Oral Insulin Participant Resources

Thank you for your participation.

To our Oral Insulin Prevention Study participants and their families--thank you for your continued dedication to Type 1 Diabetes research.  Below you will find information about the results of the Diabetes TrialNet Oral Insulin Prevention Study, as well as frequently asked questions and how to contact TrialNet if you need assistance getting in touch with your TrialNet study team.  For all study participants, you may also listen to a recording of the results by calling:

CountryPhone Number
Australia+61 (2) 80747801
Finland+358 (9) 42720212
Germany+49 (89) 26207283
Italy+39 (02) 00628023
New Zealand+64 (3) 6590171
Sweden+46 (40) 6285452
United Kingdom+44 (20) 38806872
United States/Canada866-544-8651

 

Hello. My name is Dr. Desmond Schatz. As Chair of the Oral Insulin Prevention Study, I want to first thank you, our participants and families, for the very important role you’ve played in the success of the largest oral insulin study to date, with five hundred sixty participants.

To put the results into perspective, let’s start with a brief reminder of how the study was designed.

Participants were put into groups according to their diabetes-related autoantibodies and level of insulin production. In each group, half of the people took a daily capsule of oral insulin and half took a placebo capsule.

In all groups, oral insulin was shown to be safe and well tolerated.

In the main study group of three hundred and eighty nine people, as well as another group of one hundred sixteen people, oral insulin DID NOT prevent or delay T1D onset.

However, the study also included a group of fifty five people who had less insulin production than those in the main group.  In this group, oral insulin delayed T1D onset for an average of thirty one months.

These important findings will continue to be analyzed—but through your participation in the Oral Insulin Prevention Study we know this:

  • Oral insulin was not effective in delaying type 1 diabetes for most people in our study.
  • In the group of fifty five people, oral insulin delayed T1D for an average of thirty one months. This further supports our understanding that not everyone develops T1D the same way.
  • More research is needed to explore why certain people respond to oral insulin and others don’t.
  • TrialNet is considering new trials using oral insulin to delay disease progression. Future studies may involve targeted selection of those most likely to benefit, testing other doses of oral insulin, and combining oral insulin with other medications
  • And, lastly but most importantly, your participation has made and will continue to make important contributions to T1D research!

A member of your study team will be contacting you shortly to set up a time to review your individual results and answer your questions. We are committed to continuing our journey with you on the pathway to prevention, and we encourage you to enroll in a TrialNet monitoring study.

Thank you again for your participation in the TrialNet Oral Insulin Prevention Study. You are truly a T1D research champion!

Common Questions

How do I get my individual results?

A member of your research team will contact you shortly to schedule a time to review your results. If you don’t hear from someone, please contact your study team or email info@trialnet.org

Can I participate in other TrialNet prevention trials?

You may be eligible for future prevention trials. TrialNet will let you know when new trials are available.

What are the next steps for me as a participant?

If you are a current Oral Insulin participant, and have not developed diabetes, we encourage you to talk to your study coordinator about enrolling in close monitoring in Pathway to Prevention.  If you developed type 1 diabetes while in the Oral Insulin study, we encourage you to talk to your study coordinator about enrolling in Long-Term Investigative Follow-Up in TrialNet (LIFT).  

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