Topline results of this 10-year TrialNet study were shared at the American Diabetes Association’s 77th Scientific Sessions on June 12, 2017. Now, we share them with you.
- The largest of its kind, the Oral Insulin Prevention Study was conducted over 10 years and included 560 relatives of people with type 1 diabetes.
- Participants were divided into four groups according to their diabetes-related autoantibodies and level of insulin producing beta cells.
- All participants were in stage 1 meaning they had two or more islet autoantibodies including mIAA and normal glucose tolerance
- In each group, half of the people took a 7.5 mg daily capsule of oral insulin and half took a placebo capsule.
- Group 1 consisted of 389 participants. These participants were positive for mIAA, either ICA or GAD65, and IA-2 autoantibodies. They also had higher functioning beta cells.
- Group 2 included 55 participants who had the same autoantibodies as Group 1. However, this group had lower functioning beta cells.
- Groups 3 and 4 included 116 participants positive for the mIAA autoantibody, plus GAD or IA-2 autoantibodies.
- Oral insulin was safe and well-tolerated in all groups.
- In group 1, the main study group, (389 relatives) and group 3 & 4 (combined 116 relatives), oral insulin did not prevent or delay onset of T1D.
- In group 2 (55 relatives having lower insulin production), oral insulin delayed T1D onset by an average of 31 months.
- The study further supports our understanding that not everyone develops T1D the same.
This study is an important step toward determining oral insulin’s role in delaying disease progression. TrialNet is considering conducting new trials using oral insulin to delay disease progression; but more work needs to be done.
Results of another important study, Exploring Immune Effects of Oral Insulin in Relatives at Risk for T1D, are expected later this year. This study is looking at how different doses and regimens of oral insulin effect immune response
In addition, two other prevention studies currently underway are testing the drugs Abatacept and Teplizumab to see if they can delay or prevent disease progression prior to diagnosis. TrialNet will also be launching new type 1 diabetes prevention trials and encourages all family members to get screened through the Pathway to Prevention study.
A big thank you to our amazing participants who made this research possible!
Oral Insulin study participant resources are available here.
If you are a current participant in the Immune Effects of Oral Insulin study and have questions about your study or the Oral Insulin study results, please contact your study team or firstname.lastname@example.org.