Pharmacokinetics of Insulin Detemir in Healthy Chinese Male Subjects
A Single Centre, Randomised, Double-blind, Three-period Cross-over Trial to Investigate the 24-hour Pharmacokinetics After Single Dose of Insulin Detemir in Healthy Chinese Male Subjects
1 other identifier
interventional
20
1 country
1
Brief Summary
This trial is conducted in Asia. The aim of this trial is to investigate the pharmacokinetics after a single dose of insulin detemir in healthy Chinese male subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 diabetes
Started Aug 2007
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
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 21, 2011
CompletedFirst Posted
Study publicly available on registry
December 26, 2011
CompletedOctober 28, 2016
October 1, 2016
1 month
December 21, 2011
October 27, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Area under the insulin detemir concentration curve
from time zero to 24 hour
Secondary Outcomes (7)
Area under the insulin detemir concentration curve
Maximum serum insulin detemir concentration
Time to maximum serum insulin detemir concentration
Mean residence time (MRT)
Terminal half-life
- +2 more secondary outcomes
Study Arms (3)
IDet 0.2 U/kg
EXPERIMENTALIDet 0.4 U/kg
EXPERIMENTALIDet 0.8 U/kg
EXPERIMENTALInterventions
Each subject will be randomly allocated to an insulin detemir dosing sequence. Three doses of insulin detemir (0.2, 0.4 or 0.8 U/kg) will be administered on three inconsecutive days with a wash-out period between each dosing. Injected subcutaneously (s.c., under the skin)
Eligibility Criteria
You may qualify if:
- Body mass index (BMI) between 18 and 25 kg/m\^2 (both inclusive)
- Fasting plasma glucose maximum 6 mmol/L
- Non-smoker
- Considered generally healthy upon completion of medical history, physical examination and laboratory assessments, as judged by the Investigator
You may not qualify if:
- Known or suspected allergy to trial product(s) or related products
- Previous participation in this trial. Participation is defined as randomisation
- Receipt of any investigational drug within the last three months prior to this trial
- History of alcohol or drug abuse
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 Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2011
First Posted
December 26, 2011
Study Start
August 1, 2007
Primary Completion
September 1, 2007
Study Completion
September 1, 2007
Last Updated
October 28, 2016
Record last verified: 2016-10