Diabetes, Healthy
Conditions
Brief summary
This trial is conducted in Japan. The aim of this trial is to compare insulin aspart produced by current process and the NN2000 process in healthy Japanese subjects.
Interventions
Single dose of each formulation administered subcutaneously (s.c., under the skin) on two separate visits
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Japanese * Considered generally healthy based on medical history and physical examination * Body Mass Index (BMI) between 18 and 27 kg/m\^2 (both inclusive) * Fasting plasma glucose between 3.8 mmol/L (68.4 mg/dL) and 6.0 mmol/L (108.0 mg/dL)
Exclusion criteria
* Clinically significant abnormal values in clinical laboratory tests of haematology, biochemistry, fasting plasma glucose and urinalysis * Any serious systemic infectious disease that occurred during the last 4 weeks before trial * Any inter-current illness that may affect blood glucose * Subject with a first degree relative with diabetes mellitus * Blood donation of more than 400 mL (inclusive) in total within the last 12 weeks or more than 200 mL (inclusive) in total within the last 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve of insulin aspart concentration (AUC IAsp, 0-16h) | From 0 to 16 hours after injection |
| Maximum insulin aspart concentration (Cmax IAsp) | — |
Secondary
| Measure | Time frame |
|---|---|
| Terminal elimination half life (t½) | — |
| Area under the curve of insulin aspart concentration (AUC IAsp) | — |
| Adverse events | — |
| Body weight | — |
| Time to maximum insulin aspart concentration (tmax IAsp) | — |
Countries
Japan
Outcome results
None listed