Trial Outcomes & Findings for Efficacy and Safety of Alogliptin Used in Combination With Sulfonylurea in Participants With Type 2 Diabetes in Japan (NCT NCT01318083)
NCT ID: NCT01318083
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
312 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 20 August 2008 to 18 April 2009.
Participants with a historical diagnosis of type 2 diabetes mellitus with uncontrolled blood glucose despite treatment with sulfonylurea as well as diet and exercise therapies were enrolled in one of 3, once-daily (QD) or twice daily (BID) treatment groups.
Participant milestones
| Measure |
Alogliptin 12.5 mg QD and Glimepiride QD or BID
Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
|
Alogliptin 25 mg QD and Glimepiride QD or BID
Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
|
Glimepiride 1, 2, 3 or 4 mg QD or BID
Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
105
|
104
|
103
|
|
Overall Study
COMPLETED
|
99
|
102
|
98
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
5
|
Reasons for withdrawal
| Measure |
Alogliptin 12.5 mg QD and Glimepiride QD or BID
Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
|
Alogliptin 25 mg QD and Glimepiride QD or BID
Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
|
Glimepiride 1, 2, 3 or 4 mg QD or BID
Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
|
Overall Study
Treatment Complications
|
1
|
0
|
0
|
|
Overall Study
Lack of Study Medication Compliance
|
0
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety of Alogliptin Used in Combination With Sulfonylurea in Participants With Type 2 Diabetes in Japan
Baseline characteristics by cohort
| Measure |
Alogliptin 12.5 mg QD and Glimepiride QD or BID
n=105 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
|
Alogliptin 25 mg QD and Glimepiride QD or BID
n=104 Participants
Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
|
Glimepiride 1, 2, 3 or 4 mg QD or BID
n=103 Participants
Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
|
Total
n=312 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
≤ 64 years
|
66 participants
n=39 Participants
|
73 participants
n=41 Participants
|
64 participants
n=35 Participants
|
203 participants
n=31 Participants
|
|
Age, Customized
≥ 65 years
|
39 participants
n=39 Participants
|
31 participants
n=41 Participants
|
39 participants
n=35 Participants
|
109 participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=39 Participants
|
37 Participants
n=41 Participants
|
32 Participants
n=35 Participants
|
108 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=39 Participants
|
67 Participants
n=41 Participants
|
71 Participants
n=35 Participants
|
204 Participants
n=31 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 Glimepiride QD or BID
n=104 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
|
Alogliptin 25 mg QD and Glimepiride QD or BID
n=104 Participants
Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
|
Glimepiride 1, 2, 3 or 4 mg QD or BID
n=103 Participants
Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 12).
|
-0.60 percentage of Glycosylated Hemoglobin
Standard Deviation 0.563
|
-0.66 percentage of Glycosylated Hemoglobin
Standard Deviation 0.564
|
0.34 percentage of Glycosylated Hemoglobin
Standard Deviation 0.611
|
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 Glimepiride QD or BID
n=104 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
|
Alogliptin 25 mg QD and Glimepiride QD or BID
n=104 Participants
Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
|
Glimepiride 1, 2, 3 or 4 mg QD or BID
n=103 Participants
Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 2).
|
-0.12 percentage of Glycosylated Hemoglobin
Standard Deviation 0.244
|
-0.13 percentage of Glycosylated Hemoglobin
Standard Deviation 0.206
|
0.08 percentage of Glycosylated Hemoglobin
Standard Deviation 0.229
|
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 Glimepiride QD or BID
n=104 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
|
Alogliptin 25 mg QD and Glimepiride QD or BID
n=104 Participants
Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
|
Glimepiride 1, 2, 3 or 4 mg QD or BID
n=103 Participants
Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 4).
|
-0.32 percentage of Glycosylated Hemoglobin
Standard Deviation 0.357
|
-0.36 percentage of Glycosylated Hemoglobin
Standard Deviation 0.339
|
0.09 percentage of Glycosylated Hemoglobin
Standard Deviation 0.351
|
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 Glimepiride QD or BID
n=104 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
|
Alogliptin 25 mg QD and Glimepiride QD or BID
n=104 Participants
Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
|
Glimepiride 1, 2, 3 or 4 mg QD or BID
n=103 Participants
Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 8).
|
-0.52 percentage of Glycosylated Hemoglobin
Standard Deviation 0.488
|
-0.59 percentage of Glycosylated Hemoglobin
Standard Deviation 0.504
|
0.18 percentage of Glycosylated Hemoglobin
Standard Deviation 0.525
|
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 Glimepiride QD or BID
n=104 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
|
Alogliptin 25 mg QD and Glimepiride QD or BID
n=104 Participants
Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
|
Glimepiride 1, 2, 3 or 4 mg QD or BID
n=103 Participants
Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 2).
|
-17.5 mg/dL
Standard Deviation 26.05
|
-17.4 mg/dL
Standard Deviation 29.19
|
0.2 mg/dL
Standard Deviation 24.12
|
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 Glimepiride QD or BID
n=104 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
|
Alogliptin 25 mg QD and Glimepiride QD or BID
n=104 Participants
Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
|
Glimepiride 1, 2, 3 or 4 mg QD or BID
n=103 Participants
Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 4).
|
-21.2 mg/dL
Standard Deviation 27.33
|
-22.9 mg/dL
Standard Deviation 29.33
|
2.0 mg/dL
Standard Deviation 24.83
|
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 Glimepiride QD or BID
n=104 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
|
Alogliptin 25 mg QD and Glimepiride QD or BID
n=104 Participants
Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
|
Glimepiride 1, 2, 3 or 4 mg QD or BID
n=103 Participants
Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 8).
|
-22.3 mg/dL
Standard Deviation 26.40
|
-17.4 mg/dL
Standard Deviation 28.88
|
5.3 mg/dL
Standard Deviation 29.75
|
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 Glimepiride QD or BID
n=104 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
|
Alogliptin 25 mg QD and Glimepiride QD or BID
n=104 Participants
Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
|
Glimepiride 1, 2, 3 or 4 mg QD or BID
n=103 Participants
Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 12).
|
-22.3 mg/dL
Standard Deviation 31.05
|
-15.9 mg/dL
Standard Deviation 28.12
|
6.0 mg/dL
Standard Deviation 32.97
|
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 Glimepiride QD or BID
n=101 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
|
Alogliptin 25 mg QD and Glimepiride QD or BID
n=103 Participants
Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
|
Glimepiride 1, 2, 3 or 4 mg QD or BID
n=99 Participants
Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice 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).
|
76.6 mg/dL
Standard Deviation 41.51
|
80.9 mg/dL
Standard Deviation 50.08
|
100.0 mg/dL
Standard Deviation 52.44
|
Adverse Events
Alogliptin 12.5 mg QD and Glimepiride QD or BID
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
Alogliptin 25 mg QD and Glimepiride QD or BID
Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths
Glimepiride 1, 2, 3 or 4 mg QD or BID
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alogliptin 12.5 mg QD and Glimepiride QD or BID
n=105 participants at risk
Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
|
Alogliptin 25 mg QD and Glimepiride QD or BID
n=104 participants at risk
Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
|
Glimepiride 1, 2, 3 or 4 mg QD or BID
n=103 participants at risk
Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
|
|---|---|---|---|
|
Nervous system disorders
Cerebral infarction
|
0.95%
1/105 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and 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%
0/104 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and 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%
0/103 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.95%
1/105 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and 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%
0/104 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and 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%
0/103 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.95%
1/105 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and 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%
0/104 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and 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%
0/103 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and 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.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/105 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and 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.
|
0.96%
1/104 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and 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%
0/103 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and 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 Glimepiride QD or BID
n=105 participants at risk
Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
|
Alogliptin 25 mg QD and Glimepiride QD or BID
n=104 participants at risk
Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
|
Glimepiride 1, 2, 3 or 4 mg QD or BID
n=103 participants at risk
Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
19.0%
20/105 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and 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.
|
19.2%
20/104 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and 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.
|
21.4%
22/103 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and 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
|
0.00%
0/105 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and 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.
|
1.9%
2/104 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and 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.
|
3.9%
4/103 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and 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.
|
|
Injury, poisoning and procedural complications
Fall
|
0.95%
1/105 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and 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.
|
1.9%
2/104 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and 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.
|
3.9%
4/103 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and 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.
|
|
Infections and infestations
Gastroenteritis
|
3.8%
4/105 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and 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%
0/104 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and 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.
|
1.9%
2/103 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and 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.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
1.9%
2/105 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and 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.
|
11.5%
12/104 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and 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.
|
2.9%
3/103 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and 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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/105 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and 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.
|
3.8%
4/104 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and 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.
|
0.97%
1/103 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and 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