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Could a multiple sclerosis drug help save insulin cells in type 1 diabetes?

NCT ID NCT07548996

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 96 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Jiangsu Provincial Hospital

    RECRUITING

    Nanjing, Jiangsu, 210029, China

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