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

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

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 118 Study Locations

Sponsors and Collaborators

MacroGenics

Eli Lilly and Company

Investigators

Study Director:	Anastasia G Daifotis, MD	MacroGenics

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Website containing information on Protege Program 

Responsible Party:	MacroGenics
ClinicalTrials.gov Identifier:	NCT00920582 History of Changes
Other Study ID Numbers:	CP-MGA031-03
First Posted:	June 15, 2009
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:

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