Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to evaluate the effect of Levemir® (insulin detemir) on glycaemic control, weight and incidence of hypoglycaemic events in insulin treated subjects with type 1 or type 2 diabetes.
Interventions
DRUGinsulin detemir
Prescribed by the physician solely as a result of a normal clinical evaluation. The physician determines the starting dose and frequency, as well as later changes to either dose or frequency, if any
DRUGinsulin aspart
Prescribed by the physician solely as a result of a normal clinical evaluation. The physician determines the starting dose and frequency, as well as later changes to either dose or frequency, if any
Prescribed by the physician solely as a result of a normal clinical evaluation. The physician determines 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
* Any subject with type 1 or type 2 diabetes treated with insulin in whom at the discretion of the participating physicians it was decide to switch insulin treatment to the long-acting insulin analogue insulin detemir (Levemir®) in combination with either insulin aspart (NovoRapid®) or human insulin (Actrapid®)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c (glycosylated haemoglobin) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in body weight | — |
| Insulin dose | — |
| Change in 7-point blood glucose variability | — |
| Number of hypoglycaemic episodes | — |
| Number of adverse events | — |
| Number of injections | — |
Countries
Slovakia
Outcome results
None listed