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GAD treatment and insulin secretion in recent-onset type 1 diabetes
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2008 (English)In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 359, no 18, p. 1909-1920Article in journal (Refereed) Published
Abstract [en]

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 μg 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.)

Place, publisher, year, edition, pages
Boston, Mass: Massachusetts medical society , 2008. Vol. 359, no 18, p. 1909-1920
Keyword [en]
Adolescent, Analysis of Variance, Autoantibodies/blood, C-Peptide/blood, Child, Diabetes Mellitus; Type 1/blood/immunology/metabolism/*therapy, Female, Glutamate Decarboxylase/adverse effects/immunology/*therapeutic use, Humans, Hypoglycemic Agents/therapeutic use, Immunotherapy, Injections; Subcutaneous, Insulin/administration & dosage/*secretion/therapeutic use, Male
National Category
Medical and Health Sciences Clinical Medicine Endocrinology and Diabetes
Research subject
Internal Medicine
Identifiers
URN: urn:nbn:se:oru:diva-3515DOI: 10.1056/NEJMoa0804328PubMedID: 18843118OAI: oai:DiVA.org:oru-3515DiVA, id: diva2:137812
Available from: 2008-12-08 Created: 2008-12-08 Last updated: 2017-12-14Bibliographically approved

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Åman, Jan

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