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)
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01294553
First received: February 10, 2011
Last updated: July 15, 2011
Last verified: February 2011
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Purpose
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
| Condition | Intervention |
|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: Administration of rosiglitazone/metformin |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| 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 |
Resource links provided by NLM:
Drug Information available for:
Metformin
Metformin hydrochloride
Rosiglitazone
Rosiglitazone Maleate
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Number of Participants With an Adverse Event [ Time Frame: 41.4 weeks ] [ Designated as safety issue: No ]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 Outcome Measures:
- Number of Participants With a Serious Adverse Event [ Time Frame: 41.4 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
| Enrollment: | 717 |
| Study Start Date: | June 2004 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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 Name: according to label and physician's decision based on each subject's condition
|
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
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Type II diabets mellitus patients prescribed rosiglitazone/metformin in general hospital
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT01294553 History of Changes |
| Other Study ID Numbers: | 105709 |
| Study First Received: | February 10, 2011 |
| Results First Received: | February 17, 2011 |
| Last Updated: | July 15, 2011 |
| Health Authority: | Korea: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Rosiglitazone Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013