CTLA-4 Ig (Abatacept) in Recent Onset Diabetes (TrialNet)

To be screened for the abatacept study, research volunteers need to be: (1) 6 to 45 years old; and (2) diagnosed with type 1 diabetes less than 3 months ago. Screening tests, including blood tests, will help decide who can participate in this study.

Type 1 diabetes is an autoimmune disease. This means that an individual’s immune system, the part of the body that helps fight infections, mistakenly attacks the cells in the body that produce insulin. These cells, called beta cells, are found in the pancreas.

This attack probably starts years before the development of type 1 diabetes. Once many of the beta cells are damaged, blood glucose levels go too high, and the affected individual has to start taking insulin by injection.

At this point, when diabetes has been present for less than 3 months, an individual may have beta cells left that produce some insulin. People who continue to make a little insulin may have fewer problems with low blood glucose (hypoglycemia). They may also have an easier time keeping their blood glucose levels in the normal range. This lowers the risk of the long-term complications of diabetes.

Right now, there is no proven treatment that will protect the remaining beta cells. In type 1 diabetes, the body's immune system keeps destroying them. By a few years after diagnosis, most people with type 1 diabetes are making no insulin of their own.

In this study, we are testing a drug called abatacept that might protect the remaining beta cells from further destruction. We want to see if abatacept might help people continue to make a little of their own insulin. This research study will compare people who get abatacept with those who do not get abatacept.

Previous research studies have shown that people who continue to make a little insulin may have fewer problems with low blood glucose (hypoglycemia). They may also have an easier time keeping their blood glucose levels in the normal range. This lowers the risk of the long-term complications of diabetes.

This study will help us to see whether abatacept might protect the remaining beta cells from further destruction and help people continue to make a little of their own insulin.

Abatacept is given through an intravenous (IV) infusion, with a needle placed in a vein in the arm. The infusion lasts for 30 minutes.

Two-thirds of the people in this study will get infusions of abatacept. They are in the treatment group.

One third of the people in this study will get infusions that look like abatacept but have no active drug. This is called a placebo infusion. The people getting the placebo infusions are in the control group.

Both groups will get 27 infusions over 2 years with an infusion occurring every 28 days. All study participants will be asked to return for additional visits for up to 2 years after completing the infusions.

You can't choose your group. A computer will choose your group for you. It's by chance, like drawing straws. This is called random assignment, or randomization.

This study is double-masked. While the study is going on, neither you nor your study team will know if you're in the treatment group or the control group. At the end of the study, we will tell you whether you were in the treatment group or the control group.

As a research volunteer, you can decide to stop being in this study at any time. We hope that you will stay in the study. You will be helping us learn more about how to help people with diabetes.

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