- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01707160
Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 in Healthy Volunteers
January 3, 2017 updated by: Novo Nordisk A/S
A Randomised, Double-blind 2 Way Crossover Trial to Investigate the Pharmacokinetics and Pharmacodynamics of Insulin X14 30/70 PreMix Compared to Human Insulin 30/70 PreMix in Healthy Volunteers
This trial is conducted in Europe.
The aim of this trial is to investigate the pharmacokinetics and pharmacodynamics of insulin X14 30/70 PreMix compared to human insulin 30/70 PreMix in healthy volunteers.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Leeds, United Kingdom, LS2 9NG
- Novo Nordisk INvestigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Non-smokers
- BMI (body mass index) maximum 27 kg/m^2
- HbA1c (glycosylated haemoglobin A1c): 3.4-6.1%
- FBG (fasting blood glucose) maximum 6.0 mmol/L
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment period 1
|
One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order
One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order
|
ACTIVE_COMPARATOR: Treatment period 2
|
One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order
One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Area under the Curve
|
Secondary Outcome Measures
Outcome Measure |
---|
Adverse events
|
Maximum insulin concentration (Cmax)
|
Time to maximum insulin concentration (tmax)
|
Minimum glucose concentration (Cmin(glu))
|
Time to minimum glucose concentration (tmin(glu))
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 1995
Primary Completion (ACTUAL)
December 1, 1995
Study Completion (ACTUAL)
December 1, 1995
Study Registration Dates
First Submitted
October 10, 2012
First Submitted That Met QC Criteria
October 15, 2012
First Posted (ESTIMATE)
October 16, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
January 4, 2017
Last Update Submitted That Met QC Criteria
January 3, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANA/DCD/031
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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