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.
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.
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.
Prior treatment with ATG or known allergy to ATG or rabbit-derived products.
Immunodeficient or have clinically significant chronic lymphopenia: Leukopenia (<3,000 leukocytes /μL), neutropenia (<1,500 neutrophils/μL), lymphopenia (<800 lymphocytes/μL).
Thrombocytopenia (<100,000 platelets/μL) or anemia (hemoglobin < 10g/dL).
Leukocytosis (>14,000/mL)
City of Hope Medical Center
Lead sponsor
Jaeb Center for Health Research
Collaborator