Upcoming Trials Will Focus on Preventing Type 1 Diabetes
September 17, 2002 People at risk for type 1 diabetes and those newly diagnosed will soon be able to join clinical trials testing promising new approaches to prevention and treatment. With the formation of Type 1 Diabetes TrialNet, a collaborative network of clinical centers, experts in diabetes and immunology, and specialized laboratories and other facilities will be solely dedicated to testing new approaches to understanding, preventing, and treating type 1 diabetes. Recruitment for the first trials is planned for the spring of 2003.
The goal of the prevention trials is to stop or delay the immune destruction of the insulin-producing beta cells of the pancreas in people at risk for type 1 diabetes, an autoimmune disease. Treatment trials will try to preserve remaining beta cells in people with new onset type 1 diabetes. Research has already shown that, even after a diagnosis of type 1 diabetes, the immune system continues to destroy beta cells, making blood glucose harder and harder to control for many people.
"TrialNet will expedite the application of discoveries in basic research to therapies that benefit people with type 1 diabetes and those at risk," said study chair Dr. Jay Skyler of the University of Miami. "From earlier studies, we've learned a great deal about the antibody markers for type 1 diabetes risk and how the level of risk can be assessed for individuals. We've also seen progress in understanding the autoimmune process that leads to type 1 diabetes, and recent studies suggest that process can be modulated or arrested," added Dr. Skyler, who oversaw the Diabetes Prevention Trial Type 1 (DPT-1). The DPT-1 consisted of two distinct clinical trials: a low-dose insulin injection trial that ended in 2001 and the ongoing oral insulin trial, which is testing whether insulin taken by mouth can prevent type 1 diabetes in people at moderate risk for developing it. The oral insulin trial, which recently stopped recruiting new patients, will be part of the new TrialNet.
TrialNet investigators are currently developing protocols for several agents that have shown promise in earlier studies. Before participating centers can begin enrolling patients, protocols must be approved by local institutional review boards and an NIH Data Safety Monitoring Board, which reviews each study for safety and scientific soundness and monitors its progress.
"The Juvenile Diabetes Research Foundation International enthusiastically supports TrialNet, and we're going forward with a research solicitation to expand the network by funding more international sites," said Dr. Robert Goldstein, JDRF's Chief Scientific Officer.
"Mounting individual trials for prevention of type 1 diabetes is a challenging, costly endeavor. This network provides a stable, efficient, cost-effective system for identifying people at risk for type 1 diabetes and testing the ability of promising new agents to prevent the disease," said Dr. Allen Spiegel, director of the National Institute of Diabetes and Digestive and Kidney Diseases, (NIDDK), which leads the initiative. TrialNet is co-sponsored by the National Institute of Child Health and Human Development, the National Institute of Allergy and Infectious Diseases, the JDRF, and the American Diabetes Association.
The network currently consists of 14 clinical centers. For more information about TrialNet, call 1-800-HALT-DM1 (1-800-425-8361).
TrialNet CentersChildren's Hospital of Los Angeles
Los Angeles, CA
1-888-835-3761 | Joslin Diabetes Center
Boston, MA
1-800-242-5836 |
Stanford University Medical Center
Stanford, CA
1-877-232-5182 | University of Minnesota
Minneapolis, MN
1-800-688-5252 ext.58944 |
University of California, San Francisco
San Francisco, CA
415-514-3730 | Columbia University Naomi Berrie Diabetes Center
New York, NY
212-851-5449 |
Barbara Davis Center for Childhood Diabetes University of Colorado
Denver, CO
1-800-572-3992 | University of Pittsburgh
Pittsburgh, PA
412-692-5210 |
University of Florida
Gainesville, FL
800-749-7424, dial 1, extension 334-0857 | University of Texas Southwestern
Dallas, TX
214-648-4844 |
University of Miami
Miami, FL
305-243-3781 | Benaroya Research Institute Virgina Mason Medical Center
Seattle, WA
1-800-888-4187 |
Indiana University
Indianapolis, IN
1-866-230-8486 | Hospital for Sick Children
Toronto, Canada
1-866-699-1899 |
CONTACT:
Joan Chamberlain
Jane DeMouy
(301) 496-3583
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Page last updated: April 17, 2008
