Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk"
Conditions
Autoantibody Positive | High Risk | Impaired Glucose Tolerance | Non-diabetic Relatives at Risk for Type 1 Diabetes
What is the purpose of this trial?
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.
Participation Guidelines
- Age:
- 8 Years - 45 Years
- Gender:
- Both
Click here for detailed information about who can participate in this trial.
- Sponsor:
- 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)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) - Dates:
- August 2010
- Last Updated:
- October 9, 2012
- Study HIC#:
- 1006007008
Clinicaltrials.gov ID: NCT01030861
