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Completed

NCT Number: NCT02844790

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

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Beijing, 100730, China

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

insulin degludec/insulin aspart

Drug

A single dose of IDegAsp will be administered subcutaneously (s.c., under the skin).

Primary outcomes

  1. Area under the serum insulin degludec concentration-time curve

    Time frame: From 0 to 120 hours after single dose

  2. Area under the serum insulin aspart concentration-time curve

    Time frame: From 0 to 12 hours after single dose

Secondary outcomes

  1. Maximum observed serum insulin degludec concentration

    Time frame: After single dose (within 0 to 120 hours after dosing)

  2. Maximum observed serum insulin aspart concentration

    Time frame: After single dose (within 0 to 12 hours after dosing)

  3. Time to maximum observed serum insulin degludec concentration

    Time frame: After single dose (within 0 to 120 hours after dosing)

  4. Time to maximum observed serum insulin aspart concentration

    Time frame: After single dose (within 0 to 12 hours after dosing)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 26, 2016
Registry last updated
Feb 17, 2020

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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