Actively Recruiting
Clinical Study for Dimethyl Fumarate in Preserving Islet β-Cell Function in Type 1 Diabetes Mellitus
Led by Nanjing Medical University · Updated on 2026-03-05
90
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
Sponsors
N
Nanjing Medical University
Lead Sponsor
T
The First Affiliated Hospital with Nanjing Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Study for Dimethyl Fumarate in Preserving Islet β-Cell Function in Type 1 Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent
- Aged 18 to 65 years
- Diagnosed with Type 1 Diabetes Mellitus according to ADA 2024 criteria
- Positive for at least two autoantibodies related to type 1 diabetes
- Disease duration of 100 days or less since diagnosis
- Random C-peptide level of 200 pmol/L or higher
You will not qualify if you...
- Pregnant, breastfeeding, or women of childbearing potential not using contraception
- Well-controlled blood sugar using only oral hypoglycemic agents
- Participation in other diabetes or immune-modulating trials
- ALT or AST liver enzyme levels greater than 3 times the upper limit of normal
- History of cancer, uncontrolled autoimmune diseases, or active infections
- Alcohol or drug abuse, psychiatric disorders, or conditions unsuitable for study participation
- Use of immunosuppressants within 12 weeks before the study
- Participation in other drug trials within 12 weeks before the study
- History of drug allergies, hypersensitivity, or drug addiction
- Any condition the investigators believe would affect study integrity
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Trial Site Locations
Total: 1 location
1
Deparement of Endocrinology and Metabolism, The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Actively Recruiting
Research Team
Y
Yong Gu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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