A Breakthrough T1D-funded, world-first clinical trial has shown that a commonly prescribed rheumatoid arthritis drug (baricitinib) can preserve the body’s own insulin production and suppress the progression of type 1 diabetes (T1D) in those newly diagnosed with the condition.
This comes after three decades of research out of the St Vincent’s Institute (SVI) in Melbourne, led by Professors Thomas Kay and Helen Thomas, investigating the mechanisms in T1D that lead the immune system to attack beta cells.
The BANDIT (Baricitinib in New Onset Type 1 Diabetes) trial findings demonstrated that the once-daily administration of a drug called baricitinib over a 48-week period preserved beta cell function, reduced blood glucose fluctuations, and reduced the need for insulin in those who had been diagnosed within the past 100 days. The findings were today published in a leading medical journal, The New England Journal of Medicine.
Professor Thomas Kay Principal Investigator, BANDIT studyOur BANDIT trial has determined that baricitinib can preserve beta cell function and insulin production in people recently diagnosed with type 1 diabetes. This suggests that if given early enough baricitinib may allow people with type 1 diabetes to be significantly less dependent on insulin treatment.
About baricitinib and its potential role in extending the honeymoon period T1D
In T1D, the immune system mistakenly attacks insulin-producing beta cells, meaning that those with well-established T1D can no longer produce their own insulin.
However, in people who are newly diagnosed, a small number of beta cells can still be alive and producing insulin (called the ‘honeymoon period’ of T1D). Using therapies to protect the remaining beta cells from further immune attack may help people produce insulin for longer, minimising how much insulin they have to inject as well as resulting in better long-term health.
Baricitinib is a drug which is currently used to treat rheumatoid arthritis and other conditions. It works by inhibiting a protein called Janus Kinase (JAK) which is important in the immune system attack of beta cells in T1D.
This suggests that inactivating JAK with baricitinib in those newly diagnosed may protect the remaining beta cells from immune attack, allowing people to keep producing their own insulin for longer. This would reduce their need to inject insulin.
Drugs, such as baricitinib, which target the immune system attack in T1D are called Disease Modifying Therapies (DMTs). These have the potential to one day delay, halt or even reverse T1D. Breakthrough T1D is investing heavily in research to develop and test these therapies.
About the trial
The BANDIT trial was undertaken in Australia and recruited 91 people aged 10-30 years who were newly diagnosed with T1D in the previous 100 days.
- Participants were either provided baricitinib in tablet form, once daily for 48 weeks, or a placebo.
- The trial primarily investigated the level of C-peptide (a sign of insulin production) at 48 weeks.
- It also investigated the need for injected insulin, how well blood sugar levels were controlled via CGM (continuous glucose monitoring) and HbA1c (a marker of longer-term control of blood sugar levels).
The results
- This world-first study demonstrated that the administration of baricitinib led to a stabilising of C-peptide and hence sustained insulin production at 48 weeks.
- Baricitinib use also led to decreased insulin requirements, improved time in range, and improved blood glucose variability at 12 and 24 weeks compared to the placebo group.
- Baricitinib was also well tolerated, with minimal side effects.
What does this mean for people with T1D?
These breakthrough findings suggest that baricitinib may preserve beta cell function in those newly diagnosed and may represent a new therapeutic option for delaying T1D progression. That is, a new therapy for potentially extending the honeymoon period.
This suggests that baricitinib can be safely used to suppress the progression of T1D in people newly diagnosed with the condition. More beta cell function should lead to better and easier blood glucose management and may in turn lower rates of long-term complications for those with T1D.
Lucy First T1D participant signed up to the BANDIT trial with staff member.It’s good to be part of this trial, to help researchers find new treatments for people with type 1 diabetes. Participating has also been really helpful in having access to closer monitoring and support, via the clinical trial team, in the early stages of my diagnosis.
This is an exciting first step and further work will be necessary to understand how this class of medication could be made available to people living with T1D.
Watch a video explaining the BANDIT trial and results further.
Breakthrough T1D’s vision is for a world without T1D, and we work towards this by funding the most promising research aimed at finding cures and improving lives.
Dr Dorota Pawlak Breakthrough T1D Chief Scientific Officer in AustraliaBreakthrough T1D focusses on funding research with the biggest potential for immediate impact for our community, and these results show an important step towards novel type 1 diabetes treatments. We’re proud to have supported a clinical trial that builds on many years of work led by the team at SVI – a demonstration of translational research in action with clear pathway to reduce burden of people living with T1D.
The BANDIT study was jointly funded by Breakthrough T1D in Australia, through our Type 1 Diabetes Clinical Research Network, and Breakthrough T1D in United States.
Breakthrough T1D has also funded the clinical trial network that made the BANDIT trial possible: The Australasian Type 1 Diabetes Immunotherapy Collaborative (ATIC). Read more about ATIC in our case study or on their website.
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