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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
254
Full dose of teplizumab IV for 14 days, repeated at Week 26
IV dosing daily for 14 days repeated at Week 26
One third full dose of teplizumab IV for 14 days, repeated at Week 26
Proportion of Subjects 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%.
Time frame: 52 weeks after randomization
Mean Change From Baseline in HbA1c Between Teplizumab and Placebo
Time frame: 52 weeks after randomization
The Change in Beta-cell Function as Measured by C-peptide Secretory Response Following a Mixed Meal
Time frame: 52 weeks after randomization
The Change in Beta-cell Function as Measured by C-peptide Secretory Response Following a Mixed Meal
Time frame: 104 weeks after randomization
Mean Number of Total, Major, Minor and Nocturnal Hypoglycemia Events
Number of hypoglycemic events by type per participant
Time frame: Throughout the study up to 2 years
Mean Number of Daily Insulin Injections
Time frame: 52 weeks after randomization
Number of Subjects 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%.
Time frame: 104 weeks after randomization
The Proportion of Subjects Who Have Both a Total Daily Insulin Dose < 0.5 U/Kg/Day and Hemoglobin A1c (HbA1c) Level < 7.0%
Time frame: 52 weeks after randomization
The Mean HbA1c Change From Baseline
Time frame: 104 weeks after randomization
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Full dose of teplizumab IV for 6 days followed by placebo for 8 days, repeated at Week 26
University of Alabama at Birmingham
Birmingham, Alabama, United States
NEA Clinic
Jonesboro, Arkansas, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Clinical Innovations Inc. Research Facility
Costa Mesa, California, United States
Axis Clinical Trials
Los Angeles, California, United States
Diabetes Associates Medical Group, Inc
Orange, California, United States
Clinical Innovations, Inc.
Riverside, California, United States
San Diego Clinical Trials
San Diego, California, United States
Ronald Chochinov Md Inc
Ventura, California, United States
Yale University
New Haven, Connecticut, United States
...and 108 more locations
Number of Participants With Adverse Events
Time frame: throughout the study, up to 104 weeks
Number of Participants With Serious Adverse Events
Time frame: throughout the study, up to 104 weeks