Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This study is conducted in Europe. The study aims to observe the incidence of serious adverse drug reactions in patients with type 2 diabetes during NovoMix® 30 treatment.
Interventions
DRUGbiphasic insulin aspart 30
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Any patient with diabetes 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, breast-feeding 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 12 and 26 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Weight changes | at visits at 12 and 26 weeks |
| Number of all hypoglycaemic events | in the 4 weeks preceding visit, at 12 weeks and the final visit at 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 |
Countries
Norway, Sweden
Outcome results
None listed