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:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00410033
First received: December 11, 2006
Last updated: June 15, 2012
Last verified: June 2012

December 11, 2006
June 15, 2012
December 1989
May 2006   (final data collection date for primary outcome measure)
Insulin aspart specific, human insulin specific and cross reacting antibodies [ Time Frame: measured up to at most 2.5 years after diagnosis ] [ Designated as safety issue: No ]
Insulin aspart specific, human insulin specific and cross reacting antibodies measured up to at most 2.5 years after diagnosis
Complete list of historical versions of study NCT00410033 on ClinicalTrials.gov Archive Site
  • HbA1c [ Designated as safety issue: No ]
  • Insulin requirements [ Designated as safety issue: No ]
  • Incidence of hypoglycaemic episodes [ Designated as safety issue: No ]
  • HbA1c
  • Insulin requirements
  • Incidence of hypoglycaemic episodes
Not Provided
Not Provided
 
Comparison of Antibody Levels in Children and Adolescents After Initiation of Insulin Therapy by Either Insulin Aspart or Soluble Human Insulin
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

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

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Drug: soluble human insulin
  • Drug: isophane human insulin
  • Drug: insulin aspart
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
May 2006
May 2006   (final data collection date for primary outcome measure)

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
Both
2 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00410033
ANA-1676
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Martin Pedersen, Ph.D. Novo Nordisk A/S
Novo Nordisk A/S
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP