Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This observational study is conducted in Europe. The study aims to observe the incidence of serious adverse drug reactions in subjects with type 2 diabetes during Levemir® treatment.
Interventions
DRUGinsulin detemir
Start dose and frequency as well as dose alterations to be determined by the physician according to normal clinical evaluation
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Any patient with type 2 diabetes * Currently treated with basal human insulin therapy (basal only or in combination with oral glucose lowering drugs or other insulin) * Selection of patients will be at the discretion of the treating physician after the decision to prescribe one of the study products to the patient
Exclusion criteria
* Known or suspected allergy to study product(s) or related products. * Pregnancy or breastfeeding or intention of becoming pregnant within the next 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of serious adverse drug reactions, including major hypoglycaemic events | After 26 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Number of all hypoglycaemic events | at 12 weeks and 26 weeks |
| Number of all adverse drug reactions | after 12 and 26 weeks |
| HbA1c | at 12 and 26 weeks |
| Variability in fasting plasma glucose (FPG) values and average FPG levels at visits | at 12 and 26 weeks |
| Weight changes | at 12 and 26 weeks |
Countries
Denmark, Sweden
Outcome results
None listed