Diabetes, Healthy
Conditions
Brief summary
This trial is conducted in Europe. The aim of the trial is to investigate the absolute bioavailability of insulin degludec (IDeg) in healthy subjects.
Interventions
DRUGinsulin degludec
A single dose of 0.4 U/kg body weight will be administered subcutaneously (s.c., under the skin).
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Considered generally healthy upon completion of medical history, physical examination, analysis of laboratory safety variables, vital signs and ECG (electrocardiogram), as judged by the investigator * Body mass index 18.0-27.0 kg/m\^2 (both inclusive)
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 serum insulin degludec concentration-of s.c. administration | From 0 to infinity after single dose |
| Area under the serum insulin degludec concentration-of i.v. administration | From 0 to infinity after single dose |
Secondary
| Measure | Time frame |
|---|---|
| Terminal half-life for insulin degludec | From 0 to 30 hours after single dose |
| Volume of distribution of insulin degludec, estimated during the terminal phase | From 0 to 30 hours after single dose |
Countries
Germany
Outcome results
None listed