Beta PRESERVE - Type 1 Diabetes
Research type
Research Study
Full title
A randomised, 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).
IRAS ID
1011421
Contact name
Patrick Maury
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Research summary
This study is investigating whether a new drug called teplizumab can help preserve insulin production in people recently diagnosed with Type 1 Diabetes (T1D). T1D occurs when the body stops producing insulin, a hormone needed to control blood sugar. Teplizumab is designed to protect insulin-producing cells in the pancreas from immune system attack.
Currently, there are no approved treatments to slow or stop this process. This study could lead to a new treatment that helps people with newly diagnosed T1D maintain some natural insulin production, potentially making T1D easier to manage and reducing long term complications.
This is a double-blind, randomised, placebo-controlled phase 3 study to investigate the efficacy and safety of teplizumab in people aged 1-25 years old who were diagnosed with stage 3 T1D in the last 8 weeks. “Double-blind” means that neither the participant, nor the study doctors know who is given teplizumab or placebo. This is done to make sure that the study results are not influenced in any way.
The study will last about 1.5 years for each patient. There is a screening period of 4 weeks. Participants will then be randomly assigned to receive teplizumab or placebo. This works like flipping a coin. Treatment will be given through an intravenous (IV) infusion. There are 2 treatment courses 6 months apart, each lasting 12 days, followed by a follow-up period of 1 year. During the study, participants will have regular checkups, including blood tests, continuous blood sugar monitoring and tracking of their insulin use and low/high blood sugar episodes. Participants will continue to receive standard diabetes care, including insulin treatment as needed.
REC name
London - Hampstead Research Ethics Committee
REC reference
25/LO/0514
Date of REC Opinion
17 Sep 2025
REC opinion
Further Information Favourable Opinion