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"The results of both these studies underscore the complexity of the events leading up to the onset of diabetes. The immune system's response to antigens at various stages in the development of diabetes depends on many factors. While the insulin injection trial did not prevent diabetes, the information gathered provides a platform for other prevention studies. Clinical trials are a critical step in the quest for answers, and we appreciate the participation of the patients who have helped us reach this far in our search for a cure," said Dr. Robert Goldstein, chief scientific officer at the Juvenile Diabetes Research Foundation International (JDRF). "We're looking forward to the results of the oral insulin trial, the expanded trials of the anti-CD3 mAb, and other trials soon to be testing a number of promising agents for type 1 diabetes," said Dr. Judith Fradkin, director of the Division of Diabetes, Endocrinology, and Metabolic Diseases in the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which funded both studies reported in the NEJM. "The NIH has in place an infrastructure to build on the exciting early results of the anti-CD3 mAb and to explore the potential of other new drugs. Two complementary clinical trial networks will be testing these agents in type 1 diabetes."

The Type 1 Diabetes TrialNet, led by Dr. Skyler, is a collaborative network of researchers, clinical centers, and laboratories solely dedicated to testing new approaches to understanding, preventing, and treating type 1 diabetes. TrialNet will complete the important oral insulin trial and will have the capacity to mount large-scale type 1 diabetes prevention studies as well as smaller studies in new onset diabetes. The Immune Tolerance
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Contact: Joan Chamberlain
301-496-3583
NIH/National Institute of Diabetes and Digestive and Kidney Diseases
29-May-2002