Status:
COMPLETED
Comparison of Antibody Levels in Children and Adolescents After Initiation of Insulin Therapy by Either Insulin Aspart or Soluble Human Insulin
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
2-17 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 1989
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00410033
Start Date
December 1 1989
End Date
May 1 2006
Last Update
December 22 2016
Active Locations (1)
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1
Novo Nordisk Investigational Site
Linköping, Sweden, 581 85