Adults with newly diagnosed type 1 diabetes recruited for Protege Encore clinical trial

May 18 2010

Dr. Bruce Bode announced today that he is now recruiting adults with newly diagnosed type 1 diabetes for Protege 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 Protege, 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 Protege and Protege Encore clinical trials.

The Protege 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. Bode 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. Bode is enrolling individuals 18–35 years old. Subjects will receive one of three treatment regimens, or placebo. Subjects will be followed over a 2-year period.