711
Participants
Start Date
February 28, 1994
Primary Completion Date
June 30, 2003
Study Completion Date
June 30, 2003
Parenteral Insulin
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.
Close Observation
Study visits every 6 months including an oral glucose tolerance test
Oral Insulin
Capsules oral insulin, 7.5 mg of recombinant human insulin crystals
Placebo
Placebo for oral insulin
Naomi Berrie Diabetes Center, Columbia University, 1150 St. Nicholas Ave, New York
Children's Hospital of Pittsburgh, Dept/Pediatric Endocrinology, 3705 5th Ave, Pittsburgh
DPT-1 Operations Coordinating Center, Miami
University of Miami School of Medicine, Jackson Medical Tower, Miami
Indiana University, James Whitcomb Riley Hospital for Children, 702 Barnhill Dr, Ste 5960, Indianapolis
University of Minnesota, Minneapolis
University of Texas, Children's Medical Center, 6300 Harry Hines Ste 1200, Dallas
University of Colorado Barbara Davis Center for Childhood Diabetes, Denver
Childrens Hospital of Los Angeles, Division of Endocrinology, Los Angeles
University of California-San Francisco, Milberry Union East RM 405, 500 Parnassus Ave Box 0136, San Francisco
Virginia Mason Research Center, 1201 Ninth Avenue, Seattle
Stanford University, Stanford
University of Florida Diabetes Research Center, Gainesville
Joslin Diabetes Center, Boston
Hospital for Sick Children, Division of Endocrinology, 555 University Ave, Rm 5110, Toronto
National Center for Research Resources (NCRR)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute on Minority Health and Health Disparities (NIMHD)
NIH
Office of Research on Women's Health (ORWH)
NIH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH