Could a multiple sclerosis drug help save insulin cells in type 1 diabetes?
NCT ID NCT07548996
First seen Jun 27, 2026 · Last updated Jul 22, 2026 · Updated 2 times
Summary
This study tests whether dimethyl fumarate, a drug already used for multiple sclerosis, can help preserve the body's ability to make insulin in adults with type 1 diabetes. About 96 people will either receive the drug plus standard insulin therapy or insulin alone for 24 weeks, then be followed for a year. The goal is to see if the drug slows the loss of insulin-producing beta cells, which could reduce the amount of insulin needed.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 96 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Willing and able to participate in the study and provide signed informed consent * Aged 18 to 65 years * Diagnosed with type 1 diabetes mellitus according to ADA 2024 criteria * Positive for at least 2 islet autoantibodies among insulin autoantibody (IAA), glutamic acid decarboxylase autoantibody (GADA), insulinoma-associated protein 2 autoantibody (IA-2A), islet cell antibody (ICA), and zinc transporter 8 autoantibody (ZnT8A) * Random C-peptide level greater than or equal to 200 pmol/L Note: \- For participants who have used insulin for more than 14 days, a positive IAA result must be accompanied by at least 2 additional positive autoantibodies other than IAA Exclusion Criteria: * Pregnant or breastfeeding women, positive urine pregnancy test at screening, or inability to rule out pregnancy in the opinion of the investigator * Good glycemic control with oral antidiabetic drugs alone * Participation in other studies involving diabetes treatment or immunomodulation * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of normal * Patients with renal insufficiency or evidence of renal impairment: eGFR \<60 mL/min/1.73 m²; or other renal diseases considered by the investigator to be unsuitable for study enrollment * History of malignancy, uncontrolled immune system disease, or uncontrolled infection * Alcohol abuse, drug abuse, psychiatric disorder, or other conditions considered unsuitable for participation in a drug trial * Use of other immunosuppressive agents within 12 weeks before enrollment * Participation in any other drug trial within 12 weeks before enrollment * History of multiple drug allergies, allergic diseases, hypersensitivity constitution, or drug dependence * Any disease or condition that, in the opinion of the investigator, may interfere with study participation or evaluation
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Jiangsu Provincial Hospital
RECRUITINGNanjing, Jiangsu, 210029, China
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