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.
Who can participate
Age range8 Years – 35 Years
SexALL
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Inclusion criteria
✓. Enrollment (Segment #1) or randomization (Segment #2) on Study Day 0 within 12 weeks of first visit to any physician for symptoms or signs of diabetes. Study Day 0 is the first day of study drug dosing.
✓. Diagnosis of type 1 diabetes mellitus, according to the American Diabetes Association (ADA) criteria
✓. Requirement for injected insulin therapy
✓. Have a detectable fasting or stimulated C-peptide level (above the lower limit of detection of the assay)
✓. One positive result on testing for any of the following antibodies:
✓. islet-cell autoantibodies (ICA512/IA-2),
✓. glutamic acid decarboxylase autoantibodies, or
✓. insulin autoantibodies (if present during first 2 weeks, but not beyond 2 weeks, of insulin treatment)
Exclusion criteria
✕. Prior administration of a monoclonal antibody -- within the 1 year before enrollment or randomization at Study Day 0 -- that could potentially prevent or confound a therapeutic response to MGA031
What they're measuring
1
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%.
Timeframe: 52 weeks after randomization
2
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%.
✕. Participation in any type of therapeutic drug or vaccine clinical trial within the 12 weeks before enrollment or randomization
✕. Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial
✕. Pregnant or lactating females
✕. Prior murine OKT®3 treatment at any time before enrollment or randomization
✕. Current or planned therapy with exenatide or any other agents that stimulate pancreatic beta cell regeneration or insulin secretion
✕. Current or planned therapy with inhaled insulin
✕. Uncompensated heart failure, fluid overload, myocardial infarction or evidence of ischemic heart disease, or other serious cardiac disease within the 12 weeks before enrollment or randomization