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

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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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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