16 September 2026 editorial review · Trial
PROTECT: Teplizumab in children and adolescents with recent-onset type 1 diabetes: 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 →Baseline trial evidence review: M–S
Outcome: PrimaryITT Cpeptide/secondarynull results verified. Added10Sep2026 prespecified per-protocol275participant publication with nominalTIR benefit and selection/adverseevent exclusions explicitly distinguished from originalITT.
Registry: NCT03875729. Endpoint reviewed: Change in C-peptide ln(AUC+1) Standardized by Duration of the Mixed Meal Tolerance Test (MMTT) (Baseline to Week 78). Eligibility reviewed: Age 8 Years to 17 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Additional source access: Original PROTECT primary abstract; 10 September 2026 per-protocol full report. Interpretation: The selected275participant per-protocol analysis uses nominalp values; its secondary benefits do not replace the original randomized intention-to-treat secondary null results. Exclusion of lowadherence/adverseevent discontinuations matters.