The launch of these clinical trials follows a landmark Australian clinical trial called the BANDIT study (Baricitinib in New Onset Type 1 Diabetes), which already tested baricitinib in children and young adults newly diagnosed with T1D. This project was funded by Breakthrough T1D, via our Type 1 Diabetes Clinical Research Network.
The BANDIT study was a world-first and found that a once daily pill of baricitinib taken for a year:
- preserved insulin production
- stablilised blood glucose levels
- improved time-in-range
- decreased the requirement for external insulin
- is safe for people with T1D.
The new clinical trials being run by Eli Lilly are only possible thanks to the BANDIT study showing baricitinib is safe and effective for people living with T1D to take.
The new clinical trials
BARICADE-DELAY
One of the clinical trials will test whether baricitinib can delay stage 3 T1D in people aged 1 to 36 who currently have stage 2 T1D. The study will follow participants for approximately 5 years and will track 2 groups – those taking baricitinib and those taking a placebo – to compare how long it takes them to be diagnosed with stage 3 T1D.
The BARICADE-DELAY study is now recruiting participants in Australia.
BARICADE-PRESERVE
The other clinical trial will test whether baricitinib can preserve insulin production in people aged 1 to 36 years who have been recently diagnosed with stage 3 T1D who still have some functioning beta cells (the cells destroyed in T1D that make insulin). This study will follow participants for around 60 weeks and measure their C-peptide levels. C-peptide is a molecule released alongside insulin, meaning it can be used as a measure of insulin production.
The BARICADE-PRESERVE study is now recruiting participants in Australia.
The stages of T1D
T1D develops in stages as more beta cells are gradually lost to the autoimmune attack. Learn more about the stages of T1D.
What is baricitinib?
Baricitinib is a type of drug called a JAK inhibitor, meaning it targets JAK signalling pathways. These biological pathways are associated with overactive immune responses, so blocking this pathway may turn down the autoimmune response that destroys beta cells and leads to T1D. Baricitinib is already used to treat other autoimmune conditions, including rheumatoid arthritis and alopecia.
Why preserve beta cell health?
Preserving beta cell function means someone in the early stages of T1D can keep making their own insulin for longer. This could result in people in stage 3 T1D requiring less insulin than they ordinarily would, and those in stage 2 T1D could have precious years without needing to take insulin at all. More time with less blood glucose variability also reduces the risk of T1D complications.
Australian research with a global impact
The Breakthrough T1D-funded researcher who led the BANDIT trial, Professor Thomas Kay, Director at St Vincent’s Institute of Medical Research (SVI) in Melbourne, said:
In the BANDIT trial, we tested for the first time whether baricitinib could preserve insulin producing cells under autoimmune attack in type 1 diabetes. Years of laboratory work indicated that this drug should be effective. Baricitinib given for 12 months maintained insulin production compared with its loss with placebo. We are grateful to Breakthrough T1D and Lilly for their support of the trial.
This was a very exciting outcome from our bench to bedside research. Current insulin therapy is lifesaving in diabetes but it is imperfect, and new treatments such as baricitinib show promise. Preservation of insulin production allows the body’s own amazing processes to control blood glucose and reduce the burden of type 1 diabetes.
We hope that the BARICADE trials will confirm our findings and extend them to people with earlier diabetes, before insulin is required, and lead to the use of baricitinib in clinical practice for type 1 diabetes.
Dr Dorota Pawlak, Chief Scientific Officer at Breakthrough T1D Australia, said:
We are delighted to see the calibre of Australian science and researchers here in Australia making an impact for the global T1D community. We will be eagerly watching how the BARICADE trials progress in the hope that more positive results will push baricitinib one step closer to being approved for delaying progression of T1D.
There is a huge unmet need for a treatment like this that can give people in the early stages of T1D precious time, with less of the burden that comes with managing this life-long condition, and we are optimistic that baricitinib can help meet this need. Delaying the progression of T1D is the first step on the way to one day being able to halt its development entirely and create a world without T1D.
