drugset / Trial / NCT00920582

Protege Encore Study- Clinical Trial of Teplizumab (MGA031) in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

NCT00920582

Phase 3 Terminated 254 enrolled MacroGenics Eli Lilly and Company · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

The primary purpose of this study is to determine whether teplizumab (MGA031) infusions lead to greater reductions in insulin requirements in conjunction with near normal blood sugar control compared to placebo in patients recently diagnosed with type 1 diabetes.

Timeline

Start
2009-09
Primary completion
2012-04
Completion
2012-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Teplizumab Monoclonal antibody 273 ug/m2 Intravenous
Subject Teplizumab Monoclonal antibody 826 ug/m2 Intravenous