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New treatment option for Type 1 Diabetes Mellitus
Official title An Adaptive Design Study of MTX228
ClinicalTrials.gov ID: NCT06474598
What this study is testing
What is MTX228?
MTX228 is an investigational medicine, given as an once-daily injectable medicine, being studied as a potential treatment for type 1 diabetes mellitus.
Also referred to as Tolimidone.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- 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...
- 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.
- 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...
- 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...
- 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...
- 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
- A history of alcohol or drug abuse or drug addiction in the previous 12 months
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.