83
Participants
Start Date
September 30, 2005
Primary Completion Date
March 31, 2011
Study Completion Date
March 31, 2011
Anti-CD3 mAb
Daily 14-day dose escalation course at study entry, with possible second course after 12-month interval
Diabetes Standard of Care Treatment
Receipt of intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
Iron supplementation
Immediately following randomization, all participants regardless of arm allocation begin iron supplementation with either ferrous sulfate or multivitamin with iron.
Dept. of Medicine, Division of Endocrinology and the Naomi Berrie Diabetes Center/Columbia University, New York
Medical College of Georgia, Augusta
Barbara Davis Center for Childhood Diabetes, Denver
The Diabetes Center at UCSF, San Francisco
Benaroya Research Institute, Seattle
Pacific Northwest Research Institute/University of Washington, Seattle
Yale University, New Haven
Immune Tolerance Network (ITN)
NETWORK
National Institute of Allergy and Infectious Diseases (NIAID)
NIH