The Diabetes Prevention Trial of Type 1 Diabetes (DPT-1)
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Drug: Parenteral InsulinOther: Close ObservationDrug: Oral InsulinDrug: Placebo
- Registration Number
- NCT00004984
- 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.
- Detailed Description
The study was divided into three parts: screening, staging, and intervention. 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 with an islet-cell antibody titer of 10 Juvenile Diabetes Foundation (JDF) units or higher were offered staging evaluations.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 711
- 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)
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Parenteral Insulin Parenteral Insulin High risk participants randomized to intervention Close Observation Close Observation High risk participants randomized to observation Oral Insulin Oral Insulin Intermediate risk participants randomized to intervention Placebo Placebo Intermediate risk participants randomized to placebo
- Primary Outcome Measures
Name Time Method Rate of Type 1 Diabetes Per Year Glucose tolerance is measured every 6 months for up to 6 years 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
University of Miami School of Medicine, Jackson Medical Tower
🇺🇸Miami, Florida, United States
Children's Hospital of Pittsburgh, Dept/Pediatric Endocrinology, 3705 5th Ave
🇺🇸Pittsburgh, Pennsylvania, United States
University of Florida Diabetes Research Center
🇺🇸Gainesville, Florida, United States
Indiana University, James Whitcomb Riley Hospital for Children, 702 Barnhill Dr, Ste 5960
🇺🇸Indianapolis, Indiana, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Childrens Hospital of Los Angeles, Division of Endocrinology
🇺🇸Los Angeles, California, United States
University of Colorado Barbara Davis Center for Childhood Diabetes
🇺🇸Denver, Colorado, United States
Naomi Berrie Diabetes Center, Columbia University, 1150 St. Nicholas Ave
🇺🇸New York, New York, United States
DPT-1 Operations Coordinating Center
🇺🇸Miami, Florida, United States
Joslin Diabetes Center
🇺🇸Boston, Massachusetts, United States
Hospital for Sick Children, Division of Endocrinology, 555 University Ave, Rm 5110
🇨🇦Toronto, Ontario, Canada
Stanford University
🇺🇸Stanford, California, United States
Virginia Mason Research Center, 1201 Ninth Avenue
🇺🇸Seattle, Washington, United States
University of Texas, Children's Medical Center, 6300 Harry Hines Ste 1200
🇺🇸Dallas, Texas, United States
University of California-San Francisco, Milberry Union East RM 405, 500 Parnassus Ave Box 0136
🇺🇸San Francisco, California, United States