Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects
A Trial Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects
2 other identifiers
interventional
24
1 country
1
Brief Summary
This trial was conducted in Asia. The aim of this trial was to investigate the pharmacokinetic properties (the effect of the investigated drug on the body) of NN1250 (insulin degludec) 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 diabetes
Started Sep 2011
Shorter than P25 for phase_1 diabetes
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
Study Start
First participant enrolled
September 6, 2011
CompletedFirst Submitted
Initial submission to the registry
September 9, 2011
CompletedFirst Posted
Study publicly available on registry
September 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 22, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 22, 2011
CompletedMay 30, 2019
May 1, 2019
3 months
September 9, 2011
May 28, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Area under the serum insulin degludec concentration-time curve
From 0 to 120 hours after single dose
Secondary Outcomes (2)
Maximum observed serum insulin degludec concentration
0-24 hours (derived on treatment day 1).
Time to maximum observed serum insulin degludec concentration
0-24 hours (derived on treatment day 1).
Study Arms (1)
IDeg
EXPERIMENTALInterventions
For each subject, a single dose of NN1250 will be administered subcutaneously (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
- Not able or willing to refrain from smoking during the inpatient period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100032, China
Related Publications (1)
Pei H, Jiang J, Bardtrum L, Haahr H. Pharmacokinetic properties of insulin degludec in healthy Chinese subjects. Diabetes Manag 2019;9(1):20-7
BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2011
First Posted
September 21, 2011
Study Start
September 6, 2011
Primary Completion
November 22, 2011
Study Completion
November 22, 2011
Last Updated
May 30, 2019
Record last verified: 2019-05