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)

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Administration of rosiglitazone/metformin

Study type: Observational

Funder types: Industry

Identifiers

NCT01294553

105709

Details and patient eligibility

About

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

Full 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

Enrollment: 717 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

717 participants in 1 patient group

rosiglitazone/metformin group

Description:

Korean subjects who are administered rosiglitazone/metformin according to the prescription information

Treatment:

Drug: Administration of rosiglitazone/metformin