An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety and/or Efficacy of AVANDAMET Between June 2004 and January 2010

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Administration of rosiglitazone/metformin


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Subjects administered with rosiglitazone/metformin as an adjunct to diet and exercise for the treatment of type2 diabetes mellitus Subjects who the investigator believes that they can and will comply with the requirements of the protocol and follow the administration regimen Subjects administered with rosiglitazone/metformin following the locally approved prescribing information Exclusion criteria Subjects with previous history of hypersensitivity to rosiglitazone and/or metformin or any other ingredient Subjects with previous history of lactic acidosis, renal disease or renal dysfunction, hepatic dysfunction, cardiogenic shock, heart failure, myocardial infarction, pulmonary infarction and any other status with stomach upset Subjects with type 1 diabetes mellitus Subjects with acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma Subjects with severe infection, pre/post surgery, severe trauma Subjects with malnutrition, inanition, emaciation, pituitary insufficiency, adrenal insufficiency Subjects undergoing radiologic studies involving intravascular administration of iodinated contrast materials
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| rosiglitazone/metformin group<br>Korean subjects who are administered rosiglitazone/metformin according to the prescription information | Drug: Administration of rosiglitazone/metformin<br>* Subjects who are administered rosiglitazone/metformin at least once<br>* Other names: according to label and physician's decision based on each subject's condition;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With an Adverse Event | 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. | 41.4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Serious Adverse Event | A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, please see the table entitled Serious Adverse Events in the Adverse Event section of the results record. | 41.4 weeks | 
| Number of Participants With the Indicated Unexpected Adverse Events | Unexpected adverse events are defined as those that were not described in the locally approved label by the Korean Food and Drug Administration (KFDA) at the time of surveillance completion. | 41.4 weeks |