Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This this trial is conducted in Europe. The aim of this trial is to compare glycaemic control of biphasic insulin aspart 30 (BIAsp 30) alone or combined with insulin aspart(IAsp) in patients previously treated with conventional Biphasic Human Insulin 30/70.
Interventions
DRUGbiphasic insulin aspart 30
Administrated subcutaneously (s.c., under the skin) at breakfast and evening main meals
DRUGinsulin aspart
Administrated subcutaneously (s.c., under the skin) before lunch
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes * Current treatment with conventional biphasic human insulin 30/70 b.i.d. (twice daily) for at least 3 months * HbA1c (glycosylated haemoglobin) equal to or below 12% * Willing and able to perform self blood glucose monitoring (SMBG)
Exclusion criteria
* History of drug or alcohol dependence * Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation * Previous participation in this trial * Receipt of any investigational drug within the last month prior to this trial * Known or suspected allergy to trial products or related products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c (glycosylated haemoglobin) | — |
Secondary
| Measure | Time frame |
|---|---|
| 7-point blood glucose profile | — |
| Correlation of endpoint HbA1c with baseline BMI (body mass index) and HbA1c with treatment mode stratification | — |
| Incidence of adverse events | — |
| Hypoglycaemic episodes (minor, major or nocturnal) | — |
Countries
Poland
Outcome results
None listed