Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk"
Status:
Completed
Trial end date:
2019-06-01
Target enrollment:
Participant gender:
Summary
The study will determine whether the anti-CD3 monoclonal antibody, teplizumab, can help to
prevent or delay the onset of type 1 diabetes (T1D) in relatives determined to be at very
high risk for developing the disease. Teplizumab has been studied in new onset type 1
diabetes for testing of efficacy and safety in previous studies; other studies are currently
in progress. The results of previous studies indicate that teplizumab reduces the loss of
insulin production during the first year after diagnosis in individuals with type 1 diabetes.
The purpose of this study is to determine if teplizumab can interdict the immune process that
causes the destruction of insulin secreting beta cells in the pancreas during the
"pre-diabetic" state and thereby prevent or delay the onset of type 1 diabetes.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators:
American Diabetes Association 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)