liu.seSearch for publications in DiVA
Change search
ReferencesLink to record
Permanent link

Direct link
GAD65 antigen therapy in recently diagnosed type 1 diabetes mellitus
Linköping University, Department of Clinical and Experimental Medicine, Pediatrics. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Centre of Paediatrics and Gynecology and Obstetrics, Department of Paediatrics in Linköping.
Diamyd Medical, Pittsburgh.
Linköping University, Department of Clinical and Experimental Medicine, Pediatrics. Linköping University, Faculty of Health Sciences.
University Medical Center–University Children's Hospital, Faculty of Medicine, Ljubljana, Slovenia .
Show others and affiliations
2012 (English)In: New England Journal of Medicine, ISSN 0028-4793, Vol. 366, no 5, 433-442 p.Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
Massachusetts Medical Society , 2012. Vol. 366, no 5, 433-442 p.
National Category
Medical and Health Sciences
URN: urn:nbn:se:liu:diva-89965DOI: 10.1056/NEJMoa1107096ISI: 000299724400008PubMedID: 22296077OAI: diva2:611783

Funding Agencies|Diamyd Medical||Swedish Child Diabetes Foundation (Barndiabetesfonden)

Available from: 2013-03-18 Created: 2013-03-12 Last updated: 2013-03-26

Open Access in DiVA

No full text

Other links

Publisher's full textPubMedLänk till posten i PubMed

Search in DiVA

By author/editor
Ludvigsson, JohnnyCasas, RosauraSamuelsson, UlfAlbinsson, EvaHanås, Ragnar
By organisation
PediatricsFaculty of Health SciencesDepartment of Paediatrics in LinköpingDepartment of Clinical and Experimental MedicineDepartment of Paediatrics in Norrköping
In the same journal
New England Journal of Medicine
Medical and Health Sciences

Search outside of DiVA

GoogleGoogle Scholar
The number of downloads is the sum of all downloads of full texts. It may include eg previous versions that are now no longer available

Altmetric score

Total: 235 hits
ReferencesLink to record
Permanent link

Direct link