Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
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.
Interventions
DRUGinsulin detemir
Administered once or twice daily depending on patients' needs. Dose adjusted for each patient at the discretion of their treating physician
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 110 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of serious adverse drug reactions (SADRs), including major hypoglycaemic events | Weeks 0-26 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Number of serious adverse events (SAEs) | Weeks 0-26 |
| 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 |
| Glycosylated haemoglobin (HbA1c) | Week 26 |
Countries
Ireland, United Kingdom
Outcome results
None listed