Phase 12 Study of Low Dose Anti-thymocyte Globulin ATG Followed by Adalimumab or Verapamil to Preserve Insulin Secretion in New Onset Type 1 Diabetes in Youth

What this Trial Is About

This trial studies children and young adults aged 9 to under 21 years with recent-onset type 1 diabetes T1D. The goal is to evaluate the safety and effectiveness of low-dose anti-thymocyte globulin ATG followed by either adalimumab or verapamil in preserving insulin production over two years. Researchers aim to understand treatment impacts on metabolic health and safety during this period. Participants receive low-dose ATG infusions on two consecutive days, followed by either daily oral verapamil or biweekly injections of adalimumab starting six weeks after ATG. One group receives ATG with placebo pills or injections. Treatment continues up to 156 weeks. The study is randomized with three groups and uses triple blinding. During the study, participants undergo regular assessments including metabolic tests, immune cell counts, and monitoring for adverse events. The main outcome is the level of stimulated C-peptide at 104 weeks, which reflects insulin secretion. Safety is tracked throughout with checks for infections, blood counts, and heart function. The total participation lasts approximately two years, with visits scheduled to monitor treatment effects and overall health.

A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes