| GAD65 antigen therapy in recently diagnosed type 1 diabetes mellitus. | |
| | |
MedLine Citation:
|
PMID: 22296077 Owner: NLM Status: In-Process |
Abstract/OtherAbstract:
|
BACKGROUND: The 65-kD isoform of glutamic acid decarboxylase (GAD65) is a major autoantigen in type 1 diabetes. We hypothesized that alum-formulated GAD65 (GAD-alum) can preserve beta-cell function in patients with recent-onset type 1 diabetes. METHODS: We studied 334 patients, 10 to 20 years of age, with type 1 diabetes, fasting C-peptide levels of more than 0.3 ng per milliliter (0.1 nmol per liter), and detectable serum GAD65 autoantibodies. Within 3 months after diagnosis, patients were randomly assigned to receive one of three study treatments: four doses of GAD-alum, two doses of GAD-alum followed by two doses of placebo, or four doses of placebo. The primary outcome was the change in the stimulated serum C-peptide level (after a mixed-meal tolerance test) between the baseline visit and the 15-month visit. Secondary outcomes included the glycated hemoglobin level, mean daily insulin dose, rate of hypoglycemia, and fasting and maximum stimulated C-peptide levels. RESULTS: The stimulated C-peptide level declined to a similar degree in all study groups, and the primary outcome at 15 months did not differ significantly between the combined active-drug groups and the placebo group (P=0.10). The use of GAD-alum as compared with placebo did not affect the insulin dose, glycated hemoglobin level, or hypoglycemia rate. Adverse events were infrequent and mild in the three groups, with no significant differences. CONCLUSIONS: Treatment with GAD-alum did not significantly reduce the loss of stimulated C peptide or improve clinical outcomes over a 15-month period. (Funded by Diamyd Medical and the Swedish Child Diabetes Foundation; ClinicalTrials.gov number, NCT00723411.). |
| | |
Authors:
|
Johnny Ludvigsson; David Krisky; Rosaura Casas; Tadej Battelino; Luis Castaño; James Greening; Olga Kordonouri; Timo Otonkoski; Paolo Pozzilli; Jean-Jacques Robert; Henk J Veeze; Jerry Palmer |
Related Documents
:
|
17974147 - Interleukin-8, ferritin and soluble transferrin receptors in type ii diabetes mellitus. 15306837 - At last, a weight neutral insulin? 1982987 - Bgl ii-restriction fragment length polymorphism of the insulin receptor gene in patient... 15660177 - Diabetic mastopathy in type ii diabetes mellitus. 17407587 - Irbesartan for the treatment of hypertension in patients with the metabolic syndrome: a... 3741717 - The effects of diabetes mellitus, exercise, and single doses of biguanides upon lactate... |
Publication Detail:
|
Type: Journal Article; Research Support, Non-U.S. Gov't |
Journal Detail:
|
Title: The New England journal of medicine Volume: 366 ISSN: 1533-4406 ISO Abbreviation: N. Engl. J. Med. Publication Date: 2012 Feb |
Date Detail:
|
Created Date: 2012-02-02 Completed Date: - Revised Date: - |
Medline Journal Info:
|
Nlm Unique ID: 0255562 Medline TA: N Engl J Med Country: United States |
Other Details:
|
Languages: eng Pagination: 433-42 Citation Subset: AIM; IM |
Affiliation:
|
Division of Pediatrics, Department of Clinical and Experimental Medicine, Linköping University, 58185 Linköping, Sweden. johnny.ludvigsson@liu.se |
| Data Bank Information | |
Bank Name/Acc. No.:
|
ClinicalTrials.gov/NCT00723411 |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
|
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Ulipristal acetate versus leuprolide acetate for uterine fibroids.
Next Document: Genetic variations in loci relevant to natural killer cell function are affected by ethnicity but ar...