Trial reportClinical immunology (Orlando, Fla.)2009
Treatment of patients with new onset Type 1 diabetes with a single course of anti-CD3 mAb Teplizumab preserves insulin production for up to 5 years.
Trial report in Clinical immunology (Orlando, Fla.), 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00806572 (Phase II Multiple Dose Treatment of Type 1 Diabetes Mellitus With hOKT3gamma1), which is not on this map. Cited by 105 papers, 5 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 Type 1 Diabetes Mellitus With hOKT3gamma1(Ala-Ala)
Who cites it
105 citing papers in PubMed, 5 syntheses or guidelines pooled it, 214 citations in OpenAlex.
- 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
- Anti-CD3 monoclonal antibodies in treatment of type 1 diabetes: a systematic review and meta-analysis.Endocrine · 2024Pooled it
- Developing combination immunotherapies for type 1 diabetes: recommendations from the ITN-JDRF Type 1 Diabetes Combination Therapy Assessment Group.Clinical and experimental immunology · 2010Guideline
- Teplizumab induces persistent changes in the antigen-specific repertoire in individuals at risk for type 1 diabetes.The Journal of clinical investigation · 2024Trial
- Trial
- Remodeling T cell compartments during anti-CD3 immunotherapy of type 1 diabetes.Cellular immunology · 2017Trial
- Changes in T-cell subsets identify responders to FcR-nonbinding anti-CD3 mAb (teplizumab) in patients with type 1 diabetes.European journal of immunology · 2016Trial
- Low-dose otelixizumab anti-CD3 monoclonal antibody DEFEND-1 study: results of the randomized phase III study in recent-onset human type 1 diabetes.Diabetes care · 2014Trial
- B-lymphocyte depletion with rituximab and β-cell function: two-year results.Diabetes care · 2014Trial
- Trial
- Teplizumab preserves C-peptide in recent-onset type 1 diabetes: two-year results from the randomized, placebo-controlled Protégé trial.Diabetes · 2013Trial
- Interleukin-1 antagonism in type 1 diabetes of recent onset: two multicentre, randomised, double-blind, placebo-controlled trials.Lancet (London, England) · 2013Trial
- Immune therapy and β-cell death in type 1 diabetes.Diabetes · 2013Trial
- Failure to preserve beta-cell function with mycophenolate mofetil and daclizumab combined therapy in patients with new- onset type 1 diabetes.Diabetes care · 2010Trial
- Toward Disease-Modifying Therapies in Type 1 Diabetes: Focus on Teplizumab.Diabetes care · 2026Review
- Safety and pharmacokinetics of teplizumab in children less than 8 years of age with stage 2 type 1 diabetes.Diabetologia · 2026Article
- Submicron-sized ultrasound contrast agents as therapeutic peptide delivery vehicles in type 1 diabetes.Theranostics · 2026Article
- Mitochondrial ABHD11 inhibition drives sterol metabolism to modulate T-cell effector function.Nature communications · 2025Article
45 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 7 institutions in 1 country.
Funding
Abstract
Anti-CD3 mAbs may prolong beta cell function up to 2 years in patients with new onset Type 1 diabetes (T1DM). A randomized open label trial of anti-CD3 mAb, Teplizumab, in T1DM was stopped after 10 subjects because of increased adverse events than in a previous trial related with higher dosing of drug. Teplizumab caused transient reduction in circulating T cells, but the recovered cells were not new thymic emigrants because T cell receptor excision circles were not increased. There was a trend for reduced loss of C-peptide over 2 years with drug treatment (p=0.1), and insulin use was lower (p<0.001). In 4 drug-treated subjects followed up to 60 months, C-peptide responses were maintained. We conclude that increased doses of Teplizumab are associated with greater adverse events without improved efficacy. The drug may marginate rather than deplete T cells. C-peptide levels may remain detectable up to 5 years after treatment.
Indexed as
Identifiers
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.