Diabetes, Healthy
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to compare two formulations of insulin detemir containing an isotonic agent in healthy volunteers.
Interventions
DRUGinsulin detemir
Single dose containing mannitol as isotonic agent. Administered 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
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator * Body mass index (BMI) between 18 and 27 kg/m\^2, inclusive * Non-smoker * Fasting plasma glucose maximum 6 mmol/L
Exclusion criteria
* Known or suspected allergy to trial products or related products * Previous participation in this trial * Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 months, sterilisation, the oral contraceptive pill (which should have been taken without difficulty for at least 3 months) or an approved hormonal implant) * The receipt of any investigational drug within the last 3 months prior to this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the serum insulin detemir concentration curve | — |
| Maximum serum insulin concentration | — |
Secondary
| Measure | Time frame |
|---|---|
| Terminal serum insulin half life | — |
| Area under the serum insulin detemir concentration curve | — |
| Area under the glucose infusion rate curve | — |
| Time to maximum glucose infusion rate | — |
| Adverse events | — |
| Maximum glucose infusion rate | — |
| Time to maximum serum insulin concentration | — |
Countries
United Kingdom
Outcome results
None listed