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Home > About JDRF & Our Impact > Our research > Research projects > Supporting clinical trials of ustekinumab
Ustekinumab is an immune therapy, which is already used to treat other autoimmune conditions including Crohn’s disease and psoriasis. Previous research studies have shown that ustekinumab can dampen the immune attack that leads to type 1 diabetes. It works by reducing the levels of proteins that drive the immune attack on insulin-producing beta cells.
USTEKID involves 72 adolescents aged 12-18 who were diagnosed with type 1 less than 100 days before they joined the study. The clinical trial took place at 16 sites across the UK.
Half the participants received an injection of ustekinumab every two months with seven doses in total. The other half received a non-active placebo in the same format. Neither the researchers nor the participants will know which they received until after the study has finished. This is called a double-blind trial.
Find out more about this clinical trial in this research paper. Recruitment has now finished, but you can learn one girl’s experience of taking part in the USTEKID clinical trial in our blog.
Participating in UST1D2 are 66 adults aged 18-35, who are also within 100 days of being diagnosed with type 1. UST1D2 has the same design as USTEKID to allow Tim to use the two studies for his research project. Researchers give the participants seven doses of either ustekinumab or a placebo every two months via an injection. Like USTEKID, this clinical trial is double-blind.
This trial is still recruiting participants in Toronto and Vancouver, Canada. Find out more about the UST1D2 study, including details of how to sign up.
After participants have received their treatment of ustekinumab or placebo for a year, Tim will measure the amount of insulin they can produce following a meal. He will compare the results of the ustekinumab group with the group who received a placebo.
If people can produce insulin in response to a meal, this could indicate that the treatment has preserved their beta cells. This will be one way of measuring how effective ustekinumab is for treating type 1.
The team will look at which proteins are present in blood samples from the participants. This will determine whether ustekinumab has reduced the proteins involved in the immune attack on beta cells. The researchers will also look for any biological signs (known as biomarkers) that indicate whether the drug has worked or not.
The researchers hope that giving ustekinumab to people newly diagnosed with type 1 will reduce the immune attack on their beta cells. This should help to preserve the remaining beta cells and allow people with type 1 to keep making their own insulin. The more insulin people with type 1 can produce themselves, the less they’ll need to give themselves. This helps reduce hypos and make it easier to maintain stable blood sugar levels.
Tim’s project is vital for measuring how well ustekinumab can treat type 1. In the future, any biomarkers Tim identifies could enable scientists and clinicians to better monitor people taking ustekinumab. If the drug isn’t working in some people, this would allow clinicians to suggest alternative treatment options, which may be more effective for those individuals.
We are funding the UST1D2 trial in Canada. USTEKID is part of the UK T1D Research Consortium, a clinical trials platform which we co-fund. Professor Tim Tree co-leads the Consortium with Professor Colin Dayan. We are also funding Professor Colin Dayan to establish another clinical trials platform, T1D Plus. This platform can test multiple immune therapies at the same time, including mixtures of different drugs.
Daniel Doherty’s research project aims to make islet transplants last longer and work better to benefit more people with type 1.
Lead researcher, Kourosh, says his study has the potential to transform our understanding of diabetes.
Dr Leslie Johnson will explore whether a collaborative care model that is effective for type 2 diabetes can be adapted for people with type 1.
Dr Chloe Rackham is investigating how supportive cells called mesenchymal stem cells may help protect people from developing type 1.
Dr Ify Mordi is an expert in heart disease and diabetes at the University of Dundee. We are funding Ify to run the first clinical trial of the drug sotagliflozin in people living with type 1 diabetes and heart failure.
In his JDRF-funded project, Dr Richard Oram is developing a type 1 diabetes risk score to predict who will develop type 1 diabetes in the future. The research Richard and his team at the University of Exeter are doing will help how we screen people for type 1.
The Human Islet Isolation Facility provides researchers with pancreas samples from donors with and without diabetes. We have been funding the centre since 2009. The current funding is for Professor Paul Johnson and his team to continue to run the Human Islet Isolation Facility at the University of Oxford. Their goal is to supply 1 million pancreatic islets to research each year.
Dr Emma Berry is working with young people affected by type 1 to develop a digital psychosocial wellbeing screening and monitoring tool at Queen’s University Belfast. Once complete, Emma hopes diabetes clinicians will use her tool to support young people at their diabetes appointments.
