Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Japanese Subjects

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: biphasic insulin aspart 50

Study type

Interventional

Funder types

Industry

Identifiers

NCT01527630

BIASP-1504

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

Male

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

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