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

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 |
- 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 ]
- 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 ]
- 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 ]

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Ages Eligible for Study: | 8 Years to 35 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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:
- 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
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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
- Any infectious mononucleosis-like illness within the 6 months before randomization

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

Study Director: | Anastasia G Daifotis, MD | MacroGenics |
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 |
Teplizumab Protege Protege Encore MGA031 Monoclonal antibody Type 1 Diabetes Mellitus |
T1DM MacroGenics Recent Onset Diabetes hOKT3γ1 (Ala-Ala) Encore |
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 |