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Clinical Trials/NCT02844790
NCT02844790CompletedPhase 1

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

Novo Nordisk A/S1 site in 1 country24 target enrollmentStarted: July 26, 2016Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
24
Locations
1
Primary Endpoint
Area under the serum insulin degludec concentration-time curve
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
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

  • •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

Arms & Interventions

IDegAsp

Experimental

Intervention: insulin degludec/insulin aspart (Drug)

Outcomes

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 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))

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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