Clinical Study for Dimethyl Fumarate in Preserving Islet β-Cell Function in Type 1 Diabetes Mellitus

Phase

Condition

Diabetes Mellitus, Type 1

Diabetes And Hypertension

Diabetes Mellitus Types I And Ii

Treatment

Matching placebo capsules

Dimethyl Fumarate Enteric-coated Capsules

Clinical Study ID

NCT07258394

2025-SR-439

Ages 18-65
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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 aciddecarboxylase autoantibody (GADA) Protein tyrosine phosphatase antibody (IA-2A)Islet cell antibody (ICA) Zinc transporter 8 autoantibody (ZnT8A) Note: ForIAA-positive subjects with insulin use >14 days, ≥2 additional autoantibodies mustbe positive.
Disease duration ≤100 days post-T1DM diagnosis.
Random C-peptide ≥ 200 pmol/L.

Exclusion

Exclusion Criteria:

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).
History of malignancy, uncontrolled autoimmune disorders, or active infections.
Alcohol/drug abuse, psychiatric disorders, or conditions unsuitable for trialparticipation.
Use of immunosuppressants within 12 weeks prior.
Participation in other drug trials within 12 weeks prior.
History of drug allergies, hypersensitivity, or drug addiction.
Any condition deemed by investigators to compromise study integrity.

Study Design