A Study of SIMPONI® to Arrest Beta-cell Loss in Type 1 Diabetes

Inclusion Criteria:

- Be positive for at least 1 of the following diabetes-related autoantibodies obtained
at study screening: Glutamic acid decarboxylase (GAD-65), islet antigen 2 (IA-2), zinc
transporter 8 (ZnT8), Islet Cell Cytoplasmic Autoantibodies (ICA), or Insulin (if
obtained within 10 days of the onset of exogenous insulin therapy)

- Have a peak stimulated C-peptide level greater than or equal to (>=) 0.2 picomole per
milliliter (pmol/mL) following a 4-hour Mixed-meal Tolerance Test (MMTT) obtained at
study screening

- Be medically stable on the basis of physical examination, medical history, and vital
signs performed at screening. If there are abnormalities, they must be consistent with
the underlying illness in the study population

- Females of childbearing potential must have a negative serum (beta-human chorionic
gonadotropin [beta-hCG]) test at screening and a negative urine pregnancy test at the
Week 0 visit

- Participants (or their legally acceptable representatives) are willing and able to
adhere to requirements, prohibitions, and restrictions specified in this protocol

Exclusion Criteria:

- Has a history of significant renal, vascular, pulmonary, gastrointestinal, neurologic,
hematologic, rheumatologic, or psychiatric disease or immune suppression or immune
deficiency.

- Has significant cardiovascular disease, including history of myocardial infarction,
congestive heart failure, angina, abnormal electrocardiogram or abnormal stress test

- Has active infections, is prone to infections or has chronic, recurrent or
opportunistic infectious disease, including but not limited to, chronic renal
infection, chronic chest infection (example [eg.], bronchiectasis), sinusitis,
recurrent urinary tract infection (eg., recurrent pyelonephritis, chronic cystitis),
Pneumocystis carinii, aspergillosis, latent or active granulomatous infection,
histoplasmosis, or coccidioidomycosis or an open, draining, or infected non-healing
skin wound or ulcer

- Has a clinically active infection with Epstein-Barr virus (EBV) or an EBV viral load
>=10,000 copies per milliliter (mL) of plasma obtained at study screening. Has a
clinically active infection with cytomegalovirus (CMV) or a CMV viral load >= 10,000
copies per milliliter (mL) of plasma obtained at study screening

- Current or prior (within 30 days of screening) treatment that is known to cause a
significant, ongoing change in the course of T1D or immunologic status, including
high-dose inhaled, extensive topical, or systemic glucocorticoids

- Has another autoimmune disease (eg, rheumatoid arthritis [RA], polyarticular juvenile
idiopathic arthritis [pJIA], psoriatic arthritis [PsA], ankylosing spondylitis [AS],
multiple sclerosis [MS], systemic lupus erythematosus [SLE], celiac disease
[clinically symptomatic and antibody positive, that is, tissue transglutaminase
Immunoglobulin A [IgA]) excluding clinically stable autoimmune thyroiditis whether
treated or untreated

- Has any of the following tuberculosis [TB] screening criteria: A history of latent or
active TB prior to screening (including but not limited to a positive QuantiFERON®-TB
Gold test), signs or symptoms suggestive of active TB upon medical history and/or
physical examination, recent close contact with a person with known or suspected
active TB

- Has known allergies, intolerance and/or hypersensitivity to human immunoglobulin
proteins, golimumab or any of its components or its excipients