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

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

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

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Metformin; Rosiglitazone

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