Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to evaluate the blood glucose-lowering effect of NN5401 (insulin degludec/insulin aspart (IDegAsp)) in subjects with type 2 diabetes.
Interventions
DRUGinsulin degludec/insulin aspart
0.4 U/kg body weight injected subcutaneously (under the skin) once
DRUGbiphasic insulin aspart 30
0.4 U/kg body weight injected subcutaneously (under the skin) once
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months * Body mass index below or equal to 35.0 kg/m\^2
Exclusion criteria
* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening * Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) * Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the glucose infusion rate curve (only for IDegAsp) | From 0 to 24 hours after single-dose |
Secondary
| Measure | Time frame |
|---|---|
| Area under the insulin aspart concentration-time curve | From 0 to 12 hours after single-dose administration |
| Area under the insulin aspart concentration-time curve (only for BIAsp 30) | From 0 to 24 hours after single-dose administration |
Countries
Germany
Outcome results
None listed