Trial Outcomes & Findings for Long-term Safety Study of Alogliptin Used in Combination With Thiazolidine in Participants With Type 2 Diabetes in Japan (NCT NCT01318122)
NCT ID: NCT01318122
Last Updated: 2012-02-03
Results Overview
Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
336 participants
Primary outcome timeframe
52 Weeks.
Results posted on
2012-02-03
Participant Flow
Participants enrolled at 32 investigative sites in Japan from 10 May 2008 to 03 August 2009.
Participants who had completed the core phase 2/3 thiazolidine add on study (SYR-322/CCT-004; NCT01318070) were enrolled in one of 2, once-daily (QD) treatment groups.
Participant milestones
| Measure |
CCT/004 - 12.5 mg Dose Group* → 12.5 mg Combination Group
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
\*for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study.
|
CCT/004 - 25 mg Dose Group* → 25 mg Combination Dose Group
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
\*for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study.
|
Pioglitazone Monotherapy Group* → 12.5 mg Combination Group
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
\*for participants from the pioglitazone 15 mg or 30 mg dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study.
|
Pioglitazone Monotherapy Group* → 25 mg Combination Group
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
\*for participants from the pioglitazone 15 mg or 30 mg dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study.
|
|---|---|---|---|---|
|
Enrolled - Long-Term Extension Study
STARTED
|
106
|
110
|
57
|
53
|
|
Enrolled - Long-Term Extension Study
COMPLETED
|
105
|
110
|
55
|
52
|
|
Enrolled - Long-Term Extension Study
NOT COMPLETED
|
1
|
0
|
2
|
1
|
|
Entered - Long-Term Extension Study
STARTED
|
105
|
110
|
55
|
52
|
|
Entered - Long-Term Extension Study
COMPLETED
|
96
|
99
|
49
|
48
|
|
Entered - Long-Term Extension Study
NOT COMPLETED
|
9
|
11
|
6
|
4
|
Reasons for withdrawal
| Measure |
CCT/004 - 12.5 mg Dose Group* → 12.5 mg Combination Group
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
\*for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study.
|
CCT/004 - 25 mg Dose Group* → 25 mg Combination Dose Group
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
\*for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study.
|
Pioglitazone Monotherapy Group* → 12.5 mg Combination Group
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
\*for participants from the pioglitazone 15 mg or 30 mg dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study.
|
Pioglitazone Monotherapy Group* → 25 mg Combination Group
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
\*for participants from the pioglitazone 15 mg or 30 mg dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study.
|
|---|---|---|---|---|
|
Enrolled - Long-Term Extension Study
Adverse Event
|
0
|
0
|
2
|
1
|
|
Enrolled - Long-Term Extension Study
Other
|
1
|
0
|
0
|
0
|
|
Entered - Long-Term Extension Study
Adverse Event
|
6
|
6
|
2
|
4
|
|
Entered - Long-Term Extension Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
Entered - Long-Term Extension Study
Withdrawal by Subject
|
2
|
3
|
1
|
0
|
|
Entered - Long-Term Extension Study
Lack of Efficacy
|
0
|
2
|
3
|
0
|
Baseline Characteristics
Long-term Safety Study of Alogliptin Used in 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 30 mg QD
n=166 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=165 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Total
n=331 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
≤ 64 years
|
116 participants
n=93 Participants
|
103 participants
n=4 Participants
|
219 participants
n=27 Participants
|
|
Age, Customized
≥ 65 years
|
50 participants
n=93 Participants
|
62 participants
n=4 Participants
|
112 participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=93 Participants
|
58 Participants
n=4 Participants
|
123 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
101 Participants
n=93 Participants
|
107 Participants
n=4 Participants
|
208 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 52 Weeks.Population: Full Analysis Set was defined as the population of participants randomized in the core phase 2/3 thiazolidine add on study (SYR-322/CCT-004 study; NCT01318070) and received at least 1 dose of the investigational products (SYR-322DB in combination with pioglitazone) for the treatment period.
Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD
n=166 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=165 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
|---|---|---|
|
Number of Participants With Adverse Events.
Number of Participants with Other Adverse Event
|
143 participants
|
146 participants
|
|
Number of Participants With Adverse Events.
Number of Participants with Serious Adverse Event
|
14 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 8.Population: 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 30 mg QD
n=165 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 8).
|
-0.68 percentage of Glycosylated Hemoglobin
Standard Deviation 0.371
|
-0.73 percentage of Glycosylated Hemoglobin
Standard Deviation 0.415
|
SECONDARY outcome
Timeframe: Baseline and Week 12.Population: 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 30 mg QD
n=161 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=163 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 12).
|
-0.81 percentage of Glycosylated Hemoglobin
Standard Deviation 0.459
|
-0.88 percentage of Glycosylated Hemoglobin
Standard Deviation 0.519
|
SECONDARY outcome
Timeframe: Baseline and Week 16.Population: 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 16 and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD
n=158 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=160 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 16).
|
-0.86 percentage of Glycosylated Hemoglobin
Standard Deviation 0.550
|
-0.92 percentage of Glycosylated Hemoglobin
Standard Deviation 0.571
|
SECONDARY outcome
Timeframe: Baseline and Week 20.Population: 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 20 and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD
n=155 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=160 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 20).
|
-0.84 percentage of Glycosylated Hemoglobin
Standard Deviation 0.616
|
-0.90 percentage of Glycosylated Hemoglobin
Standard Deviation 0.581
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: 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 24 and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD
n=155 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=158 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 24).
|
-0.78 percentage of Glycosylated Hemoglobin
Standard Deviation 0.612
|
-0.82 percentage of Glycosylated Hemoglobin
Standard Deviation 0.585
|
SECONDARY outcome
Timeframe: Baseline and Week 28.Population: 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 28 and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD
n=151 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=156 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 28).
|
-0.75 percentage of Glycosylated Hemoglobin
Standard Deviation 0.620
|
-0.76 percentage of Glycosylated Hemoglobin
Standard Deviation 0.597
|
SECONDARY outcome
Timeframe: Baseline and Week 32.Population: 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 32 and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD
n=150 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=152 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 32).
|
-0.72 percentage of Glycosylated Hemoglobin
Standard Deviation 0.605
|
-0.72 percentage of Glycosylated Hemoglobin
Standard Deviation 0.632
|
SECONDARY outcome
Timeframe: Baseline and Week 36.Population: 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 36 and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD
n=147 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=151 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 36).
|
-0.67 percentage of Glycosylated Hemoglobin
Standard Deviation 0.575
|
-0.69 percentage of Glycosylated Hemoglobin
Standard Deviation 0.599
|
SECONDARY outcome
Timeframe: Baseline and Week 40.Population: 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 40 and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD
n=147 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=150 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 40).
|
-0.65 percentage of Glycosylated Hemoglobin
Standard Deviation 0.573
|
-0.66 percentage of Glycosylated Hemoglobin
Standard Deviation 0.603
|
SECONDARY outcome
Timeframe: Baseline and Week 44.Population: 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 44 and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD
n=98 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=101 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 44).
|
-0.70 percentage of Glycosylated Hemoglobin
Standard Deviation 0.577
|
-0.74 percentage of Glycosylated Hemoglobin
Standard Deviation 0.629
|
SECONDARY outcome
Timeframe: Baseline and Week 48.Population: 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 48 and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD
n=98 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=101 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 48).
|
-0.73 percentage of Glycosylated Hemoglobin
Standard Deviation 0.596
|
-0.76 percentage of Glycosylated Hemoglobin
Standard Deviation 0.683
|
SECONDARY outcome
Timeframe: Baseline and Week 52.Population: 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 52 and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD
n=96 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=100 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 52).
|
-0.77 percentage of Glycosylated Hemoglobin
Standard Deviation 0.571
|
-0.79 percentage of Glycosylated Hemoglobin
Standard Deviation 0.633
|
SECONDARY outcome
Timeframe: Baseline and Final Visit (up to Week 52).Population: 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 52 or final visit and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD
n=166 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=165 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Final Visit).
|
-0.65 percentage of Glycosylated Hemoglobin
Standard Deviation 0.597
|
-0.65 percentage of Glycosylated Hemoglobin
Standard Deviation 0.659
|
SECONDARY outcome
Timeframe: Baseline and Week 8.Population: Values are from the Full Analysis Set.
The change between the value of fasting blood glucose collected at week 8 and baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD
n=165 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (Week 8).
|
-15.5 mg/dL
Standard Deviation 19.60
|
-18.1 mg/dL
Standard Deviation 20.82
|
SECONDARY outcome
Timeframe: Baseline and Week 12.Population: Values are from the Full Analysis Set.
The change between the value of fasting blood glucose collected at week 12 and baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD
n=161 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=163 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (Week 12).
|
-13.4 mg/dL
Standard Deviation 18.37
|
-16.3 mg/dL
Standard Deviation 20.54
|
SECONDARY outcome
Timeframe: Baseline and Week 16.Population: Values are from the Full Analysis Set.
The change between the value of fasting blood glucose collected at week 6 and baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD
n=158 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=160 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (Week 16).
|
-11.9 mg/dL
Standard Deviation 22.04
|
-13.4 mg/dL
Standard Deviation 20.81
|
SECONDARY outcome
Timeframe: Baseline and Week 20.Population: Values are from the Full Analysis Set.
The change between the value of fasting blood glucose collected at week 20 and baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD
n=155 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=160 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (Week 20).
|
-10.1 mg/dL
Standard Deviation 21.07
|
-13.9 mg/dL
Standard Deviation 21.74
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Values are from the Full Analysis Set.
The change between the value of fasting blood glucose collected at week 24 and baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD
n=155 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=158 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (Week 24).
|
-10.0 mg/dL
Standard Deviation 21.50
|
-10.7 mg/dL
Standard Deviation 23.02
|
SECONDARY outcome
Timeframe: Baseline and Week 28.Population: Values are from the Full Analysis Set.
The change between the value of fasting blood glucose collected at week 28 and baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD
n=151 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=156 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (Week 28).
|
-5.6 mg/dL
Standard Deviation 28.42
|
-9.1 mg/dL
Standard Deviation 21.27
|
SECONDARY outcome
Timeframe: Baseline and Week 32.Population: Values are from the Full Analysis Set.
The change between the value of fasting blood glucose collected at week 32 and baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD
n=150 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=152 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (Week 32).
|
-7.9 mg/dL
Standard Deviation 20.25
|
-10.4 mg/dL
Standard Deviation 21.27
|
SECONDARY outcome
Timeframe: Baseline and Week 36.Population: Values are from the Full Analysis Set.
The change between the value of fasting blood glucose collected at week 36 and baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD
n=147 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=151 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (Week 36).
|
-7.1 mg/dL
Standard Deviation 19.65
|
-11.9 mg/dL
Standard Deviation 18.33
|
SECONDARY outcome
Timeframe: Baseline and Week 40.Population: Values are from the Full Analysis Set.
The change between the value of fasting blood glucose collected at week 40 and baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD
n=147 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=150 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (Week 40).
|
-9.5 mg/dL
Standard Deviation 20.76
|
-10.6 mg/dL
Standard Deviation 27.38
|
SECONDARY outcome
Timeframe: Baseline and Week 44.Population: Values are from the Full Analysis Set.
The change between the value of fasting blood glucose collected at week 44 and baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD
n=98 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=101 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (Week 44).
|
-10.4 mg/dL
Standard Deviation 17.43
|
-10.4 mg/dL
Standard Deviation 21.24
|
SECONDARY outcome
Timeframe: Baseline and Week 48.Population: Values are from the Full Analysis Set.
The change between the value of fasting blood glucose collected at week 48 and baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD
n=98 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=101 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (Week 48).
|
-12.2 mg/dL
Standard Deviation 19.89
|
-14.0 mg/dL
Standard Deviation 21.91
|
SECONDARY outcome
Timeframe: Baseline and Week 52.Population: Values are from the Full Analysis Set.
The change between the value of fasting blood glucose collected at week 52 and baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD
n=96 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=100 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (Week 52).
|
-12.8 mg/dL
Standard Deviation 16.63
|
-13.6 mg/dL
Standard Deviation 26.28
|
SECONDARY outcome
Timeframe: Baseline and Final Visit (up to Week 52).Population: Values are from the Full Analysis Set.
The change between the value of fasting blood glucose collected at week 52 or final visit and baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD
n=166 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=165 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (Final Visit).
|
-11.4 mg/dL
Standard Deviation 19.29
|
-11.1 mg/dL
Standard Deviation 25.19
|
SECONDARY outcome
Timeframe: Baseline and Week 12.Population: 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 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 Pioglitazone 15 or 30 mg QD
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=163 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).
|
58.3 mg/dL
Standard Deviation 30.81
|
49.5 mg/dL
Standard Deviation 30.04
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Values are from the Full Analysis Set.
The change between the value of blood glucose measured by the meal tolerance test collected at week 24 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 Pioglitazone 15 or 30 mg QD
n=104 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=109 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 24).
|
55.9 mg/dL
Standard Deviation 30.87
|
47.9 mg/dL
Standard Deviation 29.20
|
SECONDARY outcome
Timeframe: Baseline and Week 52.Population: Values are from the Full Analysis Set.
The change between the value of blood glucose measured by the meal tolerance test collected at week 52 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 Pioglitazone 15 or 30 mg QD
n=146 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=147 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 52).
|
59.1 mg/dL
Standard Deviation 34.19
|
57.2 mg/dL
Standard Deviation 31.82
|
SECONDARY outcome
Timeframe: Baseline and Final Visit (up to Week 52).Population: Values are from the Full Analysis Set.
The change between the value of blood glucose measured by the meal tolerance test collected at week 52 or end of study 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 Pioglitazone 15 or 30 mg QD
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=163 Participants
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Final Visit).
|
59.8 mg/dL
Standard Deviation 34.26
|
56.8 mg/dL
Standard Deviation 32.12
|
Adverse Events
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD
Serious events: 14 serious events
Other events: 143 other events
Deaths: 0 deaths
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
Serious events: 11 serious events
Other events: 146 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD
n=166 participants at risk
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=165 participants at risk
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
\*for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study.
|
|---|---|---|
|
Infections and infestations
Epiglottitis
|
0.60%
1/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
0.00%
0/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
0.61%
1/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Infections and infestations
Pneumonia
|
0.60%
1/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
0.00%
0/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Infections and infestations
Sinusitis
|
0.60%
1/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
0.00%
0/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
0.61%
1/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.60%
1/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
0.00%
0/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.60%
1/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
0.00%
0/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.60%
1/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
0.00%
0/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.60%
1/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
0.00%
0/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Eye disorders
Cataract
|
0.60%
1/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
1.8%
3/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Eye disorders
Diabetic retinopathy
|
0.60%
1/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
0.00%
0/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.60%
1/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
0.00%
0/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Cardiac disorders
Myocardial infarction
|
0.60%
1/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
0.61%
1/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
0.61%
1/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.60%
1/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
0.00%
0/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
0.61%
1/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Gastrointestinal disorders
Enterocele
|
0.00%
0/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
0.61%
1/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.60%
1/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
0.00%
0/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.60%
1/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
0.00%
0/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.60%
1/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
1.2%
2/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
0.61%
1/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
Other adverse events
| Measure |
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD
n=166 participants at risk
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
n=165 participants at risk
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
\*for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
32.5%
54/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
32.7%
54/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Infections and infestations
Bronchitis
|
4.8%
8/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
1.2%
2/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Infections and infestations
Pharyngitis
|
2.4%
4/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
3.6%
6/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Nervous system disorders
Headache
|
3.0%
5/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
3.6%
6/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Eye disorders
Diabetic retinopathy
|
4.2%
7/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
3.6%
6/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Eye disorders
Conjunctivitis allergic
|
0.60%
1/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
3.0%
5/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Vascular disorders
Hypertension
|
3.6%
6/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
1.2%
2/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
7.8%
13/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
5.5%
9/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Gastrointestinal disorders
Constipation
|
2.4%
4/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
6.7%
11/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Gastrointestinal disorders
Gastritis
|
3.6%
6/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
4.8%
8/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
4.2%
7/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
4.2%
7/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.2%
12/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
4.8%
8/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
2/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
9.1%
15/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
3.6%
6/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
3.0%
5/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.0%
5/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
2.4%
4/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
General disorders
Oedema peripheral
|
2.4%
4/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
4.2%
7/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
General disorders
Oedema
|
1.2%
2/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
3.6%
6/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Investigations
Blood creatine phosphokinase increased
|
9.6%
16/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
9.1%
15/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Investigations
Brain natriuretic peptide increased
|
4.8%
8/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
3.6%
6/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Investigations
Blood pressure increased
|
0.00%
0/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
3.6%
6/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Injury, poisoning and procedural complications
Contusion
|
4.2%
7/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
3.0%
5/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
|
Injury, poisoning and procedural complications
Fall
|
3.6%
6/166 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
3.0%
5/165 • 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 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. 5 participants from alogliptin 12.5 \& 25 mg group CCT-004 study did not enter this study.
|
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