Trial Outcomes & Findings for Long-term Safety Study of Alogliptin Used in Combination With α-glucosidase Inhibitor in Participants With Type 2 Diabetes in Japan (NCT NCT01263509)
NCT ID: NCT01263509
Last Updated: 2012-02-03
Results Overview
A treatment-emergent adverse event (TEAE) is defined as an adverse event 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, which increases in intensity after the start of dosing. Adverse events data with onset occurring more than 30 days after last dose of study drug (AE start date - last dose date \>30) will be listed, but not included in the summary tables below.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
179 participants
Primary outcome timeframe
52 Weeks.
Results posted on
2012-02-03
Participant Flow
Participants enrolled at 24 investigative sites in Japan from 06 June 2007 to 02 October 2008.
Participants enrolled in one of 2, once-daily (QD) or three-times daily (TID) treatment groups. Analyses performed by treatment group or treatment dose in this study. All 213 participants randomized in the phase 2/3 α-glucosidase inhibitor (NCT01263483) study are included in the Full Analysis Set in this study, of which 179 randomized.
Participant milestones
| Measure |
12.5 mg Combination Dose Group* → 12.5 mg Combination Group
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
\*for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on study.
|
25 mg Combination Dose Group* → 25 mg Combination Dose Group
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
\*for participants from the for 25 mg combination dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on study.
|
α-glucosidase Monotherapy Group* → 12.5 mg Combination Group
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
\*for participants from the α-glucosidase inhibitor monotherapy dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on study.
|
α-glucosidase Monotherapy Group*→ 25 mg Combination Group
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
\*for participants from the α-glucosidase inhibitor monotherapy dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on study.
|
|---|---|---|---|---|
|
Enrolled - Long-Term Extension Study
STARTED
|
61
|
60
|
32
|
26
|
|
Enrolled - Long-Term Extension Study
COMPLETED
|
61
|
60
|
32
|
26
|
|
Enrolled - Long-Term Extension Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Entered - Long-Term Extension Study
STARTED
|
61
|
60
|
32
|
26
|
|
Entered - Long-Term Extension Study
COMPLETED
|
53
|
48
|
27
|
24
|
|
Entered - Long-Term Extension Study
NOT COMPLETED
|
8
|
12
|
5
|
2
|
Reasons for withdrawal
| Measure |
12.5 mg Combination Dose Group* → 12.5 mg Combination Group
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
\*for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on study.
|
25 mg Combination Dose Group* → 25 mg Combination Dose Group
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
\*for participants from the for 25 mg combination dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on study.
|
α-glucosidase Monotherapy Group* → 12.5 mg Combination Group
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
\*for participants from the α-glucosidase inhibitor monotherapy dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on study.
|
α-glucosidase Monotherapy Group*→ 25 mg Combination Group
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
\*for participants from the α-glucosidase inhibitor monotherapy dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on study.
|
|---|---|---|---|---|
|
Entered - Long-Term Extension Study
Adverse Event
|
5
|
5
|
4
|
1
|
|
Entered - Long-Term Extension Study
Lack of Efficacy
|
1
|
4
|
1
|
0
|
|
Entered - Long-Term Extension Study
Withdrawal by Subject
|
1
|
2
|
0
|
0
|
|
Entered - Long-Term Extension Study
Participant Unavailability
|
1
|
1
|
0
|
0
|
|
Entered - Long-Term Extension Study
Poor Glycosylated Hemoglobin Control
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Long-term Safety Study of Alogliptin Used in Combination With α-glucosidase Inhibitor in Participants With Type 2 Diabetes in Japan
Baseline characteristics by cohort
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=108 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=105 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Total
n=213 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
≤ 64 years
|
69 participants
n=5 Participants
|
53 participants
n=7 Participants
|
122 participants
n=5 Participants
|
|
Age, Customized
≥ 65 years
|
39 participants
n=5 Participants
|
52 participants
n=7 Participants
|
91 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 52 Weeks.Population: Adverse Event Profile in the Safety Analysis Set
A treatment-emergent adverse event (TEAE) is defined as an adverse event 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, which increases in intensity after the start of dosing. Adverse events data with onset occurring more than 30 days after last dose of study drug (AE start date - last dose date \>30) will be listed, but not included in the summary tables below.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=108 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=105 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Number of Participants With Adverse Events.
Serious Adverse Event
|
6 participants
|
7 participants
|
|
Number of Participants With Adverse Events.
Serious Adverse Event Related to Study Drug
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events.
Other Adverse Events (Incidence ≥3%)
|
85 participants
|
73 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 8.Population: Values are Summary Statistics.
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 Voglibose 0.2 mg TID
n=107 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=100 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 8).
|
-0.69 percentage of Glycosylated Hemoglobin
Standard Deviation 0.479
|
-0.79 percentage of Glycosylated Hemoglobin
Standard Deviation 0.417
|
SECONDARY outcome
Timeframe: Baseline and Week 12.Population: Values are Summary Statistics.
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 Voglibose 0.2 mg TID
n=106 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=99 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 12).
|
-0.89 percentage of Glycosylated Hemoglobin
Standard Deviation 0.589
|
-0.96 percentage of Glycosylated Hemoglobin
Standard Deviation 0.486
|
SECONDARY outcome
Timeframe: Baseline and Week 16.Population: Values are Summary Statistics.
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 Voglibose 0.2 mg TID
n=91 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=84 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 16).
|
-0.91 percentage of Glycosylated Hemoglobin
Standard Deviation 0.658
|
-0.96 percentage of Glycosylated Hemoglobin
Standard Deviation 0.587
|
SECONDARY outcome
Timeframe: Baseline and Week 20.Population: Values are Summary Statistics.
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 Voglibose 0.2 mg TID
n=90 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=83 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 20).
|
-0.90 percentage of Glycosylated Hemoglobin
Standard Deviation 0.745
|
-0.89 percentage of Glycosylated Hemoglobin
Standard Deviation 0.592
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Values are Summary Statistics.
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 Voglibose 0.2 mg TID
n=90 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=82 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 24).
|
-0.83 percentage of Glycosylated Hemoglobin
Standard Deviation 0.750
|
-0.88 percentage of Glycosylated Hemoglobin
Standard Deviation 0.624
|
SECONDARY outcome
Timeframe: Baseline and Week 28.Population: Values are Summary Statistics.
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 Voglibose 0.2 mg TID
n=88 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=82 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 28).
|
-0.81 percentage of Glycosylated Hemoglobin
Standard Deviation 0.704
|
-0.89 percentage of Glycosylated Hemoglobin
Standard Deviation 0.619
|
SECONDARY outcome
Timeframe: Baseline and Week 32.Population: Values are Summary Statistics.
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 Voglibose 0.2 mg TID
n=86 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=82 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 32).
|
-0.80 percentage of Glycosylated Hemoglobin
Standard Deviation 0.701
|
-0.85 percentage of Glycosylated Hemoglobin
Standard Deviation 0.679
|
SECONDARY outcome
Timeframe: Baseline and Week 36.Population: Values are Summary Statistics.
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 Voglibose 0.2 mg TID
n=84 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=78 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 36).
|
-0.82 percentage of Glycosylated Hemoglobin
Standard Deviation 0.717
|
-0.90 percentage of Glycosylated Hemoglobin
Standard Deviation 0.649
|
SECONDARY outcome
Timeframe: Baseline and Week 40.Population: Values are Summary Statistics.
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 Voglibose 0.2 mg TID
n=82 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=78 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 40).
|
-0.78 percentage of Glycosylated Hemoglobin
Standard Deviation 0.742
|
-0.92 percentage of Glycosylated Hemoglobin
Standard Deviation 0.672
|
SECONDARY outcome
Timeframe: Baseline and Week 44.Population: Values are Summary Statistics.
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 Voglibose 0.2 mg TID
n=53 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=51 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 44).
|
-0.88 percentage of Glycosylated Hemoglobin
Standard Deviation 0.721
|
-0.94 percentage of Glycosylated Hemoglobin
Standard Deviation 0.545
|
SECONDARY outcome
Timeframe: Baseline and Week 48.Population: Values are Summary Statistics.
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 Voglibose 0.2 mg TID
n=53 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=49 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 48).
|
-0.92 percentage of Glycosylated Hemoglobin
Standard Deviation 0.694
|
-0.94 percentage of Glycosylated Hemoglobin
Standard Deviation 0.548
|
SECONDARY outcome
Timeframe: Baseline and Week 52.Population: Values are Summary Statistics.
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 Voglibose 0.2 mg TID
n=53 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=48 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 52).
|
-0.95 percentage of Glycosylated Hemoglobin
Standard Deviation 0.692
|
-0.95 percentage of Glycosylated Hemoglobin
Standard Deviation 0.568
|
SECONDARY outcome
Timeframe: Baseline and Final Visit (up to Week 52).Population: Values are Summary Statistics.
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 Voglibose 0.2 mg TID
n=108 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=105 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Final Visit).
|
-0.81 percentage of Glycosylated Hemoglobin
Standard Deviation 0.714
|
-0.89 percentage of Glycosylated Hemoglobin
Standard Deviation 0.660
|
SECONDARY outcome
Timeframe: Baseline and Week 8.Population: Values are Summary Statistics.
The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=107 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=100 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 8).
|
-18.2 mg/dL
Standard Deviation 22.43
|
-20.4 mg/dL
Standard Deviation 23.04
|
SECONDARY outcome
Timeframe: Baseline and Week 12.Population: Values are Summary Statistics.
The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=106 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=99 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 12).
|
-17.1 mg/dL
Standard Deviation 22.02
|
-18.8 mg/dL
Standard Deviation 24.26
|
SECONDARY outcome
Timeframe: Baseline and Week 16.Population: Values are Summary Statistics.
The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=91 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=84 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 16).
|
-16.0 mg/dL
Standard Deviation 23.84
|
-15.3 mg/dL
Standard Deviation 23.33
|
SECONDARY outcome
Timeframe: Baseline and Week 20.Population: Values are Summary Statistics.
The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=90 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=83 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 20).
|
-15.6 mg/dL
Standard Deviation 23.90
|
-15.0 mg/dL
Standard Deviation 26.34
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Values are Summary Statistics.
The change between the value of fasting plasma glucose collected at week 24 and fasting plasma glucose collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=90 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=82 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 24).
|
-13.8 mg/dL
Standard Deviation 23.96
|
-15.6 mg/dL
Standard Deviation 26.84
|
SECONDARY outcome
Timeframe: Baseline and Week 28.Population: Values are Summary Statistics.
The change between the value of fasting plasma glucose collected at week 28 and fasting plasma glucose collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=88 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=82 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 28).
|
-14.5 mg/dL
Standard Deviation 22.77
|
-21.9 mg/dL
Standard Deviation 23.68
|
SECONDARY outcome
Timeframe: Baseline and Week 32.Population: Values are Summary Statistics.
The change between the value of fasting plasma glucose collected at week 32 and fasting plasma glucose collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=86 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=82 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 32).
|
-17.7 mg/dL
Standard Deviation 20.75
|
-20.1 mg/dL
Standard Deviation 29.84
|
SECONDARY outcome
Timeframe: Baseline and Week 36.Population: Values are Summary Statistics.
The change between the value of fasting plasma glucose collected at week 36 and fasting plasma glucose collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=83 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=78 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 36).
|
-17.3 mg/dL
Standard Deviation 22.93
|
-22.6 mg/dL
Standard Deviation 27.10
|
SECONDARY outcome
Timeframe: Baseline and Week 40.Population: Values are Summary Statistics.
The change between the value of fasting plasma glucose collected at week 40 and fasting plasma glucose collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=82 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=78 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 40).
|
-19.7 mg/dL
Standard Deviation 22.88
|
-22.8 mg/dL
Standard Deviation 23.49
|
SECONDARY outcome
Timeframe: Baseline and Week 44.Population: Values are Summary Statistics.
The change between the value of fasting plasma glucose collected at week 44 and fasting plasma glucose collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=53 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=51 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 44).
|
-21.5 mg/dL
Standard Deviation 19.63
|
-24.4 mg/dL
Standard Deviation 26.01
|
SECONDARY outcome
Timeframe: Baseline and Week 48.Population: Values are Summary Statistics.
The change between the value of fasting plasma glucose collected at week 48 and fasting plasma glucose collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=53 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=49 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 48).
|
-20.5 mg/dL
Standard Deviation 21.12
|
-23.1 mg/dL
Standard Deviation 27.16
|
SECONDARY outcome
Timeframe: Baseline and Week 52.Population: Values are Summary Statistics.
The change between the value of fasting plasma glucose collected at week 52 and fasting plasma glucose collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=53 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=48 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 52).
|
-20.7 mg/dL
Standard Deviation 20.37
|
-24.0 mg/dL
Standard Deviation 20.98
|
SECONDARY outcome
Timeframe: Baseline and Final Visit (up to Week 52).Population: Values are Summary Statistics.
The change between the value of fasting plasma glucose collected at week 52 or final visit and fasting plasma glucose collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=108 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=105 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Final Visit).
|
-17.5 mg/dL
Standard Deviation 23.45
|
-23.3 mg/dL
Standard Deviation 26.35
|
SECONDARY outcome
Timeframe: Baseline and Week 8.Population: Values are Summary Statistics.
The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=107 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=100 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting C-peptide (Week 8).
|
0.05 ng/mL
Standard Deviation 0.701
|
0.11 ng/mL
Standard Deviation 0.680
|
SECONDARY outcome
Timeframe: Baseline and Week 12.Population: Values are Summary Statistics.
The change between the value of fasting C-peptide collected at week 12 and fasting C-peptide collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=106 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=99 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting C-peptide (Week 12).
|
0.10 ng/mL
Standard Deviation 0.743
|
0.13 ng/mL
Standard Deviation 0.603
|
SECONDARY outcome
Timeframe: Baseline and Week 16.Population: Values are Summary Statistics.
The change between the value of fasting C-peptide collected at week 16 and fasting C-peptide collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=91 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=84 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting C-peptide (Week 16).
|
0.24 ng/mL
Standard Deviation 0.761
|
0.21 ng/mL
Standard Deviation 0.597
|
SECONDARY outcome
Timeframe: Baseline and Week 20.Population: Values are Summary Statistics.
The change between the value of fasting C-peptide collected at week 20 and fasting C-peptide collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=87 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=83 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting C-peptide (Week 20).
|
0.24 ng/mL
Standard Deviation 0.840
|
0.15 ng/mL
Standard Deviation 0.801
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Values are Summary Statistics.
The change between the value of fasting C-peptide collected at week 24 and fasting C-peptide collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=81 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=76 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting C-peptide (Week 24).
|
0.19 ng/mL
Standard Deviation 0.897
|
0.14 ng/mL
Standard Deviation 0.723
|
SECONDARY outcome
Timeframe: Baseline and Week 28.Population: Values are Summary Statistics.
The change between the value of fasting C-peptide collected at week 28 and fasting C-peptide collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=70 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=71 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting C-peptide (Week 28).
|
0.18 ng/mL
Standard Deviation 0.984
|
0.25 ng/mL
Standard Deviation 0.788
|
SECONDARY outcome
Timeframe: Baseline and Week 32.Population: Values are Summary Statistics.
The change between the value of fasting C-peptide collected at week 32 and fasting C-peptide collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=58 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=63 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting C-peptide (Week 32).
|
0.47 ng/mL
Standard Deviation 0.895
|
0.31 ng/mL
Standard Deviation 0.799
|
SECONDARY outcome
Timeframe: Baseline and Week 36.Population: Values are Summary Statistics.
The change between the value of fasting C-peptide collected at week 36 and fasting C-peptide collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=37 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=39 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting C-peptide (Week 36).
|
0.33 ng/mL
Standard Deviation 0.695
|
0.38 ng/mL
Standard Deviation 0.654
|
SECONDARY outcome
Timeframe: Baseline and Week 40.Population: Values are Summary Statistics.
The change between the value of fasting C-peptide collected at week 40 and fasting C-peptide collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=28 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=28 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting C-peptide (Week 40).
|
0.30 ng/mL
Standard Deviation 0.701
|
0.37 ng/mL
Standard Deviation 0.604
|
SECONDARY outcome
Timeframe: Baseline and Week 44.Population: Values are Summary Statistics.
The change between the value of fasting C-peptide collected at week 44 and fasting C-peptide collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=11 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=13 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting C-peptide (Week 44).
|
0.08 ng/mL
Standard Deviation 0.698
|
0.25 ng/mL
Standard Deviation 0.477
|
SECONDARY outcome
Timeframe: Baseline and Week 48.Population: Values are Summary Statistics.
The change between the value of fasting C-peptide collected at week 48 and fasting C-peptide collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=4 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=4 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting C-peptide (Week 48).
|
0.45 ng/mL
Standard Deviation 0.058
|
0.38 ng/mL
Standard Deviation 0.340
|
SECONDARY outcome
Timeframe: Baseline and Week 52.Population: Values are Summary Statistics.
The change between the value of fasting C-peptide collected at week 52 and fasting C-peptide collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=3 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=1 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting C-peptide (Week 52).
|
0.80 ng/mL
Standard Deviation 0.600
|
0.40 ng/mL
|
SECONDARY outcome
Timeframe: Baseline and Final Visit (up to Week 52).Population: Values are Summary Statistics.
The change between the value of fasting C-peptide collected at week 52 or final visit and fasting C-peptide collected at baseline.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=108 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=105 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting C-peptide (Final Visit).
|
0.31 ng/mL
Standard Deviation 0.821
|
0.29 ng/mL
Standard Deviation 0.879
|
SECONDARY outcome
Timeframe: Baseline and Week 12.Population: Values are Summary Statistics.
The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=106 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=100 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 12).
|
41.2 mg/dL
Standard Deviation 25.19
|
37.6 mg/dL
Standard Deviation 32.67
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Values are Summary Statistics.
The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=62 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=58 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 24).
|
38.0 mg/dL
Standard Deviation 29.04
|
37.1 mg/dL
Standard Deviation 33.84
|
SECONDARY outcome
Timeframe: Baseline and Week 52.Population: Values are Summary Statistics.
The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=82 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=77 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 52).
|
39.0 mg/dL
Standard Deviation 25.71
|
40.8 mg/dL
Standard Deviation 29.49
|
SECONDARY outcome
Timeframe: Baseline and Final Visit (up to Week 52).Population: Values are Summary Statistics.
The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=106 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=101 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Final Visit).
|
39.6 mg/dL
Standard Deviation 26.16
|
39.4 mg/dL
Standard Deviation 29.46
|
SECONDARY outcome
Timeframe: Baseline and Week 12.Population: Values are Summary Statistics.
The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=105 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=98 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).
|
-73.2 mg•hr/dL
Standard Deviation 63.40
|
-76.8 mg•hr/dL
Standard Deviation 58.92
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Values are Summary Statistics.
The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=62 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=58 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).
|
-69.0 mg•hr/dL
Standard Deviation 61.21
|
-70.4 mg•hr/dL
Standard Deviation 68.54
|
SECONDARY outcome
Timeframe: Baseline and Week 52.Population: Values are Summary Statistics.
The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=81 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=76 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).
|
-83.5 mg•hr/dL
Standard Deviation 58.30
|
-83.4 mg•hr/dL
Standard Deviation 53.80
|
SECONDARY outcome
Timeframe: Baseline and Final Visit (up to Week 52).Population: Values are Summary Statistics.
The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=105 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=99 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).
|
-77.5 mg•hr/dL
Standard Deviation 61.67
|
-82.2 mg•hr/dL
Standard Deviation 62.58
|
SECONDARY outcome
Timeframe: Baseline and Week 12.Population: Values are Summary Statistics.
The change between the value of insulin collected at week 12 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=99 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=92 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).
|
3.05 μU•hr/mL
Standard Deviation 15.254
|
2.95 μU•hr/mL
Standard Deviation 15.704
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Values are Summary Statistics.
The change between the value of insulin collected at week 24 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=59 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=55 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).
|
4.42 μU•hr/mL
Standard Deviation 13.445
|
2.26 μU•hr/mL
Standard Deviation 13.455
|
SECONDARY outcome
Timeframe: Baseline and Week 52.Population: Values are Summary Statistics.
The change between the value of insulin collected at week 52 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=75 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=71 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).
|
-1.28 μU•hr/mL
Standard Deviation 10.220
|
0.18 μU•hr/mL
Standard Deviation 12.425
|
SECONDARY outcome
Timeframe: Baseline and Final Visit (up to Week 52).Population: Values are Summary Statistics.
The change between the value of insulin collected at week 52 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=99 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=93 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).
|
-0.61 μU•hr/mL
Standard Deviation 11.454
|
0.01 μU•hr/mL
Standard Deviation 12.567
|
SECONDARY outcome
Timeframe: Baseline and Week 12.Population: Values are Summary Statistics.
The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=106 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=98 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).
|
0.71 ng•hr/mL
Standard Deviation 2.062
|
0.71 ng•hr/mL
Standard Deviation 2.209
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Values are Summary Statistics.
The change between the value of C-peptide collected at week 24 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=61 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=58 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).
|
1.38 ng•hr/mL
Standard Deviation 1.845
|
1.12 ng•hr/mL
Standard Deviation 2.238
|
SECONDARY outcome
Timeframe: Baseline and Week 52.Population: Values are Summary Statistics.
The change between the value of C-peptide collected at week 52 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=4 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=3 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).
|
0.96 ng•hr/mL
Standard Deviation 1.028
|
2.18 ng•hr/mL
Standard Deviation 3.384
|
SECONDARY outcome
Timeframe: Baseline and Final Visit (up to Week 52).Population: Values are Summary Statistics.
The change between the value of C-peptide collected at week 52 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=106 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=99 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).
|
1.05 ng•hr/mL
Standard Deviation 2.089
|
0.80 ng•hr/mL
Standard Deviation 2.354
|
SECONDARY outcome
Timeframe: Baseline and Week 12.Population: Values are Summary Statistics.
The change between the value of glucagons collected at week 12 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=106 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=99 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).
|
-14.3 pg•hr/mL
Standard Deviation 42.23
|
-20.0 pg•hr/mL
Standard Deviation 47.18
|
SECONDARY outcome
Timeframe: Baseline and Week 24.Population: Values are Summary Statistics.
The change between the value of glucagons collected at week 24 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=62 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=58 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).
|
-4.6 pg•hr/mL
Standard Deviation 53.17
|
-6.8 pg•hr/mL
Standard Deviation 36.78
|
SECONDARY outcome
Timeframe: Baseline and Week 52.Population: Values are Summary Statistics.
The change between the value of glucagons collected at week 52 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=82 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=76 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).
|
-12.0 pg•hr/mL
Standard Deviation 64.24
|
-22.2 pg•hr/mL
Standard Deviation 49.67
|
SECONDARY outcome
Timeframe: Baseline and Final Visit (up to Week 52).Population: Values are Summary Statistics.
The change between the value of glucagons collected at week 52 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Outcome measures
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=106 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=100 Participants
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).
|
-11.7 pg•hr/mL
Standard Deviation 59.01
|
-20.9 pg•hr/mL
Standard Deviation 50.57
|
Adverse Events
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
Serious events: 6 serious events
Other events: 85 other events
Deaths: 0 deaths
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
Serious events: 7 serious events
Other events: 73 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=108 participants at risk
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=105 participants at risk
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/108 • 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.
|
0.95%
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.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/108 • 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.
|
0.95%
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.93%
1/108 • 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.
|
0.95%
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.93%
1/108 • 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.
|
0.95%
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.93%
1/108 • 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%
0/105 • 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.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/108 • 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.
|
0.95%
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.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/108 • 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.
|
0.95%
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.
|
|
Cardiac disorders
Angina pectoris
|
0.93%
1/108 • 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%
0/105 • 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.
|
|
Gastrointestinal disorders
Salivary gland calculus
|
0.93%
1/108 • 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%
0/105 • 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.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.93%
1/108 • 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%
0/105 • 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.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.93%
1/108 • 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%
0/105 • 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.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/108 • 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.
|
0.95%
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.
|
Other adverse events
| Measure |
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
n=108 participants at risk
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
Alogliptin 25 mg QD and Voglibose 0.2 mg TID
n=105 participants at risk
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
35.2%
38/108 • 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.
|
28.6%
30/105 • 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.
|
|
Infections and infestations
Bronchitis
|
5.6%
6/108 • 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%
3/105 • 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.
|
|
Infections and infestations
Cystitis
|
3.7%
4/108 • 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%
2/105 • 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.
|
|
Infections and infestations
Pharyngitis
|
0.93%
1/108 • 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%
4/105 • 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.
|
|
Immune system disorders
Seasonal allergy
|
5.6%
6/108 • 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.
|
0.95%
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.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
11.1%
12/108 • 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.
|
4.8%
5/105 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.6%
5/108 • 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%
3/105 • 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.
|
|
Gastrointestinal disorders
Gastritis
|
0.93%
1/108 • 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%
4/105 • 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.
|
|
Gastrointestinal disorders
Abdominal distension
|
3.7%
4/108 • 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%
0/105 • 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.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
3.7%
4/108 • 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%
0/105 • 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.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.7%
4/108 • 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%
0/105 • 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.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.7%
4/108 • 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%
0/105 • 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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.4%
8/108 • 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.
|
5.7%
6/105 • 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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.9%
2/108 • 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.
|
4.8%
5/105 • 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.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/108 • 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.
|
4.8%
5/105 • 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.
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.7%
4/108 • 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%
0/105 • 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.
|
|
Injury, poisoning and procedural complications
Contusion
|
4.6%
5/108 • 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%
3/105 • 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.
|
|
Injury, poisoning and procedural complications
Fall
|
3.7%
4/108 • 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%
2/105 • 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.
|
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