Trial Outcomes & Findings for Pioglitazone Tablets Specified Drug-use Survey <Survey on Glycemic Control in Type 2 Diabetic Patients With a History of Cerebral Infarction> (NCT NCT02181842)
NCT ID: NCT02181842
Last Updated: 2019-01-16
Results Overview
The reported data were percentage of participants who achieved good glycemic control at 48 Week. Good glycemic control was defined with fasting blood glucose level \< 130 mg/dL.
COMPLETED
246 participants
48 Week
2019-01-16
Participant Flow
Participants took part in the study at 68 investigative sites in Japan, from 29 January 2009 to 30 June 2011.
Participants with a historical diagnosis of type 2 diabetes mellitus with presence of cerebral infarction as medical history were enrolled to receive pioglitazone 15 milligram (mg) - 30 mg tablet, orally, once daily for up to 48 weeks.
Participant milestones
| Measure |
Pioglitazone
Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 48 weeks before or after breakfast in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.
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|---|---|
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Overall Study
STARTED
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246
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Overall Study
COMPLETED
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244
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Overall Study
NOT COMPLETED
|
2
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Reasons for withdrawal
| Measure |
Pioglitazone
Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 48 weeks before or after breakfast in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.
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|---|---|
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Overall Study
Case Report Forms Uncollected
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2
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Baseline Characteristics
Pioglitazone Tablets Specified Drug-use Survey <Survey on Glycemic Control in Type 2 Diabetic Patients With a History of Cerebral Infarction>
Baseline characteristics by cohort
| Measure |
Pioglitazone
n=244 Participants
Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 48 weeks before or after breakfast in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.
|
|---|---|
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Age, Continuous
|
68.0 Years
STANDARD_DEVIATION 8.38 • n=39 Participants
|
|
Sex: Female, Male
Female
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81 Participants
n=39 Participants
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Sex: Female, Male
Male
|
163 Participants
n=39 Participants
|
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Region of Enrollment
Japan
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244 Participants
n=39 Participants
|
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Duration between Diagnosis of Cerebral Infarction and Start of Pioglitazone Therapy
|
1544.8 Days
STANDARD_DEVIATION 1539.58 • n=39 Participants
|
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Duration of Impaired Glucose Tolerance (IGT)
< 1 year
|
32 Participants
n=39 Participants
|
|
Duration of Impaired Glucose Tolerance (IGT)
1 - < 5 years
|
63 Participants
n=39 Participants
|
|
Duration of Impaired Glucose Tolerance (IGT)
5 - < 10 years
|
55 Participants
n=39 Participants
|
|
Duration of Impaired Glucose Tolerance (IGT)
≥ 10 years
|
60 Participants
n=39 Participants
|
|
Duration of Impaired Glucose Tolerance (IGT)
Unknown
|
34 Participants
n=39 Participants
|
|
Predisposition to Hypersensitivity
Had no Predisposition to Hypersensitivity
|
238 Participants
n=39 Participants
|
|
Predisposition to Hypersensitivity
Had Predisposition to Hypersensitivity
|
5 Participants
n=39 Participants
|
|
Predisposition to Hypersensitivity
Unknown
|
1 Participants
n=39 Participants
|
|
Smoking Classification
Never Smoked
|
146 Participants
n=39 Participants
|
|
Smoking Classification
Current Smoker
|
43 Participants
n=39 Participants
|
|
Smoking Classification
Ex-Smoker
|
52 Participants
n=39 Participants
|
|
Smoking Classification
Unknown
|
3 Participants
n=39 Participants
|
|
Drinking Habits
Never Drank
|
130 Participants
n=39 Participants
|
|
Drinking Habits
Ex-Drinker
|
44 Participants
n=39 Participants
|
|
Drinking Habits
Current Drinker
|
68 Participants
n=39 Participants
|
|
Drinking Habits
Unknown
|
2 Participants
n=39 Participants
|
|
Height
|
159.43 centimete (cm)
STANDARD_DEVIATION 8.835 • n=39 Participants
|
|
Weight
|
63.831 kilograms (kg)
STANDARD_DEVIATION 10.9416 • n=39 Participants
|
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BMI
|
25.06 kg/m^2
STANDARD_DEVIATION 3.399 • n=39 Participants
|
|
Medical History
Had no Presence of Medical History
|
176 Participants
n=39 Participants
|
|
Medical History
Had Presence of Medical History
|
68 Participants
n=39 Participants
|
|
Medical Complications
Had no Presence of Medical Complications
|
12 Participants
n=39 Participants
|
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Medical Complications
Had Presence of Medical Complications
|
232 Participants
n=39 Participants
|
|
Initial Disease Type of Cerebral Infarction
Atherothrombotic Infarction
|
99 Participants
n=39 Participants
|
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Initial Disease Type of Cerebral Infarction
Lacunar Infarction
|
129 Participants
n=39 Participants
|
|
Initial Disease Type of Cerebral Infarction
Cardioembolic Infarction
|
6 Participants
n=39 Participants
|
|
Initial Disease Type of Cerebral Infarction
Other
|
7 Participants
n=39 Participants
|
|
Initial Disease Type of Cerebral Infarction
Unknown
|
3 Participants
n=39 Participants
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|
Severity of Initial Cerebral Infarction
Small
|
157 Participants
n=39 Participants
|
|
Severity of Initial Cerebral Infarction
Moderate
|
52 Participants
n=39 Participants
|
|
Severity of Initial Cerebral Infarction
Multiple Small to Moderate-Sized
|
31 Participants
n=39 Participants
|
|
Severity of Initial Cerebral Infarction
Severe
|
3 Participants
n=39 Participants
|
|
Severity of Initial Cerebral Infarction
Unknown
|
1 Participants
n=39 Participants
|
|
Modified Rankin Scale (mRS) at Start of Pioglitazone Therapy
Grade 0
|
81 Participants
n=39 Participants
|
|
Modified Rankin Scale (mRS) at Start of Pioglitazone Therapy
Grade 1
|
103 Participants
n=39 Participants
|
|
Modified Rankin Scale (mRS) at Start of Pioglitazone Therapy
Grade 2
|
29 Participants
n=39 Participants
|
|
Modified Rankin Scale (mRS) at Start of Pioglitazone Therapy
Grade 3
|
17 Participants
n=39 Participants
|
|
Modified Rankin Scale (mRS) at Start of Pioglitazone Therapy
Grade 4
|
13 Participants
n=39 Participants
|
|
Modified Rankin Scale (mRS) at Start of Pioglitazone Therapy
Grade 5
|
0 Participants
n=39 Participants
|
|
Modified Rankin Scale (mRS) at Start of Pioglitazone Therapy
Unknown
|
1 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 48 WeekPopulation: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'Number of Participants Analyzed ' is number of participants analyzed at the given populations.
The reported data were percentage of participants who achieved good glycemic control at 48 Week. Good glycemic control was defined with fasting blood glucose level \< 130 mg/dL.
Outcome measures
| Measure |
Pioglitazone
n=116 Participants
Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 48 weeks before or after breakfast in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.
|
|---|---|
|
Percentage of Participants Achieving Good Glycemic Control (Reduction in Fasting Blood Glucose Level < 130 mg/dL)
|
42.2 Percentage of Participants
|
PRIMARY outcome
Timeframe: 48 WeekPopulation: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here ' Number of Participants Analyzed ' is number of participants analyzed at the given populations.
The reported data were percentage of participants who achieved good glycemic control at 48 Week. Good glycemic control was defined with HbA1c (NGSP) Values \< 6.9 %.
Outcome measures
| Measure |
Pioglitazone
n=115 Participants
Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 48 weeks before or after breakfast in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.
|
|---|---|
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Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.9 %)
|
40.0 Percent age of Participants
|
PRIMARY outcome
Timeframe: From Baseline, Up to 48 WeekPopulation: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'Number of Participants Analyzed' is number of participants analyzed at the given populations.
Changes from baseline in laboratory parameter at 48 Week were reported. The reported data on this outcome measure is SBP as a one of laboratory parameters.
Outcome measures
| Measure |
Pioglitazone
n=117 Participants
Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 48 weeks before or after breakfast in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.
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|---|---|
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Changes From Baseline in Laboratory Parameters (Systolic Blood Pressure (SBP)) at 48 Week
|
-6.9 mmHg
Standard Deviation 17.89
|
PRIMARY outcome
Timeframe: From Baseline, Up to 48 WeekPopulation: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'Number of Participants Analyzed' is number of participants analyzed at the given populations.
Changes from baseline in laboratory parameter at 48 Week were reported. The reported data on this outcome measure is DBP as a one of laboratory parameters.
Outcome measures
| Measure |
Pioglitazone
n=116 Participants
Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 48 weeks before or after breakfast in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.
|
|---|---|
|
Changes From Baseline in Laboratory Parameters (Diastolic Blood Pressure (DBP)) at 48 Week
|
-5 mmHg
Standard Deviation 11.96
|
PRIMARY outcome
Timeframe: From Baseline, Up to 48 WeekPopulation: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'Number of Participants Analyzed' is number of participants analyzed at the given populations.
Changes from baseline in laboratory parameter at 48 Week were reported. The reported data on this outcome measure is HDL-Cholesterol as a one of laboratory parameters.
Outcome measures
| Measure |
Pioglitazone
n=75 Participants
Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 48 weeks before or after breakfast in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.
|
|---|---|
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Changes From Baseline in Laboratory Parameters (High-Density Lipoprotein Cholesterol (HDL-Cholesterol)) at 48 Week
|
3.97 mg/dL
Standard Deviation 8.613
|
PRIMARY outcome
Timeframe: From Baseline, Up to 48 WeekPopulation: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'Number of Participants Analyzed' is number of participants analyzed at the given populations.
Changes from baseline in laboratory parameter at 48 Week were reported. The reported data on this outcome measure is LDL-Cholesterol as a one of laboratory parameters.
Outcome measures
| Measure |
Pioglitazone
n=82 Participants
Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 48 weeks before or after breakfast in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.
|
|---|---|
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Changes From Baseline in Laboratory Parameters (Low-Density Lipoprotein Cholesterol (LDL-Cholesterol)) at 48 Week
|
-1.85 mg/dL
Standard Deviation 26.076
|
PRIMARY outcome
Timeframe: From Baseline, Up to 48 WeekPopulation: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'n' is number of participants analyzed at the given populations.
The reported data were changes from baseline in laboratory parameter, that is HbA1c (National Glycohemoglobin Standardization Program Criteria; NGSP), at 48 Week in participants stratified by specific characteristics, mean daily dose of pioglitazone, at the time of enrollment. Mean daily dose of pioglitazone at the time of enrollment were categorized into \<15 mg, 15 to \<30 mg, 30 \<45 mg and 45 mg ≤ as planned (Note; final categorized number of participants was 0 in 45 mg ≤ group).
Outcome measures
| Measure |
Pioglitazone
n=189 Participants
Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 48 weeks before or after breakfast in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.
|
|---|---|
|
Changes From Baseline in Glycosylated Hemoglobin (HbA1c) at 48 Week in Participants Stratified by Dose of Pioglitazone
<15 mg
|
-0.84 Percent HbA1c
Standard Deviation 1.59
|
|
Changes From Baseline in Glycosylated Hemoglobin (HbA1c) at 48 Week in Participants Stratified by Dose of Pioglitazone
15 to <30 mg
|
-0.73 Percent HbA1c
Standard Deviation 0.806
|
|
Changes From Baseline in Glycosylated Hemoglobin (HbA1c) at 48 Week in Participants Stratified by Dose of Pioglitazone
30 <45 mg
|
-0.98 Percent HbA1c
Standard Deviation 0.68
|
PRIMARY outcome
Timeframe: From Baseline, Up to 48 WeekPopulation: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'n' is number of participants analyzed at the given populations.
The reported data were changes from baseline in laboratory parameter, that is HbA1c (NGSP), at 48 Week in participants stratified by specific characteristics, Levels of HbA1c, at the time of enrollment. Levels of HbA1c at the time of enrollment were categorized into \<6.2%, 6.2 to \<6.9%, 6.9 \<7.4%, 7.4 \<8.4%, and 8.4% ≤ as planned (Note; final categorized number of participants was 0 in \<6.2% and 6.2 to \<6.9% group).
Outcome measures
| Measure |
Pioglitazone
n=189 Participants
Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 48 weeks before or after breakfast in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.
|
|---|---|
|
Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Levels of HbA1c
6.9 <7.4%
|
-0.36 Percent HbA1c
Standard Deviation 0.504
|
|
Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Levels of HbA1c
7.4 <8.4%
|
-0.83 Percent HbA1c
Standard Deviation 0.657
|
|
Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Levels of HbA1c
8.4% ≤
|
-1.17 Percent HbA1c
Standard Deviation 1.194
|
PRIMARY outcome
Timeframe: From Baseline, Up to 48 WeekPopulation: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'n' is number of participants analyzed at the given populations.
The reported data were changes from baseline in laboratory parameter, that is HbA1c (NGSP), at 48 Week in participants stratified by specific characteristics, Gender, at the time of enrollment. Gender was categorized into male and female.
Outcome measures
| Measure |
Pioglitazone
n=189 Participants
Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 48 weeks before or after breakfast in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.
|
|---|---|
|
Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Gender
Male
|
-0.59 Percent HbA1c
Standard Deviation 0.729
|
|
Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Gender
Female
|
-1.11 Percent HbA1c
Standard Deviation 0.911
|
PRIMARY outcome
Timeframe: From Baseline, Up to 48 WeekPopulation: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'n' is number of participants analyzed at the given populations.
The reported data were changes from baseline in laboratory parameter, that is HbA1c (NGSP), at 48 Week in participants stratified by specific characteristics, Levels of BMI, at the time of enrollment. Levels of BMI at the time of enrollment were categorized into \<18.5 kg/m\^2, 18.5 to \<25 kg/m\^2, 25 \<30 kg/m\^2, and 30 kg/m\^2 ≤.
Outcome measures
| Measure |
Pioglitazone
n=189 Participants
Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 48 weeks before or after breakfast in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.
|
|---|---|
|
Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Levels of BMI
<18.5 kg/m^2
|
-0.6 Percent HbA1c
Standard Deviation 0
|
|
Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Levels of BMI
18.5 to <25 kg/m^2
|
-0.73 Percent HbA1c
Standard Deviation 0.85
|
|
Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Levels of BMI
25 <30 kg/m^2
|
-0.81 Percent HbA1c
Standard Deviation 0.776
|
|
Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Levels of BMI
30 kg/m^2 ≤
|
-1.3 Percent HbA1c
Standard Deviation 0.972
|
PRIMARY outcome
Timeframe: From Baseline, Up to 48 WeekPopulation: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'n' is number of participants analyzed at the given populations.
The reported data were changes from baseline in laboratory parameter, that is HbA1c (NGSP), at 48 Week in participants stratified by specific characteristics, presence of companion anti-diabetes drugs, at the time of enrollment. Presence of companion anti-diabetes drugs at the time of enrollment were categorized into Had presence of companion anti-diabetes drugs and Had no presence of companion anti-diabetes drugs.
Outcome measures
| Measure |
Pioglitazone
n=189 Participants
Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 48 weeks before or after breakfast in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.
|
|---|---|
|
Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Presence of Companion Anti-Diabetes Drugs
Had no Presence of Companion Drugs
|
-0.68 Percent HbA1c
Standard Deviation 0.922
|
|
Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Presence of Companion Anti-Diabetes Drugs
Had Presence of Companion Drugs
|
-0.8 Percent HbA1c
Standard Deviation 0.8
|
PRIMARY outcome
Timeframe: Baseline and 48 WeekPopulation: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'n' is number of participants analyzed at the given populations.
Fasting blood glucose level at baseline and 48 Week were reported as one of blood glucose-related laboratory parameters.
Outcome measures
| Measure |
Pioglitazone
n=185 Participants
Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 48 weeks before or after breakfast in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.
|
|---|---|
|
Blood Glucose-Related Laboratory Parameters (Fasting Blood Glucose Level) at Each Time Point
Baseline
|
172.62 mg/dL
Standard Deviation 54.016
|
|
Blood Glucose-Related Laboratory Parameters (Fasting Blood Glucose Level) at Each Time Point
48 Week
|
147.32 mg/dL
Standard Deviation 43.102
|
PRIMARY outcome
Timeframe: Baseline and 48 WeekPopulation: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'n' is number of participants analyzed at the given populations.
HbA1c (NGSP) values at baseline and 48 Week were reported as one of blood glucose-related laboratory parameters.
Outcome measures
| Measure |
Pioglitazone
n=189 Participants
Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 48 weeks before or after breakfast in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.
|
|---|---|
|
Blood Glucose-Related Laboratory Parameters (HbA1c Values) at Each Time Point
Baseline
|
7.83 Percent
Standard Deviation 0.836
|
|
Blood Glucose-Related Laboratory Parameters (HbA1c Values) at Each Time Point
48 Week
|
7.09 Percent
Standard Deviation 0.777
|
SECONDARY outcome
Timeframe: Up to 48 WeeksPopulation: Safety Analysis Set; The safety analysis set was defined as all participants who were enrolled and completed the study.
ADRs are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
Outcome measures
| Measure |
Pioglitazone
n=244 Participants
Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 48 weeks before or after breakfast in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.
|
|---|---|
|
Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
|
23 Participants
|
Adverse Events
Pioglitazone
Serious adverse events
| Measure |
Pioglitazone
n=244 participants at risk
Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 48 weeks before or after breakfast in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.41%
1/244 • Up to Week 48
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
|
|
Infections and infestations
Pneumonia
|
0.82%
2/244 • Up to Week 48
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
|
|
Infections and infestations
Urinary tract infection
|
0.41%
1/244 • Up to Week 48
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.41%
1/244 • Up to Week 48
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.41%
1/244 • Up to Week 48
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.41%
1/244 • Up to Week 48
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.41%
1/244 • Up to Week 48
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.41%
1/244 • Up to Week 48
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
|
|
Psychiatric disorders
Depression
|
0.41%
1/244 • Up to Week 48
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
|
|
Nervous system disorders
Cerebellar infarction
|
0.41%
1/244 • Up to Week 48
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.82%
2/244 • Up to Week 48
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
|
|
Nervous system disorders
Cerebral infarction
|
1.2%
3/244 • Up to Week 48
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
|
|
Nervous system disorders
Hydrocephalus
|
0.41%
1/244 • Up to Week 48
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.41%
1/244 • Up to Week 48
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
|
|
Vascular disorders
Aortic aneurysm
|
0.41%
1/244 • Up to Week 48
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
|
|
Injury, poisoning and procedural complications
Fall
|
0.41%
1/244 • Up to Week 48
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.41%
1/244 • Up to Week 48
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
|
Other adverse events
| Measure |
Pioglitazone
n=244 participants at risk
Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 48 weeks before or after breakfast in participants based upon the disease severity. Participants will receive interventions as part of routine medical care.
|
|---|---|
|
General disorders
Oedema peripheral
|
1.2%
3/244 • Up to Week 48
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
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Investigations
Weight increased
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1.6%
4/244 • Up to Week 48
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER