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

Tracking Information
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
Condition ICMJE	Diabetes Mellitus, Type 1
Intervention ICMJE	Drug: Crystallized human recombinant insulin
Study Arms	Not Provided
Publications *	Shah SC, Malone JI, Simpson NE. A randomized trial of intensive insulin therapy in newly diagnosed insulin-dependent diabetes mellitus. N Engl J Med. 1989 Mar 2;320(9):550-4.; Keller RJ, Eisenbarth GS, Jackson RA. Insulin prophylaxis in individuals at high risk of type I diabetes. Lancet. 1993 Apr 10;341(8850):927-8.; Zhang ZJ, Davidson L, Eisenbarth G, Weiner HL. Suppression of diabetes in nonobese diabetic mice by oral administration of porcine insulin. Proc Natl Acad Sci U S A. 1991 Nov 15;88(22):10252-6.; Diabetes Prevention Trial--Type 1 Diabetes Study Group. Effects of insulin in relatives of patients with type 1 diabetes mellitus. N Engl J Med. 2002 May 30;346(22):1685-91.; Barker JM, McFann KK, Orban T. Effect of oral insulin on insulin autoantibody levels in the Diabetes Prevention Trial Type 1 oral insulin study. Diabetologia. 2007 Aug;50(8):1603-6. Epub 2007 Jun 22.; Johnson SB, Baughcum AE, Hood K, Rafkin-Mervis LE, Schatz DA; DPT-1 Study Group. Participant and parent experiences in the parenteral insulin arm of the diabetes prevention trial for type 1 diabetes. Diabetes Care. 2007 Sep;30(9):2193-8. Epub 2007 Jun 11.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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: 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).
Sex/Gender	Sexes Eligible for Study: All
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
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	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)
Investigators ICMJE	Study Chair: Jay S. Skyler, MD University of Miami
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