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Sponsored by: |
DeveloGen Israel, Ltd. |
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Information provided by: | DeveloGen Israel, Ltd. |
ClinicalTrials.gov Identifier: | NCT00058981 |
Randomized, double-blind, parallel-group study to evaluate safety and efficacy of multiple subcutaneous doses of DiaPep277 in patients with Latent Autoimmune Diabetes in Adults (LADA). Study medication will be administered at time 0, 1 and 3 months, and then every 3 months for a total of 8 administrations. The total duration of the trial is 24 months (treatment for 18 months and follow-up for an additional 6 months). Patients will be male or female between the ages of 30 and 65 years, inclusive, within 2 to 60 months of the diagnosis of diabetes mellitus. Subjects must be positive for glutamic acid decarboxylate (GAD) autoantibodies. At the Screen Visit (Visit 2), all subjects will be asked to discontinue their use of all oral antidiabetic medications with the exception of metformin. The subjects will be placed on a stable regimen of insulin and diet (plus metformin if needed). Prior to the Baseline Visit (Visit 3), diabetic control must be achieved by diet and insulin (plus metformin if needed).
Condition | Intervention | Phase |
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Diabetes, Autoimmune |
Drug: DiaPep277 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Safety and Tolerability as Well as the Immunological and Clinical Efficacy of Multiple Subcutaneous Doses of DiaPep277 in LADA Subjects |
Ages Eligible for Study: | 30 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Subjects meeting all of the following inclusion criteria at screening should be considered for admission to the study:
Exclusion Criteria
Subjects meeting any of the following exclusion criteria at screening will not be enrolled in the study:
The subject has any of the following:
United States, Alabama | |
University of Alabama at Birmingham Endocrinology Department | |
Birmingham, Alabama, United States, 35294 | |
United States, Colorado | |
University of Colorado Hospital Endocrinology Practice | |
Aurora, Colorado, United States, 80010 | |
United States, Kentucky | |
University of Kentucky Department of Internal Medicine | |
Lexington, Kentucky, United States, 40536 | |
United States, Missouri | |
Washington University School of Medicine Endocrinology/Metabolic Dept | |
Saint Louis, Missouri, United States, 63110 | |
United States, New York | |
North Shore Diabetes and Endocrine Associates | |
New Hyde Park, New York, United States, 11042 | |
United States, Texas | |
Diabetes & Glandular Disease Research Associates | |
San Antonio, Texas, United States, 78229-4801 | |
United States, Washington | |
DVA Puget Sound Health Care System Endocrinology (III) Department | |
Seattle, Washington, United States, 98108 |
Principal Investigator: | Jerry P Palmer, MD | University of Washington |
Study Director: | Dana Elias, PhD | DeveloGen Israel, Ltd. |
Study ID Numbers: | 702/PO |
Study First Received: | April 15, 2003 |
Last Updated: | September 19, 2006 |
ClinicalTrials.gov Identifier: | NCT00058981 |
Health Authority: | United States: Food and Drug Administration |
Diabetes LADA latent autoimmune diabetes in adults |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Immune System Diseases |