Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Oceania and North America. The aim of this trial is to assess the long term safety and efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes who have completed the BIAsp-1234 trial.
Interventions
DRUGbiphasic insulin aspart
Individually adjusted dose, injected s.c. (under the skin) before breakfast and dinner
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
* Subjects must have been correctly included in and completed BIAsp-1234
Exclusion criteria
* Persistent non-compliance with study medication, visit schedules or other trial specific procedures during the preceding trial * Fulfilment of any withdrawal criteria prior to and including the final visit of the BIAsp-1234. * Females only: breast feeding, intention of becoming pregnant, or judged to be using inadequate contraceptive measures (adequate contraceptive methods are sterilisation,IUD (Intra Uterine Device), oral contraceptives or barrier methods) * Known or suspected allergy to trial product or related products * Development since entry into the previous trial of late diabetic micro or macro vascular complications, which in the opinion of the Investigator indicates a progressed state of disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of adverse events | — |
| Frequency of hypoglycaemic episodes | — |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c (glycosylated haemoglobin) | — |
Countries
Australia, Canada
Outcome results
None listed