A Trial Investigating the Pharmacokinetic Properties of Insulin Degludec/Insulin Aspart in Healthy Chinese Subjects
2 other identifiers
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Jul 2016
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2016
CompletedFirst Posted
Study publicly available on registry
July 26, 2016
CompletedStudy Start
First participant enrolled
July 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 27, 2016
CompletedFebruary 17, 2020
February 1, 2020
2 months
July 22, 2016
February 13, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
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)
Study Arms (1)
IDegAsp
EXPERIMENTALInterventions
A single dose of IDegAsp will be administered subcutaneously (s.c., under the skin).
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Beijing, 100730, China
Related Publications (1)
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.
BACKGROUND
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2016
First Posted
July 26, 2016
Study Start
July 26, 2016
Primary Completion
September 26, 2016
Study Completion
September 27, 2016
Last Updated
February 17, 2020
Record last verified: 2020-02