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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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
soluble human insulin
isophane human insulin
insulin aspart
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Novo Nordisk Investigational Site

Outcomes

Primary Outcome Measures

Insulin aspart specific, human insulin specific and cross reacting antibodies

Secondary Outcome Measures

HbA1c
Insulin requirements
Incidence of hypoglycaemic episodes

Full Information

First Posted
December 11, 2006
Last Updated
December 21, 2016
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00410033
Brief Title
Comparison of Antibody Levels in Children and Adolescents After Initiation of Insulin Therapy by Either Insulin Aspart or Soluble Human Insulin
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
December 1989 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
soluble human insulin
Intervention Type
Drug
Intervention Name(s)
isophane human insulin
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Primary Outcome Measure Information:
Title
Insulin aspart specific, human insulin specific and cross reacting antibodies
Time Frame
measured up to at most 2.5 years after diagnosis
Secondary Outcome Measure Information:
Title
HbA1c
Title
Insulin requirements
Title
Incidence of hypoglycaemic episodes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
18644065
Citation
Holmberg H, Mersebach H, Kanc K, Ludvigsson J; Insulin Aspart Study Group on Immunogenicity. Antibody response to insulin in children and adolescents with newly diagnosed Type 1 diabetes. Diabet Med. 2008 Jul;25(7):792-7. doi: 10.1111/j.1464-5491.2008.02468.x.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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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