TrialNet is planning:

• Studies to test interventions - newly diagnosed type 1 diabetes. 
  The aim of these will be to preserve remaining insulin function 
  
  
• Studies to test preventative treatments - people at high risk of developing diabetes. 
  The aim of these will be to delay or completely prevent the onset of type 1 diabetes

Oral Insulin Study for the Prevention of Type 1 Diabetes

What is the study about?

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 in people found to be at high risk of developing 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 is eligible?

You must be:

• Age 3-45 with a first degree relative with type 1 diabetes
• Age 3-20 with a second degree relative with type 1 diabetes
• Willing to sign Informed Consent Form
• Normal Oral Glucose Tolerance Test performed within 7 weeks of randomisation
• Specific combination of diabetes related autoantibodies

A first degree relative is a parent, sibling or child; a second degree relative is a cousin, aunt, neice, nephew or grandchild.

You will be screened for diabetes autoantibodies as part of the natural history study. If you have antibodies but cannot or do not want to be in the Oral Insulin Study, you can be in the TrialNet Natural History Study. We will monitor you closely for diabetes. In addition, there may be other TrialNet studies that you can join in the future.

What will happen if I take part?

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. For more information read the Participant Information Sheet (PDF, 88kB).

If you would like to take part in any of the studies please contact your nearest participating site.