Trial reportDiabetes2013
Teplizumab (anti-CD3 mAb) treatment preserves C-peptide responses in patients with new-onset type 1 diabetes in a randomized controlled trial: metabolic and immunologic features at baseline identify a subgroup of responders.
Trial report in Diabetes, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 235 papers, 8 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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 II Multiple-Dose Treatment of New Onset Type 1 Diabetes Mellitus With Anti-CD3 mAb
Type 1 Diabetes Extension Study
Who cites it
235 citing papers in PubMed, 8 syntheses or guidelines pooled it.
- Immunomodulatory interventions in type 1 diabetes: a systematic review and meta-analysis revealing paradoxical dissociation between beta-cell preservation and glycemic control.BMC endocrine disorders · 2025Pooled it
- Pooled it
- Anti-CD3 monoclonal antibody in treating patients with type 1 diabetes: an updated systematic review and meta-analysis.Cardiovascular diabetology · 2025Pooled it
- Pediatric Endocrine Society Statement on Considerations for Use of Teplizumab (Tzield™) in Clinical Practice.Hormone research in paediatrics · 2025Guideline
- Pooled it
- Therapeutic potential of anti-thymocyte globulin in type 1 diabetes: A systematic review.PloS one · 2025Pooled it
- Anti-CD3 monoclonal antibodies in treatment of type 1 diabetes: a systematic review and meta-analysis.Endocrine · 2024Pooled it
- ISPAD Clinical Practice Consensus Guidelines 2024: Screening, Staging, and Strategies to Preserve Beta-Cell Function in Children and Adolescents with Type 1 Diabetes.Hormone research in paediatrics · 2024Guideline
- Teplizumab induces persistent changes in the antigen-specific repertoire in individuals at risk for type 1 diabetes.The Journal of clinical investigation · 2024Trial
- Serum exocrine pancreas enzymes are biomarkers of immunotherapy response in new-onset type 1 diabetes.Frontiers in endocrinology · 2024Trial
- Trial
- First-in-human, double-blind, randomized phase 1b study of peptide immunotherapy IMCY-0098 in new-onset type 1 diabetes.BMC medicine · 2023Trial
- Trial
- Trial
- Imatinib therapy for patients with recent-onset type 1 diabetes: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial.The lancet. Diabetes & endocrinology · 2021Trial
- Teplizumab improves and stabilizes beta cell function in antibody-positive high-risk individuals.Science translational medicine · 2021Trial
- Exhausted-like CD8+ T cell phenotypes linked to C-peptide preservation in alefacept-treated T1D subjects.JCI insight · 2021Trial
- A randomised, single-blind, placebo-controlled, dose-finding safety and tolerability study of the anti-CD3 monoclonal antibody otelixizumab in new-onset type 1 diabetes.Diabetologia · 2021Trial
- Trial
- Exenatide extended release in patients with type 1 diabetes with and without residual insulin production.Diabetes, obesity & metabolism · 2020Trial
175 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
14 authors.
Funding
Abstract
Trials of immune therapies in new-onset type 1 diabetes (T1D) have shown success, but not all subjects respond, and the duration of response is limited. Our aim was to determine whether two courses of teplizumab, an Fc receptor-nonbinding anti-CD3 monoclonal antibody, reduces the decline in C-peptide levels in patients with T1D 2 years after disease onset. We also set out to identify characteristics of responders. We treated 52 subjects with new-onset T1D with teplizumab for 2 weeks at diagnosis and after 1 year in an open-label, randomized, controlled trial. In the intent to treat analysis of the primary end point, patients treated with teplizumab had a reduced decline in C-peptide at 2 years (mean -0.28 nmol/L [95% CI -0.36 to -0.20]) versus control (mean -0.46 nmol/L [95% CI -0.57 to -0.35]; P = 0.002), a 75% improvement. The most common adverse events were rash, transient upper respiratory infections, headache, and nausea. In a post hoc analysis we characterized clinical responders and found that metabolic (HbA1c and insulin use) and immunologic features distinguished this group from those who did not respond to teplizumab. We conclude that teplizumab treatment preserves insulin production and reduces the use of exogenous insulin in some patients with new-onset T1D. Metabolic and immunologic features at baseline can identify a subgroup with robust responses to immune therapy.
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What OpenQuestion holds
Registered trials
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 OpenQuestion graph.