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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rosiglitazone/metformin group | Korean subjects who are administered rosiglitazone/metformin according to the prescription information |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Administration of rosiglitazone/metformin | Drug | Subjects who are administered rosiglitazone/metformin at least once |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With an Adverse Event | 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. | 41.4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Serious Adverse Event | 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. |
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Inclusion criteria
Exclusion criteria
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Type II diabets mellitus patients prescribed rosiglitazone/metformin in general hospital
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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The objective of this post-marketing surveillance (PMS) study was to monitor the safety and efficacy of Avandamet in the real clinical setting after launch.
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| ID | Title | Description |
|---|---|---|
| FG000 | Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Participants were assigned to the appropriate dose of Avandamet tablet based on their current regimen (fixed dose combination of rosiglitazone and metformin, 1/500 milligrams [mg], 2/500 mg, 4/500 mg, 2/1000 mg, or 4/1000 mg). Participants were not to have exceeded the maximum recommended daily dose of 8/2000. All participants were to have started the rosiglitazone component of Avandamet at the lowest recommended dose, and all dose increases should have been accompanied by careful monitoring for adverse events related to fluid retention. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 41.4 weeks |
| Number of Participants With the Indicated Unexpected Adverse Events | 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. | 41.4 weeks |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Participants were assigned to appropriate dose of Avandamet tablet (fixed dose combination of rosiglitazone and metformin, 1/500 milligrams [mg], 2/500 mg, 4/500 mg, 2/1000 mg, or 4/1000 mg) per physician's decision based on participant's condition |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline characteristics were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants who had been administered the investigational drug at least once and had undergone all safety assessments. | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Baseline characteristics were collected in members of the ITT population, comprised of all participants who had been administered the investigational drug at least once and had undergone all safety assessments. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Baseline characteristics were collected in members of the ITT Population, comprised of all participants who had been administered the investigational drug at least once and had undergone all safety assessments. | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With an Adverse Event | 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. | Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had undergone all safety assessments | Posted | Number | participants | 41.4 weeks |
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| Secondary | Number of Participants With a Serious Adverse Event | 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. | ITT Population | Posted | Number | participants | 41.4 weeks |
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| Secondary | Number of Participants With the Indicated Unexpected Adverse Events | 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. | ITT Population | Posted | Number | participants | 41.4 weeks |
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Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Participants were assigned to appropriate dose of Avandamet tablet (fixed dose combination of rosiglitazone and metformin, 1/500 milligrams [mg], 2/500 mg, 4/500 mg, 2/1000 mg, or 4/1000 mg) per physician's decision based on participant's condition | 2 | 713 | 77 | 713 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycaemia | Metabolism and nutrition disorders | WHOART | Systematic Assessment |
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| Chest pain | General disorders | WHOART | Systematic Assessment |
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| Pneumonia | Immune system disorders | WHOART | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Immune system disorders | WHOART | Systematic Assessment |
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| Oedema | Metabolism and nutrition disorders | WHOART | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | WHOART | Systematic Assessment |
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| Weight increase | General disorders | WHOART | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | WHOART | Systematic Assessment |
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| Headache | General disorders | WHOART | Systematic Assessment |
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| Dysaesthesia | Nervous system disorders | WHOART | Systematic Assessment |
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| Chest pain | General disorders | WHOART | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | WHOART | Systematic Assessment |
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| Fatigue | General disorders | WHOART | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | WHOART | Systematic Assessment |
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| Impotence | Reproductive system and breast disorders | WHOART | Systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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