Safety and Efficacy of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart as Mealtime Insulin in Type 1 Diabetes
NCT ID: NCT00095082
Last Updated: 2017-01-27
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
PHASE3
447 participants
INTERVENTIONAL
2004-09-30
2005-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart in Type 2 Diabetes
NCT00097084
Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes
NCT00312104
Comparison of Insulin Detemir With Insulin Glargine in Type 2 Diabetes
NCT00106366
Effect of Insulin Detemir and Insulin Glargine on Blood Glucose Control in Subjects With Type 2 Diabetes
NCT00909480
A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, Both With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes
NCT02034513
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 detemir
insulin glargine
insulin aspart
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Current treatment with basal-bolus insulin regimen for more than or equal to 3 months
* HbA1c less than or equal to 11.0%
Exclusion Criteria
* Recurrent major hypoglycaemia
* Impaired hepatic or renal function
* Cardiac problems or uncontrolled hypertension
18 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
Anaheim, California, United States
Novo Nordisk Investigational Site
Huntington Beach, California, United States
Novo Nordisk Investigational Site
Inglewood, California, United States
Novo Nordisk Investigational Site
Irvine, California, United States
Novo Nordisk Investigational Site
La Jolla, California, United States
Novo Nordisk Investigational Site
Hollywood, Florida, United States
Novo Nordisk Investigational Site
Jacksonville, Florida, United States
Novo Nordisk Investigational Site
Lake Mary, Florida, United States
Novo Nordisk Investigational Site
Melbourne, Florida, United States
Novo Nordisk Investigational Site
Tampa, Florida, United States
Novo Nordisk Investigational Site
Vero Beach, Florida, United States
Novo Nordisk Investigational Site
Atlanta, Georgia, United States
Novo Nordisk Investigational Site
Idaho Falls, Idaho, United States
Novo Nordisk Investigational Site
Chicago, Illinois, United States
Novo Nordisk Investigational Site
Topeka, Kansas, United States
Novo Nordisk Investigational Site
Hyattsville, Maryland, United States
Novo Nordisk Investigational Site
Detroit, Michigan, United States
Novo Nordisk Investigational Site
St Louis, Missouri, United States
Novo Nordisk Investigational Site
Omaha, Nebraska, United States
Novo Nordisk Investigational Site
Las Vegas, Nevada, United States
Novo Nordisk Investigational Site
Berlin, New Jersey, United States
Novo Nordisk Investigational Site
Sea Girt, New Jersey, United States
Novo Nordisk Investigational Site
Asheville, North Carolina, United States
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States
Novo Nordisk Investigational Site
Dallas, Texas, United States
Novo Nordisk Investigational Site
Dallas, Texas, United States
Novo Nordisk Investigational Site
Houston, Texas, United States
Novo Nordisk Investigational Site
San Antonio, Texas, United States
Novo Nordisk Investigational Site
Helsinki, , Finland
Novo Nordisk Investigational Site
Kuopio, , Finland
Novo Nordisk Investigational Site
Oulu, , Finland
Novo Nordisk Investigational Site
Pori, , Finland
Novo Nordisk Investigational Site
Vantaa, , Finland
Novo Nordisk Investigational Site
Angers, , France
Novo Nordisk Investigational Site
Antibes, , France
Novo Nordisk Investigational Site
Brest, , France
Novo Nordisk Investigational Site
Grenoble, , France
Novo Nordisk Investigational Site
La Rochelle, , France
Novo Nordisk Investigational Site
Mougins, , France
Novo Nordisk Investigational Site
Toulouse, , France
Novo Nordisk Investigational Site
Alsdorf, , Germany
Novo Nordisk Investigational Site
Bad Kreuznach, , Germany
Novo Nordisk Investigational Site
Dormagen, , Germany
Novo Nordisk Investigational Site
Dresden, , Germany
Novo Nordisk Investigational Site
Flensburg, , Germany
Novo Nordisk Investigational Site
Friedrichsthal, , Germany
Novo Nordisk Investigational Site
Genthin, , Germany
Novo Nordisk Investigational Site
Hamburg, , Germany
Novo Nordisk Investigational Site
Hamburg, , Germany
Novo Nordisk Investigational Site
Hamburg, , Germany
Novo Nordisk Investigational Site
Herrenberg, , Germany
Novo Nordisk Investigational Site
Kippenheim, , Germany
Novo Nordisk Investigational Site
Rehlingen-Siersburg, , Germany
Novo Nordisk Investigational Site
Saint Ingbert, , Germany
Novo Nordisk Investigational Site
Speyer, , Germany
Novo Nordisk Investigational Site
Völklingen, , Germany
Novo Nordisk Investigational Site
Würzburg, , Germany
Novo Nordisk Investigational Site
Almere Stad, , Netherlands
Novo Nordisk Investigational Site
Apeldoorn, , Netherlands
Novo Nordisk Investigational Site
Capelle aan den IJssel, , Netherlands
Novo Nordisk Investigational Site
Dordrecht, , Netherlands
Novo Nordisk Investigational Site
Leeuwarden, , Netherlands
Novo Nordisk Investigational Site
Zoetermeer, , Netherlands
Novo Nordisk Investigational Site
Norrköping, , Sweden
Novo Nordisk Investigational Site
Örebro, , Sweden
Novo Nordisk Investigational Site
Stockholm, , Sweden
Novo Nordisk Investigational Site
Stockholm, , Sweden
Novo Nordisk Investigational Site
Umeå, , Sweden
Novo Nordisk Investigational Site
Vaxjo, , Sweden
Novo Nordisk Investigational Site
Abergavenny, , United Kingdom
Novo Nordisk Investigational Site
Ayr, , United Kingdom
Novo Nordisk Investigational Site
Brighton, , United Kingdom
Novo Nordisk Investigational Site
Bristol, , United Kingdom
Novo Nordisk Investigational Site
Cosham, , United Kingdom
Novo Nordisk Investigational Site
Dundee, , United Kingdom
Novo Nordisk Investigational Site
Glasgow, , United Kingdom
Novo Nordisk Investigational Site
Livingstone, , United Kingdom
Novo Nordisk Investigational Site
Plymouth, , United Kingdom
Novo Nordisk Investigational Site
Sheffield, , United Kingdom
Novo Nordisk Investigational Site
Watford, , United Kingdom
Novo Nordisk Investigational Site
Wirral, Merseyside, , United Kingdom
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.
Heller S, Koenen C, Bode B. Comparison of insulin detemir and insulin glargine in a basal-bolus regimen, with insulin aspart as the mealtime insulin, in patients with type 1 diabetes: a 52-week, multinational, randomized, open-label, parallel-group, treat-to-target noninferiority trial. Clin Ther. 2009 Oct;31(10):2086-97. doi: 10.1016/j.clinthera.2009.10.006.
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.
2004-000086-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN304-1430
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.