The Diabetes Prevention Trial of Type 1 Diabetes (DPT-1)
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ClinicalTrials.gov Identifier: NCT00004984 |
Recruitment Status
:
Completed
First Posted
: March 14, 2000
Last Update Posted
: January 15, 2010
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Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators:
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 Institute on Minority Health and Health Disparities (NIMHD)
Office of Research on Women's Health (ORWH)
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Tracking Information | ||||
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First Submitted Date ICMJE | March 13, 2000 | |||
First Posted Date ICMJE | March 14, 2000 | |||
Last Update Posted Date | January 15, 2010 | |||
Study Start Date ICMJE | February 1994 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE | Not Provided | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | Complete list of historical versions of study NCT00004984 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | The Diabetes Prevention Trial of Type 1 Diabetes (DPT-1) | |||
Official Title ICMJE | Not Provided | |||
Brief Summary | 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Masking: Double Primary Purpose: Prevention |
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Condition ICMJE | Diabetes Mellitus, Type 1 | |||
Intervention ICMJE | Drug: Crystallized human recombinant insulin | |||
Study Arms | Not Provided | |||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | Not Provided | |||
Original Enrollment ICMJE | Not Provided | |||
Study Completion Date | June 2003 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 3 Years to 45 Years (Child, Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00004984 | |||
Other Study ID Numbers ICMJE | DPT-1 (completed) DK60782 DK60916 DK60987 DK61010 DK61029 DK61030 DK61034 DK61035 DK61036 DK61037 DK61038 DK61040 DK61041 DK61042 DK61058 DK61055 |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | |||
Verification Date | January 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |