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Research & Clinical Trials




What was the Diabetes Prevention Trial--Type 1?
The Diabetes Prevention Trial -Type 1 (DPT-1) consisted of two clinical trials that sought to delay or prevent type 1 diabetes, also known as juvenile or insulin-dependent diabetes.

Who was eligible to participate in these trials?
Family members of people with type 1 diabetes were eligible for a no cost screening test to determine if they had islet cell antibodies (ICA), the antibodies that destroy the insulin-producing beta cells in the pancreas. Diabetes has a genetic link, so close relatives of people with the disease have an increased chance of developing it.
People were eligible for the DPT-1 screening test if they were:

  • 3 to 45 years of age and had a brother or sister, child, or parent with type 1 diabetes, or
  • 3 to 20 years of age and had a cousin, uncle or aunt, nephew or niece, grandparent, or half-sibling with type 1 diabetes.

To be eligible for one of the two DPT-1 clinical trials, a person's blood had to test positive for ICA.

How did the DPT-1 trials try to prevent type 1 diabetes?
Animal research and small studies in people indicated that small, regular doses of insulin could prevent or delay type 1 diabetes in those at risk. One DPT-1 trial, called the Insulin Injection Arm, tested whether low-dose insulin injections (shots) could prevent or delay the development of type 1 diabetes in people at high risk for developing type 1 diabetes within five years. The other DPT-1 trial, called the Oral Insulin Arm, tested whether low-dose insulin capsules, taken orally (by mouth), could prevent type 1 diabetes in people with a moderate risk for developing diabetes within five years.

What were the findings of the two DPT-1 trials?
Neither insulin injections nor insulin capsules taken orally, given in the dose and frequency used in these two trials, were successful at preventing or delaying type 1 diabetes. The findings of the Insulin Injection Arm were published in the May 30, 2002 issue of the New England Journal of Medicine. The Oral Insulin Arm results were announced on June 10, 2003 at the American Diabetes Association annual meetings.

Where did the DPT-1 trials take place?
Nine clinical centers and more than 350 screening sites in the United States and Canada took part in the two trials of the DPT-1. The DPT-1 clinical centers were:
California

Children's Hospital of Los Angeles
Box 61/ 4650 Sunset Boulevard
Los Angeles, CA 90027
Phone: 1-888-835-3761

University of Southern California
Los Angeles County Medical Center
Endocrine & Diabetes Service, Rm. 19629B
Los Angeles, CA 90033
Phone: (323) 226-7626

Stanford University
S-302 Medical Center
Stanford, CA 94305-5119
Phone: (650) 725-0497

Colorado
Barbara Davis Center for Childhood Diabetes
Box B140/ 4200 East 9th Avenue
University of Colorado
Denver, CO 80262
Phone: 1-800-572-3992

Florida
University of Florida
Box 100296
Gainesville, FL 32610-0296
Phone: 1-800-749-7424, dial 1, ext. 334-0857

University of Miami
P. O. Box 016960 (D-110)
Miami, FL 33101
Phone: (305) 243-DPT-1 (305-243-3781)

Massachusetts
Joslin Diabetes Center/Children's Hospital /Beth Israel Hospital
1 Joslin Place
Boston, MA 02215
Phone: 1-800-2-HALT-DM (1-800-242-5836)

Minnesota
University of Minnesota
424 Harvard Street SE, Box 101
Masonic Bldg. Room 203
Minneapolis, MN 55455
Phone: 1-800-688-5252, ext. 58944

Washington
Virginia Mason Research Center
1201 9th Avenue
Seattle, WA 98101
Phone: (206) 515-5233

Who sponsored the DPT-1 trials?
DPT-1 was sponsored by National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Allergy and Infectious Diseases, National Institute of Child Health and Human Development, American Diabetes Association, Juvenile Diabetes Research Foundation International, and National Center for Research Resources.

Additional promotional support and supplies were provided by Eli Lilly and Company, Becton-Dickinson & Co., Abbott Laboratories, Medisense Products, Bayer Corporation, Bristol-Myer Squibb Company, Lifescan Inc., MiniMed Inc., and Roche Diagnostics.

For information about Type 1 Diabetes TrialNet, currently screening relatives of people with type 1 diabetes in its Natural History Study, visit TRIALNET, www.diabetestrialnet.org or call the University of Florida Diabetes Research Program, (352) 334-0857.




 


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