Pharmacokinetics of Biphasic Insulin Aspart 50 and 70 in Japanese Healthy Volunteers

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: biphasic insulin aspart 70; Drug: biphasic insulin aspart 50

Study type: Interventional

Funder types: Industry

Identifiers

NCT01620333

BIASP-1164

Details and patient eligibility

About

This trial is conducted in Japan. The aim of this trial is to investigate the pharmacokinetics of biphasic insulin aspart 50 (NN-X14Mix50) and biphasic insulin aspart 70 (NN-X14Mix70) in Japanese healthy volunteers.

Enrollment: 24 patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy
• Japanese
• Body Mass Index (BMI) of 19-27 kg/m^2 (both inclusive)
• Fasting blood glucose between 3.8-6 mmol/L (68.4-108.0 mg/dL) (both inclusive
• Considered generally healthy upon completion of medical history and physical examination, as judged by the Investigator or Sub-Investigator

Exclusion criteria

• Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator or Sub-Investigator(s)
• Any serious systemic infectious disease that occurred during the 4 weeks prior to the screening, as judged by the Investigator or Sub-Investigator
• Any inter-current illness that may affect blood glucose, as judged by the Investigator or Sub-Investigator
• Hepatitis B or C, or HIV (human immunodeficiency virus)
• Use of prescription drugs within 2 weeks preceding the screening
• Use of non-prescription drugs, except routine vitamins or drugs that may not
• Blood donation of more than 1150 mL within the last 12 months
• Subjects with a first degree relative with diabetes mellitus
• History of or presence of diabetes
• History of or presence of cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematologic, neurologic, or psychiatric diseases or disorder
• Previous history of serious allergy or anaphylactic reaction
• Subjects who consume more than 28 units of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse
• Subjects who smoke more than 5 cigarettes per day

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Treatment period 1

Experimental group

Treatment:

Drug: biphasic insulin aspart 70

Drug: biphasic insulin aspart 50

Treatment period 2

Experimental group

Treatment:

Drug: biphasic insulin aspart 70

Drug: biphasic insulin aspart 50