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.
|