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 (AVANDAMETPMS)

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

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 Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Administration of rosiglitazone/metformin

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
• Enrollment (Actual): 717

Participation Criteria

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 II diabets mellitus patients prescribed rosiglitazone/metformin in general hospital

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
rosiglitazone/metformin group; Korean subjects who are administered rosiglitazone/metformin according to the prescription information	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: February 10, 2011
• First Submitted That Met QC Criteria: February 10, 2011
• First Posted (Estimate): February 11, 2011

Study Record Updates

• Last Update Posted (Actual): July 7, 2017
• Last Update Submitted That Met QC Criteria: June 7, 2017
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin; Rosiglitazone
• Other Study ID Numbers: 105709