The GPPAD-POInT Study is designed as a randomized, placebo-controlled, double blind,
multicentre, multinational primary prevention phase IIb study aiming to induce immune
tolerance to beta-cell autoantigens through regular exposure to oral insulin for a period of
29 to 32 months. The hypothesis is that regular exposure to oral insulin throughout the
period in life where beta-cell autoimmunity usually initiates will tolerize against insulin
and train the body's immune system to recognize the treatment product without reacting
adversely to it in a manner seen in children who develop T1D. This immune tolerance induction
therapy would reduce the likelihood of beta-cell autoimmunity. The study objective is to
determine whether daily administration of oral insulin from age 4 months - 7 months until age
3.00 years to children with elevated genetic risk for type 1 diabetes reduces the cumulative
incidence of beta-cell autoantibodies and diabetes in childhood.
Phase:
Phase 2
Details
Lead Sponsor:
Technische Universität München
Collaborators:
Helmholtz Zentrum München Kinderkrankenhaus auf der Bult Medical University of Warsaw Skane University Hospital Universitaire Ziekenhuizen Leuven University Hospital Carl Gustav Carus University of Oxford, Clinical Vaccine Research and Immunisation Education