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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02844790

Enrollment

Registered

2016-07-26

Start date

2016-07-26

Completion date

2016-09-27

Last updated

2020-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGinsulin degludec/insulin aspart

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026