- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00184561
Effectiveness and Safety of Biphasic Insulin Aspart 70/30 in Subjects With Type 2 Diabetes
January 5, 2017 updated by: Novo Nordisk A/S
Change in HbA1c With Biphasic Insulin Aspart 70/30 in Two Different Treatment Regiments in Subjects With Type 2 Diabetes Inadequately Controlled With Oral Anti-diabetic Drug Therapy.
This trial is conducted in Asia.
This is a clinical trial investigating the effectiveness of using Biphasic Insulin Aspart 70/30 in two different treatment regiments for 6 months in subjects with type 2 diabetes, not well controlled on their current oral anti-diabetic drug therapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
321
Phase
- Phase 4
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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Beijing
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Beijing, Beijing, China, 100029
- Novo Nordisk Investigational Site
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Beijing, Beijing, China, 100730
- Novo Nordisk Investigational Site
-
-
Guangdong
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Guangzhou, Guangdong, China, 510120
- Novo Nordisk Investigational Site
-
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Hubei
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Wuhan, Hubei, China, 430022
- Novo Nordisk Investigational Site
-
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Jiangsu
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Nanjing, Jiangsu, China, 210008
- Novo Nordisk Investigational Site
-
-
Shaanxi
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Xi'an, Shaanxi, China, 710032
- Novo Nordisk Investigational Site
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Shanghai
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Shanghai, Shanghai, China, 200003
- Novo Nordisk Investigational Site
-
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Tianjin
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Tianjin, Tianjin, China, 300070
- 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 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Type 2 diabetes
- HbA1C = 7.5%
- Insulin naïve
- Current treatment by Oral Anti-diabetic Drugs
Exclusion Criteria:
- Severe medical conditions
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 |
---|---|
Change in HbA1c
Time Frame: After 24 weeks of treatment
|
After 24 weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
---|
Adverse events
|
Hypoglycaemic episodes
|
Weight change
|
Fasting blood glucose
|
2-hour postprandial blood glucose
|
after 24 weeks of treatment.
|
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
July 1, 2005
Primary Completion (Actual)
July 1, 2006
Study Completion (Actual)
July 1, 2006
Study Registration Dates
First Submitted
August 29, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Estimate)
January 6, 2017
Last Update Submitted That Met QC Criteria
January 5, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIASP-1707
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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