Effects of Recombinant Human Glutamic Acid Decarboxylase on the Progression of Type 1 Diabetes in New Onset Subjects
NCT ID: NCT00529399
Last Updated: 2020-05-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
145 participants
INTERVENTIONAL
2009-02-28
2012-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
3 injections of GAD-Alum vaccine
GAD-Alum
Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.
2
2 injections of GAD-Alum vaccine and one injection with Aluminum hydroxide alone
GAD-Alum and Aluminum hydroxide
Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection.
3
3 injections of Aluminum hydroxide alone
Aluminum hydroxide
Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.
Interventions
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GAD-Alum
Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.
GAD-Alum and Aluminum hydroxide
Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection.
Aluminum hydroxide
Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stimulated C-peptide levels greater than or equal to 0.2 pmol/ml measured during a mixed meal tolerance test (MMTT) conducted 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
* Willing to forgo routine clinical immunizations during the first 100 days after initial study drug administration
Exclusion Criteria
* 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
3 Years
45 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
National Center for Research Resources (NCRR)
NIH
American Diabetes Association
OTHER
Juvenile Diabetes Research Foundation
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Responsible Party
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Principal Investigators
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Diane Wherrett, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Toronto, Hospital for Sick Children
Jay Skyler, M.D.
Role: STUDY_CHAIR
University of Miami
Locations
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Childrens Hospital of Los Angeles
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
University of California-San Francisco
San Francisco, California, United States
Barbara Davis Center for Childhood Diabetes/University of Colorado Health Sciences Center
Aurora, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
University of Florida
Gainesville, Florida, United States
University of Miami/ Miller School of Medicine
Miami, Florida, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Columbia University
New York, New York, United States
Childrens Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Texas/Southwestern Medical School
Dallas, Texas, United States
Benaroya Research Institute
Seattle, Washington, United States
Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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References
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Atkinson MA, Eisenbarth GS. Type 1 diabetes: new perspectives on disease pathogenesis and treatment. Lancet. 2001 Jul 21;358(9277):221-9. doi: 10.1016/S0140-6736(01)05415-0.
Pleau JM, Fernandez-Saravia F, Esling A, Homo-Delarche F, Dardenne M. Prevention of autoimmune diabetes in nonobese diabetic female mice by treatment with recombinant glutamic acid decarboxylase (GAD 65). Clin Immunol Immunopathol. 1995 Jul;76(1 Pt 1):90-5. doi: 10.1006/clin.1995.1092.
Tian J, Clare-Salzler M, Herschenfeld A, Middleton B, Newman D, Mueller R, Arita S, Evans C, Atkinson MA, Mullen Y, Sarvetnick N, Tobin AJ, Lehmann PV, Kaufman DL. Modulating autoimmune responses to GAD inhibits disease progression and prolongs islet graft survival in diabetes-prone mice. Nat Med. 1996 Dec;2(12):1348-53. doi: 10.1038/nm1296-1348.
Tisch R, Liblau RS, Yang XD, Liblau P, McDevitt HO. Induction of GAD65-specific regulatory T-cells inhibits ongoing autoimmune diabetes in nonobese diabetic mice. Diabetes. 1998 Jun;47(6):894-9. doi: 10.2337/diabetes.47.6.894.
Tisch R, Wang B, Weaver DJ, Liu B, Bui T, Arthos J, Serreze DV. Antigen-specific mediated suppression of beta cell autoimmunity by plasmid DNA vaccination. J Immunol. 2001 Feb 1;166(3):2122-32. doi: 10.4049/jimmunol.166.3.2122.
Jun HS, Chung YH, Han J, Kim A, Yoo SS, Sherwin RS, Yoon JW. Prevention of autoimmune diabetes by immunogene therapy using recombinant vaccinia virus expressing glutamic acid decarboxylase. Diabetologia. 2002 May;45(5):668-76. doi: 10.1007/s00125-002-0806-9. Epub 2002 Apr 4.
Wherrett DK, Bundy B, Becker DJ, DiMeglio LA, Gitelman SE, Goland R, Gottlieb PA, Greenbaum CJ, Herold KC, Marks JB, Monzavi R, Moran A, Orban T, Palmer JP, Raskin P, Rodriguez H, Schatz D, Wilson DM, Krischer JP, Skyler JS; Type 1 Diabetes TrialNet GAD Study Group. Antigen-based therapy with glutamic acid decarboxylase (GAD) vaccine in patients with recent-onset type 1 diabetes: a randomised double-blind trial. Lancet. 2011 Jul 23;378(9788):319-27. doi: 10.1016/S0140-6736(11)60895-7. Epub 2011 Jun 27.
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