ArticleDiabetologia2026
Safety and pharmacokinetics of teplizumab in children less than 8 years of age with stage 2 type 1 diabetes.
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 NCT05757713 (Single Arm, Open-label Study to Assess the Safety and Pharmacokinetics of a 14-day Regimen of Teplizumab in Pediatric Stage 2 Type 1 Diabetes), which is not on this map. Cited by 6 papers.
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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.
Single Arm, Open-label Study to Assess the Safety and Pharmacokinetics of a 14-day Regimen of Teplizumab in Pediatric Stage 2 Type 1 Diabetes (Participants <8 Years of Age With at Least Two Autoantibodies and Dysglycemia)
Who cites it
6 citing papers in PubMed.
- Considerations for the clinical use of teplizumab in stage 2 Type 1 diabetes: A Consensus Statement from the British Society of Paediatric Endocrinology and Diabetes (BSPED) and the Association of British Clinical Diabetologists (ABCD).Diabetic medicine : a journal of the British Diabetic Association · 2026Article
- siRNA-Mediated Reduction of Apolipoprotein CIII Delays Pancreatic Islet Deterioration and Onset of Type 1 Diabetes in Diabetes-Prone BioBreeding Rats.Biomedicines · 2026Article
- Article
- Type 1 diabetes screening: building a clinician-patient partnership for early care of chronic beta cell failure.Diabetologia · 2026Article
- Article
- The Efficacy and Safety of Teplizumab in the Treatment of Stage 3 Type 1 Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Diabetes, metabolic syndrome and obesity : targets and therapy · 2026Review
Corrections and comments
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Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aims/hypothesisTeplizumab is approved in the USA and seven other countries to delay stage 3 type 1 diabetes onset in individuals ≥8 years of age with stage 2 type 1 diabetes. As part of a US Food and Drug Administration post-marketing requirement, this study evaluated the safety, tolerability and pharmacokinetics of teplizumab in children aged <8 years with stage 2 type 1 diabetes.
methodsThe PETITE-T1D trial is a 2 year single-arm, open-label, multicentre study of 23 children <8 years of age with stage 2 type 1 diabetes. Participants received a 14 day teplizumab course. A prespecified interim analysis was performed after 15 participants completed 1 year of follow-up and included all 23 participants. Primary endpoints included treatment-emergent adverse events (TEAEs), TEAEs causing treatment discontinuation, and serious adverse events (SAEs). Other endpoints assessed immunogenicity, pharmacokinetics, pharmacodynamics and time from study treatment to stage 3 type 1 diabetes.
resultsMean participant age was 4.8 years (range 1.7-6.8). Median follow-up duration was 51.9 weeks (range 3.9-77.1). All participants experienced one or more TEAE, with most being mild to moderate. No grade 4 or 5 TEAEs were reported. Three participants (13%) had TEAEs leading to teplizumab discontinuation: anaemia, elevated liver enzymes and maculo-papular rash. Two participants (9%) each had two SAEs. Serum teplizumab concentrations peaked at day 14. Two participants progressed to stage 3 type 1 diabetes. The estimated probability of lack of progression to stage 3 was 89.6% (95% CI 64.3%, 97.3%) at the time of interim analysis. CONCLUSIONS/
interpretationTeplizumab was safe and well tolerated in children <8 years of age with stage 2 type 1 diabetes. Adverse events were consistent with those seen in previous studies, with no new safety risks identified. Two participants progressed to stage 3 type 1 diabetes during the observation period; surveillance is ongoing.
trial registrationClinicalTrials.gov NCT05757713.
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