Overview

Fr1da Insulin Intervention

Status:
Active, not recruiting
Trial end date:
2024-09-01
Target enrollment:
Participant gender:
Summary
Type 1 diabetes (T1D) results from an autoimmune destruction of the insulin-producing beta cells. The process of autoimmune destruction 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. Evidence is now emerging in humans that these approaches may be effective in chronic inflammatory diseases such as multiple sclerosis and allergy. Administration of oral insulin in multiple islet autoantibody-positive children offers the potential for inducing immunological tolerance to beta cells and thereby protect against further development progression to type 1 diabetes.
Phase:
Phase 2
Details
Lead Sponsor:
Technische Universität München
Collaborators:
Helmholtz Zentrum München
Ludwig-Maximilians - University of Munich
Technische Universität Dresden
The Leona M. and Harry B. Helmsley Charitable Trust
Treatments:
Insulin
Insulin, Globin Zinc