2. Durable Efficacy of Alefacept in New-Onset Type 1 Diabetes: Evidence for Lasting Modulation of Effector and Regulatory T Cells (231-OR)

Type 1 diabetes (T1D) results from destruction of pancreatic beta cells by autoreactive effector T cells. We hypothesized that a combination of targeted depletion and modulation of effector T cell activity by alefacept would result in prolonged preservation of endogenous insulin secretion in patients with newly diagnosed T1D. In a multicenter, randomized, double-blind, placebo-controlled trial we compared alefacept (two 12-week courses of 15 mg intramuscularly per week, separated by a 12-week pause) with placebo in patients with new-onset T1D. Endpoints assessed at 24 months included meal-stimulated C-peptide area under the curve (AUC), insulin use, hypoglycemic events, and immunologic responses.