Diabetes, Healthy
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to demonstrate a difference between the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in healthy subjects.
Interventions
DRUGbiphasic insulin aspart 30
One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days
One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days
One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days
DRUGinsulin aspart
One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days
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 40 Years
Healthy volunteers
No
Inclusion criteria
* Body mass index between 18 and 28 kg/m\^2 inclusive * HbA1c within the normal laboratory range * Non smoker for at least three months * Females of childbearing potential using acceptable methods of contraception, including tubal ligation, an intrauterine device (IUD) , the oral contraceptive pill or barrier methods
Exclusion criteria
* Subjects who have received any investigational drug in the 3 months prior to the start of dosing * Any disease requiring regular use of non topical prescription medicines * Any serious systemic infectious disease that occurred in the 4 weeks prior to the first dose of test drug * Any intercurrent illness or endocrine disorders that may affect blood glucose * Subject with a history of drug or alcohol dependence * Subject with a first degree relative with diabetes mellitus * Subject with a history of clinically relevant allergic reactions to medical products * Subjects who have donated any blood or plasma in the past 3 month preceding screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the GIR (Glucose Infusion Rate) profile (AUC GIR) in the interval 0-120 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to maximum GIR value | — |
| Area under the GIR profile | — |
| Cmax, maximum insulin aspart concentration | — |
| Maximum GIR value | — |
| tmax, the time to maximum insulin aspart concentration | — |
| t½, terminal half-life | — |
| Area under the insulin aspart concentration curve | — |
Countries
Germany
Outcome results
None listed