16 Sep βETA PRESERVE
This study is looking at how an investigational study drug, called teplizumab, might possibly help protect insulin-producing cells by affecting the immune cells that attack them. The main goal of the study is to see if teplizumab can work better than a placebo (a look-alike with no medicine in it) in helping people keep their blood sugar in a healthy range or use less mealtime insulin.
The study will last approximately 84 weeks (1.5 years) and includes 32 study site visits. Participants will receive all study-related medical care at no cost and will be closely monitored by a doctor throughout the study.
Ages 8-25 will be enrolled first, followed by 1 to 25-year-olds later in the study.
Participant Eligibility
To join this study, participants must:
– Be 1 to 25 years of age. (Ages 8-25 will be enrolled first, followed by 1 to 25-year-olds later in the study.)
-Have been recently diagnosed (within a month) with T1D.
-Be positive for at least one T1D autoantibody (proteins that attack insulin-making cells by mistake).
Other criteria may also apply. It’s okay if participants don’t know if they qualify—the study doctor will tell them if they do.
Contact
the BRI Outreach Team
(800) 888-4187
Additional Study Details
Full Study Title
A Randomized, Double-blind, 2-arm, Phase 3 Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Newly Diagnosed Stage 3 Type 1 Diabetes (T1D)
Investigator(s)
Sandra Lord, MD
Accepts Healthy Volunteers?
No
Study Site(s)
Benaroya Research Institute
1201 Ninth Ave
Seattle, Washington 98101