NCT00385697

The Protégé Study - Clinical Trial of MGA031 in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

A Phase 2/3, Randomized, Double-Blind, Multicenter, Multinational, 4-Arm, Controlled, Dose-Ranging Study to Evaluate Efficacy and Safety of MGA031, a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 554 (actual)
• Sponsor: MacroGenics · Industry
• Sex: All
• Age: 8 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this protocol is to assess the efficacy, tolerability, and safety of MGA031 when administered according to 3 different MGA031 dosing regimens in children and adults with recent-onset (diagnosis within past 12 weeks) type 1 diabetes mellitus. All regimens will be administered as an addition to insulin and other standard of care treatments. Efficacy will be defined primarily by the capacity of MGA031 to markedly reduce typical insulin requirements while maintaining relatively normal blood sugar levels. Other studies involving the study drug use the name hOKT3γ1 (Ala-Ala). MGA031, a humanized monoclonal antibody, is the name used for hOKT3γ1 (Ala-Ala) that is produced by MacroGenics, Inc. The United States Adopted Name (USAN) for MGA031 is teplizumab.

Detailed description

The Protégé Study - A Multinational Clinical Trial of MGA031 for Preserving the Capability to Produce Insulin, Reducing Insulin Usage and Improving Blood Sugar Levels in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
BIOLOGICAL	Teplizumab	Daily IV dosing for 14 days, repeated at Week 26
DRUG	Placebo	Daily IV dosing for 14 days, repeated at Week 26

Timeline

• Start date: 2006-10-01
• Primary completion: 2010-06-01
• Completion: 2011-08-01
• First posted: 2006-10-11
• Last updated: 2023-12-05
• Results posted: 2023-12-05

Locations

115 sites across 16 countries: United States, Canada, Czechia, Estonia, Germany, India, Israel, Latvia, Mexico, Netherlands, Poland, Romania, Spain, Sweden, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study