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	Intervention	Phase
Diabetes Mellitus, Type 1	Drug: Crystallized human recombinant insulin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Masking: Double-Blind Primary Purpose: Prevention

Resource links provided by NLM:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 1

Drug Information available for: Insulin human

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Study Start Date:	February 1994
Estimated Study Completion Date:	June 2003

Eligibility

Ages Eligible for Study:	3 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004984

Locations

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

Sponsors and Collaborators

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)

Investigators

Study Chair:

Jay S. Skyler, MD

University of Miami

More Information

Additional Information:

A full description of the study and the 1-800 phone number for talking to a contact person. This link exits the ClinicalTrials.gov site

Website for the American Diabetes Association which also gives information about the DPT-1. This link exits the ClinicalTrials.gov site

Website for Juvenile Diabetes Association International which also lists the DPT-1 This link exits the ClinicalTrials.gov site

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.

[No authors listed] Effects of insulin in relatives of patients with type 1 diabetes mellitus. N Engl J Med. 2002 May 30;346(22):1685-91.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00004984 History of Changes
Other Study ID Numbers:	DPT-1 (completed), DK60782, DK60916, DK60987, DK61010, DK61029, DK61030, DK61034, DK61035, DK61036, DK61037, DK61038, DK61040, DK61041, DK61042, DK61058, DK61055
Study First Received:	March 13, 2000
Last Updated:	January 14, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

diabetes
insulin
prediction
prevention
C-peptide levels

insulin autoantibodies
pancreatic beta cell autoantibodies
cellular immune responses
prediction of type 1 diabetes

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases

Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013

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