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Can a multiple sclerosis drug help preserve insulin production in type 1 diabetes?

NCT ID NCT07258394

Disease control Sponsor: Nanjing Medical University Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether dimethyl fumarate, a drug already used for multiple sclerosis, can protect the pancreas's insulin-producing cells in adults recently diagnosed with type 1 diabetes. Ninety participants will take either the drug or a placebo twice daily for 24 weeks, alongside their usual insulin. The main goal is to see if the drug helps maintain natural insulin production, measured by a C-peptide test after a mixed meal.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dimethyl fumarate
What this could lead to
If it works, this could help preserve the body's ability to produce some insulin, potentially reducing the amount of insulin injections needed.
What could go wrong
This is an early Phase 3 trial with only 90 participants. The drug may not protect beta cells better than placebo, and side effects like flushing or stomach issues are possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 90 people

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

Started

Jan 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: 1. Subjects who provide written informed consent. 2. Aged 18-65 years. 3. Diagnosed with Type 1 Diabetes Mellitus (per ADA 2024 criteria). 4. 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. 5. Disease duration ≤100 days post-T1DM diagnosis. 6. Random C-peptide ≥ 200 pmol/L. Exclusion Criteria: 1. Pregnancy, lactation, or women of childbearing potential not using contraception. 2. Well-controlled glycemia with oral hypoglycemic agents alone. 3. Participation in other diabetes/immune-modulating trials. 4. ALT/AST \>3× upper limit of normal (ULN). 5. History of malignancy, uncontrolled autoimmune disorders, or active infections. 6. Alcohol/drug abuse, psychiatric disorders, or conditions unsuitable for trial participation. 7. Use of immunosuppressants within 12 weeks prior. 8. Participation in other drug trials within 12 weeks prior. 9. History of drug allergies, hypersensitivity, or drug addiction. 10. Any condition deemed by investigators to compromise study integrity.

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 1 diabetes

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

    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

  • Deparement of Endocrinology and Metabolism, The First Affiliated Hospital with Nanjing Medical University

    RECRUITING

    Nanjing, Jiangsu, 210029, China

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