GAD treatment and insulin secretion in recent-onset type 1 diabetes
Open accessAbstract
BACKGROUND: The 65-kD isoform of glutamic acid decarboxylase (GAD) is a major autoantigen in patients with type 1 diabetes mellitus. This trial assessed the ability of alum-formulated GAD (GAD-alum) to reverse recent-onset type 1 diabetes in patients 10 to 18 years of age. METHODS: We randomly assigned 70 patients with type 1 diabetes who had fasting C-peptide levels above 0.1 nmol per liter (0.3 ng per milliliter) and GAD autoantibodies, recruited within 18 months after receiving the diagnosis of diabetes, to receive subcutaneous injections of 20 microg of GAD-alum (35 patients) or placebo (alum alone, 35 patients) on study days 1 and 30. At day 1 and months 3, 9, 15, 21, and 30, patients underwent a mixed-meal tolerance test to stimulate residual insulin secretion (measured as the C-peptide level). The effect of GAD-alum on the immune system was also studied. RESULTS: Insulin secretion gradually decreased in both study groups. The study treatment had no significant effect on change in fasting C-peptide level after 15 months (the primary end point). Fasting C-peptide levels declined from baseline levels significantly less over 30 months in the GAD-alum group than in the placebo group (-0.21 vs. -0.27 nmol per liter [-0.62 vs. -0.81 ng per milliliter], P=0.045), as did stimulated secretion measured as the area under the curve (-0.72 vs. -1.02 nmol per liter per 2 hours [-2.20 vs. -3.08 ng per milliliter per 2 hours], P=0.04). No protective effect was seen in patients treated 6 months or more after receiving the diagnosis. Adverse events appeared to be mild and similar in frequency between the two groups. The GAD-alum treatment induced a GAD-specific immune response. CONCLUSIONS: GAD-alum may contribute to the preservation of residual insulin secretion in patients with recent-onset type 1 diabetes, although it did not change the insulin requirement. (ClinicalTrials.gov number, NCT00435981.)
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GAD65-based therapies delivered via subcutaneous or intralymphatic administration have been tested in multiple clinical trials; overall efficacy in preserving insulin secretion was not shown.
“GAD₆₅based therapies delivered via subcutaneous or intralymphatic administration have been tested in multiple clinical trials.[24][25][26] Overall efficacy in preserving insulin secretion was not shown.”
From The future of type 1 diabetes therapy (2025) · cites this paper as [24]
The Methods describe one trial of subcutaneous GAD-alum injections; this paper does not test intralymphatic administration. The Results report no significant effect on the 15-month primary endpoint, but significantly less decline in insulin secretion at 30 months, so an unqualified statement that preservation was not shown overstates this source. (LLM, conf=0.88)
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- Authors
- Ludvigsson, J., Faresjö, M., Hjorth, M., Axelsson, S., Chéramy, M., Pihl, M., Vaarala, O., Forsander, G., Ivarsson, S., Johansson, C., Lindh, A., Nilsson, N.-Ö., Åman, J., Örtqvist, E., Zerhouni, P., & Casas, R.
- Affiliations
- Linköping University (SE)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2008-10-30
- Volume
- 359
- Issue
- 18
- Pages
- 1909-1920
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2041637201
- Cited by
- 520
- References
- 32
- Citations by year
- 2026: 10 · 2025: 13 · 2024: 13 · 2023: 13 · 2022: 15 · 2021: 16 · 2020: 21 · 2019: 10 · 2018: 14 · 2017: 12 · 2016: 26 · 2015: 20 · 2014: 28 · 2013: 55 · 2012: 51
- FWCI
- 38.35
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Lund University Publications (Lund University) (submittedVersion)
- 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 › Surgery › Pancreatic function and diabetes
- Keywords
- type 1 diabetes, glutamic acid decarboxylase, glutamic acid decarboxylase antibodies, residual insulin secretion, C-peptide, recent-onset diabetes, autoimmunity, mixed meal tolerance test
- MeSH terms
- Insulin Secretion, Adolescent, Analysis of Variance, Autoantibodies, C-Peptide, Child, Diabetes Mellitus, Type 1, Female, Glutamate Decarboxylase, Humans, Hypoglycemic Agents, Immunotherapy, Injections, Subcutaneous, Insulin, Male
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