Comparison of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart in Type 2 Diabetes
NCT ID: NCT00097084
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
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COMPLETED
PHASE3
324 participants
INTERVENTIONAL
2004-09-30
2005-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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insulin detemir
insulin glargine
insulin aspart
Eligibility Criteria
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Inclusion Criteria
* Treated with oral antidiabetic drugs or with any insulin regimen with or without oral antidiabetic drugs
* BMI of maximum 40 kg/m2
* HbA1c greater than or equal to 7.0% and 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
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Little Rock, Arkansas, United States
Novo Nordisk Investigational Site
Inglewood, California, United States
Novo Nordisk Investigational Site
San Francisco, California, United States
Novo Nordisk Investigational Site
Santa Ana, California, United States
Novo Nordisk Investigational Site
Spring Valley, California, United States
Novo Nordisk Investigational Site
Boca Raton, 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
Orlando, Florida, United States
Novo Nordisk Investigational Site
Palm Harbor, Florida, United States
Novo Nordisk Investigational Site
Vero Beach, Florida, United States
Novo Nordisk Investigational Site
Athens, Georgia, United States
Novo Nordisk Investigational Site
Idaho Falls, Idaho, United States
Novo Nordisk Investigational Site
Topeka, Kansas, 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
Asheville, North Carolina, United States
Novo Nordisk Investigational Site
Hermitage, Pennsylvania, 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
Dallas, Texas, United States
Novo Nordisk Investigational Site
San Antonio, Texas, United States
Novo Nordisk Investigational Site
Newport News, Virginia, United States
Novo Nordisk Investigational Site
Richmond, Virginia, United States
Novo Nordisk Investigational Site
Tacoma, Washington, United States
Novo Nordisk Investigational Site
Espoo, , Finland
Novo Nordisk Investigational Site
Helsinki, , Finland
Novo Nordisk Investigational Site
Kurikka, , Finland
Novo Nordisk Investigational Site
Lahti, , Finland
Novo Nordisk Investigational Site
Lapua, , Finland
Novo Nordisk Investigational Site
Oulu, , Finland
Novo Nordisk Investigational Site
Turku, , Finland
Novo Nordisk Investigational Site
Brest, , France
Novo Nordisk Investigational Site
Le Mans, , France
Novo Nordisk Investigational Site
Montpellier, , France
Novo Nordisk Investigational Site
Nanterre, , France
Novo Nordisk Investigational Site
Narbonne, , France
Novo Nordisk Investigational Site
Nevers, , France
Novo Nordisk Investigational Site
Orléans, , France
Novo Nordisk Investigational Site
Paris, , France
Novo Nordisk Investigational Site
Vénissieux, , France
Novo Nordisk Investigational Site
Bergen, , Norway
Novo Nordisk Investigational Site
Notodden, , Norway
Novo Nordisk Investigational Site
Sarpsborg, , Norway
Novo Nordisk Investigational Site
Ski, , Norway
Novo Nordisk Investigational Site
Stavanger, , Norway
Novo Nordisk Investigational Site
Trondheim, , Norway
Novo Nordisk Investigational Site
Ängelholm, , Sweden
Novo Nordisk Investigational Site
Falun, , Sweden
Novo Nordisk Investigational Site
Gothenburg, , Sweden
Novo Nordisk Investigational Site
Kalmar, , Sweden
Novo Nordisk Investigational Site
Lund, , Sweden
Novo Nordisk Investigational Site
Lund, , Sweden
Novo Nordisk Investigational Site
Malmo, , Sweden
Novo Nordisk Investigational Site
Motala, , Sweden
Novo Nordisk Investigational Site
Oskarshamn, , Sweden
Novo Nordisk Investigational Site
Uddevalla, , Sweden
Countries
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References
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Hollander P, Cooper J, Bregnhoj J, Pedersen CB. A 52-week, multinational, open-label, parallel-group, noninferiority, treat-to-target trial comparing insulin detemir with insulin glargine in a basal-bolus regimen with mealtime insulin aspart in patients with type 2 diabetes. Clin Ther. 2008 Nov;30(11):1976-87. doi: 10.1016/j.clinthera.2008.11.001.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2004-000087-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN304-1431
Identifier Type: -
Identifier Source: org_study_id
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