Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial investigate the the long-term safety of biphasic insulin aspart 30 in subjects with type 2 diabetes.
Interventions
DRUGbiphasic insulin aspart
Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily before breakfast and evening meal
Sponsors
Novo Nordisk A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent obtained before any trial-related activities * Completed the trial BIAsp-1236
Exclusion criteria
* Planned changes in use of any prescription medication that may interfere with glucose regulation * Known or suspected allergy to trial products or related products * Women who are having the intention of becoming pregnant, or are judged not to be using adequate contraceptive measures * Any other significant condition or concomitant disease or any condition that would interfere with participation as judged by the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Hypoglycaemic episodes | — |
| Occurrence of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c (glycosylated haemoglobin) | — |
| Prandial increment in blood glucose | — |
| 7-point blood glucose profile | — |
Countries
Finland, Norway, Sweden, United Kingdom
Outcome results
None listed