Itamar Raz, Anette G Ziegler, Thomas Linn, Guntram Schernthaner, Francois Bonnici, Larry A Distiller, Carla Giordano, Francesco Giorgino, Liat de Vries, Didac Mauricio, Vlastimil Procházka, Julio Wainstein, Dana Elias, Ann Avron, Merana Tamir, Rachel Eren, Dana Peled, Shlomo Dagan, Irun R Cohen, Paolo Pozzilli
OBJECTIVE: To evaluate safety and efficacy of DiaPep277 in preserving β-cell function in type 1 diabetic patients. RESEARCH DESIGN AND METHODS: DIA-AID 1 is a multinational, phase 3, balanced-randomized, double-blind, placebo-controlled, parallel-group clinical study. Newly diagnosed patients (N = 457, aged 16-45 years) were randomized to subcutaneous injections of DiaPep277 or placebo quarterly for 2 years. The primary efficacy end point was the change from baseline in the area under the glucagon-stimulated C-peptide curve...
2014: Diabetes Care