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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
554
Daily IV dosing for 14 days, repeated at Week 26
Daily IV dosing for 14 days, repeated at Week 26
UAB School of Medicine
Birmingham, Alabama, United States
NEA Clinic
Jonesboro, Arkansas, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Diabetes Medical Center of California
Northridge, California, United States
UCSF Medical Center
San Francisco, California, United States
Number of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%.
This is a composite endpoint is based on the proportion of subjects who have both a total daily insulin dose \<0.5 U/Kg/day and an HbAlc level 6.5% at 52 weeks after randomization.
Time frame: 52 weeks after randomization
Number of Subjects in Segment 1 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%.
This is a composite endpoint based on the proportion of subjects who have both a total daily insulin dose \<0.5 U/Kg/day and an HbAlc level 6.5%
Time frame: 52 weeks after first dose
Mean HbA1c Change From Baseline in Segment 2
Comparison among study treatments of average change from baseline HbA1C. This endpoint will be assessed in a hierarchical manner only if the composite primary endpoint shows a statistically significant difference between arms
Time frame: 52 weeks after randomization
Mean HbA1c Change From Baseline in Segment 1
The average change in HbA1c levels after dosing.
Time frame: 52 weeks after first dose
Change From Baseline in C-peptide Area Under the Curve (AUC) in Segment 2
Comparison among study treatments on the AUC of C-peptide secretory responses following a mixed meal eaten by the subject
Time frame: 104 weeks after randomization
Change From Baseline in C-peptide AUC in Segment 1
AUC of C-peptide secretory responses following a mixed meal eaten by the subject
Time frame: 104 weeks after first dose
Number of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and HbA1c Level of Less Than 6.5%
Comparison among study treatments of a composite endpoint based on the proportion of subjects who have both a total daily insulin dose \<0.5 U/Kg/day and an HbAlc level 6.5%.
Time frame: 104 weeks after randomization
Number of Subjects in Segment 1 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and HbA1c Level of Less Than 6.5%
Comparison among study treatments of a composite endpoint based on the proportion of subjects who have both a total daily insulin dose \<0.5 U/Kg/day and an HbAlc level 6.5%.
Time frame: 104 weeks after first dose
Number of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and HbA1c Level of Less Than 7.0%.
Comparison among study treatments of a composite endpoint based on the proportion of subjects who have both a total daily insulin dose \<0.5 U/Kg/day and an HbAlc level 7.0%.
Time frame: at 52 weeks after randomization
Number of Subjects in Segment 1 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and HbA1c Level of Less Than 7.0%.
Composite endpoint based on the proportion of subjects who have both a total daily insulin dose \<0.5 U/Kg/day and an HbAlc level 7.0%.
Time frame: 52 weeks after first dose
Mean HbA1c Change From Baseline in Segment 2
Comparison among study treatments of the average change from baseline in HbA1c.
Time frame: at 104 weeks after randomization
Mean HbA1c Change From Baseline in Segment 1
Comparison among study treatments of the average change from baseline in HbA1c.
Time frame: 104 weeks after first dose
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University of Colorado Health Sciences Center
Aurora, Colorado, United States
Yale University
New Haven, Connecticut, United States
Christiana Care Research Institute
Newark, Delaware, United States
Richard Hays, MD
Wellington, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
...and 105 more locations