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

Diabetes Mellitus, Type 2 Clinical Trial

— AVANDAMETPMS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01294553
• Other study ID #: 105709
• Status: Completed
• Phase: N/A
• First received: February 10, 2011
• Last updated: July 15, 2011
• Start date: June 2004
• Est. completion date: January 2010

Study information

• Verified date: February 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 717
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Administration of rosiglitazone/metformin
Subjects who are administered rosiglitazone/metformin at least once

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No