Objective
This project aims to determine if the combination of abatacept and nasal insulin is more effective than abatacept and nasal placebo for preserving pancreas function in newly-diagnosed type 1 diabetes. It also seeks to identify individuals who are most likely to respond to combination therapy and develop blood tests that predict if the therapy will be effective in a given individual.
Background Rationale
Type 1 diabetes is caused by an immune attack on the pancreas that prevents it from making sufficient insulin to control blood sugar levels. When diabetes is first diagnosed, not all of the pancreas has been destroyed and it may be possible to preserve what remains with treatment called immunotherapy that stops the immune attack. So far, immunotherapy trials have only been able to test one treatment at a time, and their effects as single therapies have been modest. It is now time to combine treatments, akin to treatments for other autoimmune diseases like rheumatoid arthritis and inflammatory bowel disease. In this trial we will take advantage of our past experience of using abatacept and nasal insulin and a national network of clinical trial sites to test, for the first time, if combining abatacept with nasal insulin improves clinical outcomes in recent-onset type 1 diabetes.
Description of Project
This clinical trial will test whether a combination of two safe therapies, abatacept and nasal insulin, can stop the immune attack that causes type 1 diabetes. Sixty-two children and young adults with recently-diagnosed type 1 diabetes will receive either abatacept and nasal insulin or abatacept and nasal placebo for one year to determine if combined immune therapy preserves pancreas function and decreases the need for insulin therapy.
Anticipated Outcome
This trial will be one of the first to determine if combination immunotherapy is a safe and effective approach to preserving pancreas function in newly-diagnosed type 1 diabetes. If it is successful, it will provide opportunities to optimise abatacept and nasal insulin treatment protocols and to test if the combination is also able to prevent at-risk people progressing to need insulin injections to control blood sugar levels.
Relevance to T1D
This trial will involve 62 children and young adults who have recently been diagnosed with type 1 diabetes. It offers these individuals an opportunity to access immunotherapy and will improve our understanding of how best to combine different treatments to improve clinical outcomes. If successful, this approach could be rapidly adopted in the clinic, as both abatacept and nasal insulin are readily available. The combination could also be used to prevent diabetes in at-risk children.