- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00564668
Comparison of Biphasic Insulin Aspart Produced by the NN2000 Process to Current Process to in Type 2 Diabetes
February 28, 2017 updated by: Novo Nordisk A/S
A 24-week, Randomised, Multi-centre, Double-blind, Parallel-group Trial to Investigate the Safety and the Efficacy of NN2000-Mix30 Compared to NN-X14Mix30 NovoRapid®30Mix) in Subjects With Type 2 Diabetes Mellitus on a Twice Daily Regimen
This trial is conducted in Japan.
The aim of this trial was to investigate the safety and efficacy of NN2000-Mix30 produced by NN2000 process compared to that of NN-X14Mix30 produced by current process in Japanese subjects with type 2 diabetes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
126
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
-
-
-
Tokyo, Japan, 1000005
- 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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects with type 2 diabetes
- Subjects with insulin treatment for at least 24 weeks
- Current treatment with premixed biphasic human insulin preparation for at least 12 weeks
- HbA1c lesser than or equal to 11.0%
Exclusion Criteria:
- Recurrent severe hypoglycaemia
- Proliferative retinopathy or maculopathy requiring acute treatment
- Impaired renal function
- Cardiac diseases
- Uncontrolled hypertension
- Subjects with known malignant tumour
- Total daily insulin dose greater than or equal to 100 IU
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: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety
Time Frame: During 24 weeks of treatment
|
During 24 weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
---|
HbA1c
|
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)
June 19, 2004
Primary Completion (Actual)
April 12, 2005
Study Completion (Actual)
April 12, 2005
Study Registration Dates
First Submitted
November 27, 2007
First Submitted That Met QC Criteria
November 27, 2007
First Posted (Estimate)
November 28, 2007
Study Record Updates
Last Update Posted (Actual)
March 1, 2017
Last Update Submitted That Met QC Criteria
February 28, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN2000-1611
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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