The Protégé Study - Clinical Trial of MGA031 in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus
Status:
Completed
Trial end date:
2011-08-01
Target enrollment:
Participant gender:
Summary
The primary purpose of this protocol is to assess the efficacy, tolerability, and safety of
MGA031 when administered according to 3 different MGA031 dosing regimens in children and
adults with recent-onset (diagnosis within past 12 weeks) type 1 diabetes mellitus. All
regimens will be administered as an addition to insulin and other standard of care
treatments. Efficacy will be defined primarily by the capacity of MGA031 to markedly reduce
typical insulin requirements while maintaining relatively normal blood sugar levels.
Other studies involving the study drug use the name hOKT3γ1 (Ala-Ala). MGA031, a humanized
monoclonal antibody, is the name used for hOKT3γ1 (Ala-Ala) that is produced by MacroGenics,
Inc. The United States Adopted Name (USAN) for MGA031 is teplizumab.