Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus

What is the trial about?

TrialNet is testing to see whether or not a daily dose of oral insulin helps to delay or prevent type 1 diabetes in relatives at risk for diabetes.

Who can participate?

Screening to determine eligibility for this study is done through the TrialNet Natural History Study. Additional eligibility requirements are as follows:

• Must be aged 3-45 years and have a first degree blood relative (sibling, child, or parent) with type 1 diabetes OR
• Must be aged 3-20 years and have a second or third degree blood relative (aunt, uncle, niece, nephew, grandparent, cousin, or half sibling) with type 1 diabetes
• Your relative must have been diagnosed with type 1 diabetes before age 40, and started taking insulin within the first year of diagnosis, for you to be eligible

What is involved?

There will be an initial study visit, a three-month follow-up visit, and then regular visits every six months throughout the study. Each study visit includes a physical exam and blood tests. The exact duration of the study is not known. We hope that the study will take no longer than 7-8 years from its start in 2007.

Participants will be asked to take one study capsule each day. A research study team member will contact participants by phone every three months to ask about health and to check that you are still taking study medication.

Half the participants will take capsules filled with insulin.

Half the participants will take a placebo (capsules that contain an inactive substance).

Participants will not know whether their capsules contain insulin or placebo.