Within-subject Variability of Insulin Detemir in Healthy Volunteers
A Single-centre, Parallel-group, Randomised, Double Blind Trial in Healthy Japanese Subjects Comparing the Within-subject Variability of Insulin Detemir and Insulin Glargine With Respect to Pharmacodynamic and Pharmacokinetic Properties
1 other identifier
interventional
40
1 country
1
Brief Summary
This trial is conducted in Europe. The aim of this trial is to compare the within-subject variability of insulin detemir to that of another basal insulin analogue, insulin glargine in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 diabetes
Started May 2004
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
May 27, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2004
CompletedFirst Submitted
Initial submission to the registry
December 20, 2011
CompletedFirst Posted
Study publicly available on registry
December 22, 2011
CompletedFebruary 24, 2017
February 1, 2017
5 months
December 20, 2011
February 22, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Maximum glucose infusion rate (GIRmax)
Secondary Outcomes (5)
Area under the glucose infusion rate curve (AUCGIR)
Time to maximum glucose infusion rate (tGIRmax)
Area under the insulin concentration curve (AUC)
Maximum insulin concentration (Cmax)
Adverse events
Study Arms (2)
Insulin detemir
EXPERIMENTALInsulin glargine
ACTIVE COMPARATORInterventions
On four different dosing days where subjects enter a 24-hour euglycaemic glucose clamp procedure, the subject will be allocated to one single dose of either 0.4 U/kg insulin detemir or 0.4 U/kg insulin glargine administered subcutaneously (s.c., under the skin)
On four different dosing days where subjects enter a 24-hour euglycaemic glucose clamp procedure, the subject will be allocated to one single dose of either 0.4 U/kg insulin detemir or 0.4 U/kg insulin glargine administered subcutaneously (s.c., under the skin)
Eligibility Criteria
You may qualify if:
- Healthy Japanese men or women
- Holding a Japanese pass-port and Japanese-born parents
- Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
- Body Mass Index (BMI) between 18 and 30 kg/m\^2, incl.
- Fasting blood glucose maximum 6 mmol/L
You may not qualify if:
- Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator
- Any serious systemic infectious disease that occurred during the four weeks prior to the first dose of the trial product, as judged by the Investigator
- Subject with history of alcohol or drug dependence
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Neuss, 41460, Germany
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
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2011
First Posted
December 22, 2011
Study Start
May 27, 2004
Primary Completion
October 31, 2004
Study Completion
October 31, 2004
Last Updated
February 24, 2017
Record last verified: 2017-02