Trial Outcomes & Findings for Pioglitazone/Glimepiride (Sonias) Combination Tablets Special Drug Use Surveillance Survey in Patients With Type 2 Diabetes Mellitus Who Respond Poorly to Pioglitazone (NCT NCT02098746)
NCT ID: NCT02098746
Last Updated: 2016-10-18
Results Overview
Frequency of adverse drug reactions is defined as the number of participants with adverse drug reactions. Frequency, seriousness, and time to onset of adverse drug reactions were tabulated by each symptom. Adverse events 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. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
COMPLETED
294 participants
12 months
2016-10-18
Participant Flow
This observational study took part at 64 investigative sites in Japan from 15 June 2011 to 31 July 2014.
Participants with a diagnosis of type 2 diabetes mellitus receiving treatment with pioglitazone/glimepiride 15 mg/1 mg once daily in routine clinical practice, because pioglitazone alone was not considered effective, were enrolled in the study.
Participant milestones
| Measure |
Pioglitazone/Glimepiride
Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
|
|---|---|
|
Overall Study
STARTED
|
294
|
|
Overall Study
COMPLETED
|
289
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Pioglitazone/Glimepiride
Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
|
|---|---|
|
Overall Study
Changes of Investigator
|
2
|
|
Overall Study
Other Miscellaneous Reasons
|
1
|
|
Overall Study
Enrolled 15 Days After the First Dose
|
1
|
|
Overall Study
Data Not Available After Treatment
|
1
|
Baseline Characteristics
Pioglitazone/Glimepiride (Sonias) Combination Tablets Special Drug Use Surveillance Survey in Patients With Type 2 Diabetes Mellitus Who Respond Poorly to Pioglitazone
Baseline characteristics by cohort
| Measure |
Pioglitazone/Glimepiride
n=289 Participants
Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
|
|---|---|
|
Age, Continuous
|
65.8 years
STANDARD_DEVIATION 12.56 • n=5 Participants
|
|
Age, Customized
<65 years
|
112 participants
n=5 Participants
|
|
Age, Customized
≥65 years
|
177 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
117 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
172 Participants
n=5 Participants
|
|
Pregnancy Status (Females Only)
Not pregnant
|
117 participants
n=5 Participants
|
|
Pregnancy Status (Females Only)
Pregnant
|
0 participants
n=5 Participants
|
|
Duration of Type 2 Diabetes
|
6.19 years
STANDARD_DEVIATION 5.444 • n=5 Participants
|
|
Duration of Type 2 Diabetes, Categorical
<2 years
|
56 participants
n=5 Participants
|
|
Duration of Type 2 Diabetes, Categorical
≥2 to <5 years
|
44 participants
n=5 Participants
|
|
Duration of Type 2 Diabetes, Categorical
≥5 to <10 years
|
58 participants
n=5 Participants
|
|
Duration of Type 2 Diabetes, Categorical
≥10 years
|
49 participants
n=5 Participants
|
|
Duration of Type 2 Diabetes, Categorical
Unknown
|
82 participants
n=5 Participants
|
|
Categories of Health Care
Outpatient
|
287 participants
n=5 Participants
|
|
Categories of Health Care
Inpatient
|
2 participants
n=5 Participants
|
|
History of Allergy
No
|
239 participants
n=5 Participants
|
|
History of Allergy
Yes
|
29 participants
n=5 Participants
|
|
History of Allergy
Unknown
|
21 participants
n=5 Participants
|
|
Complications of Type 2 Diabetes
No
|
25 participants
n=5 Participants
|
|
Complications of Type 2 Diabetes
Yes
|
264 participants
n=5 Participants
|
|
Breakdown of Complications (Tabulated in Duplicate)
Microangiopathy
|
31 participants
n=5 Participants
|
|
Breakdown of Complications (Tabulated in Duplicate)
Diabetic nephropathy
|
17 participants
n=5 Participants
|
|
Breakdown of Complications (Tabulated in Duplicate)
Diabetic retinopathy
|
9 participants
n=5 Participants
|
|
Breakdown of Complications (Tabulated in Duplicate)
Diabetic neuropathy
|
12 participants
n=5 Participants
|
|
Breakdown of Complications (Tabulated in Duplicate)
Hypertension
|
175 participants
n=5 Participants
|
|
Breakdown of Complications (Tabulated in Duplicate)
Dyslipidaemia
|
175 participants
n=5 Participants
|
|
Breakdown of Complications (Tabulated in Duplicate)
Hyperuricaemia
|
29 participants
n=5 Participants
|
|
Breakdown of Complications (Tabulated in Duplicate)
Liver disease
|
25 participants
n=5 Participants
|
|
Breakdown of Complications (Tabulated in Duplicate)
Renal disease
|
18 participants
n=5 Participants
|
|
Breakdown of Complications (Tabulated in Duplicate)
Heart disease
|
17 participants
n=5 Participants
|
|
Breakdown of Complications (Tabulated in Duplicate)
Cerebrovascular disease
|
15 participants
n=5 Participants
|
|
Breakdown of Complications (Tabulated in Duplicate)
Malignant tumor
|
1 participants
n=5 Participants
|
|
Breakdown of Complications (Tabulated in Duplicate)
Other
|
12 participants
n=5 Participants
|
|
Presence of Medical History
No
|
228 participants
n=5 Participants
|
|
Presence of Medical History
Yes
|
39 participants
n=5 Participants
|
|
Presence of Medical History
Unknown
|
22 participants
n=5 Participants
|
|
Weight
|
65.64 kg
STANDARD_DEVIATION 13.662 • n=5 Participants
|
|
Weight, Categorical
<40 kg
|
1 participants
n=5 Participants
|
|
Weight, Categorical
≥40 to <50 kg
|
24 participants
n=5 Participants
|
|
Weight, Categorical
≥50 to <60 kg
|
57 participants
n=5 Participants
|
|
Weight, Categorical
≥60 to <70 kg
|
81 participants
n=5 Participants
|
|
Weight, Categorical
≥70 kg
|
87 participants
n=5 Participants
|
|
Weight, Categorical
Unmeasured
|
39 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
25.45 kg/m^2
STANDARD_DEVIATION 4.230 • n=5 Participants
|
|
BMI, Categorical
<18.5 kg/m^2
|
8 participants
n=5 Participants
|
|
BMI, Categorical
≥18.5 to <25 kg/m^2
|
107 participants
n=5 Participants
|
|
BMI, Categorical
≥25 to <30 kg/m^2
|
97 participants
n=5 Participants
|
|
BMI, Categorical
≥30 kg/m^2
|
30 participants
n=5 Participants
|
|
BMI, Categorical
Unknown
|
47 participants
n=5 Participants
|
|
History of Alcohol (Drinking Alcohol-Containing Beverages Nearly Every Day)
Yes
|
167 participants
n=5 Participants
|
|
History of Alcohol (Drinking Alcohol-Containing Beverages Nearly Every Day)
No
|
81 participants
n=5 Participants
|
|
History of Alcohol (Drinking Alcohol-Containing Beverages Nearly Every Day)
Unknown
|
41 participants
n=5 Participants
|
|
Smoking Classification
Never Smoked
|
134 participants
n=5 Participants
|
|
Smoking Classification
Current Smoker
|
54 participants
n=5 Participants
|
|
Smoking Classification
Ex-smoker
|
55 participants
n=5 Participants
|
|
Smoking Classification
Unknown
|
46 participants
n=5 Participants
|
|
Compliance Rate with the Diet Regimen (at the Start of Treatment with Sonias Combination Tablets LD)
≥ 90%
|
73 participants
n=5 Participants
|
|
Compliance Rate with the Diet Regimen (at the Start of Treatment with Sonias Combination Tablets LD)
≥ 70%
|
118 participants
n=5 Participants
|
|
Compliance Rate with the Diet Regimen (at the Start of Treatment with Sonias Combination Tablets LD)
≥ 50%
|
53 participants
n=5 Participants
|
|
Compliance Rate with the Diet Regimen (at the Start of Treatment with Sonias Combination Tablets LD)
< 50%
|
18 participants
n=5 Participants
|
|
Compliance Rate with the Diet Regimen (at the Start of Treatment with Sonias Combination Tablets LD)
Not performed or compliance status is unknown
|
27 participants
n=5 Participants
|
|
Compliance Rate with the Exercise Regimen (at Start of Treatment with Sonias Combination Tablets LD)
≥ 90%
|
49 participants
n=5 Participants
|
|
Compliance Rate with the Exercise Regimen (at Start of Treatment with Sonias Combination Tablets LD)
≥ 70%
|
97 participants
n=5 Participants
|
|
Compliance Rate with the Exercise Regimen (at Start of Treatment with Sonias Combination Tablets LD)
≥ 50%
|
76 participants
n=5 Participants
|
|
Compliance Rate with the Exercise Regimen (at Start of Treatment with Sonias Combination Tablets LD)
< 50%
|
36 participants
n=5 Participants
|
|
Compliance Rate with the Exercise Regimen (at Start of Treatment with Sonias Combination Tablets LD)
Not performed or compliance status is unknown
|
31 participants
n=5 Participants
|
|
Glycosylated hemoglobin A1c (HbA1c) (at Start of Treatment with Sonias Combination Tablets LD)
|
7.75 %
STANDARD_DEVIATION 1.493 • n=5 Participants
|
|
HbA1c, Categorical
< 6.0%
|
8 participants
n=5 Participants
|
|
HbA1c, Categorical
≥ 6.0% to < 7.0%
|
66 participants
n=5 Participants
|
|
HbA1c, Categorical
≥ 7.0% to < 8.0%
|
110 participants
n=5 Participants
|
|
HbA1c, Categorical
≥ 8.0%
|
80 participants
n=5 Participants
|
|
HbA1c, Categorical
Unknown
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The Safety Analysis Set (safety assessment population) included all patients who received at least one dose of pioglitazone/glimepiride (N=289).
Frequency of adverse drug reactions is defined as the number of participants with adverse drug reactions. Frequency, seriousness, and time to onset of adverse drug reactions were tabulated by each symptom. Adverse events 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. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Outcome measures
| Measure |
Pioglitazone/Glimepiride
n=289 Participants
Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
|
|---|---|
|
Frequency of Adverse Drug Reactions
Anaemia
|
1 participants
|
|
Frequency of Adverse Drug Reactions
Hypoglycaemia
|
7 participants
|
|
Frequency of Adverse Drug Reactions
Generalised oedema
|
1 participants
|
|
Frequency of Adverse Drug Reactions
Oedema
|
1 participants
|
|
Frequency of Adverse Drug Reactions
Weight increased
|
6 participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The Safety Analysis Set (safety assessment population) included all patients who received at least one dose of pioglitazone/glimepiride (N=289).
Frequency of serious adverse drug reactions is defined at the number of participants with serious adverse drug reactions. Frequency of serious adverse drug reactions were tabulated by each symptom. Adverse events 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. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Outcome measures
| Measure |
Pioglitazone/Glimepiride
n=289 Participants
Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
|
|---|---|
|
Frequency of Serious Adverse Drug Reactions
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 9, 12 and at Final assessmentPopulation: The analysis was performed on the efficacy assessment population (N=250) with data available at the given time-point.
Tabulation of HbA1c values and the changes from Baseline at each test time point (test value at each test time point after Baseline - test value at Baseline). A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Pioglitazone/Glimepiride
n=250 Participants
Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
|
|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Month 3 (n=234)
|
-0.83 percent
Standard Deviation 1.030
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Month 6 (n=190)
|
-0.84 percent
Standard Deviation 1.094
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Month 9 (n=177)
|
-0.83 percent
Standard Deviation 1.088
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Month 12 (n=84)
|
-0.62 percent
Standard Deviation 1.139
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Final Assessment (n=247)
|
-0.92 percent
Standard Deviation 1.285
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 9, 12 and at Final assessmentPopulation: The analysis was performed on the efficacy assessment population (N=250) with data available at the given time-point.
Tabulation of fasting blood glucose level and the changes from Baseline at each test time point (test value at each test time point after Baseline - test value at Baseline). A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Pioglitazone/Glimepiride
n=250 Participants
Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
|
|---|---|
|
Change From Baseline in Fasting Blood Glucose Level
Month 3 (n=76)
|
-15.9 mg/dL
Standard Deviation 35.99
|
|
Change From Baseline in Fasting Blood Glucose Level
Month 6 (n=59)
|
-23.2 mg/dL
Standard Deviation 40.11
|
|
Change From Baseline in Fasting Blood Glucose Level
Month 9 (n=53)
|
-12.7 mg/dL
Standard Deviation 37.60
|
|
Change From Baseline in Fasting Blood Glucose Level
Month 12 (n=28)
|
-17.0 mg/dL
Standard Deviation 20.42
|
|
Change From Baseline in Fasting Blood Glucose Level
Final Assessment (n=83)
|
-17.7 mg/dL
Standard Deviation 42.23
|
SECONDARY outcome
Timeframe: Baseline, Months 3, 6, 9, 12 and at Final assessmentPopulation: The analysis was performed on the efficacy assessment population (N=250) with data available at the given time-point.
Tabulation of fasting insulin level and the changes from Baseline at each test time point (test value at each test time point after Baseline - test value at Baseline). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening.
Outcome measures
| Measure |
Pioglitazone/Glimepiride
n=250 Participants
Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
|
|---|---|
|
Change From Baseline in Fasting Insulin Level
Month 3 (n=33)
|
1.66 μU/dL
Standard Deviation 9.419
|
|
Change From Baseline in Fasting Insulin Level
Month 6 (n=25)
|
-0.25 μU/dL
Standard Deviation 3.976
|
|
Change From Baseline in Fasting Insulin Level
Month 9 (n=17)
|
1.32 μU/dL
Standard Deviation 3.949
|
|
Change From Baseline in Fasting Insulin Level
Month 12 (n=15)
|
-0.29 μU/dL
Standard Deviation 3.489
|
|
Change From Baseline in Fasting Insulin Level
Final Assessment (n=39)
|
0.98 μU/dL
Standard Deviation 7.310
|
Adverse Events
Pioglitazone/Glimepiride
Serious adverse events
| Measure |
Pioglitazone/Glimepiride
n=289 participants at risk
Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.35%
1/289 • 12 Months
Safety Analysis Set included all patients who received at least one dose of pioglitazone/glimepiride. At each visit the investigator documented any occurrence of adverse events. Any event that occurred during the observation period was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.35%
1/289 • 12 Months
Safety Analysis Set included all patients who received at least one dose of pioglitazone/glimepiride. At each visit the investigator documented any occurrence of adverse events. Any event that occurred during the observation period was recorded, irrespective of the relation to study treatment.
|
Other adverse events
Adverse event data not reported
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