GAD-alum and placebo produce similar C-peptide decreases in children with type 1 diabetes
WEDNESDAY, Feb. 1 (HealthDay News) -- Treating children with type 1 diabetes with the 65-kD isoform of glutamic acid decarboxylase (GAD65) formulated with alum (GAD-alum) does not significantly change levels of stimulated serum C-peptide during 15 months of follow-up, according to a study published in the Feb. 2 issue of the New England Journal of Medicine.
Johnny Ludvigsson, M.D., Ph.D., of Linköping University in Sweden, and colleagues studied 334 patients (aged 10 to 20 years) 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. Patients were randomly assigned to receive four doses of GAD-alum, two doses of GAD-alum followed by two doses of placebo, or four doses of placebo, within three months after diagnosis. Changes in the stimulated serum C-peptide level (after a mixed-meal tolerance test) were measured between the baseline visit and the 15-month visit.
The researchers found that, in all study groups, the stimulated C-peptide level declined to a similar extent, and there was no significant difference in the change in C-peptide level at 15 months between the combined active-drug groups and the placebo group. The use of GAD-alum did not affect the insulin dose, glycated hemoglobin level, or hypoglycemia rate, compared with placebo. Adverse events were infrequent and mild, with no significant differences between the three groups.
"Treatment with GAD-alum did not significantly reduce the loss of stimulated C peptide or improve clinical outcomes over a 15-month period," the authors write.
The study was funded by Diamyd Medical, which manufactures GAD-alum; one author disclosed financial ties to Diamyd.
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