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

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 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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

Resource links provided by NLM:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Type 1

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 ]

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 ]
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 ]


Enrollment:	254
Study Start Date:	September 2009
Study Completion Date:	July 2012
Primary Completion Date:	April 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 (Child, Adult)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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:	February 28, 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

ClinicalTrials.gov processed this record on June 21, 2017