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

Sponsor:	MacroGenics
Collaborator:	Eli Lilly and Company
Information provided by (Responsible Party):	MacroGenics
ClinicalTrials.gov Identifier:	NCT00920582

Purpose

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	Intervention	Phase
Type 1 Diabetes Mellitus	Drug: Teplizumab (MGA031) Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Medicines Diabetes Type 1

Drug Information available for: Immunoglobulins Mitoguazone Globulin, Immune

U.S. FDA Resources

Further study details as provided by MacroGenics:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	September 2009
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	8 Years to 35 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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
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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00920582

Show 118 Study Locations

Sponsors and Collaborators

MacroGenics

Eli Lilly and Company

Investigators

Study Director:

Anastasia G Daifotis, MD

MacroGenics

More Information

Additional Information:

Website containing information on Protege Program This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	MacroGenics
ClinicalTrials.gov Identifier:	NCT00920582 History of Changes
Other Study ID Numbers:	CP-MGA031-03
Study First Received:	June 12, 2009
Last Updated:	September 19, 2011
Health Authority:	United States: Food and Drug Administration

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 07, 2012