RecruitingPhase 2NCT06474598

An Adaptive Design Study of MTX228

A Open Label, Parallel Group Phase IIA, Adaptive Design Study of MTX228 in Adult Subjects With Type 1 Diabetes and Preserved β-Cell Function

Sponsor

University of Alberta

Enrollment

24 participants

Start Date

Nov 14, 2024

Study Type

INTERVENTIONAL

Conditions

Type 1 Diabetes Mellitus

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new investigational drug called MTX228 in people with Type 1 diabetes (T1D). Type 1 diabetes is an autoimmune condition where the body destroys the insulin-producing cells in the pancreas. This drug aims to preserve the remaining insulin-producing cells, which could help improve blood sugar control and reduce complications. **You may be eligible if...** - You have been diagnosed with Type 1 diabetes for at least 1 year - Your blood sugar levels (HbA1c) are between 6.0% and 10.0% - You still have some remaining insulin-producing capacity (C-peptide level ≥ 100 pmol/L) - You are willing to wear a continuous glucose monitor and share data - Your BMI is 35 or under and your kidneys are functioning adequately **You may NOT be eligible if...** - You have Type 2 diabetes or a form of diabetes caused by another condition - You have had more than one episode of severe low blood sugar in the past 6 months - You have a significant history of heart attack, stroke, or heart failure - You have had cancer in the past 5 years (other than certain skin cancers) - You are pregnant or breastfeeding - You have a history of substance or alcohol abuse in the past year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMTX228

Tolimidone was developed as a treatment for gastric ulcers but did not advance beyond phase 2 clinical trials because of lack of efficacy. Subsequently, tolimidone has been identified as an activator of Lyn kinase and was considered as a treatment for type 2 diabetes as an insulin sensitizer because of Lyn's interaction with insulin signaling molecules. More recently, Lyn has been identified as a critical regulator of beta-cell mass, with genetic and biochemical inactivation of Lyn provoking beta-cell death in isolated human islets and precipitated diabetes in mice, and activation of Lyn stimulating beta-cell survival and beta-cell proliferation. These findings strongly suggest that small molecule activators of Lyn, such as Tolimidone, could represent new therapeutic options to promote beta-cell regeneration in type 1 diabete

DEVICEDEXCOM G6

To monitor participants blood glucose levels continuously