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).
Nanjing Medical University
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborator
Qilu Pharmaceutical (Hainan) Co., Ltd.
Collaborator