GAD-treatment of children and adolescents with recent-onset type 1 diabetes preserves residual insulin secretion after 30 months
Abstract
Background: This study aimed to analyse data from two different studies (phase II and phase III) regarding the safety and efficacy of treatment with alum formulated glutamic acid decarboxylase GAD 65 (GAD‐alum) at 30 months after administration to children and adolescents with type 1 diabetes. Methods: The phase II trial was a double‐blind, randomised placebo‐controlled study, including 70 children and adolescents who were followed for 30 months. Participants received a subcutaneous injection of either 20 µg of GAD‐alum or placebo at baseline and 1 month later. During a subsequent larger European phase III trial including three treatment arms, participants received two or four subcutaneous injections of either 20 µg of GAD‐alum and/or placebo at baseline, 1, 3 and 9 months. The phase III trial was prematurely interrupted at 15 months, but of the 148 Swedish patients, a majority completed the 21 months follow‐up, and 45 patients completed the trial at 30 months. Both studies included GAD 65 auto‐antibodies‐positive patients with fasting C‐peptide ≥0.10 nmol/l. We have now combined the results of these two trials. Results: There were no treatment related adverse events. In patients treated with 2 GAD‐alum doses, stimulated C‐peptide area under the curve had decreased significantly less (9 m: p < 0.037; 15 m: p < 0.032; 21 m: p < 0.003 and 30 m: p < 0.004), and a larger proportion of these patients were also able to achieve a peak stimulated C‐peptide >0.2 nmol/L (p < 0.05), as compared with placebo. Conclusion: Treatment with two doses of GAD‐alum in children and adolescents with recent‐onset type 1 diabetes shows no adverse events and preserves residual insulin secretion. Copyright © 2013 John Wiley & Sons, Ltd.
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Trials of antigen therapy with different GAD protein forms have had mixed results, mostly negative.
“Antigen-based trials have used various forms of glutamate decarboxylase (GAD) protein, which have shown mixed but mostly negative results.139–141”
From Type 1 diabetes (2018) · cites this paper as [140]
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- Authors
- Ludvigsson, J., Chéramy, M., Axelsson, S., Pihl, M., Åkerman, L., Casas, R., & for the clinical GAD‐study group in Sweden
- Affiliations
- Linköping University (SE)
- Corresponding author
- Ludvigsson, Johnny
- Venue
- Diabetes/Metabolism Research and Reviews
- Publisher
- Wiley
- Published
- 2014-07
- Volume
- 30
- Issue
- 5
- Pages
- 405-414
- ISSN
- 1520-7552 (ISSN-L)
- 1520-7560
- OpenAlex
- W1485959822
- Cited by
- 42
- References
- 44
- Citations by year
- 2025: 1 · 2024: 1 · 2023: 1 · 2022: 4 · 2021: 6 · 2020: 5 · 2019: 2 · 2018: 2 · 2017: 5 · 2016: 6 · 2015: 4 · 2014: 4
- FWCI
- 3.09
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Diabetes/Metabolism Research and Reviews (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Linköpings Universitet
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Keywords
- type 1 diabetes, GAD65, glutamic acid decarboxylase, residual insulin secretion, C-peptide, children and adolescents, recent-onset type 1 diabetes, autoantibodies, immunotherapy, treatment safety
- MeSH terms
- Insulin Secretion, Adolescent, Alum Compounds, Autoantibodies, C-Peptide, Child, Diabetes Mellitus, Type 1, Double-Blind Method, Female, Glutamate Decarboxylase, Glycated Hemoglobin, Humans, Injections, Subcutaneous, Insulin, Male, Young Adult
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