(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, MD, 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 12–35 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 0.015nmol/L in the alefacept group and decreased by 0.115nmol/L in the placebo group (between group difference was not significant; P=0.065). Key secondary end points were met in the alefacept group vs. 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.