Lilly, MacroGenics complete patient enrollment for diabetes drug trial

INDIANAPOLIS Drug makers Eli Lilly & Co. and MacroGenics announced Tuesday that they have finished enrolling patients for their clinical trial of a biotech drug for treating Type 1 diabetes.

The trial, called PROTEGE, is a phase 2 and phase 3 clinical study of teplizumab involving more than 530 patients in 14 countries aged 8 to 35 with recent-onset Type 1 diabetes.

“The completion of enrollment of the PROTEGE study is an important milestone for MacroGenics and for the Type 1 diabetes research community,” MacroGenics president and CEO Scott Koenig stated. “We appreciate the dedication of the patients, their caregivers and clinical investigators who helped advance this important late-stage clinical trial.”

The patients will be followed for 12 months, at the end of which the researchers will measure their blood sugar levels, followed by another evaluation after 24 months. Another trial, the phase 3 PROTEGE Extension, collects long-term safety and efficacy data. The companies also announced Tuesday that they had started the phase 3 PROTEGE ENCORE trial.