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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Diabetes
• Intervention / Treatment: Drug: biphasic insulin aspart 50; Drug: biphasic insulin aspart 70

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan, 1000005
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment period 1	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; 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
EXPERIMENTAL: Treatment period 2	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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Area under the insulin aspart curve in the interval from 0 to 24 hours (BIAsp 70)

Secondary Outcome Measures

Outcome Measure
Mean residence time (MRT)
Adverse events
Cmax, maximum insulin aspart concentration
tmax, time to maximum insulin aspart concentration
t½, terminal elimination half life
Area under the curve from time 0 to infinity (0-∞)
Area under the insulin aspart curve in the interval from 0 to 24 hours (BIAsp 50)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

General Publications

• 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)

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: February 1, 2000
• Primary Completion (ACTUAL): April 1, 2000
• Study Completion (ACTUAL): April 1, 2000

Study Registration Dates

• First Submitted: June 13, 2012
• First Submitted That Met QC Criteria: June 13, 2012
• First Posted (ESTIMATE): June 15, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): January 5, 2017
• Last Update Submitted That Met QC Criteria: January 4, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Biphasic Insulins
• Other Study ID Numbers: BIASP-1164