The Protégé Study - Clinical Trial of MGA031 in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Type 1 Diabetes Mellitus

In brief

The primary purpose of this protocol is to assess the efficacy, tolerability, and safety of MGA031 when administered according to 3 different MGA031 dosing regimens in children and adults with recent-onset (diagnosis within past 12 weeks) type 1 diabetes mellitus. All regimens will be administered as an addition to insulin and other standard of care treatments. Efficacy will be defined primarily by the capacity of MGA031 to markedly reduce typical insulin requirements while maintaining relatively normal blood sugar levels. Other studies involving the study drug use the name hOKT3γ1 (Ala-Ala). MGA031, a humanized monoclonal antibody, is the name used for hOKT3γ1 (Ala-Ala) that is produced by MacroGenics, Inc. The United States Adopted Name (USAN) for MGA031 is teplizumab.

Key facts

Study ID

NCT00385697

Run by

MacroGenics

People needed

554

Starts

2006-10-01

Expected to finish

2011-08-01

Last updated by the study team

2023-12-05

Who can join

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

You may qualify if…

• Subjects must meet all of the following criteria:
• Enrollment (Segment #1) or randomization (Segment #2) on Study Day 0 within 12 weeks of first visit to any physician for symptoms or signs of diabetes. Study Day 0 is the first day of study drug dosing.
• Diagnosis of type 1 diabetes mellitus, according to the American Diabetes Association (ADA) criteria
• Requirement for injected insulin therapy
• Have a detectable fasting or stimulated C-peptide level (above the lower limit of detection of the assay)
• One positive result on testing for any of the following antibodies:
• islet-cell autoantibodies (ICA512/IA-2),
• glutamic acid decarboxylase autoantibodies, or
• insulin autoantibodies (if present during first 2 weeks, but not beyond 2 weeks, of insulin treatment)
• Male or female
• Subject must be in one of the following age groups:
• Age 18-35 years
• Age 12-17 years pending approval by Data Monitoring Committee
• Age 8-11 years pending approval by Data Monitoring Committee
• Body weight ≥ 36 kg

You may not qualify if…

• Subjects must have none of the following:
• Prior administration of a monoclonal antibody -- within the 1 year before enrollment or randomization at Study Day 0 -- that could potentially prevent or confound a therapeutic response to MGA031
• Participation in any type of therapeutic drug or vaccine clinical trial within the 12 weeks before enrollment or randomization
• Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial
• Pregnant or lactating females
• Prior murine OKT®3 treatment at any time before enrollment or randomization
• Current or planned therapy with exenatide or any other agents that stimulate pancreatic beta cell regeneration or insulin secretion
• Current or planned therapy with inhaled insulin
• Uncompensated heart failure, fluid overload, myocardial infarction or evidence of ischemic heart disease, or other serious cardiac disease within the 12 weeks before enrollment or randomization
• History of epilepsy, cancer, cystic fibrosis, sickle cell anemia, neuropathy, peripheral vascular disease or cerebrovascular disease
• Newly diagnosed hypothyroidism (not currently being treated but which, in the opinion of the investigator, should be treated) or active Graves' disease
• Eczema, asthma or severe atopic disease requiring treatment within the 12 weeks before enrollment or randomization
• Evidence of active infection, such as fever ≥ 38.0 degrees Celsius (100.5 degrees Fahrenheit)
• Known or suspected infection with human immunodeficiency virus (HIV)
• Evidence of active hepatitis B (HBV) or hepatitis C virus (HCV)
• Evidence of active or latent tuberculosis
• Vaccination with a live virus within the 8 weeks before enrollment or randomization or planned live virus vaccination continuing through week 52 of the study. Vaccination with an antigen or killed organism must not be given within 8 weeks before or planned within 8 weeks after each dosing cycle.
• Any infectious mononucleosis-like illness within the 6 months before enrollment or randomization
• Serologic and clinical evidence of acute infection with Epstein-Barr virus (EBV)
• Serologic evidence of acute infection with cytomegalovirus (CMV)

Where it is running

• NEA Clinic — Jonesboro, Arkansas, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Diabetes Medical Center of California — Northridge, California, United States
• UCSF Medical Center — San Francisco, California, United States
• University of Colorado Health Sciences Center — Aurora, Colorado, 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
• Humphrey Diabetes Center — Boise, Idaho, United States
• Rocky Mountain Diabetes & Osteoporosis Center — Idaho Falls, Idaho, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• University of Iowa Children's Hospital — Iowa City, Iowa, United States
• Mid-America Diabetes Associates, PA — Wichita, Kansas, United States
• Commonwealth Biomedical Research, LLC — Madisonville, Kentucky, United States
• St. Agnes Hospital — Baltimore, Maryland, United States
• Maryland Diabetes & Endocrine Associates — Rockville, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• Alzohaili Medical Consultants — Dearborn, Michigan, United States
• The Children's Mercy Hospital — Kansas City, Missouri, United States
• Creighton Diabetes Center — Omaha, Nebraska, United States
• Saint Barnabas Medical Center — Livingston, New Jersey, United States
• University of Medicine & Dentistry of NJ — New Brunswick, New Jersey, United States
• UAB School of Medicine — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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