Type 1 diabetes (T1D) results from an autoimmune destruction of the insulin-producing beta
cells. Administration of mucosal insulin in islet autoantibody-negative children who are
genetically predisposed for T1D offers the potential for inducing immunological tolerance to
beta cells and thereby protect against the development of islet autoimmunity and T1D.
Intranasal insulin has the advantage that whole protein will be exposed at the mucosa.
Therefore, the available dose of insulin when administered intranasally is likely to be
consistent between individuals. On this basis, the investigators aim to conduct a
placebo-controlled, double-blind/double-masked primary intervention pilot trial (PINIT Study)
of intranasal insulin treatment in islet autoantibody negative children to test immune
efficacy and safety in the primary prevention setting. This pilot will help to develop and
design a Phase III study aiming to test efficacy of preventing islet autoimmunity and T1D.
Phase:
Phase 2
Details
Lead Sponsor:
Technische Universität München
Collaborators:
Helmholtz Zentrum München Ludwig-Maximilians - University of Munich Technische Universität Dresden University Hospital Carl Gustav Carus