An Adaptive Design Study of MTX228

Launched by UNIVERSITY OF ALBERTA · Jun 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called MTX228, which may help people with Type 1 Diabetes by encouraging the growth of insulin-producing cells in the body. If successful, this could mean that patients might need less insulin from injections, leading to better blood sugar control and a lower risk of low blood sugar episodes. The trial aims to find the best dose of MTX228 for future studies.

To participate, individuals should have been diagnosed with Type 1 Diabetes before age 35 and need to be using insulin continuously. They should also be willing to wear a device that monitors their blood sugar levels and share that data. Other criteria include having specific blood sugar levels and kidney function. Participants in the study will be closely monitored, and they can expect to receive guidance throughout the trial. It’s important to note that certain health conditions or recent medical histories may disqualify individuals from taking part in this study.

Gender

ALL

Eligibility criteria

• 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).