Diabetes Mellitus, Type 2
Conditions
Brief summary
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
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
Interventions
DRUGAdministration of rosiglitazone/metformin
Subjects who are administered rosiglitazone/metformin at least once
Sponsors
GlaxoSmithKline
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With an Adverse Event | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Serious Adverse Event | 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 | 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. |
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 713 |
| Total | 713 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Duplicated Participants | 1 |
| Overall Study | Protocol Violation | 268 |
Baseline characteristics
| Characteristic | Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg |
|---|---|
| Age, Continuous | 56.4 Years STANDARD_DEVIATION 11.5 |
| Race/Ethnicity, Customized Korean | 713 participants |
| Race/Ethnicity, Customized Not Korean | 0 participants |
| Sex: Female, Male Female | 369 Participants |
| Sex: Female, Male Male | 344 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 77 / 713 |
| serious Total, serious adverse events | 2 / 713 |
Outcome results
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.
Time frame: 41.4 weeks
Population: Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had undergone all safety assessments
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Number of Participants With an Adverse Event | 110 participants |
95% CI: [12.8, 18.1]
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.
Time frame: 41.4 weeks
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Number of Participants With a Serious Adverse Event | 2 participants |
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.
Time frame: 41.4 weeks
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Number of Participants With the Indicated Unexpected Adverse Events | Gastritis | 42 participants |
| Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Number of Participants With the Indicated Unexpected Adverse Events | Dysaesthesia | 5 participants |
| Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Number of Participants With the Indicated Unexpected Adverse Events | Impotence | 3 participants |
| Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Number of Participants With the Indicated Unexpected Adverse Events | Paralysis | 2 participants |
| Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Number of Participants With the Indicated Unexpected Adverse Events | Temperature changed sensation | 1 participants |
| Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Number of Participants With the Indicated Unexpected Adverse Events | Insomnia | 2 participants |
| Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Number of Participants With the Indicated Unexpected Adverse Events | Depression | 2 participants |
| Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Number of Participants With the Indicated Unexpected Adverse Events | Dermatitis | 2 participants |
| Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Number of Participants With the Indicated Unexpected Adverse Events | Peptic ulcer | 1 participants |
| Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Number of Participants With the Indicated Unexpected Adverse Events | Gastric ulcer | 1 participants |
| Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Number of Participants With the Indicated Unexpected Adverse Events | Dermatitis fungal | 1 participants |
| Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Number of Participants With the Indicated Unexpected Adverse Events | Pneumonia | 1 participants |
| Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Number of Participants With the Indicated Unexpected Adverse Events | Skeletal pain | 1 participants |
| Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Number of Participants With the Indicated Unexpected Adverse Events | Osteoporosis | 1 participants |
| Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Number of Participants With the Indicated Unexpected Adverse Events | Myalgia | 1 participants |
| Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Number of Participants With the Indicated Unexpected Adverse Events | Anxiety | 1 participants |
| Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Number of Participants With the Indicated Unexpected Adverse Events | Cystitis | 1 participants |
| Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Number of Participants With the Indicated Unexpected Adverse Events | Renal calculus | 1 participants |
| Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Number of Participants With the Indicated Unexpected Adverse Events | Albuminuria | 1 participants |
| Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Number of Participants With the Indicated Unexpected Adverse Events | Urinary incontinence | 1 participants |
| Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Number of Participants With the Indicated Unexpected Adverse Events | Liver fatty | 1 participants |
| Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Number of Participants With the Indicated Unexpected Adverse Events | Vaginal haemorrhage | 1 participants |
| Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Number of Participants With the Indicated Unexpected Adverse Events | Menopausal symptoms | 1 participants |
| Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Number of Participants With the Indicated Unexpected Adverse Events | Glaucoma | 1 participants |
| Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Number of Participants With the Indicated Unexpected Adverse Events | Coughing | 1 participants |
| Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Number of Participants With the Indicated Unexpected Adverse Events | Exophthalmus | 1 participants |
| Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Number of Participants With the Indicated Unexpected Adverse Events | Teratoma benign | 1 participants |
| Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Number of Participants With the Indicated Unexpected Adverse Events | Cardiomyopathy | 1 participants |
| Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg | Number of Participants With the Indicated Unexpected Adverse Events | Arteriosclerosis | 1 participants |