Tests dimethyl fumarate against placebo in adults with new type 1 diabetes
Tests dimethyl fumarate against placebo in adults newly diagnosed with type 1 diabetes.
Plain-language title generated from the registry record
Registry title: Clinical Study for Dimethyl Fumarate in Preserving Islet β-Cell Function in Type 1 Diabetes Mellitus
Key facts
- Where
- Nanjing, ChinaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07258394, who can take part
Where in China
- Deparement of Endocrinology and Metabolism, The First Affiliated Hospital with Nanjing Medical UniversityNanjing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Nanjing Medical University
- Trial code
- NCT07258394
- Record updated
- 5 March 2026
- Original description
Purpose of the Clinical Trial:Read full original descriptionShow less
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
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.
Inclusion: 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; Disease duration ≤100 days post-T1DM diagnosis; Random C-peptide ≥ 200 pmol/L.
Exclusion: Use of immunosuppressants within 12 weeks prior; Participation in other drug trials within 12 weeks prior; Participation in other diabetes/immune-modulating trials; History of malignancy, uncontrolled autoimmune disorders, or active infections; Alcohol/drug abuse, psychiatric disorders, or conditions unsuitable for trial participation; History of drug allergies, hypersensitivity, or drug addiction; Any condition deemed by investigators to compromise study integrity; ALT/AST >3× upper limit of normal (ULN); Pregnancy, lactation, or women of childbearing potential not using contraception; Well-controlled glycemia with oral hypoglycemic agents alone.