16 September 2026 editorial review · Trial
BETA PRESERVE: confirmatory teplizumab trial in recent-onset stage-3 T1D: review notes
These notes document the scope actually reviewed, including source-access limits. They are not independent clinical certification or a guarantee that every claim was verified.
Read the trial evidence page →Primary-agent trial review — 16 September 2026
Assessment: September 14 registry: target 723 and estimated 2028 dates; endpoint regional/subgroup distinction corrected, including EU C-peptide age 5+ criterion. No results or extension of current labels inferred.
Registry: NCT07088068; RECRUITING; updated 2026-09-14; enrollment 723 (ESTIMATED); results not posted.
Endpoint comparison: For United States (US) and non-European Union (EU) countries: Glycated hemoglobin (HbA1c) change from baseline (From Baseline to Week 52); For US and non-EU countries: Total number of days without prandial insulin use (From baseline to Week 52); For EU countries: Change from baseline in mean 2 hours mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from Area Under the Curve (AUC) in participants 5 years and older (From baseline to Week 52); For EU countries: HbA1c change from baseline (From baseline to Week 52); For EU countries: Total number of days without prandial insulin use (From baseline to Week 52).
Sources for this record: A Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Stage 3 Type 1 Diabetes (registry); FDA Approves Drug for Pediatric Stage 3 Type I Diabetes (regulatory); Teplizumab and beta-Cell Function in Newly Diagnosed Type 1 Diabetes (peer-reviewed).
Limits: Source access and review depth vary. Registry fields establish the registered study, not clinical benefit, product approval or current local access. Cited-source reachability alone was not treated as verification of its claims.