Study Name: PROTECT Study
Principal Investigator: Carla Greenbaum, MD
What is the PROTECT Study?
Patients ages 8 – 17 with newly diagnosed type 1 diabetes have an opportunity to participate in the PROTECT Study, a clinical trial to see if a study drug called teplizumab can safely preserve insulin-producing cells. Importantly, this study is only open to people within a very short time after diagnosis, so if you are interested, please contact us right away.
Type 1 diabetes (T1D) occurs when the immune system mistakenly attacks insulin-producing beta cells in the pancreas, and the body is unable to create enough insulin. Teplizumab aims to correct this immune attack.
Previous clinical studies have suggested a benefit of teplizumab in prolonging insulin production in people recently diagnosed with T1D. A recent landmark study showed that this drug can delay development of T1D in at-risk individuals. The PROTECT Study is evaluating how well teplizumab works in children and adolescents who have been recently diagnosed with T1D. In addition, the study will look at whether the medicine causes any unwanted side effects.
Who can participate?
You may be eligible to participate if you:
- have been diagnosed with type 1 diabetes within the past month,
- are 8 - 17 years of age,
- are in good general health.
What will study participants be asked to do?
Study participation is around a year and a half, including two 12-day treatment courses that are six months apart, a post-treatment observation period, and a final study visit at week 78.
Study visits take place at Benaroya Research Institute in Seattle, and travel and lodging expenses can be covered for out-of-town participants.
If you’d like to participate, please contact us as soon after diagnosis as possible at 800-888-4187 or email email@example.com.