Dr. Richard Hays announced today that he is now recruiting children with newly diagnosed type 1 diabetes for Protégé Encore, a randomized, placebo-controlled Phase III clinical trial. This is the second of two Phase III studies testing the safety and efficacy of an investigational drug called teplizumab. The first study, known as Protégé, has completed enrollment of more than 530 subjects with type 1 diabetes. There is currently no approved therapy to slow the progression of type 1 diabetes.
In patients with type 1 diabetes, T cells of the immune system attack and destroy beta cells that are located in the pancreas and make insulin. Teplizumab works by binding to CD3 receptors on the surface of the T cells and, by doing so, may modulate the autoimmune attack on pancreatic beta cells and preserve or protect these cells. If effective, patients may require less injected insulin and their blood glucose levels may be easier to control.
In an earlier trial of teplizumab, a small group of subjects with diabetes of recent onset were noted to have improved function of their beta cells, improved glucose control, and reduced insulin requirements for up to two years. These findings are being further studied in the Protégé and Protégé Encore clinical trials.
The Protégé Encore trial is designed to determine if teplizumab can preserve pancreatic insulin production, which may make diabetes easier to manage. “We have a lot of enthusiasm about the teplizumab studies and their implications. It is hoped that one day we can offer a new treatment option to help patients better manage their disease.” Dr. Hays commented.
Approximately 125 study sites across 16 countries will be enrolling 400 individuals who have been to a physician with signs and symptoms of type 1 diabetes within the past 12 weeks. Most study sites are enrolling individuals 8-35 years old, and Dr. Hays is enrolling individuals 8-17 years old. Subjects will receive one of three study treatment regimens, or placebo. Subjects will be followed over a 2-year period.
Additional information on Protégé Encore and all participating study sites is available by calling www.clinicaltrials.gov.www.protegediabetes.org/news. You can also learn about the clinical trial at
About Dr. Richard Hays
Richard M. Hays, M.D., P.A., completed his undergraduate education at Johns Hopkins University in Baltimore, his M.D., at the University of Florida College of Medicine in Gainesville, and his residency at the Duke-Watts Family Medicine Residency Program in Durham, N.C. He is board certified in family medicine and is a fellow of the American Academy of Family Physicians (AAFP). Dr Hays has been in private practice since 1989, with staff privileges at Wellington Regional Medical Center in Florida, where he is chief of the Department of Family Practice. Dr. Hays is a member of several professional societies, including AAFP and the Florida Academy of Family Physicians. He is also certified by the National Committee on Quality Assurance for special qualification in care of patients with diabetes.
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