Type 1 diabetes (T1D) results from the killing of insulin-producing pancreatic beta cells by
cells of the immune system. The study aims to slow the progressive, immune-mediated loss of
insulin-producing beta cells that occurs after clinical presentation. The investigators have
identified a pathway that is important for immune cells to kill beta cells, and a drug that
will block this pathway and prevent beta cell death. This drug, baricitinib, is already in
clinical use for rheumatoid arthritis, and is currently in clinical trials for other
diseases, including childhood autoimmune diseases. It is hypothesized that baricitinib
treatment for 48 weeks will preserve beta cell function in children and young adults with
recently-diagnosed T1D.
The trial aims to recruit 83 participants aged 12-30 years who have been recently diagnosed
with T1D. Two thirds of the participants will be randomly assigned to receive baricitinib,
one third will receive placebo. The trial will test if baricitinib can slow the progressive
loss of insulin-producing beta cells in these patients. The primary objective is to determine
if baricitinib can reduce the loss of meal-stimulated plasma C-peptide, a measure of
beta-cell function. Maintaining endogenous insulin in recent-onset T1D improves glucose
control and may lead to long-term improvements in glucose and lower rates of serious diabetes
complications and death.
Phase:
Phase 2
Details
Lead Sponsor:
St Vincent's Institute of Medical Research
Collaborators:
Juvenile Diabetes Research Foundation Juvenile Diabetes Research Foundation Australia