Teplizumab: Additional Phase II/III data

Additional data from the ongoing, 2-year, double-blind, international Phase II/III Protégé trial in 513 patients ages 8-35 with recent-onset Type I diabetes showed that there was no significant difference between IV teplizumab regimens - 14-day full dose, 14-day low-dose or 6-day full dose - and placebo on the composite primary endpoint of the proportion of patients with insulin use of <0.5 U/kg/day and an HbA1c of <6.5% at 12 months (19.8%, 13.7% and 20.8%, respectively, vs. 20.4%). Data were presented at the American Diabetes Association meeting in San Diego and published in The Lancet. ...