Clinical Study Details

Title

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

Description

A study is being done to see if Anti-CD3 mAb (Teplizumab) can delay or prevent the onset of type 1 diabetes in individuals identified as being at high risk for developing the disease.

Eligibility

You (or your child) are eligible to be screened in the TrialNet Natural History to determine your risk of developing type 1 diabetes if you (or your child) are a first degree blood relative (sibling, child, or parent) between the ages of 3 and 45 years or a second degree relative (cousin, uncle, aunt, niece, nephew, grandparent, or half-sibling) between 3 and 20 years of age.
**Note: Your relative that has diabetes probably has type 1 diabetes if they were diagnosed before age 40 AND started on insulin within the first year of diagnosis.**

The pathway to this study is through the Natural History study.

Procedures

If you are in this study, you may have to stay near a study site that is not close to your home for the first 14 days of the study.

At the first 14 treatment visits, you will get study IV infusions: either teplizumab or placebo, which will determined by chance.. Neither you nor your study team will know which you are getting.

You will need to come for 5 more study visits in the first year, and every 6 months after the first year to undergo assessments of their insulin production, immunologic status, overall health and well-being

The screening, treatment, and follow-up visits might be done at different Clinical Centers.
Contact

If you are interested in having either you or your child screened for the Natural History Study and potential eligibility for this study, please contact Trudy Esrey, 650-498-4450, tesrey@stanford.edu to discuss any questions you may have and to schedule a screening appointment.

Please visit the TrialNet public website at http://www.diabetestrialnet.org