Diabetes, Healthy
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to show that the product of the new production process has a similar pharmacological profile to the traditional process used for the current commercial product Actrapid®.
Interventions
DRUGhuman insulin
Single dose of 0.2 IU/kg, administered 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
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant * Fasting blood glucose below or equal to 6 mmol/L * Body Mass Index (BMI) 22.0-27.0 kg/m\^2 (both inclusive)
Exclusion criteria
* Participated in another clinical study with an investigational drug within the last 4 weeks * Any condition requiring the regular use of any medication, including herbal remedies, over the counter medicines and vitamins. Occasional paracetamol is acceptable * Known or suspected allergy to the trial product or related products * Family history of type 1 diabetes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC (area under the curve) 0-8h (human insulin) | — |
| Cmax (maximum plasma concentration) | — |
| Area under the curve (glucose infusion rate (GIR)), 0-8h | — |
Secondary
| Measure | Time frame |
|---|---|
| tGIR (glucose infusion rate) max | — |
| tmax (time to reach maximum) | — |
| Physical examinations and vital signs | — |
| Area under the curve (C-peptide, 0-8h) | — |
| t½ (terminal half-life) | — |
| GIR (glucose infusion rate) max | — |
Countries
United Kingdom
Outcome results
None listed