Efficacy and Safety of Insulin Aspart in MDI or CSII in Children Below 7 Years of Age With Type 1 Diabetes
NCT ID: NCT00571935
Last Updated: 2016-12-21
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
PHASE4
61 participants
INTERVENTIONAL
2003-08-31
2004-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The aim of this trial is to investigate the efficacy of insulin aspart compared to soluble human insulin on blood glucose control in children below 7 years of age with type 1 diabetes.
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.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
insulin aspart
soluble human insulin
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* HbA1c below 12.0%
* Treatment with regular human insulin and insulin NPH for at least 1 month
* Receive more than 2 injections daily
Exclusion Criteria
* Known or suspected allergy to investigational product
* Receipt of of insulin aspart within 3 months prior to trial participation
7 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
Bialystok, , Poland
Novo Nordisk Investigational Site
Gliwice, , Poland
Novo Nordisk Investigational Site
Kielce, , Poland
Novo Nordisk Investigational Site
Krakow, , Poland
Novo Nordisk Investigational Site
Warsaw, , Poland
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.
Pankowska E, Nazim J, Szalecki M, Urban M. Equal metabolic control but superior caregiver treatment satisfaction with insulin aspart in preschool children. Diabetes Technol Ther. 2010 May;12(5):413-8. doi: 10.1089/dia.2009.0155.
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-1507
Identifier Type: -
Identifier Source: org_study_id