Status:
COMPLETED
Observational Study on Levemir® in Obese Diabetic Patients
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
6+ years
Brief Summary
This study is conducted in Europe. The aim of this observational study is to investigate the effect of switch from other basal insulin treatments to Levemir® on body weight in obese diabetic patients....
Eligibility Criteria
Inclusion
- Diabetes mellitus (Type 1 or type 2)
- BMI greater than 27 kg/m\^2, or more than 3 kg weight increase since start of insulin therapy
Exclusion
- Subjects currently being treated with insulin detemir
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
580 Patients enrolled
Trial Details
Trial ID
NCT00849342
Start Date
December 1 2008
End Date
January 1 2013
Last Update
August 15 2014
Active Locations (2)
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1
Alphen aan den Rijn, Netherlands
2
Ljubljana, Slovenia, SI-1000