Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus
Status:
Completed
Trial end date:
2017-06-01
Target enrollment:
Participant gender:
Summary
Type 1 diabetes (T1D) is an autoimmune disease. This means that the immune system (the part
of the body which helps fight infections) mistakenly attacks and destroys the cells that
produce insulin (islet cells found in the pancreas). As these cells are destroyed, the body's
ability to produce insulin decreases. There is evidence suggesting that repeated oral
administration of an autoantigen (the same protein that the immune system is reacting to) may
introduce a protective immunity and cause the immune system to stop its attack. An earlier,
large scale study was done to see if oral insulin could delay or prevent the development of
Type 1 diabetes in relatives at risk for developing Type 1 diabetes. The overall results
showed that for the entire study population, oral insulin did not delay or prevent Type 1
diabetes. However, an analysis that was done after the conclusion of the trial suggested a
potential beneficial effect in a subgroup of participants. The participants who seemed to
benefit from oral insulin had higher levels of insulin autoantibodies which are directed
against insulin itself ( called mIAA).
The Type 1 Diabetes TrialNet study group will further explore the potential role of oral
insulin to delay or prevent Type 1 diabetes in a similar group of people. The study will also
include a secondary group of individuals at different levels of risk than those in the
primary cohort to gather information for future studies.
Phase:
Phase 3
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators:
American Diabetes Association Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Juvenile Diabetes Research Foundation National Center for Research Resources (NCRR) National Institute of Allergy and Infectious Diseases (NIAID)