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

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Administration of rosiglitazone/metformin

• Registration Number: NCT01294553
• Lead Sponsor: GlaxoSmithKline

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 Timeline

• Study Start: 2004-06
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2011-02
• Study First Submitted: 2011-02-10
• Study First Submitted QC: 2011-02-10
• Study First Posted: 2011-02-11
• Results First Submitted: 2011-02-17
• Results First Submitted QC: 2011-02-17
• Results First Posted: 2011-03-15
• Last Update Submitted: 2017-06-07
• Last Update Posted: 2017-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 717

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
rosiglitazone/metformin group	Administration of rosiglitazone/metformin	Korean subjects who are administered rosiglitazone/metformin according to the prescription information

Primary Outcome Measures

Name	Time	Method
Number of Participants With an Adverse Event	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 Outcome Measures

Name	Time	Method
Number of Participants With a Serious Adverse Event	41.4 weeks	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	41.4 weeks	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.