Diabetes, Healthy
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to compare two formulations of biphasic insulin aspart 70 and characterise the pharmacokinetics of biphasic insulin aspart 50 and biphasic insulin aspart 70 in healthy male subjects.
Detailed description
Each subject participated in three treatment periods, and were randomly assigned to each of the six treatment sequences in varying order
Interventions
A single dose administrated subcutaneously (s.c., under the skin)
A single dose administrated subcutaneously (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
MALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Caucasian * Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator * Body mass index (BMI) between 19-27 kg/m\^2 * Fasting plasma glucose between 3.8-6.0 mmol/L
Exclusion criteria
* Participation in any other clinical trial involving other investigational products within the last three months * Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator * Any serious systemic infectious disease that occurred in the 4 weeks prior to the first dose of test drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the insulin aspart curve in the interval from 0-24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Cmax, maximum insulin aspart concentration | — |
| tmax, the time to maximum insulin aspart concentration | — |
| t½, terminal half-life | — |
| Cmin, minimum glucose concentration | — |
| tmin, time to minimum concentration | — |
Countries
United Kingdom
Outcome results
None listed