Pharmacokinetics of Insulin Detemir in Subjects With Type 2 Diabetes
NCT ID: NCT01497600
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
PHASE1
50 participants
INTERVENTIONAL
2004-02-29
2004-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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insulin detemir
insulin detemir
Each subject will be randomly allocated to three doses: 0.3, 0.6, and 1.2 U/kg. Administrated subcutaneously (s.c., under the skin)
insulin NPH
Each subject will be randomly allocated to three doses: 0.3, 0.6, and 1.2 U/kg. Administrated subcutaneously (s.c., under the skin)
insulin NPH
insulin detemir
Each subject will be randomly allocated to three doses: 0.3, 0.6, and 1.2 U/kg. Administrated subcutaneously (s.c., under the skin)
insulin NPH
Each subject will be randomly allocated to three doses: 0.3, 0.6, and 1.2 U/kg. Administrated subcutaneously (s.c., under the skin)
Interventions
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insulin detemir
Each subject will be randomly allocated to three doses: 0.3, 0.6, and 1.2 U/kg. Administrated subcutaneously (s.c., under the skin)
insulin NPH
Each subject will be randomly allocated to three doses: 0.3, 0.6, and 1.2 U/kg. Administrated subcutaneously (s.c., under the skin)
Eligibility Criteria
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Inclusion Criteria
* Insulin treatment with any insulin preparation/regimen for at least three months with or without combination with below or equal to 2 oral antidiabetic agents (OADs)
* Duration of diabetes at least 12 months
* Body Mass Index (BMI) below 33 kg/m\^2
* HbA1c maximum 10 % based on analysis from the central laboratory
Exclusion Criteria
* Current treatment with drugs known to interfere with glucose metabolism other than OADs such as systemic corticosteroids, non-selective beta-blockers, and monoamino oxidase (MAO) inhibitors
* Blood donation of more than 500 mL within the last three months
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
Chula Vista, California, United States
Countries
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References
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Hompesch M, Troupin B, Heise T, Elbroend B, Endahl L, Haahr H, Heinemann L. Time-action profile of insulin detemir and NPH insulin in patients with type 2 diabetes from different ethnic groups. Diabetes Obes Metab. 2006 Sep;8(5):568-73. doi: 10.1111/j.1463-1326.2006.00643.x.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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NN304-1439
Identifier Type: -
Identifier Source: org_study_id
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