Comparison of Antibody Levels in Children and Adolescents After Initiation of Insulin Therapy by Either Insulin Aspart or Soluble Human Insulin
NCT ID: NCT00410033
Last Updated: 2016-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
74 participants
INTERVENTIONAL
1989-12-31
2006-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
soluble human insulin
isophane human insulin
insulin aspart
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
2 Years
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novo Nordisk A/S
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novo Nordisk Investigational Site
Linköping, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Clinical Trials at Novo Nordisk
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ANA-1676
Identifier Type: -
Identifier Source: org_study_id