Observational Study to Evaluate the Safety of Levemir® in Patients With Diabetes
Completed
- Conditions
- Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2Diabetes
- Interventions
- Registration Number
- NCT01545791
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This study is conducted in Europe. The aim of the study is to observe the safety of insulin detemir (Levemir®) in patients with type 1 and type 2 diabetes patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1037
Inclusion Criteria
- Any patient with type 1 or type 2 diabetes mellitus, including newly diagnosed patients who had never received insulin or an insulin analogue before
Exclusion Criteria
- Patients whom the physician considered might be noncompliant for any reason; for example, uncooperative attitude, inability to return for the final visit and similar
- Patients previously enrolled in this study
- Patients with a hypersensitivity to insulin detemir
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Insulin detemir users insulin detemir -
- Primary Outcome Measures
Name Time Method Number of serious adverse drug reactions (SADRs), including major hypoglycaemic events Weeks 0-26
- Secondary Outcome Measures
Name Time Method Number of serious adverse events (SAEs) Weeks 0-26 Number of all adverse events (AEs) Weeks 0-26 Number of all hypoglycaemic events In the 4 weeks preceeding week 26 Weight change Week 0, week 26 Glycosylated haemoglobin (HbA1c) Week 26 Variability in fasting plasma glucose (FPG) Week 26 Average plasma glucose level Week 26 Quality of Life as assessed by a treatment satisfaction questionnaire Week 26
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇬🇧London, United Kingdom