Actively Recruiting
Open Label Adaptive Study of MTX228 Doses in Adults With Type 1 Diabetes and Preserved Beta-Cell Function
Led by University of Alberta · Updated on 2026-04-13
24
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating MTX228 as a potential treatment for adults with Type 1 Diabetes Mellitus who have preserved beta-cell function. The study aims to find the best dose of MTX228 for future testing by comparing its effects on beta-cell regrowth, insulin use, and blood sugar control. This phase 2 adaptive design trial will help determine the optimal dose for a later phase 2b study. Participants will receive one of three different oral doses of MTX228: 100 mg once daily, 100 mg twice daily, or 200 mg twice daily, each for 3 months. The treatment involves taking tablets daily, and the study is open-label with no blinding. Continuous glucose monitoring will be used during the treatment to track blood sugar levels. During the study, participants will wear a continuous glucose monitor and share their glucose data via the cloud. Researchers will measure changes in C-peptide levels to assess beta-cell function, insulin dose adjustments, time spent in different blood glucose ranges, HbA1c, fasting plasma glucose, and episodes of severe hypoglycemia. The main assessments occur at the start and after 3 months of treatment, with additional follow-up at 6 months. The total participation lasts several months, including monitoring and data collection.
CONDITIONS
Brief 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
- Positive Type 1 Diabetes autoantibody if diagnosed after age 35
- HbA1c between 6.0% and 10.0%
- Willingness to wear study-provided continuous glucose monitor and share data via cloud
- Diagnosis of Type 1 Diabetes for at least 1 year at screening
- Fasting or random C-peptide level at least 100 pmol/l (0.3 ng/mL)
- Body mass index (BMI) of 35 kg/m2 or less
- Estimated glomerular filtration rate (eGFR) greater than 45 ml/min/1.73m2
- Ability and willingness to comply with study protocol duration
- Written informed consent provided before any study assessments
You will not qualify if you...
- Diagnosis or history of monogenic, Type 2, or post-pancreatectomy diabetes
- More than one severe hypoglycemia episode in the past 6 months
- Significant cardiovascular history including recent heart attack, stroke, or unstable heart conditions
- Congestive heart failure classified as NYHA stage III or IV
- Uncontrolled high blood pressure (systolic >160 mmHg or diastolic >100 mmHg)
- Symptomatic postural hypotension
- Use of systemic corticosteroids or medications affecting insulin sensitivity
- Use of non-insulin antihyperglycemic agents within the past 30 days
- History of major unstable neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, or urological disorders
- History of cancer not in full remission for at least 5 years except certain skin cancers
- Known substance use or psychiatric illness impacting safety or study objectives
- History of alcohol or drug abuse in the last 12 months
- Positive pregnancy test or breastfeeding
- Unwillingness to use effective contraception during the study according to specified guidelines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 months
Participants receive oral tablet administration of MTX228 at assigned doses (100 mg QD, 100 mg BID, or 200 mg QD) for 3 months to evaluate effects on beta-cell function and diabetes control.
Regular visits for monitoring and assessments during treatment
Duration - 3 months
Participants are monitored for an additional 3 months after treatment to assess longer-term effects on insulin dose, glucose levels, and safety.
Visits for follow-up assessments after treatment completion
Trial Site Locations
Total: 1 location
1
University of Alberta
Edmonton, Alberta, Canada, T6G 2R3
Actively Recruiting
Research Team
D
Dominique Forrest
P
Peter Senior
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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