Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 in Healthy Male Subjects
A Single-Centre, Randomised, Balanced, Double-Blind, Cross-Over Trial Investigating the Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 in Healthy Male Subjects
1 other identifier
interventional
30
1 country
1
Brief Summary
This trial is conducted in Africa. The aim of this trial is to investigate the bioequivalence of two formulations of 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 Jan 2003
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
January 20, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
February 26, 2003
CompletedFirst Submitted
Initial submission to the registry
February 2, 2012
CompletedFirst Posted
Study publicly available on registry
February 7, 2012
CompletedFebruary 24, 2017
February 1, 2017
1 month
February 2, 2012
February 22, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Area under the insulin aspart curve in the interval from 0-16 hours
Cmax, maximum insulin aspart concentration
Secondary Outcomes (7)
tmax, the time to maximum insulin aspart concentration
Area under the insulin aspart curve
Mean residence time (MRT)
The area under the glucose infusion rate curve
GIRmax, maximum glucose infusion rate value
- +2 more secondary outcomes
Study Arms (2)
Formulation A
EXPERIMENTALFormulation B
EXPERIMENTALInterventions
A single dose of each formulation administered subcutaneously (s.c., under the skin) on 2 dosing visits separated by a wash-out period of 6-12 days
Eligibility Criteria
You may qualify if:
- Considered generally healthy upon completion of medical history and physical
- examination, as judged by the investigator
- Body Mass Index (BMI) between 19-29 kg/m\^2 (both inclusive)
- Minimum body weight of 65 kg
- Fasting blood glucose between 3.8-6.0 mmol/L
- Glycohemoglobin (HbA1c) below 6.4 %
- Non-smokers
You may not qualify if:
- Clinically significant abnormal hematology, biochemistry, urinalysis or ECG (electrocardiogram) screening tests, as judged by the investigator
- A history of any illness that, in the opinion of the Investigator and/or Sponsor, might confound the results of the study or pose additional risk in administering the investigational product to the subject
- History of or current addiction to alcohol or drugs of abuse as determined by the investigator (positive drug/alcohol abuse screen)
- Hepatitis B or C
- Subjects with a first-degree relative with diabetes mellitus
- Known or suspected allergy to trial product or related products
- Smoking during the past three months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Bloemfontein, 9324, South Africa
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
February 2, 2012
First Posted
February 7, 2012
Study Start
January 20, 2003
Primary Completion
February 26, 2003
Study Completion
February 26, 2003
Last Updated
February 24, 2017
Record last verified: 2017-02