Actively Recruiting
An Adaptive Design Study of MTX228
Led by University of Alberta · Updated on 2026-04-13
24
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
An Adaptive Design Study of MTX228
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of Type 1 Diabetes Mellitus with onset before age 35 requiring continuous insulin treatment within 1 year of diagnosis or positive autoantibody if diagnosed after age 35
- HbA1c between 6.0% and 10.0%
- Willing to wear study-provided continuous glucose monitor and share data via cloud
- Diagnosis of Type 1 Diabetes Mellitus for at least 1 year at screening
- Fasting or random C-peptide level of at least 100 pmol/L (0.3 ng/mL) during screening or pre-screening
- Body Mass Index of 35 kg/m2 or less
- Estimated glomerular filtration rate (eGFR) greater than 45 ml/min/1.73m2
- Able and willing to comply with the study protocol for the full duration
- Written informed consent obtained before any study assessments
You will not qualify if you...
- Diagnosis or history of monogenic, Type 2, or post-pancreatectomy diabetes
- History of more than 1 episode of severe (level 3) hypoglycemia in past 6 months
- Significant cardiovascular history including recent myocardial infarction, coronary procedures, unstable angina, stroke, or transient ischemic attack within 6 months
- Congestive heart failure New York Heart Association stage III or IV
- Uncontrolled high blood pressure (SBP > 160 mmHg or DBP > 100 mmHg)
- Symptomatic postural hypotension
- Use of systemic corticosteroids (except physiologic replacement doses) or other medications affecting insulin sensitivity
- Use of non-insulin antihyperglycemic agents within prior 30 days
- History of major or unstable neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, or urological disorders impacting safety or data
- History of cancer (except certain skin cancers) not in remission for at least 5 years
- Known recreational substance use or psychiatric illness affecting safety or study objectives
- History of alcohol or drug abuse or addiction in past 12 months
- Positive pregnancy test or breastfeeding for women of childbearing potential
- Unwillingness to use effective contraception during the study; males must use condoms or abstain from intercourse and refrain from sperm donation; females must be surgically sterile, post-menopausal, or using acceptable barrier contraception
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Alberta
Edmonton, Alberta, Canada, T6G 2R3
Actively Recruiting
Research Team
D
Dominique Forrest
CONTACT
P
Peter Senior
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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