- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01448070
Comparison of Human Insulin Produced by the Current Process and the NN729 Process in Healthy Volunteers
February 23, 2017 updated by: Novo Nordisk A/S
A Single Centre, Randomized, Balanced Double Blind, Cross-over Trial Investigating the Bioequivalence of Actrapid® Produced by the Current Process and Human Insulin With the Same Formulation as Actrapid®, Produced by the NN729 Process
This trial is conducted in Europe.
The aim of this trial is to show that the product of the new production process has a similar pharmacological profile to the traditional process used for the current commercial product Actrapid®.
Study Overview
Study Type
Interventional
Enrollment (Actual)
28
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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Manchester, United Kingdom, M15 6SH
- Novo Nordisk Investigational Site
-
-
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:
- Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant
- Fasting blood glucose below or equal to 6 mmol/L
- Body Mass Index (BMI) 22.0-27.0 kg/m^2 (both inclusive)
Exclusion Criteria:
- Participated in another clinical study with an investigational drug within the last 4 weeks
- Any condition requiring the regular use of any medication, including herbal remedies, over the counter medicines and vitamins. Occasional paracetamol is acceptable
- Known or suspected allergy to the trial product or related products
- Family history of type 1 diabetes
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 Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NN729 manufacturing process
|
Single dose of 0.2 IU/kg, administered subcutaneously (under the skin)
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Active Comparator: Current manufacturing process
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Single dose of 0.2 IU/kg, administered subcutaneously (under the skin)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Cmax (maximum plasma concentration)
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AUC (area under the curve) 0-8h (human insulin)
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Area under the curve (glucose infusion rate (GIR)), 0-8h
|
Secondary Outcome Measures
Outcome Measure |
---|
t½ (terminal half-life)
|
tmax (time to reach maximum)
|
GIR (glucose infusion rate) max
|
tGIR (glucose infusion rate) max
|
Area under the curve (C-peptide, 0-8h)
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Physical examinations and vital signs
|
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 (Actual)
October 15, 2002
Primary Completion (Actual)
December 20, 2002
Study Completion (Actual)
December 20, 2002
Study Registration Dates
First Submitted
October 5, 2011
First Submitted That Met QC Criteria
October 5, 2011
First Posted (Estimate)
October 7, 2011
Study Record Updates
Last Update Posted (Actual)
February 27, 2017
Last Update Submitted That Met QC Criteria
February 23, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN729-1511
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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