Pre-POINT (Primary Oral Insulin Trial)

• Research type

  Research Study

• Full title

  A dose-finding safety and immune efficacy study for primary mucosal insulin therapy in islet autoantibody negative children at high genetic risk for type 1 diabetes

• IRAS ID

  21133

• Sponsor organisation

  Dresden University of Technology

• Eudract number

  2005-001621-29

• ISRCTN Number

  ISRCTN76104595

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Pre-POINT is a feasibility 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. Type 1 diabetes results from destruction of insulin-producing beta-cells in the pancreas by the body??s immune system. Children who develop diabetes have autoantibodies to insulin and other beta cell antigens before clinical disease, and it is considered that autoimmunity to these antigens is the underlying cause of beta cell destruction. 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 randomized 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.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  10/H0106/33

• Date of REC Opinion

  13 Jul 2010

• REC opinion

  Further Information Favourable Opinion