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

NCT00410033 | Completed

• 1 other identifier: ANA-1676
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes; Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Insulin aspart specific, human insulin specific and cross reacting antibodies

  measured up to at most 2.5 years after diagnosis

Secondary Outcomes (3)

• HbA1c

• Insulin requirements

• Incidence of hypoglycaemic episodes

Interventions

soluble human insulin DRUG

isophane human insulin DRUG

insulin aspart DRUG

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Linköping, 581 85, Sweden

Location

Related Publications (1)

• 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. doi: 10.1111/j.1464-5491.2008.02468.x.

  PMID: 18644065 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Interventions

Insulin, Isophane; Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2006
• First Posted: December 12, 2006
• Study Start: December 1, 1989
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: December 22, 2016

Record last verified: 2016-12

Locations

SE (1)