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Effects of Recombinant Human Glutamic Acid Decarboxylase . . .

This study is not yet open for participant recruitment.
Study NCT00529399.   Last updated on August 20, 2008.   Information provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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Descriptive Information Fields
Brief Title  Effects of Recombinant Human Glutamic Acid Decarboxylase . . .
Official Title  Effects of Recombinant Human Glutamic Acid Decarboxylase (rhGAD65) Formulated in Alum (GAD-Alum) on the Progression of Type 1 Diabetes in New Onset Subjects
Brief Summary

The purpose of this study is to determine whether treatment with multiple injections of GAD-Alum will preserve the body's own (endogenous) insulin production in patients who have been recently diagnosed with type 1 diabetes mellitus (T1DM).

Detailed Description

Type 1 diabetes (T1D) is an autoimmune disease. This means that the immune system (the part of the body which helps fight infections) mistakenly attacks and destroys the cells that produce insulin (islet cells found in the pancreas called islet cells). As these cells are destroyed, the body's ability to produce insulin decreases. Glutamic acid decarboxylase (GAD) is one of the major autoantigens (a protein that the immune system is reacting to) involved in the autoimmune process underlying T1DM.

GAD-Alum is Recombinant human (rhGAD65) and is used as an antigen-specific immune modulator. Previous studies have shown that it may slow or prevent autoimmune destruction of pancreatic islet cells by introducing "immune tolerance". By administering excess autoantigen, the body may stop its attack on its own cells that produce insulin. If the immune system's attack can be halted in a patient with recent onset T1DM, than residual insulin secretion may be maintained. This may be beneficial in decreasing acute and long-term diabetic complications as well as improving glucose control.

Study Phase Phase II, Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  The primary outcome is the area under the stimulated C-peptide curve (AUC) over tghe first 2 years of a 4-hour mixed meal tolerance test (MMTT). [ Time Frame: Based on MMTT conducted at the two year visit ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Difference in loss of 2 hr peak C-peptide <0.2 pmol/ml; Mean HbA1c, insulin dose (units/kg), blood glucose ; prevalence of autoantibody positivity ; rates of severe hypoglycemic and adverse events. [ Time Frame: Comparison of values repeated over time per protocol ] [ Designated as safety issue: No ]
Condition  Type 1 Diabetes Mellitus
Intervention  Drug: GAD-Alum
Drug: Aluminum hydroxide
MEDLINE PMIDs 11476858,   7606872,   8946834,   9604865,   11160264,   12107747
Links Related Info This link exits the ClinicalTrials.gov site
Related Info This link exits the ClinicalTrials.gov site
Related Info This link exits the ClinicalTrials.gov site
Related Info This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Not yet recruiting
Enrollment  126
Start Date  December 2008
Completion Date December 2012
Eligibility Criteria 

Inclusion Criteria:

  • Age 8 to 45 years
  • Insulin dependent type 1-diabetes mellitus diagnosed within the previous 3 months
  • Stimulated C-peptide levels greater than or equal to 0.2 pmol/ml measured during a mixed meal tolerance test (MMTT) conducted within 3 weeks from diagnosis of diabetes
  • Presence of GAD65 antibodies
  • At least one month from last immunization
  • Willing to comply with intensive diabetes management
  • If participant is a woman with reproductive potential, she must be willing to avoid pregnancy and have a negative pregnancy test
  • Must weigh at least 25 kg at study entry
  • Willing to forgo routine clinical immunizations during the first 100 days after initial study drug administration

Exclusion Criteria:

  • Immunodeficiency or clinically significant chronic lymphopenia
  • Active infection
  • Positive PPD test result
  • Pregnant or lactating or anticipating becoming pregnant for 24 months following first injection
  • Ongoing use of medications known to influence glucose tolerance
  • Require use of systemic immunosuppressant(s)
  • Serologic evidence of current or past HIV, Hep B, or Hep C infection
  • History of malignancies
  • Ongoing use of non-insulin pharmaceuticals to affect glycemic control
  • Participation in another clinical trial with a new chemical entity within the past 3 months
  • Complicating medical issues or abnormal clinical laboratory results that interfere with study conduct or cause increased risk including neurological, or clinically significant blood count abnormalities (such as lymphopenia, leukopenia, or thrombocytopenia)
  • History of epilepsy, head trauma or cerebrovascular accident or clinical
  • History of alcohol or drug abuse
Gender Both
Ages 8 Years to 45 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries 
Administrative Information Fields
NCT ID  NCT00529399
Organization ID GAD65
Secondary IDs ††
Study Sponsor  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators †† Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Allergy and Infectious Diseases (NIAID)
National Center for Research Resources (NCRR)
American Diabetes Association
Juvenile Diabetes Research Foundation
Investigators 
Principal Investigator:     Jerry Palmer, M.D.     University of Washington    
Study Chair:     Jay Skyler, M.D.     University of Miami    
Information Provided By National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date August 2008
First Received Date  September 12, 2007
Last Updated Date August 20, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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