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

Phase 1

Completed

• Conditions: Diabetes; Healthy
• Interventions: Drug: biphasic insulin aspart 50; Drug: biphasic insulin aspart 70

• Registration Number: NCT01620333
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-02
• Primary Completion: 2000-04
• Study Completion: 2000-04
• Study First Submitted: 2012-06-13
• Study First Submitted QC: 2012-06-13
• Study First Posted: 2012-06-15
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-04
• Last Update Posted: 2017-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment period 1	biphasic insulin aspart 70	-
Treatment period 2	biphasic insulin aspart 50	-
Treatment period 2	biphasic insulin aspart 70	-
Treatment period 1	biphasic insulin aspart 50	-

Primary Outcome Measures

Name	Time	Method
Area under the insulin aspart curve in the interval from 0 to 24 hours (BIAsp 70)

Secondary Outcome Measures

Name	Time	Method
Adverse events
Cmax, maximum insulin aspart concentration
t½, terminal elimination half life
tmax, time to maximum insulin aspart concentration
Mean residence time (MRT)
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)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇯🇵 Tokyo, Japan