"2026-01-27",{"date":136,"type":119},"2028-12-31",{"name":5,"class":6},1]