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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00410033
First Posted: December 12, 2006
Last Update Posted: December 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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
Diabetes Diabetes Mellitus, Type 1 Drug: soluble human insulin Drug: isophane human insulin Drug: insulin aspart

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

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

Enrollment: 74
Study Start Date: December 1989
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00410033


Locations
Sweden
Novo Nordisk Investigational Site
Linköping, Sweden, 581 85
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Ludvigsson J, Mersebach H, Kanc Hanzel K, Holmberg H. Treatment with insulin aspart versus human insulin in children and adolescents with newly diagnosed type 1 diabetes. EASD 2007; 50(Suppl 1): S380
Holmberg H, Mersebach H, Hanzel KK, Ludvigsson J. Antibody response to insulin in children and adolescents with newly diagnosed type 1 diabetes. ADA 2007; 56 (Suppl. 1): A476 (1885-P

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00410033     History of Changes
Other Study ID Numbers: ANA-1676
First Submitted: December 11, 2006
First Posted: December 12, 2006
Last Update Posted: December 22, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Isophane insulin, beef
Insulin
Insulin Aspart
Insulin, Long-Acting
Isophane Insulin, Human
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs