Research

TrialNet - GAD - Alum Drug Study

Effects of GAD-Alum 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 recombinant human glutamic acid decarboxylase (rhGAD65) formulated in alum (GAD-alum) 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 GAD-alum works when given to people with newly diagnosed type 1 diabetes.

Eligibility Criteria

The study is considering candidates ages 16 to 45 who have been diagnosed with type 1 diabetes within 3 months of enrolling. (Enrollment eligibility will drop to age 10 by the summer of 2010.)
Males: Ages 16 to 45
Females: Ages 16 to 45

Requirements
Following the initial screening visit, participation will require 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 are scheduled in the first 3 months of the study. Participants will also need to commit to intensive diabetes management.
Visits: 11
Duration: 2 years

Status: Open for Enrollment

Sources of Support
American Diabetes Association
Juvenile Diabetes Research Foundation
National Center for Research Resources - NCRR
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