Diabetes, Healthy
Conditions
Brief summary
This trial is conducted in Africa. The aim of this trial is to determine if a new formulation (U200) of insulin aspart containing 200 U/mL is bioequivalent to that of a marketed insulin aspart formulation (U100).
Interventions
DRUGinsulin aspart
Bolus 0.1 U/kg administered simultaneously with a continuous infusion of 0.029 U/kg/h via a programmed insulin pump. A total dose of 0.35 U/kg is delivered to the subject in the 12 hour infusion
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
* Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant * Normal laboratory values, electrocardiogram (ECG), and vital signs unless the investigator considers any abnormality to be clinically irrelevant * Body mass index (BMI) 18-26 kg/m\^2 (both inclusive) * Weight 60-90 kg * Non-smoker
Exclusion criteria
* Any condition requiring the regular use of any medication * Known or suspected allergy to the trial product or related products * Family history of type 1 diabetes mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve (AUC) | — |
| Area under the glucose infusion rate curve | — |
Secondary
| Measure | Time frame |
|---|---|
| Terminal half-life (t½) | — |
| Incidence of hypoglycemic events | — |
| Cmax (maximum plasma concentration) | — |
| GIRmax: The maximal GIR (glucose infusion rate) | — |
| Adverse events | — |
| Time to reach maximum (tmax) | — |
Countries
South Africa
Outcome results
None listed