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

Novo Nordisk

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: isophane human insulin; Drug: insulin aspart; Drug: soluble human insulin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00410033

ANA-1676

Details and patient eligibility

About

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

Enrollment: 74 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)