- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00569400
Comparison of Human Insulin Produced by the Current Process and the NN729 Process in Type 1 Diabetes
February 23, 2017 updated by: Novo Nordisk A/S
Comparison of Efficacy and Safety of Human Insulin Produced by the Current Process and the NN729 Process in Type 1 Diabetes Mellitus
This trial is conducted in Asia and Oceania.
The aim of this trial is to compare the efficacy and safety of human insulin produced by the current process and the NN729 process in type 1 diabetes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
241
Phase
- Phase 3
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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Dunedin, Australia, NZ
- Novo Nordisk Investigational Site
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Hamilton, Australia, NZ
- Novo Nordisk Investigational Site
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Kippa Ring, Australia, 4021
- Novo Nordisk Investigational Site
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Miranda, Australia, 2228
- Novo Nordisk Investigational Site
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Stones Corner, Australia, 4120
- Novo Nordisk Investigational Site
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New South Wales
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Broadmeadow, New South Wales, Australia, 2292
- Novo Nordisk Investigational Site
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South Australia
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Keswick, South Australia, Australia, 5035
- Novo Nordisk Investigational Site
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Shatin, New Territories, Hong Kong
- Novo Nordisk Investigational Site
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Cheras, Malaysia, 56000
- Novo Nordisk Investigational Site
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Georgetown, Penang, Malaysia, 10450
- Novo Nordisk Investigational Site
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Kota Bharu, Kelantan, Malaysia, 16150
- Novo Nordisk Investigational Site
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Cebu City, Philippines, 6000
- Novo Nordisk Investigational Site
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Iloilo, Philippines
- Novo Nordisk Investigational Site
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Makati City, Philippines, 1200
- Novo Nordisk Investigational Site
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Marikina City, Philippines, 1800
- 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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Duration of diabetes for at least 12 months
- Basal/bolus treatment with human insulin for at least 2 months preceding trial start
- Body Mass Index (BMI) lesser than or equal to 35.0 kg/m2
- HbA1c lesser than or equal to 12.0%
Exclusion Criteria:
- Proliferative retinopathy or maculopathy requiring acute treatment or laser treatment within the last 6 months
- Any condition that the investigator and/or sponsor feel would interfere with trial participation
- Known or suspected allergy against trial product or related products
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: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Change of human insulin antibodies
Time Frame: after 26 weeks of treatment
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after 26 weeks of treatment
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Secondary Outcome Measures
Outcome Measure |
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Frequency of adverse events
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Change of human insulin antibodies
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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)
May 1, 2003
Primary Completion (Actual)
January 19, 2004
Study Completion (Actual)
January 19, 2004
Study Registration Dates
First Submitted
December 5, 2007
First Submitted That Met QC Criteria
December 6, 2007
First Posted (Estimate)
December 7, 2007
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
- NN729-1541
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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