This is a three-arm, 1:1:1 randomized, placebo controlled, double- blinded trial in which at
least 28 subjects will receive active Anti-Thymocyte Globulin and Granulocyte
colony-stimulating factor (ATG-GCSF), at least 28 subjects will receive ATG alone and at
least 28 subjects will receive placebo alone within 100 days from diagnosis of Type 1
Diabetes (T1D).
The primary objective of the study will be to determine the safety and ability of low dose
ATG plus GCSF and low dose ATG alone to retain/enhance C-peptide production in new onset T1D
patients demonstrating residual beta cell function.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators:
American Diabetes Association Amgen Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Juvenile Diabetes Research Foundation National Center for Research Resources (NCRR) National Institute of Allergy and Infectious Diseases (NIAID) Sanofi The Leona M. and Harry B. Helmsley Charitable Trust