MedTrace Logo

Intranasal Insulin for Prevention of Type 1 Diabetes

NCT00223613 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2006-09-19

No results posted yet for this study

Summary

Children born in Turku, Oulu and Tampere university cities in Finland are screened at birth for HLA alleles that carry increased risk to or protection from development of type 1 diabetes. Children carrying increased risk are followed at 3-12-month intervals for development of diabetes-associated autoantibodies. Children having at least two types of autoantibodies (of the four measured) in at least two consecutively drawn samples are randomized to receive daily intranasal insulin or placebo in a double-blinded 1:1 trial. Hypothesis is that intranasal insulin delays or prevents development of clinical type 1 diabetes. The primary outcome measure is development of clinical diabetes.

Conditions

Interventions

DRUG

daily intranasal administration of insulin

Sponsors & Collaborators

  • Oulu University Hospital

    collaborator OTHER

  • Tampere University

    collaborator OTHER

  • University of Helsinki

    collaborator OTHER

  • University of Turku

    lead OTHER

Principal Investigators

  • Olli G Simell, MD, PhD · University of Turku, Turku, Finland

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1997-08-31
Completion
2005-08-31

Countries

  • Finland

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 NCT00223613 on ClinicalTrials.gov