GPPAD-POInT (Global Platform of Autoimmune Diabetes - Primary Oral Insulin Trial)

Summary

The GPPAD-POInT Study is designed as a randomized, placebo-controlled, double blind, multicentre, multinational primary prevention phase IIb study aiming to induce immune tolerance to beta-cell autoantigens through regular exposure to oral insulin for a period of 29 to 32 months. The hypothesis is that regular exposure to oral insulin throughout the period in life where beta-cell autoimmunity usually initiates will tolerize against insulin and train the body's immune system to recognize the treatment product without reacting adversely to it in a manner seen in children who develop T1D. This immune tolerance induction therapy would reduce the likelihood of beta-cell autoimmunity. The study objective is to determine whether daily administration of oral insulin from age 4 months - 7 months until age 3.00 years to children with elevated genetic risk for type 1 diabetes reduces the cumulative incidence of beta-cell autoantibodies and diabetes in childhood.

Conditions

• Diabetes Mellitus, Type 1

Interventions

DRUG

Oral Insulin

treatment starting at 4 months - 7 months until age 3.0 years; dose escalation scheme: daily treatment with 7.5 mg or placebo for 2 months; increasing to daily treatment with 22.5 mg or placebo for the following 2 months; increasing to daily treatment with 67.5 mg or placebo until the end of the treatment period.

OTHER

Placebo

treatment starting at age 4 months - 7 months until age 3.0 years; daily treatment with insulin or placebo capsules containing filling substance (microcrystalline cellulose).

Sponsors & Collaborators

• Helmholtz Zentrum München

  collaborator INDUSTRY

• University Hospital Carl Gustav Carus

  collaborator OTHER

• Kinderkrankenhaus auf der Bult

  collaborator OTHER

• Skane University Hospital

  collaborator OTHER

• Universitaire Ziekenhuizen KU Leuven

  collaborator OTHER

• Medical University of Warsaw

  collaborator OTHER

• University of Oxford, Clinical Vaccine Research and Immunisation Education

  collaborator UNKNOWN

• Technical University of Munich

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

4 Months

Max Age

7 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-02-07

Primary Completion

2024-06-28

Completion

2024-06-28

Countries

• Belgium
• Germany
• Poland
• Sweden
• United Kingdom

Study Locations