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SVI leads world-first clinical trial

Posted: 12th November 2020

Researchers at St Vincent’s Institute of Medical Research (SVI) in Melbourne are leading a clinical trial to test a treatment intended to stop the immune system from destroying the insulin-producing cells of people with newly diagnosed type 1 diabetes.

“When type 1 diabetes is first diagnosed there are a substantial number of insulin-producing cells still present. The BANDIT (baricitinib in new onset type 1 diabetes) Trial will help determine if the drug baricitinib, currently used to treat rheumatoid arthritis, will protect the insulin-producing cells from immune attack. This would allow people who have recently been diagnosed with the disease to continue to produce insulin for a longer period and improve their glucose control,” said SVI’s Professor Helen Thomas, co-investigator of the BANDIT Trial and head of Australia’s largest type 1 diabetes research group.

People between 12-30 years old who have recently been diagnosed with type 1 diabetes are being sought to take part in the trial, which will run for two years.

People with type 1 diabetes are dependent on insulin injections to regulate their blood glucose levels. This has been the mainstay of treatment since insulin’s discovery almost 100 years ago; however, despite its life-saving role, long-term complications of the condition include heart attack and stroke, vision impairment, kidney disease and nerve damage.

“It is tremendously exciting for us to be the first group anywhere in the world to test the efficacy of baricitinib as a potential type 1 diabetes treatment,” said Professor Tom Kay, Director of SVI, lead investigator of the BANDIT Trial and recipient of the 2020 Australian Diabetes Society (ADS) Kellion Award*.

“If the trial proves successful, production of insulin will be maintained and people with type 1 diabetes will be significantly less dependent on insulin treatment.”

JDRF are funding the trial through the federally funded Emerging Priorities and Consumer Driven Research Initiative, as well as leveraged international funding. Dr Dorota Pawlak, Chief Scientific Officer of JDRF Australia, said, “This is a fantastic opportunity for Australian research and an important step towards novel type 1 diabetes treatments.  We’re proud to be supporting a clinical trial that builds on many years of work led by the team at SVI – a demonstration of translational research in action.”    

Associate Professor John Wentworth, endocrinologist at The Royal Melbourne Hospital, Director of the Type 1 Diabetes TrialNet collaborative and co-investigator on the BANDIT Trial said, “This is a great opportunity for Australian researchers and trial participants. We will, for the first time, determine if this tablet can be used to treat type 1 diabetes.”

Libby Rose was 12 when she first received a diagnosis of type 1 diabetes. The impact, physically and emotionally, was immediate. “I was overwhelmed; I didn't understand what was going on. And because of the stress, my sugar levels kept rising, which caused me to become sick again.”

Her mother, Tracy, was stressed too. “I want my daughter and others to be able to live a carefree life, free of calculations, side effects, needles, pain, external pumps hidden inside pockets and the concern about long-term health issues. I really hope that this trial provides other families with an alternative treatment option for this disease.

“It’s too late for us to be a part of the trial, but if we could, we would certainly be interested to help make the lives of people who might be diagnosed with type 1 diabetes in the future look more ‘normal’.”

During the first year, participants will be required to attend a trial site once a month and take either a baricitinib tablet or a placebo tablet once a day. In the second year, participants will be required to visit their trial site on two occasions for follow up to check blood glucose and other levels.

The BANDIT Trial will run at The Royal Melbourne Hospital, The Royal Children’s Hospital and St Vincent’s Hospital. People with type 1 diabetes who have been diagnosed in the last 100 days, and are between the ages of 12-30, are eligible.

More information is available at www.svi.edu.au/bandit 

About St Vincent’s Institute

St Vincent’s Institute of Medical Research (SVI) is a Melbourne-based, independent medical research institute that conducts biomedical research into the cause, prevention and treatment of high-impact diseases such as cancer, heart disease, diabetes, obesity, bone diseases and Alzheimer’s. SVI is affiliated with St. Vincent’s Hospital and the University of Melbourne. www.svi.edu.au.

* The ADS Kellion Award was awarded to Professor Kay on the 12th of November 2020. It is presented each year to an Australian who has demonstrated innovative leadership and has made an outstanding and highly original contribution to the advancement of knowledge in diabetes research, clinical or service areas in Australia.  It is the premier award bestowed on an individual by the Australian Diabetes Society.

About type 1 diabetes

  • Type 1 diabetes is an autoimmune disease in which the body’s immune system mistakenly attacks and kills the cells in the pancreas that produce insulin.
  • People with type 1 diabetes are dependent on insulin injection in order to survive.
  • Type 1 diabetes is most commonly diagnosed in children, but adults can also be diagnosed with the disease.
  • Approximately 150,000 Australians have type 1 diabetes – we have one of the highest rates of type 1 diabetes in the world.
  • The estimated health care cost in Australia for treating people with type 1 diabetes in 2012 was $570 million annually. (latest figures available)