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

NCT ID: NCT01620333

Last Updated: 2017-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-02-29
• Study Completion Date: 2000-04-30

Brief Summary

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.

Conditions

Diabetes; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment period 1

Group Type: EXPERIMENTAL

biphasic insulin aspart 50

Intervention Type: DRUG

A single dose of 0.08 U/kg body weight, administered subcutaneously (s.c., under the skin) on two dosing visits in random order separated by 6-12 days

biphasic insulin aspart 70

Intervention Type: DRUG

A single dose of 0.08 U/kg body weight, administered subcutaneously (s.c., under the skin) on two dosing visits in random order separated by 6-12 days

Treatment period 2

Group Type: EXPERIMENTAL

biphasic insulin aspart 50

Intervention Type: DRUG

A single dose of 0.08 U/kg body weight, administered subcutaneously (s.c., under the skin) on two dosing visits in random order separated by 6-12 days

biphasic insulin aspart 70

Intervention Type: DRUG

A single dose of 0.08 U/kg body weight, administered subcutaneously (s.c., under the skin) on two dosing visits in random order separated by 6-12 days

Interventions

biphasic insulin aspart 50

A single dose of 0.08 U/kg body weight, administered subcutaneously (s.c., under the skin) on two dosing visits in random order separated by 6-12 days

Intervention Type: DRUG

biphasic insulin aspart 70

A single dose of 0.08 U/kg body weight, administered subcutaneously (s.c., under the skin) on two dosing visits in random order separated by 6-12 days

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR,1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Tokyo, , Japan

Countries

Japan

References

Irie S, Furuie H, Matsuguma K, Matsumura Y. Pharmacokinetics and pharmacodynamics of biphasic insulin aspart 50 and biphasic insulin aspart 70 in healthy Japanese subjects. Diabetologia 2006; 49 (Suppl 1): 612

Reference Type: RESULT

Irie S, Matsumura Y, Furuie H, Matsuguma K. Comparison of the pharmacokinetic and pharmacodynamic properties of biphasic insulin aspart 50 and biphasic insulin aspart 70 in healthy Japanese. Diabetic Medicine 2006; 23 (Suppl 4): 331 (P915)

Reference Type: RESULT

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

BIASP-1164

Identifier Type: -

Identifier Source: org_study_id