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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:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01294553
First received: February 10, 2011
Last updated: July 15, 2011
Last verified: February 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01294553

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Rosiglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014