Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This study is conducted in Asia, Europe, Japan and North America. The aim of this observational study is to evaluate the safety and effectiveness while using NovoMix® 30 during 26 weeks under normal clinical practice, in the countries participating in the study. The primary outcome is the incidence of major hypoglycaemic events reported as serious adverse drugs reaction conditions on hypoglycaemic events.
Interventions
DRUGbiphasic insulin aspart
Start dose and frequency to be prescribed by the physician as a result of a 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
* Age according to approved label and physician discretion * Type 2 diabetes including newly-diagnosed subjects who have never received insulin or an insulin analogue before
Exclusion criteria
* Subjects who previously enrolled in this study * Subjects who are unlikely to comply with protocol requirements * Hypersensitivity to biphasic insulin aspart or to any of the excipients * Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of major hypoglycaemic events reported as serious adverse drug reactions | during treatment |
Countries
Canada, China, Greece, India, Iran, Italy, Japan, Poland, Russia, Saudi Arabia, South Korea
Outcome results
None listed