63
Participants
Start Date
September 30, 2006
Primary Completion Date
August 31, 2011
Study Completion Date
August 31, 2013
mAb hOKT3gamma1(Ala-Ala), Teplizumab
This is a randomized, two-arm, double blind placebo controlled phase II trial in which 60 participants with recent-onset T1DM are randomized at a 1:1 ratio to receive Teplizumab or placebo over a 14 day treatment period. The course of Teplizumab comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2.
Placebo Arm
Children's Hospital of Philadelphia (CHOP), Philadelphia
Barbara Davis Diabetes Center, Aurora
University of California at San Francisco, San Francisco
Yale University, New Haven
Collaborators (1)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Juvenile Diabetes Research Foundation
OTHER
Yale University
OTHER