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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01620333
First received: June 13, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Diabetes
Healthy
Drug: biphasic insulin aspart 50
Drug: biphasic insulin aspart 70
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Area under the insulin aspart curve in the interval from 0 to 24 hours (BIAsp 70) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cmax, maximum insulin aspart concentration [ Designated as safety issue: No ]
  • tmax, time to maximum insulin aspart concentration [ Designated as safety issue: No ]
  • t½, terminal elimination half life [ Designated as safety issue: No ]
  • Mean residence time (MRT) [ Designated as safety issue: No ]
  • Area under the curve from time 0 to infinity (0-∞) [ Designated as safety issue: No ]
  • Area under the insulin aspart curve in the interval from 0 to 24 hours (BIAsp 50) [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: February 2000
Study Completion Date: April 2000
Primary Completion Date: April 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620333

Locations
Japan
Tokyo, Japan, 103
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Tomio Sasaki Novo Nordisk Pharma Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01620333     History of Changes
Other Study ID Numbers: BIASP-1164
Study First Received: June 13, 2012
Last Updated: June 13, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Biphasic Insulins
Insulin
Insulin Aspart
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014