Abatacept

This TrialNet study is currently open in Taunton and Birmingham. Other TrialNet centres will open across the UK when they have eligible participants.

What is the purpose of the study?

We know that development of type 1 diabetes occurs over time as the immune system destroys insulin producing cells. As this takes place, blood glucose values increase gradually until they are high enough to diagnose diabetes. Before this, blood glucose values may be higher than normal but not high enough to diagnose type 1 diabetes. We call these “abnormal glucose levels”. 

The purpose of the study is to see if giving a medication called abatacept can help delay or prevent the development of abnormal glucose levels and diabetes in people who have markers associated with risk of type 1 diabetes (autoantibodies). 

What is the drug that is being tested?

The medication is an intravenous infusion containing abatacept. Abatacept is approved as a treatment for rheumatoid arthritis and juvenile idiopathic arthritis. In a previous TrialNet study abatacept was shown to have some effect on preserving insulin secretion after diagnosis. There is also a placebo (dummy drug) group in the study. This group will be given infusions which contains no active ingredient. This is a ‘blinded’ randomised trial so that neither participants, or the researchers will know which infusions participants are receiving until the study has been completed. 

What will happen during the study?

The study will have two phases, a treatment phase for the first year and then a monitoring phase. During the treatment phase, participants will receive the study medication 14 times over a year. During the monitoring phase participants will have visits every six months.  The exact duration of the study is not known. We anticipate that your participation will be no longer than 5-6 years. If participants develop diabetes, they will no longer be included in the study. Internationally, there will be about 206 research volunteers enrolled in the study.

Who is eligible?

TrialNet Natural History Study (Pathway to Prevention) participants who are positive to multiple autoantibodies and have a normal glucose tolerance, aged 6-45 yrs.

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