ArticleDiabetologia2026
Preserving beta cell function in children and adolescents with newly diagnosed stage 3 type 1 diabetes: per-protocol population analysis from the PROTECT randomised trial.
Article in Diabetologia, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03875729 (Phase 3 Randomized Double-Blind Multinational Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab, a Humanized Fc Receptor), which is not on this map. Not yet cited in PubMed.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase 3 Randomized Double-Blind Multinational Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab, a Humanized Fc Receptor (FcR) Non-Binding Anti-cluster of Differentiation 3 (CD3) Monoclonal Antibody, in Children and Adolescents With Newly Diagnosed Type 1 Diabetes
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Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aims/hypothesisIn the PROTECT randomised trial, teplizumab demonstrated significantly greater beta cell function preservation vs placebo in the intent-to-treat (ITT) population. Analyses of the pre-specified per-protocol (PP) population and PP subgroups are presented to further evaluate the efficacy of teplizumab.
methodsParticipants aged 8-17 years with stage 3 type 1 diabetes with a peak stimulated C-peptide level ≥0.2 nmol/l (ITT population: N=328) were randomised 2:1 to receive two 12-day courses of teplizumab or placebo intravenously. Participants with <80% treatment adherence, who took prohibited medication, received incorrect study treatment or were pregnant were excluded from the PP population. Subgroup analyses were based on the presence of HLA-DR3 or HLA-DR4 and the type of baseline type 1 diabetes autoantibodies.
resultsThe PP population comprised 275 participants (teplizumab, n=180; placebo, n=95). At week 78, the primary endpoint of the least squares (LS) mean difference in change of stimulated C-peptide concentration from baseline between teplizumab and placebo was 0.14 nmol/l (95% CI 0.10, 0.18; p<0.001). At week 78, teplizumab treatment significantly reduced the exogenous insulin dose (LS mean difference -0.17 U kg CONCLUSIONS/
interpretationTeplizumab treatment per protocol led to greater beta cell function preservation, greater TIR and lower exogenous insulin use compared with placebo. Beta cell function preservation was maintained irrespective of HLA subtype or the presence of type 1 diabetes autoantibodies.
trial registrationClinicalTrials.gov NCT03875729
fundingThe study was funded by Provention Bio, a Sanofi company.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.