Trial Outcomes & Findings for Efficacy and Safety of Alogliptin Used Combination With Metformin in Participants With Type 2 Diabetes in Japan (NCT NCT01318109)
NCT ID: NCT01318109
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 or final visit and glycosylated hemoglobin collected at baseline.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
288 participants
Primary outcome timeframe
Baseline and Week 12.
Results posted on
2012-02-03
Participant Flow
Participants enrolled at 30 investigative sites in Japan from 22 August 2008 to 28 April 2009.
Participants with a historical diagnosis of type 2 diabetes mellitus with uncontrolled blood glucose despite treatment with metformin as well as diet and exercise were enrolled in one of 3, once-daily (QD), twice daily (BID) or three times daily (TID) treatment groups.
Participant milestones
| Measure |
Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
|
Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID
Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
|
Metformin 500mg BID or 750mg TID
Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
92
|
96
|
100
|
|
Overall Study
COMPLETED
|
91
|
93
|
100
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
0
|
Reasons for withdrawal
| Measure |
Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
|
Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID
Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
|
Metformin 500mg BID or 750mg TID
Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Schedule Conflict
|
0
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety of Alogliptin Used Combination With Metformin in Participants With Type 2 Diabetes in Japan
Baseline characteristics by cohort
| Measure |
Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID
n=92 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
|
Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID
n=96 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
|
Metformin 500mg BID or 750mg TID
n=100 Participants
Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
|
Total
n=288 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
53.4 years
STANDARD_DEVIATION 8.80 • n=93 Participants
|
52.3 years
STANDARD_DEVIATION 8.02 • n=4 Participants
|
52.1 years
STANDARD_DEVIATION 8.05 • n=27 Participants
|
52.6 years
STANDARD_DEVIATION 8.28 • n=483 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
90 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=93 Participants
|
66 Participants
n=4 Participants
|
72 Participants
n=27 Participants
|
198 Participants
n=483 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 or final visit and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID
n=92 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
|
Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID
n=96 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
|
Metformin 500mg BID or 750mg TID
n=100 Participants
Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 12).
|
-0.54 percentage of Glycosylated Hemoglobin
Standard Deviation 0.562
|
-0.64 percentage of Glycosylated Hemoglobin
Standard Deviation 0.488
|
0.21 percentage of Glycosylated Hemoglobin
Standard Deviation 0.641
|
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 Metformin 500mg BID or 750mg TID
n=92 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
|
Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID
n=96 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
|
Metformin 500mg BID or 750mg TID
n=100 Participants
Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 2).
|
-0.13 percentage of Glycosylated Hemoglobin
Standard Deviation 0.196
|
-0.13 percentage of Glycosylated Hemoglobin
Standard Deviation 0.150
|
0.06 percentage of Glycosylated Hemoglobin
Standard Deviation 0.197
|
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 Metformin 500mg BID or 750mg TID
n=92 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
|
Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID
n=96 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
|
Metformin 500mg BID or 750mg TID
n=100 Participants
Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 4).
|
-0.29 percentage of Glycosylated Hemoglobin
Standard Deviation 0.279
|
-0.31 percentage of Glycosylated Hemoglobin
Standard Deviation 0.268
|
0.09 percentage of Glycosylated Hemoglobin
Standard Deviation 0.302
|
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 Metformin 500mg BID or 750mg TID
n=92 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
|
Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID
n=96 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
|
Metformin 500mg BID or 750mg TID
n=100 Participants
Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 8).
|
-0.49 percentage of Glycosylated Hemoglobin
Standard Deviation 0.488
|
-0.56 percentage of Glycosylated Hemoglobin
Standard Deviation 0.404
|
0.13 percentage of Glycosylated Hemoglobin
Standard Deviation 0.465
|
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 baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID
n=91 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
|
Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID
n=95 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
|
Metformin 500mg BID or 750mg TID
n=100 Participants
Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 2).
|
-19.2 mg/dL
Standard Deviation 21.10
|
-23.2 mg/dL
Standard Deviation 24.17
|
0.0 mg/dL
Standard Deviation 26.37
|
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 baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID
n=91 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
|
Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID
n=96 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
|
Metformin 500mg BID or 750mg TID
n=100 Participants
Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 4).
|
-19.8 mg/dL
Standard Deviation 25.28
|
-23.5 mg/dL
Standard Deviation 26.05
|
-2.2 mg/dL
Standard Deviation 23.37
|
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 baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID
n=91 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
|
Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID
n=96 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
|
Metformin 500mg BID or 750mg TID
n=100 Participants
Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 8).
|
-22.0 mg/dL
Standard Deviation 23.05
|
-21.3 mg/dL
Standard Deviation 25.30
|
-3.1 mg/dL
Standard Deviation 26.23
|
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 baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID
n=91 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
|
Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID
n=96 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
|
Metformin 500mg BID or 750mg TID
n=100 Participants
Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 12).
|
-19.0 mg/dL
Standard Deviation 23.23
|
-23.1 mg/dL
Standard Deviation 27.84
|
-0.8 mg/dL
Standard Deviation 32.20
|
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 at 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID
n=91 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
|
Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID
n=94 Participants
Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
|
Metformin 500mg BID or 750mg TID
n=100 Participants
Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).
|
61.7 mg/dL
Standard Deviation 43.42
|
64.2 mg/dL
Standard Deviation 34.76
|
70.6 mg/dL
Standard Deviation 35.31
|
Adverse Events
Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID
Serious events: 2 serious events
Other events: 37 other events
Deaths: 0 deaths
Metformin 500mg BID or 750mg TID
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID
n=92 participants at risk
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
|
Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID
n=96 participants at risk
Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
|
Metformin 500mg BID or 750mg TID
n=100 participants at risk
Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/92 • 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 through 30 days after receiving the last 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.
|
1.0%
1/96 • 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 through 30 days after receiving the last 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%
0/100 • 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 through 30 days after receiving the last 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
Mallory-Weiss syndrome
|
0.00%
0/92 • 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 through 30 days after receiving the last 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.
|
1.0%
1/96 • 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 through 30 days after receiving the last 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%
0/100 • 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 through 30 days after receiving the last 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 Metformin 500mg BID or 750mg TID
n=92 participants at risk
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
|
Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID
n=96 participants at risk
Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
|
Metformin 500mg BID or 750mg TID
n=100 participants at risk
Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
19.6%
18/92 • 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 through 30 days after receiving the last 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.
|
22.9%
22/96 • 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 through 30 days after receiving the last 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.
|
20.0%
20/100 • 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 through 30 days after receiving the last 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
Headache
|
6.5%
6/92 • 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 through 30 days after receiving the last 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%
0/96 • 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 through 30 days after receiving the last 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%
0/100 • 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 through 30 days after receiving the last 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
Conjunctivitis allergic
|
1.1%
1/92 • 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 through 30 days after receiving the last 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.
|
3.1%
3/96 • 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 through 30 days after receiving the last 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.
|
1.0%
1/100 • 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 through 30 days after receiving the last 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
Constipation
|
1.1%
1/92 • 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 through 30 days after receiving the last 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.
|
4.2%
4/96 • 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 through 30 days after receiving the last 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.
|
2.0%
2/100 • 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 through 30 days after receiving the last 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
Diarrhoea
|
5.4%
5/92 • 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 through 30 days after receiving the last 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.
|
1.0%
1/96 • 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 through 30 days after receiving the last 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.
|
1.0%
1/100 • 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 through 30 days after receiving the last 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
Abdominal discomfort
|
1.1%
1/92 • 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 through 30 days after receiving the last 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.
|
3.1%
3/96 • 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 through 30 days after receiving the last 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.
|
1.0%
1/100 • 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 through 30 days after receiving the last 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.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/92 • 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 through 30 days after receiving the last 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.
|
3.1%
3/96 • 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 through 30 days after receiving the last 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.
|
1.0%
1/100 • 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 through 30 days after receiving the last 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 lactic acid increased
|
0.00%
0/92 • 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 through 30 days after receiving the last 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.
|
1.0%
1/96 • 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 through 30 days after receiving the last 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.
|
3.0%
3/100 • 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 through 30 days after receiving the last 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