The Diabetes Prevention Trial of Type 1 Diabetes (DPT-1)
NCT ID: NCT00004984
Last Updated: 2020-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
711 participants
INTERVENTIONAL
1994-02-28
2003-06-30
Brief Summary
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Detailed Description
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Staging confirmed the presence of islet-cell antibodies, measured insulin antibodies, assessed the first-phase insulin response to intravenous glucose, assessed oral glucose tolerance, and determined the presence or absence of HLA-DQA1\*0102, DQB1\*0602, a protective haplotype, the presence of which excluded subjects from further participation.
Islet-cell antibody-positive subjects were then defined as having a high risk of diabetes (a five-year risk of more than 50 percent) and were deemed eligible for the parenteral insulin trial if they had a first-phase insulin response below the threshold (as defined below) on two occasions, if their oral glucose-tolerance results were not completely normal,or both.
Relatives who tested positive for islet-cell antibodies and insulin antibodies and who had a first-phase insulin response above the threshold and normal glucose tolerance were defined as having intermediate risk (a five-year risk of 26 to 50 percent) and were deemed eligible for the ongoing oral insulin trial.
All randomized subjects were seen every six months, at which time an oral glucose-tolerance test was administered to assess glycemic status, the primary study end point. Mixed-meal tolerance tests were performed at base line, at years 1, 3, and 5, and at the end of the study. Intravenous glucose-tolerance testing was performed at years 2, 4, and 6 and at the end of the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Parenteral Insulin
High risk participants randomized to intervention
Parenteral Insulin
Subcutaneous injections of recombinant human ultralente insulin in the morning and in the evening; the initial dose for each injection was 0.125 U per kilogram of body weight.
Close Observation
High risk participants randomized to observation
Close Observation
Study visits every 6 months including an oral glucose tolerance test
Oral Insulin
Intermediate risk participants randomized to intervention
Oral Insulin
Capsules oral insulin, 7.5 mg of recombinant human insulin crystals
Placebo
Intermediate risk participants randomized to placebo
Placebo
Placebo for oral insulin
Interventions
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Parenteral Insulin
Subcutaneous injections of recombinant human ultralente insulin in the morning and in the evening; the initial dose for each injection was 0.125 U per kilogram of body weight.
Close Observation
Study visits every 6 months including an oral glucose tolerance test
Oral Insulin
Capsules oral insulin, 7.5 mg of recombinant human insulin crystals
Placebo
Placebo for oral insulin
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
3 Years
45 Years
ALL
Yes
Sponsors
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National Center for Research Resources (NCRR)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute on Minority Health and Health Disparities (NIMHD)
NIH
Office of Research on Women's Health (ORWH)
NIH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Responsible Party
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Principal Investigators
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Jay S. Skyler, MD
Role: STUDY_CHAIR
University of Miami
Locations
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Childrens Hospital of Los Angeles, Division of Endocrinology
Los Angeles, California, United States
University of California-San Francisco, Milberry Union East RM 405, 500 Parnassus Ave Box 0136
San Francisco, California, United States
Stanford University
Stanford, California, United States
University of Colorado Barbara Davis Center for Childhood Diabetes
Denver, Colorado, United States
University of Florida Diabetes Research Center
Gainesville, Florida, United States
DPT-1 Operations Coordinating Center
Miami, Florida, United States
University of Miami School of Medicine, Jackson Medical Tower
Miami, Florida, United States
Indiana University, James Whitcomb Riley Hospital for Children, 702 Barnhill Dr, Ste 5960
Indianapolis, Indiana, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Naomi Berrie Diabetes Center, Columbia University, 1150 St. Nicholas Ave
New York, New York, United States
Children's Hospital of Pittsburgh, Dept/Pediatric Endocrinology, 3705 5th Ave
Pittsburgh, Pennsylvania, United States
University of Texas, Children's Medical Center, 6300 Harry Hines Ste 1200
Dallas, Texas, United States
Virginia Mason Research Center, 1201 Ninth Avenue
Seattle, Washington, United States
Hospital for Sick Children, Division of Endocrinology, 555 University Ave, Rm 5110
Toronto, Ontario, Canada
Countries
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References
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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. doi: 10.1056/NEJM198903023200902.
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. doi: 10.1016/0140-6736(93)91215-8.
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. doi: 10.1073/pnas.88.22.10252.
Skyler JS, Krischer JP, Wolfsdorf J, Cowie C, Palmer JP, Greenbaum C, Cuthbertson D, Rafkin-Mervis LE, Chase HP, Leschek E. Effects of oral insulin in relatives of patients with type 1 diabetes: The Diabetes Prevention Trial--Type 1. Diabetes Care. 2005 May;28(5):1068-76. doi: 10.2337/diacare.28.5.1068.
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. doi: 10.1056/NEJMoa012350.
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. doi: 10.1007/s00125-007-0694-0. 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. doi: 10.2337/dc06-2422. Epub 2007 Jun 11.
Related Links
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Website for the American Diabetes Association which also gives information about the DPT-1.
Other Identifiers
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DPT-1
Identifier Type: -
Identifier Source: org_study_id
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