Status:
COMPLETED
An Observational Study to Compare the Safety and Effectiveness of NovoMix® 30 and Levemir™ for the Treatment of Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
Brief Summary
This study is conducted in Asia. The aim of this observational study is to compare the clinical safety profile and effectiveness of NovoMix® 30 and Levemir™ for the treatment of diabetes in the Philip...
Eligibility Criteria
Inclusion
- Patients diagnosed with type 1 or type 2 diabetes mellitus
- Patients uncontrolled on oral antidiabetic drugs
- Insulin naïve patients or patients currently on human insulin
Exclusion
- Subjects who are unlikely to comply with protocol requirements
- Subjects who are previously enrolled in NovoMix® 30 and Levemir™ study
- Subjects on NovoMix® 30 and Levemir™ therapy
- Subjects with hypersensitivity to NovoMix® 30 or to any of the excipients
- Subjects with hypersensitivity to Levemir™ or to any of the excipients
- Females of child bearing potential who are pregnant, breast feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures are required by local law or practice
- Contraindications and warnings specified in the current prescribing information
Key Trial Info
Start Date :
November 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
3131 Patients enrolled
Trial Details
Trial ID
NCT00789711
Start Date
November 1 2008
End Date
August 1 2009
Last Update
October 31 2016
Active Locations (1)
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1
Novo Nordisk Investigational Site
Manila, Philippines, 1605