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

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 1

In brief

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.

Key facts

Study ID

NCT00004984

Run by

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

People needed

711

Starts

1994-02-01

Expected to finish

2003-06-01

Last updated by the study team

2020-04-24

Who can join

Age: 3 and older, up to 45. Sex: any. Healthy volunteers: accepted.

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).

Where it is running

• 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

Full record on ClinicalTrials.gov

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