Research

TrialNet - Abatacept Drug Study

Effects of CTLA-4 Ig on The Progression of Type 1 Diabetes in New Onset Subjects

Protocol Description

The goal of this multi-center TrialNet study is to learn if the drug CTLA-4 Ig, also known as abatacept, can help people with newly diagnosed type 1 diabetes by delaying or stopping further destruction of insulin-producing beta cells. Researchers will perform blood tests and will collect information about participants’ diabetes to learn how abatacept works when given to people with newly diagnosed type 1 diabetes.

Eligibility Criteria

The study includes candidates diagnosed with type 1 diabetes within 3 months of enrolling.
Males: Ages 6 to 45
Females: Ages 6 to 45

Requirements
Participation involves a series of visits to Children’s Hospital of Pittsburgh of UPMC for blood testing and administration of the study drug or a placebo, as determined by random assignment. Three dosages will be given in the first month, followed by monthly dosages thereafter for a total of 27 infusions. Participants also commit to intensive diabetes management.
Visits: 28
Duration: 2 years

Status: Closed to Enrollment

Sources of Support
American Diabetes Association
Juvenile Diabetes Research Foundation
National Institute of Allergy and Infectious Diseases
National Institute of Child Health and Human Development
National Institute of Diabetes and Digestive and Kidney Diseases

Additional Resources
Study description at National Institutes of Health