Clinical Trial


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


Brief description

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

Keywords

  •   Type 1 Diabetes Mellitus

Sponsored By

MacroGenics

Unique Study ID

NCT00385697

Investigators and Research Sites Near You - Found( 3 )

No Investigator Listed

Sanofi
B15 2GW, Birmingham, United Kingdom
Distance from Current Trial is 0 miles

Jereme D Wilroy, PhD

University of Alabama at Birmingham
35209, Birmingham, Alabama, United States
Distance from Current Trial is 0 miles

Ansar Mahmood

University of Aberdeen
B15 2TH, Birmingham, United Kingdom
Distance from Current Trial is 0 miles
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