City of Hope Medical Center
This multi-center randomized controlled trial will assess the safety and efficacy of ATG followed by either adalimumab or verapamil in preserving insulin secretion 2 years from randomization in persons aged 9 to \<21 with recent-onset stage 3 T1D.
The primary objective of this study is to assess the safety and efficacy of ATG followed by either adalimumab or verapamil in preserving insulin secretion 2 years from randomization in persons with T1D. The secondary objectives are to assess metabolic and safety endpoints at 2 years and at timepoints between baseline and two years.
Key Inclusion Criteria: 1. Recent-onset stage 3 T1D diagnosed by standard ADA criteria, with the ability to be randomized within 6 months from the date of T1D diagnosis and within 37 days of Screening Visit. 2. At least one positive T1D auto-antibody. * If clearly positive (≥20% above local lab's ULN) at screening, repeat antibody testing for central lab is not required. * Insulin auto-antibodies are only considered if exogenous insulin use is \<10 days when blood is drawn. 3. Must have stimulated C-peptide levels ≥0.2 pmol/mL (≥0.6 ng/mL) measured during MMTT conducted prior to random…
ATG (brand name Thymoglobulin) a polyclonal T cell antibody preparation. The first dose (0.5 mg/kg) will be infused on day 0, during a period of 6 hours. The second dose (2 mg/kg) will be given on day 1, over a period of 4 to 6 hours.
Daily oral (pill) administration at 60, 120, 240 or 360 mg based on weight and ECG findings.
40 mg administered subcutaneously every other week beginning 6 weeks after the last dose of ATG until the 156-week visit.