The purpose of this study is to determine whether treatment with multiple injections of GAD-Alum will preserve the body's own (endogenous) insulin production in patients who have been recently diagnosed with type 1 diabetes mellitus (T1DM). This study is sponsored by Type 1 Diabetes TrialNet.
Type 1 diabetes is an autoimmune disease. This means that your immune system, the part of the body that helps fight infections, mistakenly attacked the cells in your body that produced insulin. These cells, called beta cells, are found in your pancreas.
This attack probably started years ago. Once many of your beta cells were damaged, your blood glucose levels went too high, and you had to start taking insulin by injection.
At this point, when you have had diabetes for less than three months, you 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 whether a protein called glutamic acid decarboxylase (GAD) will help people continue making some of their own insulin. This research study will compare people who get GAD injections with those who get placebo injections (shots that look the same but have no GAD).
Two-thirds of the people in this study will get injections of the GAD protein. They are in the treatment group.
One third of the people in this study will get injections that look like abatacept but have no active drug. This is called a placebo injection. The people getting the placebo injections are in the control group.
Both groups will have 13 study visits over 2 years. At 3 of these visits, participants will get injections of either the GAD protein or placebo. 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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