Clinical Study Details
Title |
Effects of CTLA4-Ig (Abatacept) on the Progression of Type 1 Diabetes Mellitus in New Onset Subjects |
Description |
The goal of this study is to learn if a medication, Abatacept (CTLA4-Ig) , can help people with newly diagnosed type 1 diabetes by delaying or stopping further destruction of the cells in the body that make insulin. Abatacept is approved by the U.S. Food and Drug Administration and has been used for other automimmune diseases such as Rheumatoid Arthritis and Multiple Sclerosis, and we are testing a new use for it in this study. We will follow people in the study by performing blood tests and will collect information about their diabetes management to learn whether Abatacept works when given to people with newly diagnosed type 1diabetes. |
Eligibility |
Eligible participants need to be: • Diagnosed with type 1 diabetes in the last 3 months based on American Diabetes Association (ADA) criteria• 6 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 Abatacept 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 Abatacept 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 a dose of either the Abatacept or placebo through a vein in your arm. You will need to come to the study site to receive 27 infusions over the next two years. During the study period, all participants will receive intensive management of their diabetes. You will be asked to undergo additional follow-up post-treatment for up to two years with a study visit every 6 months. |
Contact |
If you are interested in having either you or your child participate in the CTLA4-Ig (Abatacept) Study, please review the consent form. Once you have reviewed the forms, please contact the TrialNet Research Team – toll free at 1-877-232-5182 or Adriana Soto at 650-725-6577or adrianas@stanford.edu to discuss your eligibility and any questions you may have. |
Please see the forms below and Patient Handbook for more details Intervention Consent TrialNet public website at http://www.diabetestrialnet.org |
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