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

February 13, 2020 updated by: Novo Nordisk A/S
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100730
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IDegAsp
Drug: insulin degludec/insulin aspart
A single dose of IDegAsp will be administered subcutaneously (s.c., under the skin).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the serum insulin degludec concentration-time curve
Time Frame: From 0 to 120 hours after single dose
From 0 to 120 hours after single dose
Area under the serum insulin aspart concentration-time curve
Time Frame: From 0 to 12 hours after single dose
From 0 to 12 hours after single dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum observed serum insulin degludec concentration
Time Frame: After single dose (within 0 to 120 hours after dosing)
After single dose (within 0 to 120 hours after dosing)
Maximum observed serum insulin aspart concentration
Time Frame: After single dose (within 0 to 12 hours after dosing)
After single dose (within 0 to 12 hours after dosing)
Time to maximum observed serum insulin degludec concentration
Time Frame: After single dose (within 0 to 120 hours after dosing)
After single dose (within 0 to 120 hours after dosing)
Time to maximum observed serum insulin aspart concentration
Time Frame: After single dose (within 0 to 12 hours after dosing)
After single dose (within 0 to 12 hours after dosing)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Aixin S, Yang L, Panpan X, Qi W , Lei Y, Hongfei X, Ran LZ, Haahr H. A study investigating the pharmacokinetic properties of insulin degludec/insulin aspart in healthy Chinese subjects. Diabetes Manag. 2019; 9 (2): 48-56.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2016

Primary Completion (Actual)

September 26, 2016

Study Completion (Actual)

September 27, 2016

Study Registration Dates

First Submitted

July 22, 2016

First Submitted That Met QC Criteria

July 22, 2016

First Posted (Estimate)

July 26, 2016

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 13, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN5401-1984
  • U1111-1173-7678 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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