Status:
COMPLETED
Observational Study of Safety and Tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the Treatment of Type 1 and Type 2 Diabetes Mellitus
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
Up to 6 years
Brief Summary
This study is conducted in Asia. The aim of this observational study is to evaluate the safety and tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the treatment of Filipino patients with Type 1...
Eligibility Criteria
Inclusion
- Patients diagnosed with Type 1 or Type 2 Diabetes Mellitus.
- Newly diagnosed insulin naive patients
- Patients currently on human insulin or on basal insulin
- Patients prescribed with Levemir™ FlexPen™ (Insulin Detemir) therapy
- Usage should be in accordance with the current prescribing information (See attached prescribing information)
Exclusion
- Previous history of hypersensitivity to Insulin Detemir (Levemir™) and its excipients (See attached prescribing information)
- Contraindications and warnings specified in the current prescribing information (See attached prescribing information)
- Pregnant women, those planning to become pregnant, or women who are breastfeeding
- Patients who are already on human premix or premix analogue (unless they are going to be shifted to basal-bolus therapy)
- Children below 6 years old
Key Trial Info
Start Date :
February 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
2286 Patients enrolled
Trial Details
Trial ID
NCT00655200
Start Date
February 1 2008
End Date
September 1 2008
Last Update
November 22 2023
Active Locations (1)
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1
Manila, Philippines, 1605