PINIT Study: Primary Intranasal Insulin Trial

Summary

Type 1 diabetes (T1D) results from an autoimmune destruction of the insulin-producing beta cells. Administration of mucosal 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. Intranasal insulin has the advantage that whole protein will be exposed at the mucosa. Therefore, the available dose of insulin when administered intranasally is likely to be consistent between individuals. On this basis, the investigators aim to conduct a placebo-controlled, double-blind/double-masked primary intervention pilot trial (PINIT Study) of intranasal insulin treatment in islet autoantibody negative children to test immune efficacy and safety in the primary prevention setting. This pilot will help to develop and design a Phase III study aiming to test efficacy of preventing islet autoimmunity and T1D.

Conditions

• Diabetes Mellitus, Type 1

Interventions

DRUG

intranasal insulin

Total of 6 months treatment; daily for the first 7 intervention days and one day per week thereafter (formulation containing rH-insulin, benzalkonium chloride, glycerol and water)

OTHER

Placebo

Total of 6 months treatment; daily for the first 7 intervention days and one day per week thereafter placebo (formulation containing benzalkonium chloride, glycerol and water)

Sponsors & Collaborators

• Technische Universität Dresden

  collaborator OTHER

• Ludwig-Maximilians - University of Munich

  collaborator OTHER

• Helmholtz Zentrum München

  collaborator INDUSTRY

• University Hospital Carl Gustav Carus

  collaborator OTHER

• Technical University of Munich

  lead OTHER

Principal Investigators

• Peter Achenbach, PD Dr. · Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Lehrstuhl für Diabetes und Gestationsdiabetes, der Technischen Universität München, Kölner Platz 1, 80804 München, Germany

• Anette-G. Ziegler, Prof. Dr. · Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Lehrstuhl für Diabetes und Gestationsdiabetes, der Technischen Universität München, Kölner Platz 1, 80804 München, Germany

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

7 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-05-25

Primary Completion

2021-06-07

Completion

2021-06-07

Countries

• Germany

Study Locations