The Diabetes Prevention Trial of Type 1 Diabetes (DPT-1)

ClinicalTrials.gov Identifier:
NCT00004984
First received: March 13, 2000
Last updated: January 14, 2010
Last verified: January 2010

March 13, 2000
January 14, 2010
February 1994
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Complete list of historical versions of study NCT00004984 on ClinicalTrials.gov Archive Site
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The Diabetes Prevention Trial of Type 1 Diabetes (DPT-1)
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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.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Double-Blind
Primary Purpose: Prevention
Diabetes Mellitus, Type 1
Drug: Crystallized human recombinant insulin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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June 2003
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Inclusion Criteria:

  • Individuals 3-45 years old who have an immediate family member with type 1 diabetes (such as a child, parent, or sibling)
  • Individuals 3-20 years old who have an extended family member with type 1 diabetes (such as a cousin, niece, nephew, aunt, uncle, grandparent, or half-sibling)

Exclusion Criteria:

  • To be eligible, a person must:
  • Not have diabetes already.
  • Have no previous history of being treated with insulin or oral diabetes medications.
  • Have not received any prior therapy for prevention of type 1 diabetes such as insulin, nicotinamide, or immunosuppressive drugs (i.e. have not been involved in any previous clinical studies of these agents.)
  • Have no known serious diseases.
  • If you are a woman, you must not be planning to become pregnant during the course of the study. You will not be excluded from participation, but are not encouraged to volunteer in the first place if you plan to have a baby during the trial period).
Both
3 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00004984
DPT-1 (completed), DK60782, DK60916, DK60987, DK61010, DK61029, DK61030, DK61034, DK61035, DK61036, DK61037, DK61038, DK61040, DK61041, DK61042, DK61058, DK61055
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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)
Study Chair: Jay S. Skyler, MD University of Miami
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP