Improves four-hour C-peptide area under curve, lowers insulin use, reduces hypoglycemic events
MONDAY, Sept. 23 (HealthDay News) -- For patients with type 1 diabetes, alefacept improves four-hour C-peptide area under the curve (AUC), and lowers insulin use and hypoglycemic events, according to a study published online Sept. 23 in The Lancet Diabetes & Endocrinology.
Mark R. Rigby, M.D., from the Indiana University and Riley Hospital for Children at Indiana University Health in Indianapolis, and colleagues conducted a phase 2 study involving 73 patients with type 1 diabetes, aged 12 to 35 years, within 100 days of diagnosis. Participants were randomized to receive alefacept (33 patients) or placebo (16 patients). The primary end point was the change in mean two-hour C-peptide AUC from baseline at 12 months.
The researchers found that the mean two-hour C-peptide AUC increased by 0.015 nmol/L in the alefacept group and decreased by 0.115 nmol/L in the placebo group (between group difference was not significant; P = 0.065). Key secondary end points were met in the alefacept group versus the placebo group at 12 months, including significantly increased mean four-hour C-peptide AUC; significantly lower use of insulin; and a significantly lower rate of hypoglycemic events. There was no significant difference between the groups in mean glycated hemoglobin concentrations at week 52.
"Alefacept could be useful to preserve β-cell function in patients with new-onset type 1 diabetes," the authors write.
One author disclosed financial ties to Andromeda Biotech.
Abstract (http://www.thelancet.com/journals/landia/article/PIIS2213-8587(13)70111-6/abstract )Full Text (subscription or payment may be required) (http://www.thelancet.com/journals/landia/article/PIIS2213-8587(13)70111-6/fulltext )Editorial (subscription or payment may be required) (http://www.thelancet.com/journals/landia/article/PIIS2213-8587(13)70123-2/fulltext )