BARICADE-DELAY

• People with stage 1b or 2 type 1 diabetes (have screened positive for two or more type 1 diabetes autoantibodies)
• People aged between 1 and 35 years of age
• Able to attend study visits at Box Hill Hospital (Box Hill) or Royal Melbourne Hospital (Parkville), (Royal Children’s Hospital coming soon)

• Whether baricitinib may be able to delay the start of Stage 3 type 1 diabetes in people who are in the early stages of the disease (Stage 1b or Stage 2)
• Whether baricitinib works better than a placebo (a placebo is an inactive or “pretend” study drug)
• The possible side effects people might have when taking baricitinib.

In this study 2 out of every 3 people will receive baricitinib and 1 out of every 3 people will receive a placebo. Baricitinib (and the study placebo) is taken in tablet form or as a liquid for those who cannot swallow tablets.

If you meet the criteria to enter this clinical trial, the study treatment will be given for approximately 2 years and 3 months. To monitor your health closely, you will need to attend the clinic for study related visits approximately 16 times over 2.5 years.

At each visit the study team will monitor your blood glucose levels, insulin production and overall health to ensure that you are well and that the study treatment is safe and effective.

This trial is important to people living with diabetes because this daily medication (taken as liquid or a tablet) may be able to protect the insulin making cells in people with type 1 diabetes and allow them to delay the need to give insulin.