Overview

Pre-POINT-Early Study

Status:
Completed
Trial end date:
2017-12-01
Target enrollment:
Participant gender:
Summary
Type 1 diabetes (T1D) results from an autoimmune destruction of the insulin-producing beta cells within the pancreatic islets of Langerhans. This process is identified by circulating islet autoantibodies to beta cell antigens, and is mediated by a lack of immunological self-tolerance. Self-tolerance is achieved by T cell exposure to antigen in the thymus or periphery in a manner that deletes autoreactive effector T cells or induces regulatory T cells. Immunological tolerance can be achieved by administration of antigen under appropriate conditions. Administration of oral 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.
Phase:
Phase 2
Details
Lead Sponsor:
Technische Universität München
Collaborators:
German Center for Diabetes Research
Helmholtz Zentrum München
Ludwig-Maximilians - University of Munich
Technische Universität Dresden
Treatments:
Insulin
Insulin, Globin Zinc