Evidence map›Paper›PMID 19404608›Full record

Trial reportDiabetologia2009

GAD65 vaccination: 5 years of follow-up in a randomised dose-escalating study in adult-onset autoimmune diabetes.

C-D Agardh, K F Lynch, M Palmér, K Link, A Lernmark

Open access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Diabetologia, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 2 pooled it
7.3field-weighted citation impact, top 3% 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

45 citing papers in PubMed, 2 syntheses or guidelines pooled it, 92 citations in OpenAlex.

  1. Pooled it
  2. Interventions for latent autoimmune diabetes (LADA) in adults.The Cochrane database of systematic reviews · 2011 · on this map
    Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Review
  7. Latent autoimmune diabetes in youth.Frontiers in immunology · 2025
    Review
  8. Efficacy of Regimens in the Treatment of Latent Autoimmune Diabetes in Adults: A Network Meta-analysis.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2023
    Article
  9. Review
  10. Teplizumab: type 1 diabetes mellitus preventable?European journal of clinical pharmacology · 2023
    Review
  11. Adult-onset autoimmune diabetes.Nature reviews. Disease primers · 2022
    Review
  12. Vaccine for Diabetes-Where Do We Stand?International journal of molecular sciences · 2022
    Review
  13. Review
  14. Review
  15. Article
  16. Article
  17. Review
  18. Latent Autoimmune Diabetes in Adults: Current Status and New Horizons.Endocrinology and metabolism (Seoul, Korea) · 2018
    Review
  19. Article
  20. 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

5 authors at 3 institutions in 1 country.

C-D AgardhDepartment of Endocrinology, University Hospital MAS, Malmö, Sweden. carl-david.agardh@med.lu.se
K F Lynch
M Palmér
K Link
A Lernmark
Malmö University · SEKarolinska University Hospital · SELund University · SE

Funding

ISLET CELL MEMBRANE ANTIBODIES IN DIABTESR01DK026190 · NIDDK · UNIVERSITY OF WASHINGTON · PI HAMPE, CHRISTIANE S · 1986 to 2016
$4.9M
NIDDK NIH HHS DK 26190NIDDK NIH HHS DK 53004NIDDK NIH HHS R01 DK026190
6 · The paper itself

Abstract

aims/hypothesisThe aim of this study was to ascertain whether treatment of GAD65 autoantibody (GADA)-positive diabetic patients with alum-formulated recombinant GAD65 (GAD-alum) is safe and does not compromise beta cell function.

methodsThis Phase 2, placebo-controlled, dose-escalation clinical trial, which was randomized through a central office, was performed in 47 GADA-positive type 2 diabetic patients, who received subcutaneous injections of GAD-alum (4 [n = 9], 20 [n = 8], 100 [n = 9] or 500 [n = 8] microg) or placebo (n = 13) at weeks 1 and 4 of the trial. Participants and caregivers were blinded to group assignments. The primary outcome was safety as assessed by neurological tests, medications and beta cell function evaluated over 5 years, representing the end of the trial.

resultsNo severe study-related adverse events occurred during the 5 year follow-up. None of the dose groups was associated with an increased risk of starting insulin treatment compared with the placebo group. The use of oral hypoglycaemic agents did not differ between the dose groups. After 5 years, fasting C-peptide levels declined in the placebo group (-0.24; 95% CI -0.41 to -0.07 log(10) nmol/l; p = 0.01) and the 500 microg dose group (-0.37; 95% CI -0.57 to -0.17 log(10) nmol/l; p = 0.003), but not in the 4 microg (-0.10; 95% CI -0.28 to 0.07 log(10) nmol/l; p = 0.20), 20 microg (0.04; 95% CI -0.12 to 0.19 log(10) nmol/l; p = 0.58) and 100 microg (0.00; 95% CI -0.20 to -0.20 log(10) nmol/l; p = 0.98) dose groups. CONCLUSIONS/

interpretationThe primary outcome of safety was achieved, since no severe study-related adverse events occurred.

trial registrationBecause the study was initiated before 1 July 2005, the protocol was not registered in a registry.

Indexed as

Administration, OralAlum CompoundsAutoantibodiesAutoimmune DiseasesDiabetes Mellitus, Type 2Dose-Response Relationship, DrugFollow-Up StudiesGlutamate DecarboxylaseHumansHypoglycemic AgentsInjections, SubcutaneousInsulinInsulin-Secreting CellsVaccines, SyntheticAlum CompoundsAutoantibodiesGlutamate Decarboxylaseglutamate decarboxylase 2Hypoglycemic AgentsInsulinVaccines, Synthetic

Identifiers

PMID19404608
OpenAlexW2069486925

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.