Evidence map›Paper›PMID 39796229›Full record

Trial reportInternational journal of molecular sciences2025

Redosing with Intralymphatic GAD-Alum in the Treatment of Type 1 Diabetes: The DIAGNODE-B Pilot Trial.

Rosaura Casas, Andrea Tompa, Karin Åkesson, Pedro F Teixeira, Anton Lindqvist, Johnny Ludvigsson

Abstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in International journal of molecular sciences, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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

1 citing paper in PubMed.

  1. 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

6 authors.

Rosaura CasasDivision of Pediatrics, Department of Biomedical and Clinical Sciences, Faculty of Medicine and Health Sciences, Linköping University, 581 83 Linköping, Sweden.
Andrea TompaDepartment of Clinical Diagnostics, School of Health and Welfare, Jönköping University, 551 11 Jönköping, Sweden.ORCID 0000-0002-7995-3546
Karin ÅkessonDepartment of Pediatrics, Ryhov County Hospital, 551 85 Jönköping, Sweden.
Pedro F TeixeiraDiamyd Medical AB, 111 56 Stockholm, Sweden.
Anton LindqvistDiamyd Medical AB, 111 56 Stockholm, Sweden.
Johnny LudvigssonDivision of Pediatrics, Department of Biomedical and Clinical Sciences, Faculty of Medicine and Health Sciences, Linköping University, 581 83 Linköping, Sweden.

Funding

Barndiabetesfonden (Swedish Child Diabetes Foundation), 0000Diamyd Medical , unrestricted grant 0000
6 · The paper itself

Abstract

Immunotherapies aimed at preserving residual beta cell function in type 1 diabetes have been successful, although the effect has been limited, or raised safety concerns. Transient effects often observed may necessitate redosing to prolong the effect, although this is not always feasible or safe. Treatment with intralymphatic GAD-alum has been shown to be tolerable and safe in persons with type 1 diabetes and has shown significant efficacy to preserve C-peptide with associated clinical benefit in individuals with the human leukocyte antigen DR3DQ2 haplotype. To further explore the feasibility and advantages of redosing with intralymphatic GAD-alum, six participants who had previously received active treatment with intralymphatic GAD-alum and carried HLA DR3-DQ2 received one additional intralymphatic dose of 4 μg GAD-alum in the pilot trial DIAGNODE-B. The participants also received 2000 U/day vitamin D (Calciferol) supplementation for two months, starting one month prior to the GAD-alum injection. During the 12-month follow-up, residual beta cell function was estimated with Mixed-Meal Tolerance Tests, and clinical and immune responses were observed. C-peptide decreased minimally, and most patients showed stable HbA1c and IDAA1c. The mean % TIR increased while the mean daily insulin dose decreased at month 12 compared to the baseline. Redosing with GAD-alum seems to be safe and tolerable, and may prolong the disease modification elicited by the original GAD-alum treatment.

Indexed as

Alum CompoundsDiabetes Mellitus, Type 1Glutamate DecarboxylaseAdolescentAdultC-PeptideFemaleHumansInsulin-Secreting CellsMalePilot ProjectsYoung AdultAlum Compoundsaluminum sulfateC-PeptideGlutamate DecarboxylaseautoantigenGAD-alumimmunotherapyintralymphaticlymph noderedosingtype 1 diabetes

Identifiers

PMID39796229
PMCPMC11720063

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Registered trials

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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.