Purpose of the Clinical Trial:
This 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.
Primary Research Questions:
Does 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?
Study Design:
Researchers will compare dimethyl fumarate with a placebo (an identical substance without active ingredients) to determine whether Dimethyl fumarate can effectively treat type 1 diabetes.
Participant Activities:
Take 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.
Record symptoms, blood glucose control, islet function, and insulin usage throughout the trial.
Subjects who provide written informed consent.
Aged 18-65 years.
Diagnosed with Type 1 Diabetes Mellitus (per ADA 2024 criteria).
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.
Pregnancy, lactation, or women of childbearing potential not using contraception.
Well-controlled glycemia with oral hypoglycemic agents alone.
Participation in other diabetes/immune-modulating trials.
ALT/AST >3× upper limit of normal (ULN).
Parallel
Dimethyl Fumarate Enteric-coated Capsules
DrugThe 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).
Matching placebo capsules
DrugThe 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).
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.
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.
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.
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.
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.
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/L during a 2-hour MMTT).
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.
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 \< 6.5%).
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Nanjing Medical University
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborator
Qilu Pharmaceutical (Hainan) Co., Ltd.
Collaborator
