Relatives of People with Type 1 Diabetes: Age 3 and Older – An Oral Insulin Prevention Study
Study Name: Exploring Immune Effects of Oral Insulin in Relatives at Risk for Type 1 Diabetes Mellitus
Study Sponsor: TrialNet
Principal Investigator: Stephen E. Gitelman, MD
Who can sign up for this study? Subjects must:
- Have a relative with type 1 diabetes (T1D)
- Be 3 years old or older
- Be enrolled in the TrialNet Pathway to Prevention Study
- Have two or more type 1 diabetes autoantibodies, one of which must be the insulin autoantibody, as determined in the TrialNet Pathway to Prevention Study
- Have a normal Oral Glucose Tolerance Test as determined in the TrialNet Pathway to Prevention Study (Exception: subjects 3 to 7 years of age can have an abnormal Glucose Tolerance Test)
What is this study about? TrialNet, the study sponsor, is currently conducting the Oral Insulin Prevention Study, which is testing if 7.5 mg of oral insulin taken once a day can delay or prevent T1D in people who are at risk for the disease. This prevention study started in 2007 and has included more than 500 people. Enrollment for this study is complete and the results of the study will be available likely in early 2017.
This new oral insulin study, the Immune Effects of Oral Insulin study, is being conducted to learn more about the immune effects of oral insulin using different doses. We hope to ascertain additional scientific information about oral insulin and gain a better understanding of how much oral insulin should be given to produce a more favorable immune response that could help delay or prevent T1D.
What will happen in this study? Each participant will receive either:
- 67.5 mg capsules of oral insulin to be taken daily, OR
- 500 mg capsules of oral insulin to be taken once every two weeks
There is no placebo (“dummy” pill) in this study. Subjects will take the study capsules for 6 months. They will have study visits in the clinic at the UCSF Mission Bay Medical Center months 0, 1, 2, 3, 6, 7, 8, 9 and 12. Blood tests and other assessments will be completed at the visits. Oral Glucose Tolerance Tests will be completed at the start of the study and at months 6 and 12.
How long will this study last? This study will last one year for each participant.
Subject Payment: Subjects will be paid $50 for completing each study visit. Subjects will also have the costs of parking paid while at the clinic for study visits. For those visits in which an OGTT is done, subjects will also receive a voucher for a meal at the UCSF Mission Bay Medical Center.
For more information, please contact: Kathleen Fraser at (844) 813-8273 (toll-free) or firstname.lastname@example.org