A Phase 3, Randomized, Double-Blind, Multinational, Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus
A Phase 3, Randomized, Double-Blind, Multinational, Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus
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.
Inclusion Criteria:
Subjects 8-35 years old
Body weight > 36 Kg
Diagnosis of diabetes mellitus according to the American Diabetes Association (ADA) criteria
Randomization on Study Day 0 within 12 weeks of first visit to any physician for symptoms or signs of diabetes
Requires insulin for T1DM or has required insulin at some time between diagnosis and administration of study drug
Detectable fasting or stimulated C-peptide level (above the lower limit of the reportable range of the assay) at screening
Diagnosis of T1DM as evidenced by one positive result on testing for any of the following antibodies at screening:
Exclusion Criteria:
Prior administration of a monoclonal antibody-within the 1 year before randomization
Participation in any type of therapeutic drug or vaccine clinical trial within the last 12 weeks before randomization at Study Day 0
Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial
Pregnant females or lactating females who intend to provide their own breast milk to the baby during the study
Current therapy with GLP-1 receptor agonists (e.g., exenatide or pramlintide), or any other agents that might stimulate pancreatic beta cell regeneration or insulin secretion
Current treatment with oral antidiabetic agents
Evidence of active or latent tuberculosis
Vaccination with a live virus or organism within the 8 weeks before randomization continuing through Week 52 of the study.
Any infectious mononucleosis-like illness within the 6 months before randomization
Chicago, Illinois 60612, United States
Columbia, Missouri 65212, United States
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Hyderabad, Andhra Pradesh 500001, India
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