Clinical Trial Details
| Trial ID: | L5327 |
| Source ID: | NCT00529399 |
| Associated Drug: | Gad-Alum |
| Title: | Effects of Recombinant Human Glutamic Acid Decarboxylase on the Progression of Type 1 Diabetes in New Onset Subjects |
| Acronym: | TN08 |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00529399/results |
| Conditions: | Type 1 Diabetes Mellitus |
| Interventions: | DRUG: GAD-Alum|DRUG: GAD-Alum and Aluminum hydroxide|DRUG: Aluminum hydroxide |
| Outcome Measures: | Primary: The Primary Outcome is the Area Under the Stimulated C-peptide Curve (AUC) at the One Year Visit, The primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes., Based on mixed meal tolerance test (MMTT) conducted at the one year visit | |
| Sponsor/Collaborators: | 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 |
| Gender: | ALL |
| Age: | CHILD, ADULT |
| Phases: | PHASE2 |
| Enrollment: | 145 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2009-02 |
| Completion Date: | 2012-05 |
| Results First Posted: | 2016-12-07 |
| Last Update Posted: | 2020-05-07 |
| Locations: | Childrens Hospital of Los Angeles, Los Angeles, California, 90027, United States|Stanford University, Palo Alto, California, 94305, United States|University of California-San Francisco, San Francisco, California, 94143, United States|Barbara Davis Center for Childhood Diabetes/University of Colorado Health Sciences Center, Aurora, Colorado, 80045, United States|Yale University School of Medicine, New Haven, Connecticut, 06520, United States|University of Florida, Gainesville, Florida, United States|University of Miami/ Miller School of Medicine, Miami, Florida, 33136, United States|Indiana University School of Medicine, Indianapolis, Indiana, 46202, United States|Joslin Diabetes Center, Boston, Massachusetts, 02215, United States|University of Minnesota, Minneapolis, Minnesota, 55455, United States|Columbia University, New York, New York, 10032, United States|Childrens Hospital of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States|University of Texas/Southwestern Medical School, Dallas, Texas, 75390-8858, United States|Benaroya Research Institute, Seattle, Washington, 98101, United States|Hospital for Sick Children, Toronto, Ontario, M5G 1X8, Canada |
| URL: | https://clinicaltrials.gov/show/NCT00529399 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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