The Diabetes Prevention Trial of Type 1 Diabetes (DPT-1)
Status:
Completed
Trial end date:
2003-06-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Center for Research Resources (NCRR) National Institute of Allergy and Infectious Diseases (NIAID) National Institute on Minority Health and Health Disparities (NIMHD) Office of Research on Women's Health (ORWH)