Recruitment of children and adults with type 1 diabetes commences in Protege Encore teplizumab trial

May 20 2010

Dr. Barry Reiner announced that he is now recruiting children and 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 2 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 currently have several patients enrolled in this study, and we are eager to learn the outcomes and implications for those with type 1 diabetes," Dr. Reiner commented.

Approximately 125 study sites across 16 countries will be enrolling 400 individuals 8–35 years old who have been to a physician with signs and symptoms of type 1 diabetes within the past 12 weeks. Subjects will receive one of three study treatment regimens, or placebo. Subjects will be followed over a 2-year period.