Investigation of the Pharmacokinetic Properties of Biphasic Insulin Aspart 50 in Healthy Chinese Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01242826
First received: November 16, 2010
Last updated: June 15, 2012
Last verified: March 2012
  Purpose

This trial is conducted in Asia. The aim of this clinical trial is to investigate the pharmacokinetic properties (the rate at which the trial drug is eliminated from the body) after a single subcutaneous (under the skin) injection of biphasic insulin aspart 50 (BIAsp 50). In addition, the safety and tolerability of BIAsp 50 will be observed


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Trial Investigating the Pharmacokinetic Properties of Biphasic Insulin Aspart 50 (BIAsp 50) in Healthy Chinese Subjects

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Area under the serum insulin aspart concentration-time curve from 0 to 24hours [ Time Frame: 24 hours profile after single dose of trial drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the serum insulin aspart concentration-time curve between different time intervals [ Time Frame: 24 hours profile after single dose of trial drug ] [ Designated as safety issue: No ]
  • Maximum observed serum insulin aspart concentration [ Time Frame: 24 hours profile after single dose of trial drug ] [ Designated as safety issue: No ]
  • Number of adverse events. [ Time Frame: After 3-10 days of treatment ] [ Designated as safety issue: No ]
  • Number of hypoglycaemic events [ Time Frame: After 3-10 days of treatment ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: February 2011
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: biphasic insulin aspart 50
A single dose of 0.3 U/kg BIAsp 50 for subcutaneous (under the skin) injection

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ECG), as judged by the Investigator (the Physician)
  • Body Mass Index (BMI): 19.0-24.0 kg/m2 (both inclusive)

Exclusion Criteria:

  • Clinically significant abnormal haematology, biochemistry, lipids or urinalysis screening tests, as judged by the Investigator (the Physician)
  • A history of any illness that, in the opinion of the Investigator (the Physician), might confound the results of the trial or a pose risk in administering the trial product to the subject
  • Subject who has donated any blood or plasma in the past month or more than 400 mL within 3 months prior to screening (trial entry)
  • Not able or willing to refrain from smoking during the inpatient period
  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: NCT01242826

Locations
China, Beijing
Beijing, Beijing, China, 100730
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Xu Hongfei, MD Novo Nordisk (China) Pharmaceuticals Co., Ltd
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01242826     History of Changes
Other Study ID Numbers: BIASP-3881, U1111-1116-2307
Study First Received: November 16, 2010
Last Updated: June 15, 2012
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 28, 2014