- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00696163
Observational Study to Assess the Quality of Life and Clinical Outcomes in Subjects Using NovoMix® 30 for the Treatment of Diabetes (IMPROVE Life)
October 27, 2016 updated by: Novo Nordisk A/S
A Multicentre, Open Label, Nonrandomised, Non- Interventional, A Multicentre, Open Label, Nonrandomised, Non- Interventional, Observational Study to Evaluate the Quality of Life and Clinical Outcomes in Subjects Using Biphasic Insulin Aspart 30 (NovoMix® 30) for the Treatment of Diabetes Mellitus
This study is conducted in Asia.
The aim of this observational study is to evaluate the quality of life and clinical outcomes in subjects using NovoMix® 30 (biphasic insulin aspart 30) for the treatment of diabetes mellitus under normal clinical practice conditions in India.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
24975
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
-
-
-
Bangalore, India, 560001
- 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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Type 2 diabetes
Description
Inclusion Criteria:
- Type 2 diabetes, including newly-diagnosed who have never received insulin or an insulin analogue before, at the discretion of the physician.
Exclusion Criteria:
- Currently treated with NovoMix® 30
- Subjects who are unlikely to comply with protocol requirements
- Previously enrolled in this study
- Hypersensitivity to biphasic insulin aspart or to any of the excipients
- Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months
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
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
A
|
Being an observational study, dose of NovoMix 30 will be according to treating physician's discretion
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Quality of Life from baseline (using QoLD questionnaire)
Time Frame: From baseline to 26 weeks of treatment
|
From baseline to 26 weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety
Time Frame: After 26 weeks
|
After 26 weeks
|
Efficacy
Time Frame: After 26 weeks
|
After 26 weeks
|
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, 2008
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
June 10, 2008
First Submitted That Met QC Criteria
June 10, 2008
First Posted (Estimate)
June 12, 2008
Study Record Updates
Last Update Posted (Estimate)
October 31, 2016
Last Update Submitted That Met QC Criteria
October 27, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIASP-3555
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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