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Clinical Trial Recruits Children to Test Type 1 Diabetes Drug

March 26, 2010
News Office: Kate Vidinsky (415) 502-6397

The Immune Tolerance Network (ITN) is recruiting patients age 12 to 17 who have been recently diagnosed with type 1 diabetes for a clinical trial, called the Study of Thymoglobulin to Arrest Type 1 Diabetes (START). Type 1 diabetes is the form of the disease that commonly strikes when patients are children, teens and young adults. This clinical trial to test a new drug previously accepted only adults age 18 to 35.

UCSF Children's Hospital is one of 10 centers nationwide that are recruiting more than 60 young patients for the study. "We're extremely excited to see this trial open to pediatric enrollment," said Dr. Stephen Gitelman, director of the UCSF Pediatric Diabetes Program and the study's principal investigator. "Clinical trials like the START trial are very important because people need expanded treatment options for newly diagnosed type I diabetes."

The research project received the approval of its Data Safety and Monitoring Board to accept patients age 12 to 17 after a review of safety data from the initial group of 10 adult study participants.

Each year, more than 15,000 children — 40 a day — are diagnosed with type 1 diabetes in the United States. The condition comes on suddenly, causes dependence on injected or pumped insulin for life and carries the constant threat of devastating complications.

Considered an auto-immune disease, type 1 diabetes is caused by a malfunctioning immune system, which attacks the insulin-producing beta cells in the pancreas.

The START project is studying whether the drug Thymoglobulin can delay or permanently stop this attack after a short period of treatment with the drug. Thymoglobulin, an FDA-approved drug used in organ transplantation, has been used to treat other autoimmune diseases. Researchers believe that it may work in diabetes by eliminating destructive immune cells from the bloodstream and by changing how the remaining immune cells work.

Researchers will determine if Thymoglobulin can "reset" the immune system so immune cells accept the beta cells rather than continuing to attack them.

The trial is open to individuals age 12 to 35 who have been diagnosed with new-onset type 1 diabetes in the past three months.

This project is supported by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), and the Juvenile Diabetes Research Foundation.

For more information about the trial at UCSF, please contact Kathleen Fraser, clinical trials coordinator at the UCSF Diabetes Center, at (415) 353-9084 or kfraser@diabetes.ucsf.edu. For more information about UCSF diabetes research, please visit www.diabetes.ucsf.edu.

To read more about the START trial, visit www.type1diabetestrial.org.