The goal of this clinical trial is to learn if golimumab is effective at preventing progression to Stage 2 diabetes in participants with presymptomatic Type 1 Diabetes. The expected duration of this study is approximately 6 years.
Participants will:
* Take golimumab or placebo injections monthly for the duration of the study or until they are diagnosed with either stage 2 or stage 3 Type 1 Diabetes * Visit a study clinic every 6 months for Oral Glucose Tolerance Tests (OGTTs) and other tests until the end of the study
Willing to provide informed consent or have a parent or legal guardians provide informed consent when the participant is <18 years of age.
Weight ≥15 kg at the time of screening.
Aged ≥2 to <45 years.
A confirmed history of either IA2A alone or at least two or more diabetes-related biochemical autoantibodies (mIAA, GADA, ICA, IA-2A, ZnT8A) present on the same sample. Confirmed autoantibody result means that the presence of the antibody has been verified on more than one occasion. For multiple autoantibody positivity, the same autoantibodies do not need to be present on the different tests. Confirmation must occur within the six months prior to screening. In the absence of other antibodies, ICA and GADA positivity alone will not suffice for eligibility in this study.
Leukocytes <3,500/μL or >14,000/μL
Neutrophils <1,500/mL
Platelet count <100,000 /μL
Hemoglobin <6.2 mmol/L (10.0 g/dL)