MedTrace Logo

Trial of Intranasal Insulin in Children and Young Adults at Risk of Type 1 Diabetes

NCT00336674 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2020-10-08

No results posted yet for this study

Summary

In people with type 1 diabetes the beta cells of the pancreas no longer make insulin because the body's immune system has attacked and destroyed the beta cells. It is thought that exposure of the mucous membranes to insulin may cause act like a vaccine effect whereby protective immune cells are stimulated and these then counteract the "bad" immune cells that damage the beta cells. This study aims to determine if intranasal insulin can protect beta cells and stop progression to diabetes in individuals who are at risk.

Conditions

Interventions

BIOLOGICAL

Intranasal insulin

440IU Insulin

OTHER

Placebo

Placebo insulin carrier solution containing benzalkonium chloride and glycerol

Sponsors & Collaborators

  • Melbourne Health

    lead OTHER

Principal Investigators

  • Leonard C Harrison, MBBS MD DSc · Melbourne Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2019-11-13
Completion
2019-11-13

Countries

  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00336674 on ClinicalTrials.gov