Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to investigate pharmacokinetics, pharmacodynamics and safety of biphasic insulin aspart 30 in subjects with type 2 diabetes.
Interventions
DRUGbiphasic insulin aspart 30
Injected subcutaneously (s.c., under the skin) before breakfast and dinner, dosage adjusted throughout the trial according to individual needs
Injected subcutaneously (s.c., under the skin) before breakfast and dinner, dosage adjusted throughout the trial according to individual needs
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes for at least 12 months * Treated with a combination of soluble/protracted human insulin in the ratio of 30/70 in a twice-daily regimen for at least 6 months * BMI (body mass index) below 39 kg/m\^2 * HbA1c (glycosylated haemoglobin) below 12%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the serum insulin curve | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall shape of the 24 hour serum insulin profile | — |
| Cmax (maximum plasma concentration) | — |
| tmax (time to reach maximum) | — |
| Area under the curve following each injections derived from 24 hours serum insulin profiles | — |
| Overall shape of the 24 hour serum glucose profile | — |
| Serum glucose excursions (EXC) | — |
Countries
Netherlands, United Kingdom
Outcome results
None listed