- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00318786
Efficacy and Safety of Three Times a Day BIAsp-70 Compared to Two Times a Day BIAsp-30 in Subjects With Type 2 Diabetes
January 5, 2017 updated by: Novo Nordisk A/S
Trial to Investigate the Efficacy and the Safety of Thrice-Daily NN2000-Mix70 (NovoRapid 70 Mix) Compared to Twice-Daily NN-X14Mix30 (NovoRapid 30 Mix) in Subjects With Type 2 Diabetes Mellitus
This trial is conducted in Japan.
This a clinical trial to study the efficacy and safety of three times a day BIAsp-70 compared to two times a day BIAsp-30 in subjects with type 2 diabetes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
289
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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-
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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
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects with type 2 diabetes
- Current treatment using intermediate-acting, long-acting insulin (including long-acting insulin analogue) or pre-mixed human insulin for at least 24 weeks
- HbA1c at least 7.5% and below 10.0%
Exclusion Criteria:
- Proliferative retinopathy or maculopathy requiring acute treatment
- Impaired hepatic and/or renal function
- Cardiac diseases
- Uncontrolled hypertension
- Known hypoglycemia unawareness or recurrent major hypoglycemia
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 |
---|---|
Hemoglobin A1C (HbA1C)
Time Frame: After 16 weeks of treatment
|
After 16 weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
---|
HbA1C, after 28 weeks of treatment; Plasma glucose levels
|
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
April 1, 2006
Primary Completion (Actual)
June 1, 2007
Study Completion (Actual)
June 1, 2007
Study Registration Dates
First Submitted
April 26, 2006
First Submitted That Met QC Criteria
April 26, 2006
First Posted (Estimate)
April 27, 2006
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-1598
- JapicCTI-060241 (Registry Identifier: japic)
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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