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

Healthy Clinical Trial

Official title:

A Randomised, Open-labelled, Single-centre, Two-period Crossover Trial Characterizing the Pharmacokinetics and Pharmacodynamics of NN-X14Mix50 and NN-X14Mix70 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01620333
• Other study ID #: BIASP-1164
• Status: Completed
• Phase: Phase 1
• First received: June 13, 2012
• Last updated: January 4, 2017
• Start date: February 2000
• Est. completion date: April 2000

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2000
• Est. primary completion date: April 2000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• 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
• 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

Locations

Country	Name	City	State
Japan	Novo Nordisk Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

References & Publications (2)

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

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)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the insulin aspart curve in the interval from 0 to 24 hours (BIAsp 70)			No
Secondary	Cmax, maximum insulin aspart concentration			No
Secondary	tmax, time to maximum insulin aspart concentration			No
Secondary	t½, terminal elimination half life			No
Secondary	Mean residence time (MRT)			No
Secondary	Area under the curve from time 0 to infinity (0-8)			No
Secondary	Area under the insulin aspart curve in the interval from 0 to 24 hours (BIAsp 50)			No
Secondary	Adverse events			No

External Links

•   Clinical Trials at Novo Nordisk