January 20, 2010
The Immune Tolerance Network's (ITN's) START research trial for new-onset type 1 diabetes has received the approval of its Data Safety and Monitoring Board to accept patients aged 12-18 years into the study. The decision was made after a review of safety data from the initial group of 10 adult subjects enrolled into the study. The trial is now open to individuals between the ages of 12-35 who have been diagnosed with new-onset type 1 diabetes within the past 3 months. The START trial is being conducted under the direction of principal investigator Dr. Stephen Gitelman at the University of California, San Francisco and at 9 other research centers in the US
Type 1 diabetes is an autoimmune disease caused by an errant immune system attack on the insulin-producing beta cells located in the pancreas. The goal of the START trial is to determine whether the drug Thymoglobulin can delay or permanently halt this attack after only a short period of treatment with the drug. Thymoglobulin is a mixture of antibodies that targets T cells, the subset of immune system cells implicated in the destruction of beta cells. Although considered an experimental treatment for type 1 diabetes, Thymoglobulin is already in use worldwide and has received FDA approval for the treatment of organ transplant rejection. It is also used for treatment of other autoimmune conditions, including aplastic anemia.
Researchers are hopeful that this combination will offer an improvement upon existing treatment regimens, although they are careful to point out that it is still an experimental treatment. "We're extremely excited to see this trial open to pediatric enrollment," said principal investigator of the trial, Dr. Gitelman. "Clinical trials like the START trial are very important because people need expanded treatment options for newly diagnosed type I diabetes ."
The START trial, short for "Study of Thymoglobulin to Arrest Type 1 diabetes," aims to enroll a total of 66 subjects at 10 clinical centers across the US. It is a project of the Immune Tolerance Network and is supported by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and the Juvenile Diabetes Research Foundation.
More information about the START trial is available at www.type1diabetestrial.org
The START study is being conducted at the following research institutions:
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