Primary Oral Insulin Trial

Pre-POINT is a pilot study to determine a suitable dose of oral insulin in children at risk of developing diabetes. The aim of this trial is to induce a protective immune response to islet autoantigens before development of autoimmunity.

Children with a >50% risk of developing diabetes will be identified using information about other family members with diabetes and genetic typing. Up to 25 children will be randomised to increasing doses of insulin administered orally to determine a dose that is safe and bioavailable to the immune system. Children will be monitored for the development of islet autoantibodies and diabetes. Blood samples will be taken to investigate whether the study drug has induced a protective immune response to insulin. Depending upon the outcome of Pre-POINT, the study will continue to the Phase II POINT study which will determine the efficacy of oral insulin administration in autoantibody negative high risk children.

Read the information sheet: Pre-POINT (PDF, 89kB)Pre-POINT (PDF, 89kB)

Further information is available on the Pre-POINT website.