Evidence map›Paper›PMID 36576974›Full record

Trial reportDiabetes care2023

Two-Year Follow-up From the T1GER Study: Continued Off-Therapy Metabolic Improvements in Children and Young Adults With New-Onset T1D Treated With Golimumab and Characterization of Responders.

Mark R Rigby, Beverly Hayes, Yinglei Li, Frank Vercruysse, Joseph A Hedrick, Teresa Quattrin

Open access · bronzeAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Diabetes care, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 1 pooled it
8.0field-weighted citation impact, top 2% of its field
1 · What the graph read from 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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 1 synthesis or guideline pooled it, 47 citations in OpenAlex.

  1. Pooled it
  2. Frontiers in endocrinology · 2023
    Trial
  3. Type 1 Diabetes Mellitus Pathogenesis: Mechanisms, Early Diagnostic Strategies, and Emerging Therapeutic Approaches.Pathophysiology : the official journal of the International Society for Pathophysiology · 2026
    Review
  4. Review
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  6. Article
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  9. Can we cure autoimmunity?Current opinion in immunology · 2026
    Review
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  13. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 2 countries.

Mark R Rigby1Janssen Pharmaceuticals Inc. Research and Development, Springhouse, PA.ORCID 0000-0002-5490-5951
Beverly Hayes1Janssen Pharmaceuticals Inc. Research and Development, Springhouse, PA.
Yinglei Li1Janssen Pharmaceuticals Inc. Research and Development, Springhouse, PA.
Frank Vercruysse2Janssen Pharmaceuticals Inc. Research and Development, Beerse, Belgium.
Joseph A Hedrick1Janssen Pharmaceuticals Inc. Research and Development, Springhouse, PA.ORCID 0000-0003-1629-4907
Teresa Quattrin3The Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY.ORCID 0000-0002-2385-9278
Springhouse · USJanssen (Belgium) · BEWomen & Children's Hospital of Buffalo · US

Funding

University of Buffalo Clinical and Translational Science Institute - Supplement SchulyerUL1TR001412 · NCATS · STATE UNIVERSITY OF NEW YORK AT BUFFALO · PI MURPHY, TIMOTHY F · 2015 to 2024
$33.8M
NCATS NIH HHS UL1 TR001412
6 · The paper itself

Abstract

objectiveThe T1GER (A Study of SIMPONI to Arrest β-Cell Loss in Type 1 Diabetes) study showed many metabolic benefits of the tumor necrosis factor-α blocker golimumab in children and young adults with type 1 diabetes (T1D). Off-therapy effects are reported. RESEARCH DESIGNS AND

methodsT1GER was a phase 2, placebo-controlled, randomized trial in which golimumab or placebo was administered for 52 weeks to participants 6-21 years old diagnosed with T1D within 100 days of randomization. Assessments occurred during the 52-week on-therapy and 52-week off-therapy periods.

resultsAfter treatment was stopped, C-peptide area under the curve (AUC) remained greater in the treatment versus control group. At weeks 78 and 104, the golimumab group had lower reductions in the 4-h C-peptide AUC baseline than the placebo group, where specifically the golimumab group had reductions of 0.31 and 0.41 nmol/L, and the placebo group had reductions of 0.64 and 0.74 nmol/L. There were also trends in less insulin use, higher peak C-peptide levels and those in partial remission, and higher peak C-peptide levels in the golimumab group. Golimumab responders, defined as having an increase or minimal loss of C-peptide AUC and/or being in partial remission at week 52, showed even greater improvements in most metabolic parameters on and off therapy and had less hypoglycemia during the off-therapy period versus placebo. Adverse events, including infections, were similar between the groups during all time periods of the study.

conclusionsIn children and young adults with new-onset T1D, golimumab preserved endogenous β-cell function and resulted in other favorable metabolic parameters on and off therapy. A subpopulation had disease stabilization while on therapy, with improved metabolic parameters off therapy.

Indexed as

Diabetes Mellitus, Type 1AdolescentAdultAntibodies, MonoclonalChildC-PeptideDouble-Blind MethodFollow-Up StudiesHumansTreatment OutcomeYoung AdultAntibodies, MonoclonalC-Peptidegolimumab

Identifiers

PMID36576974
PMCPMC10020023
OpenAlexW4313280480

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.