Pre-POINT-Early Study

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.

Conditions

• 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 22.5 mg or placebo for the following 3 months; increasing to daily treatment with 67.5 mg or placebo for the last 6 months of the treatment period.

DRUG

Placebo

Total of 12 months treatment; daily treatment with insulin or placebo capsules containing filling substance (microcrystalline cellulose).

Sponsors & Collaborators

• Technische Universität Dresden

  collaborator OTHER

• Ludwig-Maximilians - University of Munich

  collaborator OTHER

• Helmholtz Zentrum München

  collaborator INDUSTRY

• German Center for Diabetes Research

  collaborator OTHER

• Technical University of Munich

  lead OTHER

Principal Investigators

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

• Ezio Bonifacio, Prof. Dr., PhD · DFG-Center for Regenerative Therapies Dresden, Dresden University of Technology

• Peter Achenbach, PD Dr., MD · Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Lehrstuhl für Diabetes und Gestationsdiabetes, der Technischen Universität München

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

2 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-08-31

Primary Completion

2017-12-31

Completion

2017-12-31

Countries

• Germany

Study Locations