Autoimmunity-blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes (AbATE)
Diabetes Mellitus, Type 1
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring T1D, type 1 diabetes, type 1 diabetes mellitus, juvenile diabetes, autoimmune diabetes, autoimmune, anti-CD3 mAb, mAb hOKT3g1(Ala-Ala), teplizumab
Eligibility Criteria
Inclusion Criteria: Diagnosis of type 1 diabetes (according to American Diabetes Association [ADA] criteria) within the 8 weeks prior to study entry Weigh at least 25 kg (55 lbs) Insulin autoantibodies assessed within 10 days of any insulin use OR anti-glutamic acid decarboxylase (GAD) autoantibodies OR anti-ICA512/IA-2 autoantibodies Subjects or guardian(s) willing to provide informed consent Exclusion Criteria: Prior participation in a clinical trial that could potentially affect diabetes condition or immunologic status Participation in another investigational clinical trial within the 6 weeks prior to study entry Pregnancy or breastfeeding
Sites / Locations
- The Diabetes Center at UCSF
- Barbara Davis Center for Childhood Diabetes
- Yale University
- Medical College of Georgia
- Dept. of Medicine, Division of Endocrinology and the Naomi Berrie Diabetes Center/Columbia University
- Benaroya Research Institute
- Pacific Northwest Research Institute/University of Washington
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Anti-CD3 mAb Plus Diabetes Standard of Care Treatment
Diabetes Standard of Care Treatment
Subjects receive 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and 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 initiated status post treatment randomization.
Subjects receive 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 initiated status post treatment randomization.