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| 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 |
| Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00529399 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Type 1 Diabetes Mellitus |
Drug: GAD-Alum Drug: Aluminum hydroxide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| 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 |
| Estimated Enrollment: | 126 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
3 injections of GAD-Alum vaccine
|
Drug: 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.
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2: Experimental
2 injections of GAD-Alum vaccine and one injection with Aluminum hydroxide alone
|
Drug: GAD-Alum
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.
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3: Placebo Comparator
3 injections of Aluminum hydroxide alone
|
Drug: 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.
|
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.
Eligibility| Ages Eligible for Study: | 3 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jay S Skyler, MD | 305-243-6146 | jskyler@miami.edu |
| Contact: Lisa E Rafkin, MS | 305-243-6146 | lrafkin@miami.edu |
| United States, California | |
| Stanford University | Recruiting |
| Palo Alto, California, United States, 94305 | |
| Contact: Trudy Esrey, RN 650-498-4450 tesray@stanford.edu | |
| Principal Investigator: Darrell Wilson, MD | |
| Childrens Hospital of Los Angeles | Recruiting |
| Los Angeles, California, United States, 90027 | |
| Contact: Mary Halvorson, RN 323-669-4606 mhalvorson@chla.usc.edu | |
| Principal Investigator: Roshanak Monzavi, MD | |
| University of California-San Francisco | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Celia Hamilton, RN 415-476-5026 hamiltonc@peds.ucsf.edu | |
| Principal Investigator: Stephen Gitelman, MD | |
| United States, Colorado | |
| Barbara Davis Center for Childhood Diabetes/University of Colorado Health Sciences Center | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Susan George, RN 303-724-7501 Susan.George@ucdenver.edu | |
| Principal Investigator: Peter Gottleib, MD | |
| United States, Connecticut | |
| Yale University School of Medicine | Recruiting |
| New Haven, Connecticut, United States, 06520 | |
| Contact: Laurie Feldman 203-737-2760 laurie.feldman@yale.edu | |
| Principal Investigator: Kevan Herold, MD | |
| United States, Florida | |
| University of Miami/ Miller School of Medicine | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Della Matheson, RN 305-243-3781 dmatheso@miami.edu | |
| Principal Investigator: Jennifer B Marks, MD | |
| University of Florida | Recruiting |
| Gainesville, Florida, United States | |
| Contact: Roberta Cook, RN 352-334-0865 cookrb@peds.ufl.edu | |
| Principal Investigator: Desmond Schatz, MD | |
| United States, Indiana | |
| Indiana University School of Medicine | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Martha Mendez, RN 317-278-8879 mwmendez@iupui.edu | |
| Principal Investigator: Henry Rodriquez, MD | |
| United States, Massachusetts | |
| Joslin Diabetes Center | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Debbie Conboy, RN 617-732-2647 Debbie.Conboy@joslin.harvard.edu | |
| Principal Investigator: Tihamer Orban, MD | |
| United States, Minnesota | |
| University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Jennifer Smith, RN 612-624-6682 smit5759@umn.edu | |
| Contact: Theresa Albright-Fischer, RN 612-626-2182 albr0088@umn.edu | |
| Principal Investigator: Tony Moran, MD | |
| United States, New York | |
| Columbia University | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Ellen Greenberg, MPH 212-851-5425 emg25@columbia.edu | |
| Principal Investigator: Robin S Goland, MD | |
| United States, Pennsylvania | |
| Childrens Hospital of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Karen Riley, RN 412-692-5210 karen.riley@chp.edu | |
| Principal Investigator: Dorothy Becker, MD | |
| United States, Texas | |
| University of Texas/Southwestern Medical School | Recruiting |
| Dallas, Texas, United States, 75390-8858 | |
| Contact: Marilyn Alford, RN 214-648-3816 Marilyn.Alford@UTSouthwestern.edu | |
| Principal Investigator: Philip Raskin, MD | |
| United States, Washington | |
| Benaroya Research Institute | Recruiting |
| Seattle, Washington, United States, 98101 | |
| Contact: Marli McCulloch 206-515-5233 Marli@benaroyaresearch.org | |
| Principal Investigator: Carla Greenbaum, MD | |
| Canada, Ontario | |
| Hospital for Sick Children | Recruiting |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Contact: Lesley A Eisel, RN 416-813-7654 ext 1798 lesley.eisel@sickkids.ca | |
| Principal Investigator: Diane Wherrett, MD | |
| Principal Investigator: | Diane Wherrett, M.D. | University of Toronto, Hospital for Sick Children |
| Study Chair: | Jay Skyler, M.D. | University of Miami |
More Information
| Responsible Party: | NIDDK ( Ellen Leschek ) |
| Study ID Numbers: | GAD65 |
| Study First Received: | September 12, 2007 |
| Last Updated: | January 21, 2010 |
| ClinicalTrials.gov Identifier: | NCT00529399 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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treatment of type 1 diabetes new onset type 1 diabetes juvenile diabetes Type 1 diabetes TrialNet immune tolerance immunotherapy antigen-specific tolerance |
vaccine induced tolerance Beta-cell function T-cells DPT-1 T1D diabetes mellitus TrialNet |
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Diabetes Mellitus, Type 1 Metabolic Diseases Autoimmune Diseases Immunologic Factors Immune System Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Diabetes Mellitus |
Adjuvants, Immunologic Endocrine System Diseases Pharmacologic Actions Aluminum Hydroxide Aluminum sulfate Antacids Glucose Metabolism Disorders |