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ADA: Vaccine to Halt Diabetes Progression Unsuccessful

Glutamic acid decarboxylase with aluminum hydroxide fails to prevent C-peptide decline

TUESDAY, June 28 (HealthDay News) -- Vaccination with glutamic acid decarboxylase formulated with aluminum hydroxide (GAD-alum) fails to prevent C-peptide decline in recent-onset type 1 diabetes, according to a study published online June 27 in The Lancet to coincide with its presentation at the American Diabetes Association's 71st Scientific Sessions, held from June 24 to 28 in San Diego.

Diane K. Wherrett, M.D., from the University of Toronto, and colleagues investigated whether immunization with GAD-alum would preserve insulin production in 145 patients (aged 3 to 45 years) with type 1 diabetes of less than 100 days onset. The patients received GAD-alum (48), GAD-alum plus alum (aluminum hydroxide) (49), or alum alone (48). Subcutaneous injections were given at baseline, after four weeks, and eight weeks later. The outcomes studied included geometric mean area under the curve (AUC) of serum C-peptide during the first two hours of a four-hour mixed meal tolerance test at one year, changes in glycated hemoglobin A1c (HbA1c), and insulin dose and safety.

The investigators found that, at one year, the two-hour AUC adjusted for age, gender, and baseline C-peptide value, was 0.412 nmol/L, 0.382 nmol/L, and 0.413 nmol/L in the GAD-alum, GAD-alum plus alum, and alum groups, respectively. The ratio of the population mean to the adjusted mean two-hour AUC was 0.9980 for GAD-alum versus alum, and 0.9260 for GAD-alum plus alum versus alum. The groups did not differ with respect to HbA1c, insulin use, and adverse events.

"Administration of GAD-alum does not arrest C-peptide decline in patients with recent-onset type 1 diabetes," write the authors of an accompanying editorial.

Several authors disclosed financial ties with the pharmaceutical industry. GAD-alum and placebos were provided by Diamyd Medical. Glucose monitoring devices and strips were provided by Roche Diagnostics.

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