Phase 2/3 study of teplizumab for type 1 diabetes

MacroGenics and Eli Lilly announced that they achieved their targeted patient enrollment for their Phase 2/3 PROTEGE trial evaluating teplizumab for the treatment of recent-onset type 1 diabetes.  The PROTEGE trial is a randomized, double-blind, 4-arm, controlled study designed to evaluate the safety and efficacy of teplizumab in more than 530 patients from 8-35 years of age across 14 countries, including the U.S. The primary composite endpoint for PROTEGE includes both the patient’s total daily insulin usage and his/her HbA1c levels at 12 months. Secondary endpoints are evaluated at 24 months. Longer term safety and efficacy data from patients who complete the PROTEGE trial are being collected in a separate Phase 3 study called the PROTEGE Extension trial.

The companies also announced today that they have initiated the PROTEGE ENCORE trial, another Phase 3 global study of teplizumab in individuals with recent-onset type 1 diabetes, designed to capture patient-reported outcome measures in addition to safety and efficacy data.

Teplizumab is a humanized monoclonal antibody engineered to alter the function of the T lymphocytes that mediate the destruction of the insulin-producing beta cells of the islets of the pancreas. If teplizumab is effective and has the ability to preserve or protect beta cells of the pancreas, patients may require less injected insulin and their blood glucose levels may be easier to control.

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