Comparison of Two Formulations of Biphasic Insulin Aspart 70
A Randomised, Double Blind, Single Centre, Three Period Crossover Trial Testing the Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 and Characterising the Pharmacokinetics of Biphasic Insulin Aspart 50 in Healthy Male Subjects
1 other identifier
interventional
24
1 country
1
Brief Summary
This trial is conducted in Europe. The aim of this trial is to compare two formulations of biphasic insulin aspart 70 and characterise the pharmacokinetics of biphasic insulin aspart 50 and biphasic insulin aspart 70 in healthy male 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 Nov 1999
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
November 3, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 1999
CompletedFirst Submitted
Initial submission to the registry
January 25, 2012
CompletedFirst Posted
Study publicly available on registry
February 1, 2012
CompletedFebruary 24, 2017
February 1, 2017
27 days
January 25, 2012
February 22, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Area under the insulin aspart curve in the interval from 0-24 hours
Secondary Outcomes (5)
Cmax, maximum insulin aspart concentration
tmax, the time to maximum insulin aspart concentration
t½, terminal half-life
Cmin, minimum glucose concentration
tmin, time to minimum concentration
Study Arms (3)
BIAsp 70 clinical trial formulation
EXPERIMENTALBIAsp 70 final formulation
EXPERIMENTALBIAsp 50 final formulation
EXPERIMENTALInterventions
A single dose administrated subcutaneously (s.c., under the skin)
A single dose administrated subcutaneously (s.c., under the skin)
Eligibility Criteria
You may qualify if:
- Caucasian
- Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
- Body mass index (BMI) between 19-27 kg/m\^2
- Fasting plasma glucose between 3.8-6.0 mmol/L
You may not qualify if:
- Participation in any other clinical trial involving other investigational products within the last three months
- Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator
- Any serious systemic infectious disease that occurred in the 4 weeks prior to the first dose of test drug
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Leeds, LS2 9NG, United Kingdom
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
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2012
First Posted
February 1, 2012
Study Start
November 3, 1999
Primary Completion
November 30, 1999
Study Completion
November 30, 1999
Last Updated
February 24, 2017
Record last verified: 2017-02