Type 1 Diabetes TrialNet
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Information for Study Participants

Anti-CD3 mAb (Teplizumab) for Prevention Of Diabetes In Relatives At Risk For Type 1 Diabetes Mellitus

Status: Recruiting

Eligibility Criteria

You can be screened for the Teplizumab Study, if:

  • You have been referred by TrialNet’s Pathway to Prevention Study
  • You are 8 to 45 years old (Enrollment will initially be limited to subjects 16-45 years of age)

About this Study

Type 1 diabetes is an autoimmune disease. The immune system attacks and destroys the cells in the body that make insulin. These cells are called beta cells. Beta cell destruction starts years before the person shows any symptoms of diabetes.

If someone in your family has type 1 diabetes, you and other family members may be at risk. A major goal of TrialNet studies is to delay or prevent diabetes in people at risk for developing type 1 diabetes.

Right now, there is no approved treatment that will stop the immune system from destroying the rest of a person’s beta cells. TrialNet is now testing a medication called teplizumab. We will see if teplizumab helps stop or slow down the autoimmune reaction that is destroying beta cells in people who are at high risk of developing type 1 diabetes.

This study is enrolling people at high risk of developing type 1 diabetes. We estimate they have about a 75% risk of developing type 1 diabetes over the next 5 years. If you are at increased risk for developing type 1 diabetes, but cannot or do not want to be in the Teplizumab Study, you can be in the TrialNet Pathway to Prevention Study. We will monitor you closely for diabetes. In addition, there may be other TrialNet studies that you can join in the future.

What will I be asked to do?

You will complete a 14-day study infusion.

  • Half of the people will receive infusions of teplizumab.
  • Half of the people will receive infusions of placebo (infusions that contain an inactive substance).
  • Neither you nor your study team will know which you are getting.

During the first year, you will need to come to a study center for additional study visits and blood tests. After the first year, study visits will be every 6 months, and at other times as needed.

Participation

To see if you might be eligible for this study and for a referral to a TrialNet site:

The blood test to determine whether or not you are at risk for Type 1 Diabetes is part of the Pathway to Prevention Study. Please see the list of Clinical Centers for more information.

Information will be kept confidential.

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