A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes
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.
• Must have stimulated C-peptide levels ≥0.2 pmol/mL measured during MMTT conducted prior to randomization.
• Age 9 to \<21 years at the time of randomization.
• Body weight \>30kg.
• BMI \<95th percentile for age and gender.
• Willing to comply with intensive diabetes management.
• Female participants with childbearing potential are not currently pregnant, are willing to avoid pregnancy and breastfeeding, and to undergo pregnancy testing prior to MMTTs for the duration of the study.
• Women of childbearing potential (WOCBP) must use an acceptable form of birth control. Acceptable forms include oral/injection contraceptives, transdermal contraceptives, diaphragm, intrauterine devices, condoms with spermicide, documented surgical sterilization of either the participant or their partner or abstinence.
• Male participants with potential to father children must be willing to use abstinence or adequate contraceptive methods for the duration of the study.
• Males must agree to be sexually abstinent or use a condom and agree not to donate sperm for the treatment period and for a minimum of 1 spermatogenesis cycle (90 days after last dose of study drug) after last treatment.
• Willing to provide informed consent and child assent as applicable.
• Sufficient cognitive ability, per investigator judgment, to provide informed consent for study participation on an IRB approved consent form.
• Able to read and understand English or Spanish (both participant and legally authorized representative, if applicable).
• Must be fully vaccinated for age.
• Must have been vaccinated for flu (if currently in flu season).
• Must be willing to not receive live vaccines throughout the treatment period.
• Must be willing to not use any non-insulin glucose-lowering agents such as GLP-1 agonists (including for weight loss indication), symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas) for the duration of study treatment. Participants are required to go off these drugs at least 30 days prior to screening.