Diabetes, Healthy
Conditions
Brief summary
This trial was conducted in North America. The aim of this clinical trial was to investigate if two formulations of NN1250 (insulin degludec) have the same level of drug exposure to the body.
Interventions
DRUGinsulin degludec
Single dose of NN1250, formulation 1, 0.4U/kg body weight injected subcutaneously (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
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Considered generally healthy upon completion of medical history, physical examination, 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 Insulin Degludec concentration-time curve from 0 to 120 hours after single dose | From 0 to 120 hours after dosing |
| Maximum observed Insulin Degludec concentration after single dose | From 0 to 120 hours after dosing |
Secondary
| Measure | Time frame |
|---|---|
| Time to maximum observed Insulin Degludec concentration after single dose | From 0 to 120 hours after dosing |
| Area under the Insulin Degludec concentration-time curve from 0 to 24 hours after single dose | From 0-24 hours after dosing |
| Terminal half-life for Insulin Degludec | From 0 to 120 hours after dosing |
Countries
United States
Outcome results
None listed