Observational Study to Observe the Efficacy of Levemir® (Insulin Detemir) in Patients With Type 2 Diabetes.
- Registration Number
- NCT00793273
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This study is conducted in Europe. The aim of this observational study is to observe the efficacy of Levemir® treatment in patients with type 2 diabetes in everyday clinical practice in Switzerland. Furthermore the time period between diagnosis of type 2 diabetes and insulin initiation is evaluated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1074
Inclusion Criteria
- Patients with type 2 diabetes mellitus
- Insulin-naive or currently treated with another basal insulin
- Inclusion of patients at the discretion of the treating physician after the decision to prescribe Levemir®
Exclusion Criteria
- Type 1 diabetes mellitus
- Patients treated with short acting or with premix insulin
- Women who are pregnant, breast feeding or have the intention to become pregnant
- Known or suspected allergy to the study product or related product
- Any exclusion criteria according to the Swiss Levemir® SPC (Summary of Product Characteristics)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description A insulin detemir -
- Primary Outcome Measures
Name Time Method Change in FPG (fasting plasma glucose) of treatment after 12 to 16 weeks Change in HbA1c of treatment after 12 to 16 weeks
- Secondary Outcome Measures
Name Time Method Insulin dose and concomitant oral antidiabetic medication time period between diagnosis of type 2 diabetes and insulin initiation after 12 to 16 weeks Occurrence of adverse events after 12 to 16 weeks