Study Name: A randomized, double-blind, Phase 3 study to investigate efficacy and safety of teplizumab compared with placebo in participants 1 to 25 years of age with recently diagnosed Stage 3 Type 1 Diabetes (T1D)
Principal Investigator: Michael Haller, M.D.
What is the Beta PRESERVE study?
Teplizumab is a novel form of therapy for patients diagnosed with autoimmune Type 1 Diabetes (T1D). It is already approved for use in patients with stage 2 T1D.
The purpose of this research is to evaluate teplizumab, an investigational drug, and its ability to protect cells producing insulin in young adults, adolescents, and children recently diagnosed with symptomatic T1D.
Who can participate?
- Participants who are between 1 and 25 years old
- Have recently been diagnosed with T1D (randomized to study drug within 56 days of diagnosis)
What does participation in Beta PRESERVE look like
The Beta PRESERVE study will include approximately 723 participants around the world and will last about 19 months from the time of screening until the end of the study. If you/your child decide to take part, participation will include the following stages:
Screening:
Blood work
Treatment:
If you are eligible, you will be randomly chosen to receive either teplizumab or a placebo (an inactive substance). There is a 2 in 3 chance of receiving teplizumab. Neither you nor your study doctor will know which one you receive. There will be two 12-day infusion periods, 6 months apart. The test drug (or placebo) will be given through the vein in your arm (intravenously, IV). During the study duration, the study team will monitor your health through check-ups and medical tests.
Want to learn more?
Call (352) 294-5760 or email our Study Coordinators: