Trial Outcomes & Findings for 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 (NCT NCT01294553)
NCT ID: NCT01294553
Last Updated: 2017-07-07
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
717 participants
Primary outcome timeframe
41.4 weeks
Results posted on
2017-07-07
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
982
|
|
Overall Study
COMPLETED
|
713
|
|
Overall Study
NOT COMPLETED
|
269
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Duplicated Participants
|
1
|
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Overall Study
Protocol Violation
|
268
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg
n=713 Participants
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
|
|---|---|
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Age, Continuous
|
56.4 Years
STANDARD_DEVIATION 11.5 • n=99 Participants
|
|
Sex: Female, Male
Female
|
369 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
344 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Korean
|
713 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Not Korean
|
0 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 41.4 weeksPopulation: Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had undergone all safety assessments
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.
Outcome measures
| Measure |
Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg
n=713 Participants
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
|
|---|---|
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Number of Participants With an Adverse Event
|
110 participants
|
SECONDARY outcome
Timeframe: 41.4 weeksPopulation: ITT Population
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.
Outcome measures
| Measure |
Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg
n=713 Participants
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
|
|---|---|
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Number of Participants With a Serious Adverse Event
|
2 participants
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SECONDARY outcome
Timeframe: 41.4 weeksPopulation: ITT Population
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.
Outcome measures
| Measure |
Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg
n=713 Participants
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
|
|---|---|
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Number of Participants With the Indicated Unexpected Adverse Events
Albuminuria
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1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Liver fatty
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1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Gastritis
|
42 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Dysaesthesia
|
5 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Impotence
|
3 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Paralysis
|
2 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Insomnia
|
2 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Depression
|
2 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Dermatitis
|
2 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Peptic ulcer
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Gastric ulcer
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Temperature changed sensation
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Dermatitis fungal
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Pneumonia
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Skeletal pain
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Osteoporosis
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Myalgia
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Anxiety
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Cystitis
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Renal calculus
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Urinary incontinence
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Vaginal haemorrhage
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Menopausal symptoms
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Glaucoma
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Coughing
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Exophthalmus
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Teratoma benign
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Cardiomyopathy
|
1 participants
|
|
Number of Participants With the Indicated Unexpected Adverse Events
Arteriosclerosis
|
1 participants
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Adverse Events
Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg
Serious events: 2 serious events
Other events: 77 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg
n=713 participants at risk
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
|
|---|---|
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Metabolism and nutrition disorders
Hyperglycaemia
|
0.14%
1/713
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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General disorders
Chest pain
|
0.14%
1/713
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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Immune system disorders
Pneumonia
|
0.14%
1/713
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
Other adverse events
| Measure |
Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg
n=713 participants at risk
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
|
|---|---|
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Immune system disorders
Upper respiratory tract infection
|
2.4%
17/713
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Metabolism and nutrition disorders
Oedema
|
2.2%
16/713
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Gastrointestinal disorders
Gastritis
|
1.3%
9/713
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
General disorders
Weight increase
|
1.1%
8/713
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.84%
6/713
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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General disorders
Headache
|
0.84%
6/713
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Nervous system disorders
Dysaesthesia
|
0.70%
5/713
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
General disorders
Chest pain
|
0.56%
4/713
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Gastrointestinal disorders
Constipation
|
0.42%
3/713
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
General disorders
Fatigue
|
0.42%
3/713
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.42%
3/713
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
|
|
Reproductive system and breast disorders
Impotence
|
0.42%
3/713
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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Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER