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Sponsors and Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Center for Research Resources (NCRR) National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Center on Minority Health and Health Disparities (NCMHD) Office of Research on Women's Health (ORWH) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00004984 |
The Diabetes Prevention Trial of Type 1 (DPT-1) is a multicenter randomized, controlled clinical trial designed to determine whether it is possible to delay or prevent the clinical onset of type 1 diabetes through daily doses of insulin in individuals determined to be at risk for the disease. The parenteral insulin trial in DPT-1 has been completed, however, the oral insulin trial is still recruiting. Over 350 sites in the United States, Canada, and Puerto Rico are taking part in the study. Screening of patients is ongoing; approximately 100,000 nondiabetic relatives of persons with type 1 diabetes have been screened to detect the presence of islet cell antibodies. Those individuals found to have islet cell antibodies are being staged to determine their risk of diabetes based on genetic, immunologic, and metabolic characteristics. Those individuals found to be at intermediate risk of diabetes are randomized to receive insulin orally or to receive placebo. Patients are being followed for up to six years.
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Type 1 |
Drug: Crystallized human recombinant insulin |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Efficacy Study |
Ages Eligible for Study: | 3 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Childrens Hospital of Los Angeles, Division of Endocrinology | |
Los Angeles, California, United States, 90027 | |
Stanford University | |
Stanford, California, United States, 94305-5208 | |
University of California-San Francisco, Milberry Union East RM 405, 500 Parnassus Ave Box 0136 | |
San Francisco, California, United States, 94143 | |
United States, Colorado | |
University of Colorado Barbara Davis Center for Childhood Diabetes | |
Denver, Colorado, United States, 80262 | |
United States, Florida | |
DPT-1 Operations Coordinating Center | |
Miami, Florida, United States, 33136 | |
University of Florida Diabetes Research Center | |
Gainesville, Florida, United States, 32610-0296 | |
University of Miami School of Medicine, Jackson Medical Tower | |
Miami, Florida, United States, 33136 | |
United States, Indiana | |
Indiana University, James Whitcomb Riley Hospital for Children, 702 Barnhill Dr, Ste 5960 | |
Indianapolis, Indiana, United States, 46202 | |
United States, Massachusetts | |
Joslin Diabetes Center | |
Boston, Massachusetts, United States, 02215 | |
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 | |
United States, New York | |
Naomi Berrie Diabetes Center, Columbia University, 1150 St. Nicholas Ave | |
New York, New York, United States, 10032 | |
United States, Pennsylvania | |
Children's Hospital of Pittsburgh, Dept/Pediatric Endocrinology, 3705 5th Ave | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Texas | |
University of Texas, Children's Medical Center, 6300 Harry Hines Ste 1200 | |
Dallas, Texas, United States, 75235 | |
United States, Washington | |
Virginia Mason Research Center, 1201 Ninth Avenue | |
Seattle, Washington, United States, 98101 | |
Canada, Ontario | |
Hospital for Sick Children, Division of Endocrinology, 555 University Ave, Rm 5110 | |
Toronto, Ontario, Canada, M5G-1X8 |
Study Chair: | Jay S. Skyler, MD | University of Miami |
Study ID Numbers: | DPT-1, DK60782, DK60916, DK60987, DK61010, DK61029, DK61030, DK61034, DK61035, DK61036, DK61037, DK61038, DK61040, DK61041, DK61042, DK61058, DK61055 |
Study First Received: | March 13, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004984 History of Changes |
Health Authority: | United States: Food and Drug Administration |
diabetes insulin prediction prevention C-peptide levels |
insulin autoantibodies pancreatic beta cell autoantibodies cellular immune responses prediction of type 1 diabetes |
Hypoglycemic Agents Autoimmune Diseases Metabolic Diseases Autoantibodies Diabetes Mellitus, Type 1 Diabetes Mellitus |
Endocrine System Diseases Diabetes Mellitus Type 1 Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Insulin |
Hypoglycemic Agents Autoimmune Diseases Metabolic Diseases Immune System Diseases Diabetes Mellitus, Type 1 Physiological Effects of Drugs |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions Insulin |