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Completed

NCT Number: NCT01242826

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

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

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Healthy Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing, Beijing Municipality, 100730, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biphasic insulin aspart 50

Drug

A single dose of 0.3 U/kg BIAsp 50 for subcutaneous (under the skin) injection

Primary outcomes

  1. Area under the serum insulin aspart concentration-time curve from 0 to 24hours

    Time frame: 24 hours profile after single dose of trial drug

Secondary outcomes

  1. Area under the serum insulin aspart concentration-time curve between different time intervals

    Time frame: 24 hours profile after single dose of trial drug

  2. Maximum observed serum insulin aspart concentration

    Time frame: 24 hours profile after single dose of trial drug

  3. Number of adverse events.

    Time frame: After 3-10 days of treatment

  4. Number of hypoglycaemic events

    Time frame: After 3-10 days of treatment

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Trial Investigating the Pharmacokinetic Properties of Biphasic Insulin Aspart 50 (BIAsp 50) in Healthy Chinese Subjects

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Nov 17, 2010
Registry last updated
May 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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