Comparison of Antibody Levels in Children and Adolescents After Initiation of Insulin Therapy by Either Insulin Aspart or Soluble Human Insulin

This study has been completed.

First Received: December 11, 2006 Last Updated: November 24, 2008 History of Changes

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00410033

Purpose

This trial is conducted in Europe. This is a single-centre, retrospective trial aiming at comparing the antibody levels in children and adolescents.

Condition	Intervention	Phase
Diabetes Mellitus, Type 1	Drug: soluble human insulin Drug: isophane human insulin Drug: insulin aspart	Phase III

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Insulin aspart

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Safety/Efficacy Trial Using Stored Serum Samples to Investigate the Immunogenicity of Insulin Aspart and Soluble Human Insulin in Children and Adolescents From Onset of Type 1 Diabetes

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Insulin aspart specific, human insulin specific and cross reacting antibodies [ Time Frame: measured up to at most 2.5 years after diagnosis ]

Secondary Outcome Measures:

HbA1c
Insulin requirements
Incidence of hypoglycaemic episodes

Estimated Enrollment:	80
Study Start Date:	December 1989

Eligibility

Ages Eligible for Study:	2 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Informed consent obtained before any trial-related activities
Any subjects at onset of Type 1 Diabetes
Treatment with either Insulin Aspart and Soluble Human Insulin or Soluble Human Insulin and Isophane Human Insulin / Mixtard® for at least 9 months from the time of diagnosis of diabetes

Exclusion Criteria:

Treatment with immunosuppressive agents
For the Insulin Aspart + Isophane Human Insulin: Treatment with insulin analogues other than Insulin Aspart or treatment with fast acting human insulin for a period of 7 days or more during the treatment period
For the Soluble Human Insulin and Isophane Human Insulin group: Treatment with insulin analogues
Other diseases influencing immune response
Unable or unwilling to provide consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00410033

Locations

Sweden

Linköping, Sweden

LINKÖPING, Sweden, 581 85

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Martin Pedersen, Ph.D.

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided by Novo Nordisk

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Holmberg H, Mersebach H, Kanc K, Ludvigsson J; Insulin Aspart Study Group on Immunogenicity. Antibody response to insulin in children and adolescents with newly diagnosed Type 1 diabetes. Diabet Med. 2008 Jul;25(7):792-7.

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	ANA-1676
Study First Received:	December 11, 2006
Last Updated:	November 24, 2008
ClinicalTrials.gov Identifier:	NCT00410033 History of Changes
Health Authority:	Sweden: Medical Products Agency

Study placed in the following topic categories:

Metabolic Diseases
Autoimmune Diseases
Diabetes Mellitus
Endocrine System Diseases
Diabetes Mellitus Type 1
Insulin
Antibodies

Hypoglycemic Agents
Diabetes Mellitus, Type 1
Insulin, Asp(B28)-
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Immunoglobulins

Additional relevant MeSH terms:

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

Insulin, Asp(B28)-
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on May 06, 2009