Evidence map›Paper›PMID 21896927›Full record

Trial reportDiabetes2011

C-peptide response and HLA genotypes in subjects with recent-onset type 1 diabetes after immunotherapy with DiaPep277: an exploratory study.

Raffaella Buzzetti, Simona Cernea, Antonio Petrone, Marco Capizzi, Marialuisa Spoletini, Simona Zampetti, Chiara Guglielmi, Chiara Venditti, Paolo Pozzilli, DiaPep Trialists Group

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
5.4field-weighted citation impact, top 4% 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

18 citing papers in PubMed, 46 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Review
  5. Study of Water- and Organic-Soluble Extracts fromJournal of diabetes research · 2022
    Article
  6. Article
  7. Article
  8. Review
  9. Review
  10. Review
  11. Review
  12. Type 1 diabetes.Lancet (London, England) · 2014
    Review
  13. Trials in type 1 diabetes: Antigen-specific therapies.Clinical immunology (Orlando, Fla.) · 2013
    Review
  14. Progress in immune-based therapies for type 1 diabetes.Clinical and experimental immunology · 2013
    Review
  15. Review
  16. Dead or alive?Diabetes care · 2012
    Article
  17. Review
  18. Review
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

10 authors at 2 institutions in 1 country.

Raffaella BuzzettiDepartment of Medicina Interna e Specialità Mediche, Division of Diabetes, University Sapienza, Rome, Italy. raffaella.buzzetti@uniroma1.it
Simona Cernea
Antonio Petrone
Marco Capizzi
Marialuisa Spoletini
Simona Zampetti
Chiara Guglielmi
Chiara Venditti
Paolo Pozzilli
DiaPep Trialists Group
Sapienza University of Rome · ITUniversità Campus Bio-Medico · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo investigate whether lower risk HLA class II genotypes would influence the efficacy of DiaPep277 therapy in protecting β-cell function evaluated by C-peptide secretion in recent-onset type 1 diabetic subjects. RESEARCH DESIGN AND

methodsData were collected from type 1 diabetic subjects enrolled in multicenter phase II studies with a randomized, double-blind, and placebo-controlled design in whom fasting and stimulated C-peptide levels were measured. HLA genotypes were classified in high, moderate, and low risk categories.

resultsA total of 146 subjects (aged 4.3 to 58.5 years) were enrolled, including 76 children (<18 years old) and 70 adults. At baseline, there was a significant increase in fasting, maximal, and area under the curve (AUC) C-peptide from high to moderate and low risk HLA genotypes in adults (P for trend <0.04) but not in children. Children showed a decrease of the three parameters over time regardless of therapy and HLA genotype. DiaPep277-treated adults with low risk genotype had significantly higher maximal and AUC C-peptide versus placebo at 12 months (0.04 ± 0.07 vs. -0.28 ± 0.09 nmol/L, P < 0.01, and 0.53 ± 1.3 vs. -4.59 ± 1.5 nmol/L, P < 0.05, respectively). In the moderate risk genotype group, Δmaximal and AUC C-peptide values were significantly higher in DiaPep277-treated versus placebo-treated patients (P < 0.01 and P < 0.05, respectively).

conclusionsThis exploratory study demonstrates that type 1 diabetic adults with low and moderate risk HLA genotypes benefit the most from intervention with DiaPep277; the only subgroup with an increase of C-peptide at 12 months after diagnosis was the low risk DiaPep277-treated subgroup.

Indexed as

Genes, MHC Class IIAdolescentAdultAge FactorsChaperonin 60ChildChild, PreschoolC-PeptideDiabetes Mellitus, Type 1Double-Blind MethodFemaleGenetic Association StudiesHumansHypoglycemic AgentsImmunologic FactorsInsulin-Secreting CellsChaperonin 60C-PeptideDiaPep 277Hypoglycemic AgentsImmunologic FactorsPeptide Fragments

Identifiers

PMID21896927
PMCPMC3198071
OpenAlexW2143220398

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.