NEW ONSET OF TYPE 1 DIABETES MYCOPHENOLATE MOFETIL-DACLIZUMAB

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. NEW ONSET OF TYPE 1 DIABETES MYCOPHENOLATE MOFETIL ¿?? DACLIZUMAB CLINICAL TRIAL (Protocol TN-02) Preservation of Pancreatic Production of Insulin through Immunosuppression - 1 Study EDITION: May 30, 2007 IND 11528 Version 2.0 Sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases; NIDDK;, the National Institute of Allergy and Infectious Diseases; NIAID;, the National Institute of Child Health and Human Development , the National Center for Research Resources, the Juvenile Diabetes Research Foundation International;, and the American Diabetes Association;. The great body of evidence developed over the last 10 ¿?? 20 years suggests that type 1 diabetes in humans is a chronic, slowly progressive autoimmune disease. The objective of this study is to identify immune intervention strategies that will prevent the progression of beta cell destruction from the time of onset of type 1 diabetes. The persistence of at least some beta cells should improve long-term diabetes care and prevent not only complications of the disease itself but also hypoglycemia, which is a consequence of its management. The aim is to arrest beta cell destruction in newly diabetic subjects because immune modulation may not work well alone once the autoimmune process has progressed to complete or near complete destruction of beta cells. The complications of long-term diabetes are well known, and the costs of caring for diabetes and its complications are currently greater than $100 billion a year. The Diabetes Control and Complications Trial and other studies have demonstrated that improved metabolic control can reduce the long-term complications of diabetes [6]. Thus, an intervention, which could restore normal islet function and maintain production of insulin would significantly improve the prognosis for metabolic control of diabetes and thus reduce long-term complications.