CompletedNCT02844790Updated Feb 17, 2020

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

A Phase 1 interventional study of insulin degludec/insulin aspart in Healthy, sponsored by Novo Nordisk A/S. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-17.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 24
Allocation: Not applicable
Ages: 18 Years to 45 Years
Sex: All

Study 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.

Conditions studied

Healthy

In context

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: All
Accepts 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

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 design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 24 participants (actual)

Study arms

Experimental
IDegAsp
Drug: insulin degludec/insulin aspart

Interventions

Druginsulin degludec/insulin aspart
A single dose of IDegAsp will be administered subcutaneously (s.c., under the skin).

What researchers measure

Primary outcomes

Area under the serum insulin degludec concentration-time curve
Time frame: 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

Secondary outcomes

Maximum observed serum insulin degludec concentration
Time frame: 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)
Time to maximum observed serum insulin degludec concentration
Time frame: 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)

Study locations

1 site

Novo Nordisk Investigational Site
Beijing, 100730, China

References and documents

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.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02844790
Lead sponsor: Novo Nordisk A/S
Responsible party: Sponsor
First posted: Jul 26, 2016
Start date: Jul 26, 2016
Primary completion: Sep 26, 2016
Completion: Sep 27, 2016
Last update: Feb 17, 2020

Study contacts

Global Clinical Registry (GCR, 1452)

study director · Novo Nordisk A/S

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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