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

Phase 1

Completed

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

• Registration Number: NCT01242826
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2010-11-16
• Study First Submitted QC: 2010-11-16
• Study First Posted: 2010-11-17
• Study Start: 2011-02
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-28
• Last Update Posted: 2015-05-29

Recruitment & Eligibility

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

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	biphasic insulin aspart 50	-

Primary Outcome Measures

Name	Time	Method
Area under the serum insulin aspart concentration-time curve from 0 to 24hours	24 hours profile after single dose of trial drug

Secondary Outcome Measures

Name	Time	Method
Area under the serum insulin aspart concentration-time curve between different time intervals	24 hours profile after single dose of trial drug
Maximum observed serum insulin aspart concentration	24 hours profile after single dose of trial drug
Number of adverse events.	After 3-10 days of treatment
Number of hypoglycaemic events	After 3-10 days of treatment