Who is eligible for clinical trial NCT06474598?

Participants must meet protocol criteria for Type 1 Diabetes Mellitus. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06474598 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-04-07

An Adaptive Design Study of MTX228 (NCT06474598)

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: University of Alberta

🩺 Plain-English Summary (8th-Grade Level)

MTX228 has been identified as a medication that might allow the re-growth of insulin producing beta cells in people with Type 1 Diabetes. Promoting the re-growth of lost beta cells would be beneficial to people with Type 1 Diabetes because it would allow them to take less insulin by injection and would improve their overall blood sugar control while reducing the risk and rate of low blood sugars. This open-label dose selection study aims to determine the optimal dose ofMTX228 for use in a future phase IIb study. The purpose is to investigate the relative effectiveness of different doses of MTX228 and to select the most effective dose for further investigation in a phase 2b study.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (15 items).

Location: University of Alberta — Edmonton, Alberta

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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:
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
Congestive heart failure defined as New York Heart Association (NYHA) stage III and IV
Uncontrolled hypertension defined as SBP \> 160 mmHg and/or DBP \> 100 mmHg
Symptomatic postural hypotension
Use of systemic corticosteroids (except physiologic replacement doses for adrenal insufficiency) or other medications that would influence insulin sensitivity
Use of non-insulin antihyperglycemic agents within prior 30 days.
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.
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)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

University of Alberta — Edmonton, Alberta

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗