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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00410033
• Other study ID #: ANA-1676
• Status: Completed
• Phase: N/A
• First received: December 11, 2006
• Last updated: December 21, 2016
• Start date: December 1989
• Est. completion date: May 2006

Study information

• Verified date: December 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• soluble human insulin

• isophane human insulin

• insulin aspart

Locations

Country	Name	City	State
Sweden	Novo Nordisk Investigational Site	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

Holmberg H, Mersebach H, Hanzel KK, Ludvigsson J. Antibody response to insulin in children and adolescents with newly diagnosed type 1 diabetes. ADA 2007; 56 (Suppl. 1): A476 (1885-P

Ludvigsson J, Mersebach H, Kanc Hanzel K, Holmberg H. Treatment with insulin aspart versus human insulin in children and adolescents with newly diagnosed type 1 diabetes. EASD 2007; 50(Suppl 1): S380

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin aspart specific, human insulin specific and cross reacting antibodies		measured up to at most 2.5 years after diagnosis	No
Secondary	HbA1c			No
Secondary	Insulin requirements			No
Secondary	Incidence of hypoglycaemic episodes			No

External Links

•   Clinical Trials at Novo Nordisk