Last updated: 11/07/2018 01:16:42
An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of AVANDAMET between June 2004 and January 2010AVANDAMETPMS
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
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
Trial 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
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants with an adverse event
Timeframe: 41.4 weeks
Secondary outcomes:
Number of participants with a serious adverse event
Timeframe: 41.4 weeks
Number of participants with the indicated unexpected adverse events
Timeframe: 41.4 weeks
Interventions:
Drug: Administration of rosiglitazone/metformin
Enrollment:
717
Observational study model:
Other
Primary completion date:
2009-27-12
Time perspective:
Prospective
Clinical publications:
Yil-Seob Lee, Han-Kyu Lee, Shin-Young Oh, So-Hyun Park. Post-marketing Surveillance of the Safety and Effectiveness of Rosiglitazone/Metformin in Korean Patients with Type 2 Diabetes. J Korean Soc Clin Pharmacol Ther. 2012;20(2):195-204.
Medical condition
Diabetes Mellitus, Type 2
Product
metformin, rosiglitazone, rosiglitazone/metformin
Collaborators
Not applicable
Study date(s)
June 2004 to December 2009
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable+ years
Accepts healthy volunteers
No
- Inclusion criteria
- Subjects administered with rosiglitazone/metformin as an adjunct to diet and exercise for the treatment of type2 diabetes mellitus
Inclusion and exclusion criteria
Inclusion 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 location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2009-27-12
Actual study completion date
2009-27-12
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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