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

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

Outcome

Missed primary endpoint

Stopped (Business): “Business decision”

registry analysis (superiority test); Herold Regimen vs Placebo; p = 0.609; Odds Ratio (OR) 1.348 (95% CI 0.431 to 4.219); Mantel Haenszel NCT00920582 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Teplizumab	Monoclonal antibody	273 ug/m2	Intravenous
Subject	Teplizumab	Monoclonal antibody	826 ug/m2	Intravenous

Indications