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| | RECENT ONSET OF TYPE 1 DIABETES: AGE 18 TO 35 YEARS WITHIN 12 WEEKS OF DIAGNOSIS - TREATMENT OF TYPE 1 DIABETES MELLITUS WITH TEPLIZUMAB - HOKT3Y1 (ALA-ALA) Study Name: Treatment of Type 1 Diabetes Mellitus with teplizumab (hOKT3γ1 (Ala-Ala)) [Protégé study] Study Sponsors: Macrogenics Principal Investigator: Umesh Masharani, M.D. Who can sign up for this study? Volunteers must be between 18 to 35 years old and have been diagnosed with type 1 diabetes within the past 12 weeks. What is this study about? Researchers with the Protégé study are testing an investigational medication – teplizumab – to further evaluate its safety and see if it helps people with newly diagnosed type 1 diabetes. They hope it will protect the remaining beta cells of the pancreas before they have lost their ability to make insulin. What will happen in this study? Volunteers who qualify and are enrolled will receive one 14-day treatment of either the study drug or a placebo. They will receive a second 14-day treatment 6 months later. All volunteers will be monitored for 2 year total to assess their overall diabetes health and to perform laboratory testing to determine the effects of the treatment to their immune system and beta cells. This will require several visits to UCSF for laboratory testing during this period. How long will this study last? Each volunteer will be followed for 2 years. Reimbursement: You will not be charged for any of the study treatments and you will receive reimbursement for your time and effort. For more information: contact Study Coordinator Shelley McCoy at 415-353-9087 or email at shmccoy@medicine.ucsf.edu | Related Items |
