Fr1da Insulin Intervention

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.

Conditions

• Stage 1 Diabetes Mellitus, Type 1

Interventions

DRUG

Oral Insulin

Total of 12 months treatment; dose escalation scheme: daily treatment with 7.5 mg or placebo for 3 months; increasing to daily treatment with 67.5 mg or placebo for the following 9 months of the treatment period. Follow-up will continue for 24 months after the last administration of treatment.

OTHER

Placebo

Total of 12 months intervention period; daily administration of insulin or placebo capsules containing filling substance (microcrystalline cellulose). Follow-up will continue for 24 months after the last administration of treatment.

Sponsors & Collaborators

• Technische Universität Dresden

  collaborator OTHER

• Ludwig-Maximilians - University of Munich

  collaborator OTHER

• Helmholtz Zentrum München

  collaborator INDUSTRY

• Technical University of Munich

  lead OTHER

Principal Investigators

• Anette-G. Ziegler, Prof. Dr., MD · Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München

• Ezio Bonifacio, Prof. Dr., PhD · Paul Langerhans Institute Dresden (PLID) of the Helmholtz Zentrum München at the Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden

• Peter Achenbach, PD. Dr., MD · Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München

• Katharina Warncke, Dr., MD · Forschergruppe Diabetes, Klinikum rechts der Isar, Techn. Universität München and Kinderklinik München Schwabing, Klinik u. Poliklinik f. Kinder- und Jugendmedizin, Klinikum Schwabing, StKM GmbH und Klinikum rechts der Isar der Techn. Universität München

• Christiane Winkler, Dr., PhD · Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-12-11

Primary Completion

2024-09-30

Completion

2024-09-30

Countries

• Germany

Study Locations