Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial is conducted in Japan. The aim of this clinical trial is to investigate the blood sugar lowering effect of NN5401 (insulin degludec/insulin aspart (IDegAsp)) in Japanese subjects with type 1 diabetes. Each subject will be randomised to one of the two possible treatment sequences (NN5401 followed by biphasic insulin aspart (BIAsp) 30 or biphasic insulin aspart 30 followed by NN5401).
Interventions
DRUGinsulin degludec/insulin aspart
Single dose of 0.5 U/kg body weight injected s.c. (under the skin)
DRUGbiphasic insulin aspart 30
Single dose of 0.5 U/kg body weight injected s.c. (under the skin)
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Japanese subject * Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months * Body mass index (BMI): 18.0-28.0 kg/m\^2 (both inclusive)
Exclusion criteria
* Loss of more than 400 mL blood (inclusive) in total with in the last 12 weeks or more than 200 mL blood (inclusive) in total within the last 4 weeks prior to screening * Smoker (defined as a subject who is smoking more than 5 cigarettes (not inclusive 5) 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 after a single dose | From 4-12 hours |
Secondary
| Measure | Time frame |
|---|---|
| Area under the insulin aspart concentration-time curve after a single dose | From 0-12 hours |
Countries
Japan
Outcome results
None listed