A Trial Investigating the Pharmacokinetic Properties of Insulin Degludec/Insulin Aspart in Healthy Chinese Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: insulin degludec/insulin aspart

• Registration Number: NCT02844790
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Asia. The aim of this trial is to investigate the pharmacokinetic (the exposure of the trial drug in the body) properties of insulin degludec/insulin aspart in healthy Chinese subjects.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-07-22
• Study First Submitted QC: 2016-07-22
• Study Start: 2016-07-26
• Study First Posted: 2016-07-26
• Primary Completion: 2016-09-26
• Study Completion: 2016-09-27
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

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

Inclusion Criteria

• Male or female Chinese subject aged 18-45 years (both inclusive)
• Considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ECG), as judged by the investigator
• Body mass index 19.0-24.0 kg/m^2 (both inclusive)

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Exclusion Criteria

• A history of any illness that, in the opinion of the investigator, might confound the results of the trial or 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
• Smoking more than 5 cigarettes (including nicotine substitute products), or the equivalent, per

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IDegAsp	insulin degludec/insulin aspart	-

Primary Outcome Measures

Name	Time	Method
Area under the serum insulin degludec concentration-time curve	From 0 to 120 hours after single dose
Area under the serum insulin aspart concentration-time curve	From 0 to 12 hours after single dose

Secondary Outcome Measures

Name	Time	Method
Maximum observed serum insulin aspart concentration	After single dose (within 0 to 12 hours after dosing)
Time to maximum observed serum insulin degludec concentration	After single dose (within 0 to 120 hours after dosing)
Maximum observed serum insulin degludec concentration	After single dose (within 0 to 120 hours after dosing)
Time to maximum observed serum insulin aspart concentration	After single dose (within 0 to 12 hours after dosing)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇨🇳 Beijing, China