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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Alberta
  Edmonton, Alberta, Canada Recruiting

Study contacts

• Study coordinator: Dominique Forrest
• Email: dforres1@ualberta.ca
• Phone: 7802481770

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• VV-14300: a gene therapy approach for adults with type 1 diabetes not well controlled on an automated insulin system

  This trial tests VV-14300 in adults with type 1 diabetes who aren’t reaching their blood sugar goals despite using an automated insulin delivery system.

  Recruiting Phase 1/2 Kriya Therapeutics, Inc. · Toronto and 1 other locations · NCT07831798

• New gene therapies VV-14299 and VV-14300 for adults with Type 1 Diabetes failing automated insulin delivery

  This study tests VV-14299 and VV-14300, or VV-14300 alone, in adults with long-standing Type 1 Diabetes whose blood sugar remains poorly controlled despite using an automated insulin delivery system.

  Recruiting Phase 1/2 Kriya Therapeutics, Inc. · Melbourne · NCT07829302

• Oral verapamil in newly diagnosed children and teens with type 1 diabetes

  This study tests whether taking verapamil by mouth can help preserve pancreatic beta cells and reduce insulin needs in kids and teens with recently diagnosed type 1 diabetes.

  Recruiting Phase 2/3 Ain Shams University · Cairo · NCT07804849

• Preventing device-related skin rashes in kids with type 1 diabetes using hydrocolloid vs silicone patches

  This study tests whether silicone-based or hydrocolloid patches help prevent recurring skin irritation from insulin pumps or CGMs in children and teens with type 1 diabetes.

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• AI-assisted remote insulin pump optimization for people with type 1 diabetes

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  Recruiting The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Nanjing, Jiangsu · NCT07732777

• Near-sensor insulin delivery with CGM in people with type 1 diabetes

  A small early-feasibility study tests a dual-port insulin patch pump that includes a CGM sensor to see if delivering insulin near the sensor affects glucose readings and whether an automated control algorithm can manage glucose.

  Recruiting Early Phase 1 ClinSurge Research · Toronto, Ontario · NCT07655076

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.