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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Type 1 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT00920582

Run by

MacroGenics

People needed

254

Starts

2009-09-01

Expected to finish

2012-07-01

Last updated by the study team

2023-12-20

Who can join

Age: 8 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• NEA Clinic — Jonesboro, Arkansas, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Clinical Innovations Inc. Research Facility — Costa Mesa, California, United States
• Axis Clinical Trials — Los Angeles, California, United States
• Diabetes Associates Medical Group, Inc — Orange, California, United States
• Clinical Innovations, Inc. — Riverside, California, United States
• San Diego Clinical Trials — San Diego, California, United States
• Ronald Chochinov Md Inc — Ventura, California, United States
• Yale University — New Haven, Connecticut, United States
• Christiana Care Research Institute — Newark, Delaware, United States
• Richard Hays, MD — Wellington, Florida, United States
• Atlanta Diabetes Associates — Atlanta, Georgia, United States
• John H Stoger Jr. Hospital of Cook County, Cook County Hospital — Chicago, Illinois, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• University of Iowa Children's Hospital — Iowa City, Iowa, United States
• Mid-America Diabetes Associates — Wichita, Kansas, United States
• St. Agnes Hospital — Baltimore, Maryland, United States
• Maryland Diabetes & Endocrine Associates — Rockville, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Alzohaili Medical Consultants — Dearborn, Michigan, United States
• Children's Hospitals and Clinics of Minnesota — Saint Paul, Minnesota, United States
• University of Missouri - Columbia, Cosmopolitan Diabetes and Endocrinology — Columbia, Missouri, United States
• The Children's Mercy Hospital — Kansas City, Missouri, United States
• Saint Barnabas Medical Center — Livingston, New Jersey, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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