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

This study is currently recruiting participants.

Verified by Melbourne Health, January 2007

First Received: June 12, 2006 Last Updated: March 8, 2007 History of Changes

Sponsor:	Melbourne Health
Collaborator:	Diabetes Vaccine Development Centre
Information provided by:	Melbourne Health
ClinicalTrials.gov Identifier:	NCT00336674

Purpose

In people with type I 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.

Condition	Intervention	Phase
Type 1 Diabetes	Biological: Intranasal insulin	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomised, Double-Blind, Placebo-Controlled Trial of Intranasal Insulin (1.6mg and 16mg) in Children and Young Adults at Risk of Type 1 Diabetes: Intranasal Insulin Trial II

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin

U.S. FDA Resources

Further study details as provided by Melbourne Health:

Primary Outcome Measures:

Diagnosis of Diabetes AT 5 years according to ADA/WHO criteria.

Secondary Outcome Measures:

B cell function: measured as FPIR yearly and
glucose and insulin responses in OGTT 6monthly.
Insulin Action: Insulin resistance measured by HOMA-R 6 monthly.
Immune function: measured by levels of circulating antibodies to insulin, GAD and IA-2 and T cell responses to proinsulin, denatured insulin, GAD and tetanus at 5 years.

Estimated Enrollment:	264
Study Start Date:	December 2006
Estimated Study Completion Date:	December 2012

Eligibility

Ages Eligible for Study:	4 Years to 30 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

First-degree or second-degree relative of a person with T1D diagnosed before age 40.
Age 4-30 years if first-degree relative; age 4-20 years if second-degree relative.
Confirmed serum antibodies to two or more islet antigens.
HLA not DR2, DQ6.
Normal oral glucose tolerance test (OGTT).
FPIR at or above threshold: greater than or equal to 10th percentile for siblings, offspring and second-degree relatives of person with T1D (greater than or equal to 100uU/ml if aged 8 or more years OR greater than or equal to 60 uU/ml if aged less than 8) and greater than or equal to the 1st percentile for parents of someone with T1D (greater than ore equal to 60uU/ml).
Provision of written consent. -

Exclusion Criteria:

History of treatment with insulin or oral hypoglycemic agents
Known diabetes by ADA/WHO criteria
Pregnant or lactating or of child-bearing potential not using an adequate method of contraception
Concomitant disease or treatment which may interfere with assessment or cause immunosuppression, as judged by the investigators.
Uncorrected vitamin D deficiency
Known alcohol or drug abuse, psychiatric or other condition that could be associated with poor compliance.
Known liver disease, or persisting elevation of plasma AST or ALT levels.
Impaired renal function
Any defect or pathology of nasal passage which would preclude application of the intranasal spray.

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Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00336674

Contacts

Contact: Professor Leonard C Harrison, MD DSc FRACP

61 3 9345 2461

harrison@wehi.edu.au

Locations

Australia, Victoria
Royal Melbourne Hospital	Recruiting
Melbourne, Victoria, Australia, 3050
Principal Investigator: Leonard C Harrison, MD DSc FRACP

Sponsors and Collaborators

Melbourne Health

Diabetes Vaccine Development Centre

Investigators

Principal Investigator:

Leonard C Harrison, MBBS MD DSc

Melbourne Health

More Information

No publications provided

Study ID Numbers:	INIT II
Study First Received:	June 12, 2006
Last Updated:	March 8, 2007
ClinicalTrials.gov Identifier:	NCT00336674 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Melbourne Health:

Type 1 diabetes

Additional relevant MeSH terms:

Hypoglycemic Agents
Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1
Physiological Effects of Drugs

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on November 27, 2009