Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Japan. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 (NN-X14Mix50) in healthy Japanese subjects.
Interventions
A single dose of each formulation administered subcutaneously (s.c., under the skin) on 2 dosing visits separated by a wash-out period of 6-21days
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Considered generally healthy upon completion of medical history and physical examination, as judged by the Investigator or Sub-Investigator. * Body Mass Index (BMI) between 19-29 kg/m\^2 (inclusive) * Fasting plasma glucose between 3.8-6.0 mmol/L (both inclusive)
Exclusion criteria
* Clinically significant abnormal haematology, biochemistry or urinalysis screening tests, as judged by the Investigator or Sub-Investigator * Any serious systemic infectious disease that had occurred during the 4 weeks prior to the screening, as judged by the Investigator or Sub-Investigator * Any inter-current illness that might affect blood glucose, as judged by the Investigator or Sub-Investigator * Hepatitis B or C, or HIV (human immunodeficiency virus) positive * Subjects with a first degree relative with diabetes mellitus * History of or presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematologic, neurologic, or psychiatric diseases or disorder * Subjects who consumed more than 28 units of alcohol per week or who had a significant history of alcoholism or drug/chemical abuse * Subjects who smoked more than 5 cigarettes per day * Subjects who had taken part in strenuous exercise within 7 days prior to the screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the insulin aspart concentration-time curve in the interval from 0 to 16 hours | — |
| Cmax, maximum insulin aspart concentration | — |
Secondary
| Measure | Time frame |
|---|---|
| Area under the insulin aspart concentration-time curve | — |
| Tmax, time to maximum insulin aspart concentration | — |
| MRT, mean residence time | — |
| t½, terminal half-life | — |
Countries
Japan
Outcome results
None listed