An Open Label, Multi-centre, Non-interv… | Clinical Trial

Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Administration of rosiglitazone/metformin

Drug

Subjects who are administered rosiglitazone/metformin at least once

Other names: according to label and physician's decision based on each subject's condition

Primary outcomes

Number of Participants With an Adverse Event

Time frame: 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 outcomes

Number of Participants With a Serious Adverse Event

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Acronym: AVANDAMETPMS

Important dates

Study start: 2004
Primary completion: 2010
Study completion: 2010
First posted: Feb 11, 2011
Registry last updated: Jul 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed