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	Treatment or Intervention	Phase
Diabetes Mellitus, Type 1	Drug: Crystallized human recombinant insulin	Phase III

Ages Eligible for Study:  3 Years   -   45 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

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).

California
      Childrens Hospital of Los Angeles, Division of Endocrinology, Los Angeles,  California,  90027,  United States
      Stanford University, Stanford,  California,  94305-5208,  United States
      University of California-San Francisco, Milberry Union East RM 405, 500 Parnassus Ave Box 0136, San Francisco,  California,  94143,  United States
Colorado
      University of Colorado Barbara Davis Center for Childhood Diabetes, Denver,  Colorado,  80262,  United States
Florida
      DPT-1 Operations Coordinating Center, Miami,  Florida,  33136,  United States
      University of Florida Diabetes Research Center, Gainesville,  Florida,  32610-0296,  United States
      University of Miami School of Medicine, Jackson Medical Tower, Miami,  Florida,  33136,  United States
Indiana
      Indiana University, James Whitcomb Riley Hospital for Children, 702 Barnhill Dr, Ste 5960, Indianapolis,  Indiana,  46202,  United States
Massachusetts
      Joslin Diabetes Center, Boston,  Massachusetts,  02215,  United States
Minnesota
      University of Minnesota, Minneapolis,  Minnesota,  55455,  United States
New York
      Naomi Berrie Diabetes Center, Columbia University, 1150 St. Nicholas Ave, New York,  New York,  10032,  United States
Pennsylvania
      Children's Hospital of Pittsburgh, Dept/Pediatric Endocrinology, 3705 5th Ave, Pittsburgh,  Pennsylvania,  15213,  United States
Texas
      University of Texas, Children's Medical Center, 6300 Harry Hines Ste 1200, Dallas,  Texas,  75235,  United States
Washington
      Virginia Mason Research Center, 1201 Ninth Avenue, Seattle,  Washington,  98101,  United States
Canada, Ontario
      Hospital for Sick Children, Division of Endocrinology, 555 University Ave, Rm 5110, Toronto,  Ontario,  M5G-1X8,  Canada

Study chairs or principal investigators

Jay S. Skyler, MD,  Study Chair,  University of Miami School of Medicine   

Study ID Numbers:  DPT-1; DK60782; DK60916; DK60987; DK61010; DK61029; DK61030; DK61034; DK61035; DK61036; DK61037; DK61038; DK61040; DK61041; DK61042; DK61058; DK61055
Record last reviewed:  June 2003
Record first received:  March 13, 2000
ClinicalTrials.gov Identifier:  NCT00004984
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-29