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

This study has been completed.

Sponsor:

Collaborators:

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)

Information provided by:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

ClinicalTrials.gov Identifier:

NCT00004984

First received: March 13, 2000

Last updated: January 14, 2010

Last verified: January 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

March 13, 2000

Last Updated Date

January 14, 2010

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 *

* 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

Estimated 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

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