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 | RxWiki

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

Overview[ - collapse ][ - ]

Purpose	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
Condition	Diabetes Mellitus, Type 2
Intervention	Drug: Administration of rosiglitazone/metformin
Phase	N/A
Sponsor	GlaxoSmithKline
Responsible Party	GlaxoSmithKline
ClinicalTrials.gov Identifier	NCT01294553
First Received	February 10, 2011
Last Updated	July 15, 2011
Last verified	February 2011

Tracking Information[ + expand ][ + ]

First Received Date	February 10, 2011
Last Updated Date	July 15, 2011
Start Date	June 2004
Estimated Primary Completion Date	January 2010
Current Primary Outcome Measures	Number of Participants With an Adverse Event [Time Frame: 41.4 weeks] [Designated as safety issue: No]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.
Current Secondary Outcome Measures	Number of Participants With a Serious Adverse Event [Time Frame: 41.4 weeks] [Designated as safety issue: No]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. Number of Participants With the Indicated Unexpected Adverse Events [Time Frame: 41.4 weeks] [Designated as safety issue: No]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.

Descriptive Information[ + expand ][ + ]

Brief Title	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
Official Title	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
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 Type	Observational
Study Phase	N/A
Study Design	Time Perspective: Prospective
Condition	Diabetes Mellitus, Type 2
Intervention	Drug: Administration of rosiglitazone/metformin Subjects who are administered rosiglitazone/metformin at least once Other Names: according to label and physician's decision based on each subject's condition
Study Arm (s)	rosiglitazone/metformin group Korean subjects who are administered rosiglitazone/metformin according to the prescription information

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	717
Estimated Completion Date	January 2010
Estimated Primary Completion Date	January 2010
Eligibility Criteria	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
Gender	Both
Ages	N/A
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Not Provided

Administrative Information[ + expand ][ + ]

NCT Number	NCT01294553
Other Study ID Numbers	105709
Has Data Monitoring Committee	No
Information Provided By	GlaxoSmithKline
Study Sponsor	GlaxoSmithKline
Collaborators	Not Provided
Investigators	Study Director: GSK Clinical Trials GlaxoSmithKline
Verification Date	February 2011