Trial Outcomes & Findings for Efficacy and Safety of Alogliptin Plus Metformin in Patients With Type 2 Diabetes (NCT NCT01023581)
NCT ID: NCT01023581
Last Updated: 2013-03-26
Results Overview
The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
784 participants
Primary outcome timeframe
Baseline and Week 26.
Results posted on
2013-03-26
Participant Flow
Participants took part in the study at 198 investigative sites worldwide from 16 November 2009 to 30 June 2011.
Participants with a diagnosis of type 2 diabetes and glycemia inadequately controlled on diet and exercise alone were randomly assigned with equal probability to 1 of 7 treatment groups, including placebo, alogliptin alone, metformin alone or a combination of alogliptin and metformin.
Participant milestones
| Measure |
Placebo
Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
|
Alogliptin 25 QD
Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
|
Alogliptin 12.5 BID
Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
|
Metformin 500 BID
Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
|
Metformin 1000 BID
Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
|
Alogliptin 12.5 BID + Metformin 500 BID
Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
|
Alogliptin 12.5 BID + Metformin 1000 BID
Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
109
|
112
|
113
|
114
|
111
|
111
|
114
|
|
Overall Study
Received Study Treatment
|
106
|
112
|
110
|
109
|
111
|
106
|
114
|
|
Overall Study
COMPLETED
|
74
|
89
|
71
|
94
|
95
|
92
|
94
|
|
Overall Study
NOT COMPLETED
|
35
|
23
|
42
|
20
|
16
|
19
|
20
|
Reasons for withdrawal
| Measure |
Placebo
Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
|
Alogliptin 25 QD
Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
|
Alogliptin 12.5 BID
Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
|
Metformin 500 BID
Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
|
Metformin 1000 BID
Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
|
Alogliptin 12.5 BID + Metformin 500 BID
Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
|
Alogliptin 12.5 BID + Metformin 1000 BID
Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
4
|
7
|
3
|
2
|
5
|
11
|
|
Overall Study
Major protocol deviation
|
2
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
8
|
7
|
2
|
5
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
13
|
8
|
16
|
10
|
6
|
8
|
5
|
|
Overall Study
Pregnancy
|
0
|
0
|
0
|
2
|
0
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
9
|
3
|
6
|
2
|
1
|
2
|
1
|
|
Overall Study
Physician Decision
|
2
|
0
|
2
|
1
|
1
|
1
|
1
|
|
Overall Study
Other
|
1
|
0
|
1
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety of Alogliptin Plus Metformin in Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Placebo
n=109 Participants
Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
|
Alogliptin 25 QD
n=112 Participants
Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
|
Alogliptin 12.5 BID
n=113 Participants
Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
|
Metformin 500 BID
n=114 Participants
Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
|
Metformin 1000 BID
n=111 Participants
Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
|
Alogliptin 12.5 BID + Metformin 500 BID
n=111 Participants
Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
|
Alogliptin 12.5 BID + Metformin 1000 BID
n=114 Participants
Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
|
Total
n=784 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age Continuous
|
53.1 years
STANDARD_DEVIATION 9.60 • n=5 Participants
|
52.6 years
STANDARD_DEVIATION 9.38 • n=7 Participants
|
53.7 years
STANDARD_DEVIATION 9.70 • n=5 Participants
|
54.6 years
STANDARD_DEVIATION 10.20 • n=4 Participants
|
52.6 years
STANDARD_DEVIATION 11.30 • n=21 Participants
|
53.7 years
STANDARD_DEVIATION 11.59 • n=8 Participants
|
54.6 years
STANDARD_DEVIATION 10.42 • n=8 Participants
|
53.5 years
STANDARD_DEVIATION 10.33 • n=24 Participants
|
|
Age, Customized
<65 years
|
100 participants
n=5 Participants
|
103 participants
n=7 Participants
|
96 participants
n=5 Participants
|
95 participants
n=4 Participants
|
94 participants
n=21 Participants
|
91 participants
n=8 Participants
|
96 participants
n=8 Participants
|
675 participants
n=24 Participants
|
|
Age, Customized
≥65 years
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
17 participants
n=5 Participants
|
19 participants
n=4 Participants
|
17 participants
n=21 Participants
|
20 participants
n=8 Participants
|
18 participants
n=8 Participants
|
109 participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
63 Participants
n=8 Participants
|
52 Participants
n=8 Participants
|
410 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
48 Participants
n=8 Participants
|
62 Participants
n=8 Participants
|
374 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
45 participants
n=5 Participants
|
43 participants
n=7 Participants
|
43 participants
n=5 Participants
|
45 participants
n=4 Participants
|
42 participants
n=21 Participants
|
45 participants
n=8 Participants
|
39 participants
n=8 Participants
|
302 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
64 participants
n=5 Participants
|
69 participants
n=7 Participants
|
70 participants
n=5 Participants
|
69 participants
n=4 Participants
|
69 participants
n=21 Participants
|
66 participants
n=8 Participants
|
75 participants
n=8 Participants
|
482 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
5 participants
n=5 Participants
|
8 participants
n=7 Participants
|
5 participants
n=5 Participants
|
3 participants
n=4 Participants
|
6 participants
n=21 Participants
|
9 participants
n=8 Participants
|
5 participants
n=8 Participants
|
41 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Asian
|
20 participants
n=5 Participants
|
17 participants
n=7 Participants
|
21 participants
n=5 Participants
|
19 participants
n=4 Participants
|
20 participants
n=21 Participants
|
20 participants
n=8 Participants
|
26 participants
n=8 Participants
|
143 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
1 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
8 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
6 participants
n=8 Participants
|
5 participants
n=8 Participants
|
37 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
White
|
76 participants
n=5 Participants
|
84 participants
n=7 Participants
|
83 participants
n=5 Participants
|
85 participants
n=4 Participants
|
79 participants
n=21 Participants
|
76 participants
n=8 Participants
|
78 participants
n=8 Participants
|
561 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
1 participants
n=24 Participants
|
|
Body Mass Index (BMI)
|
31.15 kg/m^2
STANDARD_DEVIATION 5.269 • n=5 Participants
|
30.81 kg/m^2
STANDARD_DEVIATION 5.219 • n=7 Participants
|
30.36 kg/m^2
STANDARD_DEVIATION 5.159 • n=5 Participants
|
30.19 kg/m^2
STANDARD_DEVIATION 4.842 • n=4 Participants
|
30.51 kg/m^2
STANDARD_DEVIATION 5.043 • n=21 Participants
|
30.92 kg/m^2
STANDARD_DEVIATION 5.353 • n=8 Participants
|
31.04 kg/m^2
STANDARD_DEVIATION 5.375 • n=8 Participants
|
30.71 kg/m^2
STANDARD_DEVIATION 5.173 • n=24 Participants
|
|
Diabetes Duration
|
4.25 years
STANDARD_DEVIATION 4.778 • n=5 Participants
|
3.65 years
STANDARD_DEVIATION 4.119 • n=7 Participants
|
3.97 years
STANDARD_DEVIATION 4.800 • n=5 Participants
|
3.78 years
STANDARD_DEVIATION 3.904 • n=4 Participants
|
4.08 years
STANDARD_DEVIATION 4.587 • n=21 Participants
|
4.13 years
STANDARD_DEVIATION 4.777 • n=8 Participants
|
4.22 years
STANDARD_DEVIATION 4.972 • n=8 Participants
|
4.01 years
STANDARD_DEVIATION 4.563 • n=24 Participants
|
|
Baseline HbA1c
≤8.5%
|
65 participants
n=5 Participants
|
67 participants
n=7 Participants
|
67 participants
n=5 Participants
|
67 participants
n=4 Participants
|
66 participants
n=21 Participants
|
66 participants
n=8 Participants
|
67 participants
n=8 Participants
|
465 participants
n=24 Participants
|
|
Baseline HbA1c
>8.5%
|
44 participants
n=5 Participants
|
45 participants
n=7 Participants
|
46 participants
n=5 Participants
|
47 participants
n=4 Participants
|
45 participants
n=21 Participants
|
45 participants
n=8 Participants
|
47 participants
n=8 Participants
|
319 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 26.Population: Full analysis set (patients who took at least 1 dose of study medication) where baseline and at least 1 postbaseline assessment were available. Analysis includes only data collected on or after baseline and within 7 days after last dose of study medication or hyperglycemic rescue, whichever came first. Last observation carried forward was utilized.
The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).
Outcome measures
| Measure |
Placebo
n=102 Participants
Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
|
Alogliptin 25 QD
n=104 Participants
Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
|
Alogliptin 12.5 BID
n=104 Participants
Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
|
Metformin 500 BID
n=103 Participants
Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
|
Metformin 1000 BID
n=108 Participants
Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
|
Alogliptin 12.5 BID + Metformin 500 BID
n=102 Participants
Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
|
Alogliptin 12.5 BID + Metformin 1000 BID
n=111 Participants
Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
|
0.15 percentage glycosylated hemoglobin
Standard Error 0.094
|
-0.52 percentage glycosylated hemoglobin
Standard Error 0.094
|
-0.56 percentage glycosylated hemoglobin
Standard Error 0.093
|
-0.65 percentage glycosylated hemoglobin
Standard Error 0.094
|
-1.11 percentage glycosylated hemoglobin
Standard Error 0.092
|
-1.22 percentage glycosylated hemoglobin
Standard Error 0.094
|
-1.55 percentage glycosylated hemoglobin
Standard Error 0.090
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, and 20.Population: The full analysis set where a baseline assessment and at least 1 valid postbaseline assessment were available. The analysis includes only data collected on or after baseline and within 7 days after the last dose of study medication or hyperglycemic rescue, whichever came first. Last observation carried forward was utilized.
The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) was assessed at Weeks 4, 8, 12, 16 and 20. Least squares means are from an analysis of covariance (ANCOVA) model with treatment and geographic region as fixed effects, and baseline HbA1c as a covariate.
Outcome measures
| Measure |
Placebo
n=106 Participants
Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
|
Alogliptin 25 QD
n=112 Participants
Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
|
Alogliptin 12.5 BID
n=110 Participants
Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
|
Metformin 500 BID
n=109 Participants
Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
|
Metformin 1000 BID
n=111 Participants
Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
|
Alogliptin 12.5 BID + Metformin 500 BID
n=106 Participants
Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
|
Alogliptin 12.5 BID + Metformin 1000 BID
n=114 Participants
Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in HbA1c Over Time
Week 4 (n=95, 97, 89, 94, 102, 94, 101)
|
0.09 percentage glycosylated hemoglobin
Standard Error 0.058
|
-0.34 percentage glycosylated hemoglobin
Standard Error 0.057
|
-0.42 percentage glycosylated hemoglobin
Standard Error 0.060
|
-0.37 percentage glycosylated hemoglobin
Standard Error 0.058
|
-0.58 percentage glycosylated hemoglobin
Standard Error 0.056
|
-0.70 percentage glycosylated hemoglobin
Standard Error 0.058
|
-0.75 percentage glycosylated hemoglobin
Standard Error 0.056
|
|
Change From Baseline in HbA1c Over Time
Week 8 (n=102, 104, 104, 103, 108, 102, 111)
|
0.08 percentage glycosylated hemoglobin
Standard Error 0.073
|
-0.51 percentage glycosylated hemoglobin
Standard Error 0.073
|
-0.58 percentage glycosylated hemoglobin
Standard Error 0.072
|
-0.59 percentage glycosylated hemoglobin
Standard Error 0.073
|
-0.86 percentage glycosylated hemoglobin
Standard Error 0.071
|
-1.08 percentage glycosylated hemoglobin
Standard Error 0.073
|
-1.17 percentage glycosylated hemoglobin
Standard Error 0.070
|
|
Change From Baseline in HbA1c Over Time
Week 12 (n=102, 104, 104, 103, 108, 102, 111)
|
0.12 percentage glycosylated hemoglobin
Standard Error 0.081
|
-0.53 percentage glycosylated hemoglobin
Standard Error 0.080
|
-0.62 percentage glycosylated hemoglobin
Standard Error 0.080
|
-0.68 percentage glycosylated hemoglobin
Standard Error 0.081
|
-1.02 percentage glycosylated hemoglobin
Standard Error 0.079
|
-1.22 percentage glycosylated hemoglobin
Standard Error 0.081
|
-1.40 percentage glycosylated hemoglobin
Standard Error 0.078
|
|
Change From Baseline in HbA1c Over Time
Week 16 (n=102, 104, 104, 103, 108, 102, 111)
|
0.13 percentage glycosylated hemoglobin
Standard Error 0.087
|
-0.58 percentage glycosylated hemoglobin
Standard Error 0.087
|
-0.63 percentage glycosylated hemoglobin
Standard Error 0.086
|
-0.72 percentage glycosylated hemoglobin
Standard Error 0.087
|
-1.09 percentage glycosylated hemoglobin
Standard Error 0.085
|
-1.26 percentage glycosylated hemoglobin
Standard Error 0.087
|
-1.50 percentage glycosylated hemoglobin
Standard Error 0.084
|
|
Change From Baseline in HbA1c Over Time
Week 20 (n=102, 104, 104, 103, 108, 102, 111)
|
0.12 percentage glycosylated hemoglobin
Standard Error 0.092
|
-0.57 percentage glycosylated hemoglobin
Standard Error 0.091
|
-0.59 percentage glycosylated hemoglobin
Standard Error 0.091
|
-0.68 percentage glycosylated hemoglobin
Standard Error 0.092
|
-1.14 percentage glycosylated hemoglobin
Standard Error 0.089
|
-1.25 percentage glycosylated hemoglobin
Standard Error 0.092
|
-1.54 percentage glycosylated hemoglobin
Standard Error 0.088
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26.Population: Full analysis set where a baseline assessment and at least 1 valid postbaseline assessment were available. Includes only data collected on or after baseline and within 1 day after the last dose of study medication or hyperglycemic rescue, whichever came first. Last observation carried forward was utilized.
The change from Baseline in fasting plasma glucose was assessed at Weeks 1, 2, 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as fixed effects, and baseline fasting plasma glucose as a covariate.
Outcome measures
| Measure |
Placebo
n=106 Participants
Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
|
Alogliptin 25 QD
n=112 Participants
Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
|
Alogliptin 12.5 BID
n=110 Participants
Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
|
Metformin 500 BID
n=109 Participants
Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
|
Metformin 1000 BID
n=111 Participants
Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
|
Alogliptin 12.5 BID + Metformin 500 BID
n=106 Participants
Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
|
Alogliptin 12.5 BID + Metformin 1000 BID
n=114 Participants
Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose Over Time
Week 1 (n=102, 103, 94, 95, 104, 101, 109)
|
5.7 mg/dL
Standard Error 3.40
|
-3.9 mg/dL
Standard Error 3.38
|
-11.9 mg/dL
Standard Error 3.54
|
-12.6 mg/dL
Standard Error 3.52
|
-23.1 mg/dL
Standard Error 3.36
|
-32.7 mg/dL
Standard Error 3.41
|
-36.3 mg/dL
Standard Error 3.29
|
|
Change From Baseline in Fasting Plasma Glucose Over Time
Week 2 (n=105, 112, 105, 102, 108, 106, 111)
|
4.6 mg/dL
Standard Error 3.58
|
-7.4 mg/dL
Standard Error 3.46
|
-11.6 mg/dL
Standard Error 3.58
|
-14.5 mg/dL
Standard Error 3.63
|
-22.2 mg/dL
Standard Error 3.53
|
-34.5 mg/dL
Standard Error 3.56
|
-43.6 mg/dL
Standard Error 3.48
|
|
Change From Baseline in Fasting Plasma Glucose Over Time
Week 4 (n=105, 112, 106, 106, 110, 106, 111)
|
7.2 mg/dL
Standard Error 3.69
|
-11.5 mg/dL
Standard Error 3.57
|
-16.6 mg/dL
Standard Error 3.67
|
-16.9 mg/dL
Standard Error 3.67
|
-29.0 mg/dL
Standard Error 3.60
|
-37.6 mg/dL
Standard Error 3.67
|
-44.1 mg/dL
Standard Error 3.58
|
|
Change From Baseline in Fasting Plasma Glucose Over Time
Week 8 (n=105, 112, 106, 106, 110, 106, 112)
|
7.1 mg/dL
Standard Error 4.00
|
-10.9 mg/dL
Standard Error 3.87
|
-12.1 mg/dL
Standard Error 3.98
|
-11.8 mg/dL
Standard Error 3.98
|
-30.7 mg/dL
Standard Error 3.91
|
-32.9 mg/dL
Standard Error 3.98
|
-43.8 mg/dL
Standard Error 3.87
|
|
Change From Baseline in Fasting Plasma Glucose Over Time
Week 12 (n=105, 112, 106, 106, 110, 106, 112)
|
11.6 mg/dL
Standard Error 4.16
|
-9.7 mg/dL
Standard Error 4.03
|
-14.7 mg/dL
Standard Error 4.14
|
-14.0 mg/dL
Standard Error 4.14
|
-30.7 mg/dL
Standard Error 4.06
|
-31.6 mg/dL
Standard Error 4.14
|
-44.7 mg/dL
Standard Error 4.03
|
|
Change From Baseline in Fasting Plasma Glucose Over Time
Week 16 (n=105, 112, 106, 106, 110, 106, 112)
|
10.1 mg/dL
Standard Error 4.17
|
-7.1 mg/dL
Standard Error 4.04
|
-14.7 mg/dL
Standard Error 4.15
|
-13.3 mg/dL
Standard Error 4.15
|
-33.5 mg/dL
Standard Error 4.07
|
-35.9 mg/dL
Standard Error 4.15
|
-47.7 mg/dL
Standard Error 4.04
|
|
Change From Baseline in Fasting Plasma Glucose Over Time
Week 20 (n=105, 112, 106, 106, 110, 106, 112)
|
8.7 mg/dL
Standard Error 4.36
|
-9.2 mg/dL
Standard Error 4.22
|
-12.3 mg/dL
Standard Error 4.34
|
-10.9 mg/dL
Standard Error 4.34
|
-35.1 mg/dL
Standard Error 4.25
|
-33.8 mg/dL
Standard Error 4.34
|
-44.6 mg/dL
Standard Error 4.22
|
|
Change From Baseline in Fasting Plasma Glucose Over Time
Week 26 (n=105, 112, 106, 106, 110, 106, 112)
|
12.4 mg/dL
Standard Error 4.52
|
-6.1 mg/dL
Standard Error 4.37
|
-9.7 mg/dL
Standard Error 4.49
|
-11.5 mg/dL
Standard Error 4.49
|
-31.9 mg/dL
Standard Error 4.41
|
-31.7 mg/dL
Standard Error 4.49
|
-45.9 mg/dL
Standard Error 4.37
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 50 other events
Deaths: 0 deaths
Alogliptin 25 QD
Serious events: 1 serious events
Other events: 38 other events
Deaths: 0 deaths
Alogliptin 12.5 BID
Serious events: 4 serious events
Other events: 34 other events
Deaths: 0 deaths
Metformin 500 BID
Serious events: 3 serious events
Other events: 44 other events
Deaths: 0 deaths
Metformin 1000 BID
Serious events: 2 serious events
Other events: 43 other events
Deaths: 0 deaths
Alogliptin 12.5 BID + Metformin 500 BID
Serious events: 2 serious events
Other events: 40 other events
Deaths: 0 deaths
Alogliptin 12.5 BID + Metformin 1000 BID
Serious events: 2 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=106 participants at risk
Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
|
Alogliptin 25 QD
n=112 participants at risk
Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
|
Alogliptin 12.5 BID
n=110 participants at risk
Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
|
Metformin 500 BID
n=109 participants at risk
Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
|
Metformin 1000 BID
n=111 participants at risk
Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
|
Alogliptin 12.5 BID + Metformin 500 BID
n=106 participants at risk
Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
|
Alogliptin 12.5 BID + Metformin 1000 BID
n=114 participants at risk
Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
|
|---|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/112 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/110 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/109 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/111 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.88%
1/114 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/112 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/110 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
0.92%
1/109 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/111 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/114 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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
Myocardial ischaemia
|
0.94%
1/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/112 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/110 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/109 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/111 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/114 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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
Wandering pacemaker
|
0.00%
0/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/112 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/110 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/109 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
0.90%
1/111 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/114 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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
Gallbladder empyema
|
0.00%
0/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/112 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/110 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/109 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/111 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.88%
1/114 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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
Pneumonia
|
0.00%
0/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/112 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
0.91%
1/110 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/109 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/111 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/114 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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
Urinary tract infection
|
0.00%
0/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
0.89%
1/112 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/110 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/109 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/111 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/114 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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
Cerebrovascular accident
|
0.00%
0/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/112 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
0.91%
1/110 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/109 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/111 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/114 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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
Ischaemic stroke
|
0.00%
0/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/112 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
0.91%
1/110 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/109 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/111 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/114 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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
Tremor
|
0.94%
1/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/112 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/110 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/109 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/111 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/114 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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
Ankle fracture
|
0.00%
0/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/112 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/110 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
0.92%
1/109 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/111 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/114 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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
Multiple drug overdose intentional
|
0.00%
0/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/112 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
0.91%
1/110 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/109 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/111 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/114 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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
Alveolitis allergic
|
0.00%
0/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/112 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/110 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
0.92%
1/109 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/111 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/114 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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
Pulmonary fibrosis
|
0.00%
0/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/112 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/110 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
0.92%
1/109 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/111 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/114 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/112 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/110 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/109 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/111 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
0.94%
1/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/114 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.94%
1/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/112 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/110 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/109 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/111 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/114 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
|
Psychiatric disorders
Delusion
|
0.00%
0/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/112 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/110 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/109 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/111 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
0.94%
1/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/114 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/112 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/110 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/109 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
0.90%
1/111 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/114 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
|
Vascular disorders
Hypotension
|
0.00%
0/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/112 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/110 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/109 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/111 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.88%
1/114 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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 |
Placebo
n=106 participants at risk
Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
|
Alogliptin 25 QD
n=112 participants at risk
Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
|
Alogliptin 12.5 BID
n=110 participants at risk
Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
|
Metformin 500 BID
n=109 participants at risk
Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
|
Metformin 1000 BID
n=111 participants at risk
Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
|
Alogliptin 12.5 BID + Metformin 500 BID
n=106 participants at risk
Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
|
Alogliptin 12.5 BID + Metformin 1000 BID
n=114 participants at risk
Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
|
|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
26.4%
28/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
17.0%
19/112 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.8%
13/110 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
17.4%
19/109 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
8.1%
9/111 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
7.5%
8/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.88%
1/114 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
2.8%
3/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
5.4%
6/112 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
4.5%
5/110 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
7.3%
8/109 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
3.6%
4/111 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
6.6%
7/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
5.3%
6/114 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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
|
2.8%
3/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
0.89%
1/112 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
2.7%
3/110 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
3.7%
4/109 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
9.0%
10/111 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
6/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
7.0%
8/114 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
5.7%
6/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
0.89%
1/112 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
1.8%
2/110 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
6.4%
7/109 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
5.4%
6/111 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
6/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
1.8%
2/114 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
|
Vascular disorders
Hypertension
|
4.7%
5/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
2.7%
3/112 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
1.8%
2/110 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
5.5%
6/109 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
0.90%
1/111 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
4.7%
5/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
7.0%
8/114 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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
Creatinine renal clearance decreased
|
3.8%
4/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
0.89%
1/112 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
3.6%
4/110 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/109 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
5.4%
6/111 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
4.7%
5/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
7.9%
9/114 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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
Upper respiratory tract infection
|
2.8%
3/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
2.7%
3/112 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
2.7%
3/110 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
3.7%
4/109 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
2.7%
3/111 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
7.5%
8/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
1.8%
2/114 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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
Nausea
|
1.9%
2/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/112 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
2.7%
3/110 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
3.7%
4/109 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
5.4%
6/111 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
2.8%
3/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
5.3%
6/114 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
2.8%
3/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
2.7%
3/112 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
0.91%
1/110 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
2.8%
3/109 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
5.4%
6/111 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
6/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.88%
1/114 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
1.9%
2/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
6.2%
7/112 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
0.91%
1/110 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
1.8%
2/109 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
3.6%
4/111 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
2.8%
3/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
1.8%
2/114 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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
Dyspepsia
|
2.8%
3/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/112 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
0.91%
1/110 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/109 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
1.8%
2/111 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
7.0%
8/114 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.94%
1/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/112 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
0.91%
1/110 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
5.5%
6/109 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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.
|
0.90%
1/111 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
4/106 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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%
0/114 • Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
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
Sr. VP, Clinical Science
Takeda Global Research and Development Center, Inc.
Phone: 800-778-2860
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER