Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Subjects
Single-Centre, Randomised, Balanced, Double- Blind, Cross-Over Trial Investigating the Bioequivalence of Formulation 2 and Formulation 4 of Biphasic Insulin Aspart 50 in Healthy Male Subjects
1 other identifier
interventional
30
1 country
1
Brief Summary
This trial is conducted in Europe. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 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 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
November 11, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 17, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
December 17, 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 (5)
tmax, time to maximum insulin aspart concentration
Area under the insulin aspart curve
Mean residence time (MRT)
t½, terminal half-life
Incidence of hypoglycaemic events
Study Arms (2)
Formulation A
EXPERIMENTALFormulation B
EXPERIMENTALInterventions
A single dose administrated subcutaneously (s.c., under the skin) on two separate dosing visits. A wash-out period of 6-12 days will take place between dosing visits
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 19.0-30.0 kg/m\^2
- Glycohemoglobin (HbA1c) within laboratory normal range
- Non-smokers
You may not qualify if:
- The receipt of any investigational drug within the last 3 months prior to this trial.
- Clinically significant abnormal haematology, biochemistry, urinalysis or ECG (electrocardiogram) screening tests, as judged by the investigator
- Liver enzyme values (ALAT and ASAT) exceeding 2 times the upper reference limit according to the local laboratory
- History of or current addiction to alcohol or drugs of abuse as determined by the investigator (positive urine drug screen and breath alcohol screen)
- HIV (human immunodeficiency virus), Hepatitis B or C positive
- Subjects with a first-degree relative with diabetes mellitus
- A history of multiple and/or severe allergies to drugs or foods or a history of anaphylactic reactions
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
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
November 11, 2003
Primary Completion
December 17, 2003
Study Completion
December 17, 2003
Last Updated
February 24, 2017
Record last verified: 2017-02