Endocrinology and Diabetes In the Department of Pediatrics

Clinical Study Details

Title

Type 1 Diabetes TrialNet:GAD Study

Description

The goal of this study is to learn if a if three injections of GAD can help people with newly diagnosed type 1 diabetes by delaying or stopping further destruction of the cells in the body that make insulin. We will follow people in the study by performing blood tests and will collect information about their diabetes management to learn whether rituximab works when given to people with newly diagnosed type 1 diabetes.

Eligibility

Eligible participants need to be:

• Diagnosed with type 1 diabetes in the last 3 months based on American Diabetes Association (ADA) criteria
• 16 to 45 years old;
• Willing to comply with intensive diabetes management (taking daily multiple insulin injections and monitoring blood sugar closely to maintain good blood sugar control).

Study subjects enrolled will be those who meet the eligibility criteria and provide written informed consent.

Procedures

If you qualify and consent to the study, participants will be randomly assigned (like the flip of a coin) into either a group that gets the rituximab or a placebo group. A placebo looks like medicine, but has no medicine in it so that people in the study will not know whether they are receiving GAD or not. You will have a 2 out of 3 chance of getting the medicine and a 1 out of 3 chance of getting the placebo. After you are assigned to a study group, you will receive three separate doses of either GAD or the placebo by a SQ injections. During the study period, all participants will receive intensive management of their diabetes.

Contact

If you are interested in having either you or your child participate in the GAD Study, please review the consent form. Once you have reviewed the forms, please contact Adriana Soto at (650) 725-6577 or by email at adrianas@stanford.edu to discuss your eligibility and any questions you may have.

Please review the consent forms, as well as the TrialNet public website, for more information.

TrialNet public website at http://www.diabetestrialnet.org

 

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