Testing MTX228 for regrowing insulin-producing cells in Type 1 Diabetes

A Open Label, Parallel Group Phase IIA, Adaptive Design Study of MTX228 in Adult Subjects With Type 1 Diabetes and Preserved β-Cell Function

This study is testing a new medication called MTX228 to see if it can help people with Type 1 Diabetes regrow insulin-producing cells and reduce their need for insulin.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Alberta (Academic / other)
• Locations: 1 site (Edmonton, Alberta)
• Trial ID: NCT06474598 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of different doses of MTX228, a medication previously developed for gastric ulcers, on the regeneration of insulin-producing beta cells in individuals with Type 1 Diabetes Mellitus. The goal is to determine the optimal dose that promotes beta-cell survival and proliferation, potentially allowing patients to reduce their insulin dependency and improve blood sugar control. Participants will be monitored using continuous glucose monitoring (CGM) devices to assess the medication's effectiveness. The findings will inform a subsequent phase 2b study to further evaluate the most effective dose.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with Type 1 Diabetes before age 35, requiring insulin treatment, and meeting specific clinical criteria.

Not a fit: Patients with monogenic diabetes, Type 2 diabetes, or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve blood sugar control and reduce the need for insulin injections in patients with Type 1 Diabetes.

How similar studies have performed: While MTX228 has not been tested in Type 1 Diabetes, similar approaches targeting beta-cell regeneration have shown promise in other studies.

Eligibility criteria

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).

Where this trial is running

Edmonton, Alberta

• University of Alberta — Edmonton, Alberta, Canada (Recruiting)

Study contacts

• Study coordinator: Dominique Forrest

Conditions Type 1 Diabetes Mellitus