Diabetes, Healthy
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to test for bioequivalence between two formulations of Insulatard® in healthy subjects.
Interventions
Single dose of each formulation, administered subcutaneously (s.c., under the skin) on two separate dosing visits
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 18.0 and 27.0 kg/m\^2, inclusive * Non-smoker, defined as no nicotine consumption for at least one year * Fasting plasma glucose below or equal to 100 mg/dL (5.6 mmol/L)
Exclusion criteria
* Previous participation in this trial or other clinical trials within the last 3 months * Body weight above 87.5 kg * 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, or sterilisation, or the oral contraceptive pill, which should have been taken without difficulty for at least 3 months, an approved hormonal implant) * History of alcohol or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the serum insulin concentration-time curve (AUC 0-24 hours) | — |
| Maximum serum insulin concentration (Cmax) | — |
Secondary
| Measure | Time frame |
|---|---|
| Area under the serum insulin concentration-time curve (AUC 0-inifinity hours) | — |
| Time to maximum serum insulin concentration (tmax) | — |
| Terminal serum insulin half life (t½) | — |
| Adverse events | — |
Countries
Germany
Outcome results
None listed