Observational Study of Safety and Tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the Treatment of Type 1 and Type 2 Diabetes Mellitus
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT00655200
- Lead Sponsor
- Novo Nordisk A/S
- 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 and Type 2 Diabetes Mellitus.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2286
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description A insulin detemir -
- Primary Outcome Measures
Name Time Method Safety profile of Insulin Detemir among Filipino patients 3 months follow-up visit
- Secondary Outcome Measures
Name Time Method