Protege Encore Study- Clinical Trial of Teplizumab (MGA031) in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Teplizumab Herold Regimen; Placebo; Teplizumab 33.3% Herold Regimen; Teplizumab Curtailed Herold Regimen
Intervention description: 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; Full dose of teplizumab IV for 6 days followed by placebo for 8 days, repeated at Week 26
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 254.0
Sex: All
Minimum age: 8 Years
Maximum age: 35 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects 8-35 years old

          2. Body weight > 36 Kg

          3. Diagnosis of diabetes mellitus according to the American Diabetes Association (ADA)
             criteria

          4. Randomization on Study Day 0 within 12 weeks of first visit to any physician for
             symptoms or signs of diabetes

          5. Requires insulin for T1DM or has required insulin at some time between diagnosis and
             administration of study drug

          6. Detectable fasting or stimulated C-peptide level (above the lower limit of the
             reportable range of the assay) at screening

          7. Diagnosis of T1DM as evidenced by one positive result on testing for any of the
             following antibodies at screening:

               -  Islet-cell autoantibodies 512 (ICA512)/islet antigen-2 (IA-2),

               -  Glutamic acid decarboxylase (GAD) autoantibodies, or

               -  Insulin autoantibodies (in subjects on insulin for more than 2 weeks, ICA512/IA-2
                  or GAD must be positive).

        Exclusion Criteria:

          1. Prior administration of a monoclonal antibody-within the 1 year before randomization

          2. Participation in any type of therapeutic drug or vaccine clinical trial within the
             last 12 weeks before randomization at Study Day 0

          3. Any medical condition that, in the opinion of the investigator, would interfere with
             safe completion of the trial

          4. Pregnant females or lactating females who intend to provide their own breast milk to
             the baby during the study

          5. 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

          6. Current treatment with oral antidiabetic agents

          7. Evidence of active or latent tuberculosis

          8. Vaccination with a live virus or organism within the 8 weeks before randomization
             continuing through Week 52 of the study.

               -  Influenza vaccination with a killed virus, including booster vaccinations, within
                  4 weeks before or after each dosing cycle.

               -  Vaccination with other antigens or killed organisms within 8 weeks before or
                  after each dosing cycle

          9. Any infectious mononucleosis-like illness within the 6 months before randomization