Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Brief summary
This study is conducted in Europe. The aim of this study is to evaluate efficacy and safety of insulin detemir (Levemir®) used as basal insulin on the glycaemic control, weight and incidence of hypoglycaemic events in insulin treated subjects with type 1 or type 2 diabetes treated with insulin NPH under normal clinical practice conditions in Slovakia.
Interventions
DRUGinsulin detemir
Prescribed insulin detemir and insulin aspart based on the clinical judgement of the physician. The insulin preparations were prescribed by the physician solely as a result of a normal clinical evaluation. The physician determined the starting dose and frequency, as well as later changes to either dose or frequency, if any.
DRUGinsulin aspart
Prescribed insulin detemir and insulin aspart based on the clinical judgement of the physician. The insulin preparations were prescribed by the physician solely as a result of a normal clinical evaluation. The physician determined the starting dose and frequency, as well as later changes to either dose or frequency, if any.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Type 1 or type 2 diabetes treated with insulin NPH
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c (glycosylated haemoglobin) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in fasting plasma glucose (FPG) | — |
| Change in 4-points glucose profiles | — |
| Change in weight | — |
| Number of hypoglycaemic events | — |
| Number of adverse events | — |
| Change in lipid profile | — |
Countries
Slovakia
Outcome results
None listed