Observational Study in Type 2 Diabetes Treated by an Intensive Insulin Treatment (ICT) Containing Once Daily Levemir® (Insulin Detemir)
- Registration Number
- NCT00657930
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This study is conducted in Europe. The aim of this observational study is to gain practical experience with once-daily Levemir administration in type 2 diabetes patients who were previously treated with Insulatard®, Humulin® N (NPH insulins) as basal insulin as part of their ICT under normal clinical practice conditions in Hungary.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2289
Inclusion Criteria
- Type 2 diabetic subjects on intensive insulin treatment (ICT)
- Eligibility for once daily insulin detemir administration
- Informed consent obtained before any observation-related activities
Exclusion Criteria
- Known or suspected allergy to insulin detemir
- Subjects previously enrolled in the observation
- Women who are pregnant, breast feeding or have the intention of becoming pregnant within 6 months.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description A insulin detemir -
- Primary Outcome Measures
Name Time Method Efficacy (HbA1c) 24 weeks
- Secondary Outcome Measures
Name Time Method Hypoglycaemia frequency 24 weeks FBG variability 24 weeks Insulin dose change 24 weeks Body weight 24 weeks