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Can an immune drug double as a diabetes treatment?

NCT ID NCT05307731

Disease control Sponsor: General Hospital of Shenyang Military Region 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Researchers are testing whether adding fingolimod to standard diabetes care can improve blood sugar control in adults with type 2 diabetes. The trial enrolls 40 people aged 18 to 70 whose blood sugar is not fully controlled on no medication or one oral drug. Half receive fingolimod plus guideline-based treatment, and half receive guideline-based treatment alone. The team tracks changes in long-term blood sugar, insulin, and C-peptide to see how the pancreas responds.

What this could mean

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

Active substance
fingolimod, an immune-modulating drug, added to standard diabetes treatment
What this could lead to
If it works, fingolimod could offer a new way to help control blood sugar in type 2 diabetes, possibly by protecting the insulin-producing cells of the pancreas.
What could go wrong
This is a small pilot study with only 40 participants, so any hint of benefit would need confirmation in much larger trials. Fingolimod can slow heart rate and raise infection risk, and it is not approved for diabetes.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 40 people

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

Started

Mar 2022

Expected to finish

Mar 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 70 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. Age: 18-70 years old; 2. clinically diagnosed type 2 diabetes. 3. Glycosylated hemoglobin: 6.5% - 9.5%; 4. No drug treatment or only one oral hypoglycemic drug within 6 months; 5. Fasting blood glucose: \< 13.9mmol/l for those without medication, or \< 13.3mmol/l for those with medication; 6. if the antidiabetic drugs are taken, the dosage and the drug must be stable in the past 3 months. 7. Body mass index (BMI) ≤ 45 kg / m2; 8. Sign informed consent Exclusion Criteria: 1. patients with type 1 diabetes; 2. diabetic complications (ketoacidosis, hypertonic state, lactic acidosis). 3. Allergic to the study drug; 4. Abnormal liver and kidney function (transaminase greater than 2.5 times the upper limit of normal value; creatinine greater than 133umol / L); 5. Complicated with other serious organ diseases; 6. Recent disease history (within the past 6 months): myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or class III / IV heart failure; 7. Presence or history of mobitz type II second or third degree AV block or sick sinus syndrome, unless the patient has a pacemaker; 8. Baseline QT interval extension (male \> 450ms or female \> 460ms); 9. Treatment with class IA or class III antiarrhythmic drugs; 10. Patients with systemic infection (including but not limited to bacteria, fungi, viruses, etc.); 11. Participating in other clinical trials within 3 months; 12. Other circumstances that the investigator considers unsuitable for participating in this clinical study.

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

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

Diabetes mellitus type 2

How to take part

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  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

  • Department of Neurology, General Hospital of Northern Theater Command

    RECRUITING

    Shenyang, 110016, China

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