World-first clinical trial finds drug can suppress progression of type 1 diabetes in people newly diagnosed

The BANDIT (Baricitinib in New Onset Type 1 Diabetes) trial found that taking a pill of baricitinib once-daily for 48 weeks preserved insulin-producing beta cell function, decreased blood glucose fluctuations, and reduced the need for insulin in people diagnosed with type 1 within the past 100 days.

The findings were published today in a leading medical journal, The New England Journal of Medicine.

Reduced need for insulin treatment

JDRF-funded researcher Professor Thomas Kay, who led the BANDIT study, said: “Our 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.”

How does baricitinib work?

Baricitinib is a drug that is currently used to treat rheumatoid arthritis and alopecia, among other conditions. It works by inhibiting a protein that is important in the immune system attack of the insulin-producing beta cells in type 1.

The immune attack on beta cells happens gradually, so people with type 1, especially those recently diagnosed, may still have some beta cells that are able to make insulin. The BANDIT trial suggests that baricitinib may protect the surviving beta cells from immune attack, allowing people to keep producing their own insulin for longer and reducing their need to take insulin.

What happened in the BANDIT clinical trial?

The BANDIT trial took place in Australia with 91 people aged 10-30 years who had been newly diagnosed with type 1 in the previous 100 days. These participants were either given a tablet of baricitinib or a placebo, once daily for 48 weeks.

At the beginning and end of the trial, researchers measured the participants’ C-peptide levels with a simple blood test to find out how much insulin they could make themselves. They also investigated the need for injected insulin, how well blood sugar levels could be managed via continuous glucose monitoring (CGM) and HbA1c (a marker of longer-term blood sugar levels).

The results of the clinical trial

This world-first study demonstrated that the daily dose of baricitinib resulted in stable C-peptide levels, demonstrating sustained insulin production at 48 weeks. Baricitinib also led to decreased insulin requirements, improved time in range, and improved blood glucose variability at 12 and 24 weeks compared to the people who took the placebo. The researchers also found that baricitinib was safe to use, with no side effects attributed to the drug.

How could baricitinib help people with type 1?

These breakthrough findings suggest that baricitinib may preserve beta cell function in people newly diagnosed with type 1. Having even some beta cell function should lead to better and easier blood glucose management, which could also lower rates of long-term complications of type 1.

This means the drug has the potential to be a new treatment to safely delay the progression of type 1. This clinical trial is an exciting first step and further work will be necessary to understand how this type of medication could be made available to people living with type 1

Research funded by JDRF

Dr Dorota Pawlak, JDRF Australia Chief Scientific Officer, said: “JDRF focus 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 type 1 diabetes.”

Research into multiple autoimmune conditions

Type 1 diabetes, rheumatoid arthritis and alopecia (all of which baricitinib may be able to treat) are autoimmune conditions, meaning the immune system mistakenly attacks the body’s own cells. In the UK, we’re partnering with autoimmune research organisations, including Alopecia UK and Versus Arthritis, to find cures for multiple autoimmune conditions through our Connect Immune Research initiative. Research like the BANDIT trial demonstrates what is possible when we work across different disease areas to share knowledge and potential treatments.