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Could a failed ulcer drug help regrow insulin cells in type 1 diabetes?

NCT ID NCT06474598

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This phase 2 trial is testing a drug called MTX228 (Tolimidone) in 24 adults with type 1 diabetes who still produce some insulin. The goal is to see if the drug can help regrow the beta cells that make insulin, which could lower the amount of insulin they need to inject and improve blood sugar control. Researchers will compare different doses to find the most effective one for a future larger study.

What this could mean

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

Active substance
MTX228 (Tolimidone)
What this could lead to
If successful, this could point toward a treatment that helps people with type 1 diabetes produce some of their own insulin again, reducing their need for injected insulin.
What could go wrong
This is a small, early-phase trial with only 24 participants, so results may not apply widely. The drug previously failed for other conditions, and its effect on beta-cell regrowth is unproven.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 24 people

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

Started

Nov 2024

Expected to finish

Dec 2027

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: * clinical diagnosis of T1DM with onset before the age of 35 requiring continuous treatment with insulin within 1 year of diagnosis and the presence of positive T1DM autoantibody titer if diagnosed after age 35 (past or present * HbA1c between 6.0 - 10.0 %. * Willing to wear study-provided CGM and share CGM data via cloud. * Diagnosis of T1DM ≥1year at time of screening. * Fasting or random (post-prandial) C-peptide level ≥ 100 pmol/l (or 0.3 ng/mL) during screening or pre-screening. Pre-screening C-peptide levels may be obtained by the study team (subject to patient's written consent) up to 56 days before planned enrolment to reduce the number of screen failures. * BMI ≤ 35 kg/m2 * eGFR \>45 ml/min/1.73m2 * Able and willing to comply with the study protocol for the duration of the study * Written informed consent must be obtained before any study-related assessment is performed. Exclusion Criteria: * Diagnosis or history indicative of monogenic, Type 2 or post-pancreatectomy diabetes * History of \>1 episode of severe (level 3) hypoglycemia in the prior 6 months * Significant cardiovascular history defined as: 1. History of myocardial infarction, coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accidents within six months prior to entry into the study 2. Congestive heart failure defined as New York Heart Association (NYHA) stage III and IV 3. Uncontrolled hypertension defined as SBP \> 160 mmHg and/or DBP \> 100 mmHg 4. Symptomatic postural hypotension 5. Use of systemic corticosteroids (except physiologic replacement doses for adrenal insufficiency) or other medications that would influence insulin sensitivity 6. Use of non-insulin antihyperglycemic agents within prior 30 days. 7. History of significant other major or unstable neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, or urological disorder including previous solid organ or cell transplant that would impact patient safety or data interpretation. 8. History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years before screening (any history of treated cervical intraepithelial neoplasia is allowed) 9. Known recreational substance use or psychiatric illness that, in the opinion of the Investigator, may impact the safety of the subject or objectives with scheduled visits 10. A history of alcohol or drug abuse or drug addiction in the previous 12 months 11. A positive pregnancy blood test for women of childbearing age or breast-feeding women 12 Are unwilling to use an "effective" method of contraception during the course of the study. Sexually active male patients, who could have children, are required to use a condom or abstained from intercourse, and refrain from sperm donation for the purposes of conception. Females have to be surgically sterile (via hysterectomy or bilateral tubal ligation) or post-menopausal or using a medically acceptable barrier method of contraception (i.e. IUD, barrier methods with spermicide or abstinence).

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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

    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

  • University of Alberta

    RECRUITING

    Edmonton, Alberta, T6G 2R3, Canada

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