Status:
COMPLETED
The Protégé Study - Clinical Trial of MGA031 in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus
Lead Sponsor:
MacroGenics
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
8-35 years
Phase:
PHASE2
PHASE3
Brief Summary
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-...
Detailed Description
The Protégé Study - A Multinational Clinical Trial of MGA031 for Preserving the Capability to Produce Insulin, Reducing Insulin Usage and Improving Blood Sugar Levels in Children and Adults With Recen...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
554 Patients enrolled
Trial Details
Trial ID
NCT00385697
Start Date
October 1 2006
End Date
August 1 2011
Last Update
December 5 2023
Active Locations (115)
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1
UAB School of Medicine
Birmingham, Alabama, United States, 35294
2
NEA Clinic
Jonesboro, Arkansas, United States, 72401
3
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
4
Diabetes Medical Center of California
Northridge, California, United States, 91325