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

NCT00004984 | Completed Phase 3 DMC FDA Drug

• 17 other identifiers: DPT-1U01DK060782U01DK060916U01DK060987U01DK061010U01DK061029U01DK061030U01DK061034U01DK061035U01DK061036U01DK061037U01DK061038U01DK061040U01DK061041U01DK061042U01DK061058U01DK061055
• Study Type: interventional
• Target: 711
• Locations: 2 countries
• Sites: 15

Brief Summary

The Diabetes Prevention Trial of Type 1 (DPT-1) was 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. Subjects were recruited from study clinics and through media campaigns.First-degree relatives, 3 to 45 years of age, and second-degree relatives, 3 to 20 years of age, of patients with diabetes were screened for islet-cell antibodies. Those individuals found to be at high risk of diabetes were randomized to receive either close observation or low-dose parenteral insulin. Those individuals found to be at intermediate risk of diabetes are randomized to receive insulin orally or to receive placebo. Patients were followed for up to six years.

Conditions

Diabetes Mellitus, Type 1

Keywords

diabetes; insulin; prediction; prevention; C-peptide levels; insulin autoantibodies; pancreatic beta cell autoantibodies; cellular immune responses; prediction of type 1 diabetes

Outcome Measures

Primary Outcomes (1)

• Rate of Type 1 Diabetes Per Year

  The rate of type 1 diabetes per year is calculated by dividing the number of participants who develop diabetes by the total number of years of follow-up. The diagnosis of diabetes is as defined by the American Diabetes Association (ADA) based on oral glucose testing or the presence of symptoms and unequivocal hyperglycemia.

  Glucose tolerance is measured every 6 months for up to 6 years

Study Arms (4)

Parenteral Insulin

EXPERIMENTAL

High risk participants randomized to intervention

Drug: Parenteral Insulin

Close Observation

ACTIVE COMPARATOR

High risk participants randomized to observation

Other: Close Observation

Oral Insulin

EXPERIMENTAL

Intermediate risk participants randomized to intervention

Drug: Oral Insulin

Placebo

PLACEBO COMPARATOR

Intermediate risk participants randomized to placebo

Drug: Placebo

Interventions

Parenteral Insulin DRUG

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.

Parenteral Insulin

Close Observation OTHER

Study visits every 6 months including an oral glucose tolerance test

Close Observation

Oral Insulin DRUG

Capsules oral insulin, 7.5 mg of recombinant human insulin crystals

Oral Insulin

Placebo DRUG

Placebo for oral insulin

Placebo

Eligibility Criteria

• Age: 3 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead
• National Center for Research Resources (NCRR): collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• Office of Research on Women's Health (ORWH): collaborator

Study Sites (15)

Childrens Hospital of Los Angeles, Division of Endocrinology

Los Angeles, California, 90027, United States

Location

University of California-San Francisco, Milberry Union East RM 405, 500 Parnassus Ave Box 0136

San Francisco, California, 94143, United States

Location

Stanford University

Stanford, California, 94305-5208, United States

Location

University of Colorado Barbara Davis Center for Childhood Diabetes

Denver, Colorado, 80262, United States

Location

University of Florida Diabetes Research Center

Gainesville, Florida, 32610-0296, United States

Location

DPT-1 Operations Coordinating Center

Miami, Florida, 33136, United States

Location

University of Miami School of Medicine, Jackson Medical Tower

Miami, Florida, 33136, United States

Location

Indiana University, James Whitcomb Riley Hospital for Children, 702 Barnhill Dr, Ste 5960

Indianapolis, Indiana, 46202, United States

Location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Naomi Berrie Diabetes Center, Columbia University, 1150 St. Nicholas Ave

New York, New York, 10032, United States

Location

Children's Hospital of Pittsburgh, Dept/Pediatric Endocrinology, 3705 5th Ave

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Texas, Children's Medical Center, 6300 Harry Hines Ste 1200

Dallas, Texas, 75235, United States

Location

Virginia Mason Research Center, 1201 Ninth Avenue

Seattle, Washington, 98101, United States

Location

Hospital for Sick Children, Division of Endocrinology, 555 University Ave, Rm 5110

Toronto, Ontario, M5G-1X8, Canada

Location

Related Publications (7)

• 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.

  PMID: 2644534 BACKGROUND

• 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.

  PMID: 8096268 BACKGROUND

• 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.

  PMID: 1946445 BACKGROUND

• 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.

  PMID: 15855569 RESULT

• 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.

  PMID: 12037147 RESULT

• 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.

  PMID: 17583798 DERIVED

• 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.

  PMID: 17563348 DERIVED

Related Links

• Website for the American Diabetes Association which also gives information about the DPT-1.

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus; Insulin Resistance

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Jay S. Skyler, MD

  University of Miami

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The oral insulin study was masked, but the parenteral insulin study was not masked
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2000
• First Posted: March 14, 2000
• Study Start: February 1, 1994
• Primary Completion: June 1, 2003
• Study Completion: June 1, 2003
• Last Updated: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share

Locations

CA (1); US (14)