Observational Study on Levemir® in Obese Diabetic Patients
NCT ID: NCT00849342
Last Updated: 2014-08-15
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
580 participants
OBSERVATIONAL
2008-12-31
2013-01-31
Brief Summary
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Included in the study is a retrospective part to evaluate the weight progress since initiation of insulin treatment of another basal insulin and/or oral antidiabetic drugs (OAD) and/or bolus insulin therapy. Retrospective data will be collected at baseline and at approximately 6 and 12 months before starting insulin detemir therapy.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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A
insulin detemir
Safety and effectiveness (weight and HbA1c) data collection in connection with the use of the drug Levemir® in daily clinical practice.
Interventions
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insulin detemir
Safety and effectiveness (weight and HbA1c) data collection in connection with the use of the drug Levemir® in daily clinical practice.
Eligibility Criteria
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Inclusion Criteria
* BMI greater than 27 kg/m\^2, or more than 3 kg weight increase since start of insulin therapy
Exclusion Criteria
* Subjects who were previously enrolled in this study;
* Subjects with a hypersensitivity to insulin detemir or to any of the excipients.
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months Female patients will be reminded to use adequate contraceptive during the study, where is relevant.
6 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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Alphen aan den Rijn, , Netherlands
Ljubljana, , Slovenia
Countries
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Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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NN304-3708
Identifier Type: -
Identifier Source: org_study_id
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