Comparison of Antibody Levels in Children and Adolescents After Initiation of Insulin Therapy by Either Insulin Aspart or Soluble Human Insulin
Not Applicable
Completed
- Conditions
- Diabetes Mellitus, Type 1Diabetes
- Registration Number
- NCT00410033
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 74
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Insulin aspart specific, human insulin specific and cross reacting antibodies measured up to at most 2.5 years after diagnosis
- Secondary Outcome Measures
Name Time Method Insulin requirements HbA1c Incidence of hypoglycaemic episodes
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇸🇪Linköping, Sweden