INNODIA set to speed up clinical trials for type 1 diabetes drugs
April 2020

The INNODIA project has developed a clinical trial master protocol, meaning launching new clinical trials for drugs to cure type 1 diabetes will be faster and easier. ###Before a clinical trial can start, the organisers have to submit the protocol of their study to regulatory authorities for approval. Preparing this protocol takes a lot of time.

To speed up the process, INNODIA has developed a master protocol for certain clinical trials of treatments that could potentially stop type 1 diabetes. ‘The idea of a master protocol is that rather than starting off with a new protocol every time you want to do one of these studies, you have a protocol that can be re-used for different studies – a recyclable protocol,’ explains David Dunger, of the University of Cambridge, who led INNODIA’s work on the master protocol. The basic design would always be the same, but what would change would be the annex describing the drug (or drugs) under investigation and the minor modifications needed to assess safety and efficacy.

The INNODIA clinical trial master protocol is specifically designed for phase 2 clinical trials of people who have just been diagnosed with type 1 diabetes. Most significantly, the European Medicines Agency (EMA) has given its green light to the master protocol, something that Professor Dunger describes as ‘a major step forward’. INNODIA is now set to use the protocol for its own clinical trials.

Patients play a central role in INNODIA’s work and Professor Dunger describes the Patient Advisory Committee’s work on the master protocol as ‘fantastic’. He also emphasises the benefits for patients of using a master protocol to set up clinical trials.

‘I think the message for the patients is that in the future we will see a very much better organised and timely way of doing studies, which will get more studies done, quicker, and coming up with the right drugs,’ he concludes.

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• Watch project coordinator Chantal Mathieu’s video message on the impacts of COVID-19 on the project

INNODIA team adds piece to type 1 diabetes puzzle
September 2018

An international team of scientists has identified the molecules that trigger the immune system in people with type 1 diabetes. The scientists hope that their findings will aid in the development of vaccines to prevent and treat the disease.### The work, funded in part by IMI through the INNODIA project, is published in the journal Cell Metabolism. Type 1 diabetes is an auto-immune disease. It occurs when immune cells called T lymphocytes attack the pancreatic beta cells, which are responsible for the production of the hormone insulin. To make up for the loss of these cells, people with type 1 diabetes have to inject themselves with insulin to manage their blood sugar levels. In this study, the researchers analysed the molecules on the surface of the pancreatic beta cells and how the T lymphocytes respond to them. They found that in both healthy people and diabetes patients, T lymphocytes recognised these molecules when they encountered them in the blood. However, in diabetes patients, the immune cells also recognised them in the pancreas. The team will use this new-found knowledge to develop vaccines to prevent and treat type 1 diabetes. However, while conventional vaccines seek to boost the immune response, the aim here will be to neutralise it.

Study sheds new light on mechanisms behind type 1 diabetes
March 2018

Scientists from the IMI project INNODIA have shed new light on the role of white blood cells and the thymus in the development of type 1 diabetes. The work is published in the journal Science Immunology. ###Type 1 diabetes is an autoimmune disease that occurs when the immune system destroys the pancreatic beta cells responsible for producing insulin, the hormone that regulates blood sugar levels. The immune cells that attack the beta cells are a sub-group of white blood cells called CD8+ T lymphocytes. T lymphocytes are created in the bone marrow and pass through an organ called the thymus before entering the blood stream. Scientists thought that the thymus presented T lymphocytes with fragments of proteins similar to those found in the beta cells of the pancreas; T lymphocytes that recognise the beta cell protein fragments are destroyed. They also thought that in people with type 1 diabetes, this process does not work properly, and the thymus allows auto-immune T lymphocytes that respond to beta cells to pass into the blood stream. However, in this latest study, scientists found that these auto-immune CD8+ T lymphocytes are found in similar numbers in the blood of both healthy people and people with diabetes. However, the team did find higher levels of the T lymphocytes in the pancreas of people with diabetes. The team believes that healthy people may be able to control these auto-immune T lymphocytes thanks to regulatory T lymphocytes. People with diabetes may lack this ability to control the auto-immune T lymphocytes; furthermore, if their pancreas is inflamed, this may make the beta cells even more ‘visible’ to the autoimmune T cells.

INNODIA recruits first patients for diabetes study
December 2016

The INNODIA project has recruited the first patient in a major clinical study of type 1 diabetes. The goal of INNODIA is to improve our understanding of type 1 diabetes and so pave the way for the development of novel treatments to prevent and cure it. In the new study, scientists will collect blood samples and data from people just diagnosed with type 1 diabetes and their relatives.### They will then follow the evolution of the disease in the study participants. ‘This way we will be able to better understand the relationship between changes in beta cell function, immune profiles, genetic and environmental factors and their role in the onset of the disease,’ says INNODIA coordinator Chantal Mathieu of the University of Leuven in Belgium. Patients were heavily involved in the design of the study. ‘Listening to the patient’s voice and following their advice was crucial in setting up this effort,’ said Olivier Arnaud of JDRF International. Looking to the future, the project will open further study centres in Europe, giving more patients the opportunity to take part. In a video, diabetes patient and INNODIA Patient Advisory Committee member Kyle Rose explains: ‘These [studies] are what are going to allow new therapies, new drugs to be developed so that we can all lead healthier lives as people with diabetes. It can really make a difference.’