Status:
COMPLETED
Observational Study to Evaluate the Safety While Using Levemir®
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18+ years
Brief Summary
This study is conducted in Africa. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using insulin Levemir® under normal clinical practice condit...
Eligibility Criteria
Inclusion
- After the physician decision has been made to use insulin detemir, any subject with Type 1 or Type 2 diabetes mellitus is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before. The selection of the subjects will be at the discretion of the individual physician.
Exclusion
- Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit;
- Subjects currently being treated with insulin detemir;
- Subjects who previously enrolled in this study
- Subjects with a hypersensitivity to insulin detemir or to any of the excipients
- Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures. (Adequate contraceptive measures are an intrauterine device, oral contraceptives and barrier methods)
Key Trial Info
Start Date :
July 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
3593 Patients enrolled
Trial Details
Trial ID
NCT00701155
Start Date
July 1 2007
End Date
March 1 2008
Last Update
November 2 2023
Active Locations (1)
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1
Giza, Egypt, 0020