Open Label Phase 2 Study to Find the Best Dose of MTX228 Tablets for Adults With Type 1 Diabetes and Preserved Beta-Cell Function

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.

An Adaptive Design Study of MTX228