An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety and/or Efficacy of Avandamet® Administered in Korean Diabetic Patients According to the Prescribing Information
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 717
- Primary Endpoint
- Number of Participants With an Adverse Event
Overview
Brief Summary
An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of rosiglitazone/metformin administered in Korean Diabetic patients according to the prescribing information
Detailed Description
An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of rosiglitazone/metformin administered in Korean Diabetic patients according to the prescribing information
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
rosiglitazone/metformin group
Korean subjects who are administered rosiglitazone/metformin according to the prescription information
Intervention: Administration of rosiglitazone/metformin (Drug)
Outcomes
Primary Outcomes
Number of Participants With an Adverse Event
Time Frame: 41.4 weeks
An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, please see the table entitled "Other (non-serious) adverse events" in the Adverse Event section of the results record.
Secondary Outcomes
- Number of Participants With a Serious Adverse Event(41.4 weeks)
- Number of Participants With the Indicated Unexpected Adverse Events(41.4 weeks)