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Protege Encore Study- Clinical Trial of Teplizumab (MGA031) in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00920582
Recruitment Status : Completed
First Posted : June 15, 2009
Last Update Posted : March 7, 2013
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
MacroGenics

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: Teplizumab (MGA031) Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 254 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2009
Actual Primary Completion Date : April 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: Teplizumab (MGA031)
IV dosing daily for 14 days times 2 courses
Other Name: MGA031
Experimental: 2 Drug: Teplizumab (MGA031)
IV dosing daily for 14 days times 2 courses
Other Name: MGA031
Experimental: 3 Drug: Teplizumab (MGA031)
IV dosing daily for 14 days times 2 courses
Other Name: MGA031
Placebo Comparator: 4 Drug: Placebo
IV dosing daily for 14 days times 2 courses


Outcome Measures
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Primary Outcome Measures :
  1. Successful versus unsuccessful clinical responses. A successful response requires that both components of a composite endpoint are met. The composite endpoint includes both the subject's total daily insulin usage and his/her HbA1c levels. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Successful versus unsuccessful clinical responses. A successful response requires that both components of a composite endpoint are met. The composite endpoint includes both the subject's total daily insulin usage and his/her HbA1c levels [ Time Frame: Up to 24 months ]
  2. C-peptide secretory responses, as defined by the total area under the curve of the C-peptide response to a mixed meal [ Time Frame: 12 and up to 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   8 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00920582


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Sponsors and Collaborators
MacroGenics
Eli Lilly and Company
Investigators
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Study Director: Anastasia G Daifotis, MD MacroGenics
More Information
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Responsible Party: MacroGenics
ClinicalTrials.gov Identifier: NCT00920582     History of Changes
Other Study ID Numbers: CP-MGA031-03
First Posted: June 15, 2009    Key Record Dates
Last Update Posted: March 7, 2013
Last Verified: February 2013
Keywords provided by MacroGenics:
Teplizumab
Protege
Protege Encore
MGA031
Monoclonal antibody
Type 1 Diabetes Mellitus
 T1DM
MacroGenics
Recent Onset Diabetes
hOKT3γ1 (Ala-Ala)
Encore
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs