Study Name: TrialNet Oral Insulin Prevention Trial

Principal Investigator: Carla Greenbaum, MD

Phone: 800-888-4187

Email: diabetes@BenaroyaResearch.org

What is the Oral Insulin Prevention Trial?

If someone in your family has type 1 diabetes, you and other family members may be at risk. TrialNet is working to delay or prevent diabetes in people at risk for developing type 1 diabetes. TrialNet is now testing oral insulin (insulin taken by mouth, not by injection). We will see if oral insulin helps to delay or prevent type 1 diabetes. Results from a recently completed study (called DPT-1) suggest that oral insulin might delay or prevent type 1 diabetes in some people found to be at risk.

Who can participate?

• Individuals ages 3 to 45 years

• Identified as being at risk for type 1 diabetes through participation in the TrialNet Natural History study.

What will study participants be asked to do?

You will take one study capsule each day. Half of the people will take capsules filled with insulin. Half of the people will take a placebo (capsules that contain an inactive substance). You will not know whether your capsules contain insulin or a placebo.

You will come to a study center for blood tests every 6 months, and at other times as needed.