- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00657319
Glycaemic Control and Quality of Care in Type 2 Diabetes on NovoMix® 30 Previously Treated With Mixtard® Insulins
January 6, 2017 updated by: Novo Nordisk A/S
This observational study is conducted in Europe.
The objective of this retrospective observational cohort analysis is to assess the changes of glycaemic control and quality of care in those Type 2 diabetic patients who were previously treated with Mixtard® insulins after 6 months of their switch to analog premix insulin NovoMix® 30 therapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
3495
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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Budapest, Hungary, 1025
- 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
Sampling Method
Probability Sample
Study Population
Adult with type 2 diabetes mellitus on premix insulin treatment.
Description
Inclusion Criteria:
- Subjects diagnosed with type 2 diabetes previously treated with BHI for at least 12 months
- Analogue premix administration for the last 6 months
Exclusion Criteria:
- Known or suspected allergy to insulin aspart
- Newly diagnosed 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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
A
|
The observation is performed under normal clinical practice conditions without any additionally required diagnostic/therapeutic features.
Physicians are allowed to decide the treatment regimen according to the medical standards.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HbA1C
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
General conditions (reason of switch, BMI, selected laboratory parameters, quality of care)
Time Frame: 6 months
|
6 months
|
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.
General Publications
- Gerö L. Improvement in metabolic control in type 2 diabetic patients after switching from biphasic human insulin (BHI) to biphasic insulin aspart 30/70 (BIAsp 30): An observational study in Hungary. ADA American Diabetes Association 2009; Country: USA City: New Orleans
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
October 1, 2007
Primary Completion (Actual)
March 1, 2008
Study Completion (Actual)
April 1, 2008
Study Registration Dates
First Submitted
April 8, 2008
First Submitted That Met QC Criteria
April 8, 2008
First Posted (Estimate)
April 14, 2008
Study Record Updates
Last Update Posted (Estimate)
January 9, 2017
Last Update Submitted That Met QC Criteria
January 6, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIASP-1939
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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