Trial Outcomes & Findings for Efficacy and Safety of Alogliptin Used Combination With Thiazolidine in Participants With Type 2 Diabetes in Japan (NCT NCT01318070)
NCT ID: NCT01318070
Last Updated: 2012-02-03
Results Overview
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and glycosylated hemoglobin collected at baseline.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
339 participants
Primary outcome timeframe
Baseline and Week 12.
Results posted on
2012-02-03
Participant Flow
Participants enrolled at 33 investigative sites in Japan from 22 November 2007 to 22 October 2008.
Participants with historical diagnosis of type 2 diabetes with uncontrolled blood glucose despite treatment with pioglitazone as well as diet and exercise therapies were enrolled in one of 3, once-daily (QD) treatment groups.
Participant milestones
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD
Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
Pioglitazone 15 mg or 30 mg QD
Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
111
|
113
|
115
|
|
Overall Study
COMPLETED
|
109
|
111
|
108
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
7
|
Reasons for withdrawal
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD
Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
Pioglitazone 15 mg or 30 mg QD
Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
5
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
|
Overall Study
Principal Investigator Discretion
|
1
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety of Alogliptin Used Combination With Thiazolidine in Participants With Type 2 Diabetes in Japan
Baseline characteristics by cohort
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD
n=111 Participants
Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=113 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
Pioglitazone 15 mg or 30 mg QD
n=115 Participants
Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
Total
n=339 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
≤ 64 years
|
77 participants
n=99 Participants
|
70 participants
n=107 Participants
|
77 participants
n=206 Participants
|
224 participants
n=7 Participants
|
|
Age, Customized
≥ 65 years
|
34 participants
n=99 Participants
|
43 participants
n=107 Participants
|
38 participants
n=206 Participants
|
115 participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
126 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
213 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12.Population: Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD
n=111 Participants
Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=113 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
Pioglitazone 15 mg or 30 mg QD
n=115 Participants
Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 12).
|
-0.91 percentage of Glycosylated Hemoglobin
Standard Deviation 0.441
|
-0.97 percentage of Glycosylated Hemoglobin
Standard Deviation 0.517
|
-0.19 percentage of Glycosylated Hemoglobin
Standard Deviation 0.552
|
SECONDARY outcome
Timeframe: Baseline and Week 2.Population: Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 2 and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD
n=110 Participants
Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=111 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
Pioglitazone 15 mg or 30 mg QD
n=115 Participants
Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 2).
|
-0.22 percentage of Glycosylated Hemoglobin
Standard Deviation 0.150
|
-0.22 percentage of Glycosylated Hemoglobin
Standard Deviation 0.154
|
-0.04 percentage of Glycosylated Hemoglobin
Standard Deviation 0.186
|
SECONDARY outcome
Timeframe: Baseline and Week 4.Population: Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD
n=111 Participants
Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=113 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
Pioglitazone 15 mg or 30 mg QD
n=115 Participants
Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 4).
|
-0.47 percentage of Glycosylated Hemoglobin
Standard Deviation 0.236
|
-0.46 percentage of Glycosylated Hemoglobin
Standard Deviation 0.254
|
-0.10 percentage of Glycosylated Hemoglobin
Standard Deviation 0.301
|
SECONDARY outcome
Timeframe: Baseline and Week 8.Population: Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD
n=111 Participants
Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=113 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
Pioglitazone 15 mg or 30 mg QD
n=115 Participants
Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 8).
|
-0.76 percentage of Glycosylated Hemoglobin
Standard Deviation 0.353
|
-0.81 percentage of Glycosylated Hemoglobin
Standard Deviation 0.398
|
-0.17 percentage of Glycosylated Hemoglobin
Standard Deviation 0.433
|
SECONDARY outcome
Timeframe: Baseline and Week 2.Population: Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
The change between the value of fasting plasma glucose collected at week 2 and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD
n=110 Participants
Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=113 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
Pioglitazone 15 mg or 30 mg QD
n=115 Participants
Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 2).
|
-12.8 mg/dL
Standard Deviation 14.68
|
-17.0 mg/dL
Standard Deviation 18.36
|
-3.9 mg/dL
Standard Deviation 18.25
|
SECONDARY outcome
Timeframe: Baseline and Week 4.Population: Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
The change between the value of fasting plasma glucose collected at week 4 and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD
n=111 Participants
Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=113 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
Pioglitazone 15 mg or 30 mg QD
n=115 Participants
Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 4).
|
-14.4 mg/dL
Standard Deviation 18.45
|
-17.9 mg/dL
Standard Deviation 20.16
|
-3.1 mg/dL
Standard Deviation 19.54
|
SECONDARY outcome
Timeframe: Baseline and Week 8.Population: Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
The change between the value of fasting plasma glucose collected at week 8 and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD
n=111 Participants
Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=113 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
Pioglitazone 15 mg or 30 mg QD
n=115 Participants
Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 8).
|
-17.1 mg/dL
Standard Deviation 16.96
|
-21.3 mg/dL
Standard Deviation 20.20
|
-4.2 mg/dL
Standard Deviation 22.29
|
SECONDARY outcome
Timeframe: Baseline and Week 12.Population: Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
The change between the value of fasting plasma glucose collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD
n=111 Participants
Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=113 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
Pioglitazone 15 mg or 30 mg QD
n=115 Participants
Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 12).
|
-14.9 mg/dL
Standard Deviation 18.42
|
-18.9 mg/dL
Standard Deviation 20.96
|
-2.4 mg/dL
Standard Deviation 26.84
|
SECONDARY outcome
Timeframe: Baseline and Week 12.Population: Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
The change between the value of blood glucose measured by the meal tolerance test collected at week 12 or final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD
n=110 Participants
Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=111 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
Pioglitazone 15 mg or 30 mg QD
n=109 Participants
Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).
|
58.3 mg/dL
Standard Deviation 28.75
|
49.4 mg/dL
Standard Deviation 29.27
|
70.6 mg/dL
Standard Deviation 39.58
|
Adverse Events
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Pioglitazone 15 mg or 30 mg QD
Serious events: 5 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD
n=111 participants at risk
Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=113 participants at risk
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
Pioglitazone 15 mg or 30 mg QD
n=115 participants at risk
Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
|---|---|---|---|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/111 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug.
At each visit the investigator had to document any occurrence of adverse events 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.
|
0.00%
0/113 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug.
At each visit the investigator had to document any occurrence of adverse events 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.
|
0.87%
1/115 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug.
At each visit the investigator had to document any occurrence of adverse events 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.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/111 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug.
At each visit the investigator had to document any occurrence of adverse events 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.
|
0.88%
1/113 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug.
At each visit the investigator had to document any occurrence of adverse events 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.
|
0.00%
0/115 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug.
At each visit the investigator had to document any occurrence of adverse events 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.00%
0/111 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug.
At each visit the investigator had to document any occurrence of adverse events 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.
|
0.00%
0/113 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug.
At each visit the investigator had to document any occurrence of adverse events 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.
|
0.87%
1/115 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug.
At each visit the investigator had to document any occurrence of adverse events 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.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/111 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug.
At each visit the investigator had to document any occurrence of adverse events 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.
|
0.00%
0/113 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug.
At each visit the investigator had to document any occurrence of adverse events 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.
|
0.87%
1/115 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug.
At each visit the investigator had to document any occurrence of adverse events 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.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/111 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug.
At each visit the investigator had to document any occurrence of adverse events 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.
|
0.00%
0/113 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug.
At each visit the investigator had to document any occurrence of adverse events 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.
|
0.87%
1/115 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug.
At each visit the investigator had to document any occurrence of adverse events 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.
|
|
Eye disorders
Cataract
|
0.00%
0/111 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug.
At each visit the investigator had to document any occurrence of adverse events 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.
|
0.88%
1/113 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug.
At each visit the investigator had to document any occurrence of adverse events 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.
|
0.87%
1/115 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug.
At each visit the investigator had to document any occurrence of adverse events 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.
|
|
Injury, poisoning and procedural complications
Fall
|
0.90%
1/111 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug.
At each visit the investigator had to document any occurrence of adverse events 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.
|
0.00%
0/113 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug.
At each visit the investigator had to document any occurrence of adverse events 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.
|
0.00%
0/115 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug.
At each visit the investigator had to document any occurrence of adverse events 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.
|
Other adverse events
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD
n=111 participants at risk
Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=113 participants at risk
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
Pioglitazone 15 mg or 30 mg QD
n=115 participants at risk
Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
4.5%
5/111 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug.
At each visit the investigator had to document any occurrence of adverse events 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.
|
11.5%
13/113 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug.
At each visit the investigator had to document any occurrence of adverse events 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.
|
5.2%
6/115 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug.
At each visit the investigator had to document any occurrence of adverse events 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.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/111 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug.
At each visit the investigator had to document any occurrence of adverse events 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.
|
0.00%
0/113 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug.
At each visit the investigator had to document any occurrence of adverse events 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.
|
3.5%
4/115 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug.
At each visit the investigator had to document any occurrence of adverse events 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.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/111 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug.
At each visit the investigator had to document any occurrence of adverse events 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.
|
3.5%
4/113 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug.
At each visit the investigator had to document any occurrence of adverse events 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.
|
2.6%
3/115 • Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug.
At each visit the investigator had to document any occurrence of adverse events 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.
|
Additional Information
General Manager
Japan Development Center, Pharmaceutical Development Division
Phone: +81-6-6204-5257
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The clinical trial contract states that information should never be disclosed without prior consent of the sponsor, although it does not specify the number of days during which disclosure of information is limited.
- Publication restrictions are in place
Restriction type: OTHER