Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to investigate the efficacy and safety of biphasic insulin aspart (NovoMix®30) to that of biphasic human insulin (Mixtard® 30) in subjects with type 2 diabetes.
Interventions
DRUGbiphasic insulin aspart
Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily
Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily
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 for at least 24 months * Insulin treatment for the pase 3 months * HbA1c (glycosylated haemoglobin) below 13% * BMI (Body Mass Index) below 40 kg/m\^2 * Ability and willingness to perform self-blood glucose monitoring
Exclusion criteria
* Receipt of any investigational drug within 4 weeks prior to this trial * Treatment of OHAs (Oral Hypoglycaemic Agents) within 4 weeks prior to this trial * Total daily insulin dosage less than or equal to 1.8 IU/kg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c (glycolated haemoglobin) | — |
Secondary
| Measure | Time frame |
|---|---|
| Prandial increment in blood glucose | — |
| 7-point blood glucose profile | — |
| Number and severity of adverse events | — |
| Number and severity of local tolerability issues at the injection site | — |
| Number and severity of hypoglycaemic episodes | — |
Countries
Denmark, Norway, Sweden
Outcome results
None listed