Trial Outcomes & Findings for Efficacy of Alogliptin With Pioglitazone (Actos®) in Subjects With Type 2 Diabetes Mellitus (NCT NCT00395512)
NCT ID: NCT00395512
Last Updated: 2013-03-27
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
655 participants
Primary outcome timeframe
Baseline and Week 26
Results posted on
2013-03-27
Participant Flow
Participants took part in the study at 268 investigative sites in 23 countries from 02 November 2006 to 13 February 2008.
Participants with a diagnosis of type 2 diabetes who were inadequately controlled with diet and exercise were randomized to 1 of 4 treatment groups in a 1:1:1:1 ratio as follows: Alogliptin alone, pioglitazone alone, alogliptin 25 mg + pioglitazone 30 mg and alogliptin 12.5 mg + pioglitazone 30 mg.
Participant milestones
| Measure |
Alogliptin 25 mg
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
164
|
163
|
164
|
164
|
|
Overall Study
Safety Set
|
164
|
163
|
164
|
163
|
|
Overall Study
COMPLETED
|
126
|
126
|
136
|
126
|
|
Overall Study
NOT COMPLETED
|
38
|
37
|
28
|
38
|
Reasons for withdrawal
| Measure |
Alogliptin 25 mg
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
8
|
6
|
6
|
|
Overall Study
Protocol Violation
|
2
|
3
|
6
|
7
|
|
Overall Study
Lost to Follow-up
|
2
|
6
|
5
|
5
|
|
Overall Study
Withdrawal by Subject
|
6
|
5
|
5
|
12
|
|
Overall Study
Physician Decision
|
6
|
4
|
2
|
2
|
|
Overall Study
Other
|
1
|
1
|
0
|
0
|
|
Overall Study
Hyperglycemic Rescue
|
18
|
10
|
4
|
6
|
Baseline Characteristics
Efficacy of Alogliptin With Pioglitazone (Actos®) in Subjects With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Total
n=655 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
52.6 years
STANDARD_DEVIATION 10.38 • n=5 Participants
|
51.5 years
STANDARD_DEVIATION 10.72 • n=7 Participants
|
52.8 years
STANDARD_DEVIATION 11.01 • n=5 Participants
|
53.5 years
STANDARD_DEVIATION 11.37 • n=4 Participants
|
52.6 years
STANDARD_DEVIATION 10.88 • n=21 Participants
|
|
Age, Customized
< 65 years
|
144 participants
n=5 Participants
|
143 participants
n=7 Participants
|
140 participants
n=5 Participants
|
130 participants
n=4 Participants
|
557 participants
n=21 Participants
|
|
Age, Customized
≥ 65 years
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
24 participants
n=5 Participants
|
34 participants
n=4 Participants
|
98 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
335 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
320 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
63 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
248 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
101 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
407 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
135 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
132 Participants
n=4 Participants
|
526 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Weight
|
86.72 kg
STANDARD_DEVIATION 19.033 • n=5 Participants
|
85.53 kg
STANDARD_DEVIATION 16.254 • n=7 Participants
|
85.39 kg
STANDARD_DEVIATION 20.374 • n=5 Participants
|
84.38 kg
STANDARD_DEVIATION 20.378 • n=4 Participants
|
85.50 kg
STANDARD_DEVIATION 19.062 • n=21 Participants
|
|
Body Mass Index (BMI)
|
31.61 kg/m^2
STANDARD_DEVIATION 5.587 • n=5 Participants
|
30.87 kg/m^2
STANDARD_DEVIATION 4.938 • n=7 Participants
|
31.32 kg/m^2
STANDARD_DEVIATION 5.354 • n=5 Participants
|
30.71 kg/m^2
STANDARD_DEVIATION 5.621 • n=4 Participants
|
31.13 kg/m^2
STANDARD_DEVIATION 5.382 • n=21 Participants
|
|
Duration of diabetes
|
3.23 years
STANDARD_DEVIATION 3.559 • n=5 Participants
|
3.20 years
STANDARD_DEVIATION 3.739 • n=7 Participants
|
3.05 years
STANDARD_DEVIATION 3.328 • n=5 Participants
|
3.36 years
STANDARD_DEVIATION 4.166 • n=4 Participants
|
3.21 years
STANDARD_DEVIATION 3.704 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 26Population: The Full analysis Set (all randomized patients who took at least 1 dose of double-blind study drug) where a Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation 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 |
Alogliptin 25 mg
n=160 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=153 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=158 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=158 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Week 26 in Glycosylated Hemoglobin (HbA1c)
|
-0.96 percentage of glycosylated hemoglobin
Standard Error 0.081
|
-1.15 percentage of glycosylated hemoglobin
Standard Error 0.083
|
-1.71 percentage of glycosylated hemoglobin
Standard Error 0.081
|
-1.56 percentage of glycosylated hemoglobin
Standard Error 0.081
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16 and 20.Population: The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation 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) at 4 week intervals during the study. Least Squares Means were from an Analysis of Covariance (ANCOVA) model with treatment and geographic region as class variables and baseline HbA1c as a covariate.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in HbA1c Over Time
Week 8 (n=160, 153, 158, 158)
|
-0.84 percentage of glycosylated hemoglobin
Standard Error 0.058
|
-0.72 percentage of glycosylated hemoglobin
Standard Error 0.060
|
-1.19 percentage of glycosylated hemoglobin
Standard Error 0.059
|
-1.03 percentage of glycosylated hemoglobin
Standard Error 0.059
|
|
Change From Baseline in HbA1c Over Time
Week 12 (n=160, 153, 158, 158)
|
-0.98 percentage of glycosylated hemoglobin
Standard Error 0.070
|
-1.04 percentage of glycosylated hemoglobin
Standard Error 0.071
|
-1.57 percentage of glycosylated hemoglobin
Standard Error 0.070
|
-1.34 percentage of glycosylated hemoglobin
Standard Error 0.070
|
|
Change From Baseline in HbA1c Over Time
Week 16 (n=160, 153, 158, 158)
|
-1.01 percentage of glycosylated hemoglobin
Standard Error 0.080
|
-1.17 percentage of glycosylated hemoglobin
Standard Error 0.082
|
-1.67 percentage of glycosylated hemoglobin
Standard Error 0.081
|
-1.43 percentage of glycosylated hemoglobin
Standard Error 0.081
|
|
Change From Baseline in HbA1c Over Time
Week 20 (n=160, 153, 158, 158)
|
-1.00 percentage of glycosylated hemoglobin
Standard Error 0.077
|
-1.20 percentage of glycosylated hemoglobin
Standard Error 0.079
|
-1.72 percentage of glycosylated hemoglobin
Standard Error 0.078
|
-1.54 percentage of glycosylated hemoglobin
Standard Error 0.078
|
|
Change From Baseline in HbA1c Over Time
Week 4 (n=145, 146, 144, 150)
|
-0.55 percentage of glycosylated hemoglobin
Standard Error 0.043
|
-0.30 percentage of glycosylated hemoglobin
Standard Error 0.043
|
-0.62 percentage of glycosylated hemoglobin
Standard Error 0.043
|
-0.51 percentage of glycosylated hemoglobin
Standard Error 0.043
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26.Population: The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation 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 class variables and baseline plasma glucose as a covariate.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose Over Time
Week 1 (n=148, 146, 152, 151)
|
-14.6 mg/dL
Standard Error 2.93
|
-7.3 mg/dL
Standard Error 2.95
|
-26.6 mg/dL
Standard Error 2.90
|
-23.3 mg/dL
Standard Error 2.91
|
|
Change From Baseline in Fasting Plasma Glucose Over Time
Week 2 (n=161, 156, 162, 159)
|
-16.7 mg/dL
Standard Error 2.87
|
-14.2 mg/dL
Standard Error 2.92
|
-33.5 mg/dL
Standard Error 2.87
|
-30.9 mg/dL
Standard Error 2.90
|
|
Change From Baseline in Fasting Plasma Glucose Over Time
Week 4 (n=162, 157, 162, 161)
|
-26.7 mg/dL
Standard Error 2.72
|
-31.9 mg/dL
Standard Error 2.76
|
-41.4 mg/dL
Standard Error 2.72
|
-39.7 mg/dL
Standard Error 2.73
|
|
Change From Baseline in Fasting Plasma Glucose Over Time
Week 8 (n=162, 157, 162, 162)
|
-29.0 mg/dL
Standard Error 2.80
|
-38.0 mg/dL
Standard Error 2.84
|
-50.4 mg/dL
Standard Error 2.80
|
-48.4 mg/dL
Standard Error 2.81
|
|
Change From Baseline in Fasting Plasma Glucose Over Time
Week 12 (n=162, 157, 162, 162)
|
-29.5 mg/dL
Standard Error 3.01
|
-42.4 mg/dL
Standard Error 3.05
|
-51.9 mg/dL
Standard Error 3.01
|
-49.3 mg/dL
Standard Error 3.01
|
|
Change From Baseline in Fasting Plasma Glucose Over Time
Week 16 (n=162, 157, 162, 162)
|
-26.9 mg/dL
Standard Error 3.11
|
-40.6 mg/dL
Standard Error 3.16
|
-52.7 mg/dL
Standard Error 3.12
|
-46.6 mg/dL
Standard Error 3.12
|
|
Change From Baseline in Fasting Plasma Glucose Over Time
Week 20 (n=162, 157, 162, 162)
|
-28.3 mg/dL
Standard Error 3.06
|
-42.0 mg/dL
Standard Error 3.11
|
-54.0 mg/dL
Standard Error 3.07
|
-47.5 mg/dL
Standard Error 3.07
|
|
Change From Baseline in Fasting Plasma Glucose Over Time
Week 26 (n=162, 157, 162, 162)
|
-25.8 mg/dL
Standard Error 3.26
|
-37.3 mg/dL
Standard Error 3.31
|
-50.2 mg/dL
Standard Error 3.27
|
-48.5 mg/dL
Standard Error 3.27
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 4, 8, 12, 16, 20 and 26.Population: Full analysis set including patients with at least one non-missing fasting plasma glucose result in the specified interval in each treatment group.
Marked Hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL. Study week windows are defined to place hyperglycemia into visit categories.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Marked Hyperglycemia
Week 1 to < Week 4 (n=162, 157, 162, 161)
|
31.5 percentage of participants
|
31.8 percentage of participants
|
18.5 percentage of participants
|
28.6 percentage of participants
|
|
Percentage of Participants With Marked Hyperglycemia
Week 4 to < Week 8 (n=153, 147, 148, 147)
|
19.0 percentage of participants
|
15.0 percentage of participants
|
10.8 percentage of participants
|
14.3 percentage of participants
|
|
Percentage of Participants With Marked Hyperglycemia
Week 8 to < Week 12 (n=151, 146, 152, 146)
|
15.2 percentage of participants
|
11.6 percentage of participants
|
7.2 percentage of participants
|
8.2 percentage of participants
|
|
Percentage of Participants With Marked Hyperglycemia
Week 12 to < Week 16 (n=153, 141, 148, 139)
|
16.3 percentage of participants
|
9.2 percentage of participants
|
8.1 percentage of participants
|
7.9 percentage of participants
|
|
Percentage of Participants With Marked Hyperglycemia
Week 16 to < Week 20 (n=142, 135, 144, 131)
|
16.2 percentage of participants
|
14.8 percentage of participants
|
2.8 percentage of participants
|
6.9 percentage of participants
|
|
Percentage of Participants With Marked Hyperglycemia
Week 20 to Week 26 (n=130, 132, 143, 128)
|
17.7 percentage of participants
|
11.4 percentage of participants
|
10.5 percentage of participants
|
6.3 percentage of participants
|
|
Percentage of Participants With Marked Hyperglycemia
Overall (n=162, 157, 162, 162)
|
44.4 percentage of participants
|
38.2 percentage of participants
|
25.3 percentage of participants
|
30.9 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20 and 26.Population: Full analysis set including patients with visits during or after the specified interval in each treatment group.
Rescue was defined as meeting 1 of the following criteria, confirmed by a 2nd sample drawn within 5 days after the first sample and analyzed by the central laboratory: 1. After more than 4 weeks of treatment but prior to the Week 8 Visit: a single fasting plasma glucose ≥310 mg/dL (≥17.5 mmol/L); 2. From the Week 8 Visit but prior to the Week 12 Visit: a single fasting plasma glucose ≥275 mg/dL (≥15.27 mmol/L); 3. From the Week 12 Visit through the End-of-Treatment Visit: HbA1c ≥8.5% and ≤0.5% reduction in HbA1c as compared with the Baseline HbA1c.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Meeting Rescue Criteria
Week 4 to < Week 8 (n=160, 156, 161, 160)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0.6 percentage of participants
|
|
Percentage of Participants Meeting Rescue Criteria
Week 8 to < Week 12 (n=158, 151, 157, 153)
|
1.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Meeting Rescue Criteria
Week 12 to < Week 16 (n=156, 145, 153, 144)
|
2.6 percentage of participants
|
3.4 percentage of participants
|
1.3 percentage of participants
|
2.1 percentage of participants
|
|
Percentage of Participants Meeting Rescue Criteria
Week 16 to < Week 20 (n=150, 138, 149, 134)
|
7.3 percentage of participants
|
2.2 percentage of participants
|
0 percentage of participants
|
1.5 percentage of participants
|
|
Percentage of Participants Meeting Rescue Criteria
Week 20 to Week 26 (n=132, 133, 146, 130)
|
0.8 percentage of participants
|
1.5 percentage of participants
|
1.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Meeting Rescue Criteria
Overall (n=160, 156, 161, 160)
|
11.3 percentage of participants
|
6.4 percentage of participants
|
2.5 percentage of participants
|
3.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 26Population: Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.
Clinical response at Week 26 was assessed by the percentage of participants with HbA1c ≤6.5%.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 6.5%
|
11.6 percentage of participants
|
16.6 percentage of participants
|
27.4 percentage of participants
|
26.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 26Population: Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.
Clinical response at Week 26 was assessed by the percentage of participants with HbA1c ≤ 7%.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.0%
|
24.4 percentage of participants
|
33.7 percentage of participants
|
62.8 percentage of participants
|
53.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 26Population: Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.
Clinical response at Week 26 was assessed by the percentage of participants with HbA1c ≤ 7.5%.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.5%
|
44.5 percentage of participants
|
55.8 percentage of participants
|
72.0 percentage of participants
|
72.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.
Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of ≥ 0.5%.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 0.5%
|
66.5 percentage of participants
|
70.6 percentage of participants
|
89.6 percentage of participants
|
85.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.
Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of ≥ 1%.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 1.0%
|
43.3 percentage of participants
|
54.6 percentage of participants
|
75.6 percentage of participants
|
68.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.
Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of ≥ 1.5%.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 1.5%.
|
29.3 percentage of participants
|
33.1 percentage of participants
|
57.3 percentage of participants
|
50.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: Full Analysis Set. Participants who did not complete the scheduled Week 26 visit were assessed based on their response at the time of discontinuation.
Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of ≥ 2.0%.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 2.0%
|
17.7 percentage of participants
|
19.6 percentage of participants
|
34.1 percentage of participants
|
33.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20 and 26.Population: The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Proinsulin is a precursor to insulin, and was measured as an indicator of pancreatic function. The change from Baseline in fasting proinsulin was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as class variables and baseline proinsulin as a covariate.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Fasting Proinsulin
Week 4 (n=136, 134, 135, 145)
|
-4.9 pmol/L
Standard Error 1.74
|
-12.1 pmol/L
Standard Error 1.75
|
-16.0 pmol/L
Standard Error 1.74
|
-12.3 pmol/L
Standard Error 1.68
|
|
Change From Baseline in Fasting Proinsulin
Week 8 (n=150, 143, 146, 155)
|
-3.7 pmol/L
Standard Error 1.57
|
-14.9 pmol/L
Standard Error 1.60
|
-18.2 pmol/L
Standard Error 1.59
|
-17.7 pmol/L
Standard Error 1.54
|
|
Change From Baseline in Fasting Proinsulin
Week 12 (n=150, 143, 147, 155)
|
-5.9 pmol/L
Standard Error 1.48
|
-16.0 pmol/L
Standard Error 1.52
|
-18.6 pmol/L
Standard Error 1.50
|
-16.7 pmol/L
Standard Error 1.46
|
|
Change From Baseline in Fasting Proinsulin
Week 16 (n=150, 143, 147, 155)
|
-3.4 pmol/L
Standard Error 1.88
|
-16.3 pmol/L
Standard Error 1.93
|
-16.0 pmol/L
Standard Error 1.90
|
-13.1 pmol/L
Standard Error 1.85
|
|
Change From Baseline in Fasting Proinsulin
Week 20 (n=150, 143, 147, 155)
|
-8.1 pmol/L
Standard Error 1.75
|
-16.1 pmol/L
Standard Error 1.79
|
-19.8 pmol/L
Standard Error 1.76
|
-15.5 pmol/L
Standard Error 1.72
|
|
Change From Baseline in Fasting Proinsulin
Week 26 (n=150, 143, 147, 155)
|
-4.8 pmol/L
Standard Error 1.64
|
-13.2 pmol/L
Standard Error 1.68
|
-18.3 pmol/L
Standard Error 1.66
|
-15.1 pmol/L
Standard Error 1.61
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20 and 26.Population: The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
The change from Baseline in fasting insulin was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as class variables and baseline insulin as a covariate.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Insulin
Week 4 (n=135, 133, 133, 145)
|
0.43 μIU/mL
Standard Error 0.684
|
-4.74 μIU/mL
Standard Error 0.689
|
-4.67 μIU/mL
Standard Error 0.687
|
-4.27 μIU/mL
Standard Error 0.659
|
|
Change From Baseline in Insulin
Week 8 (n=150, 142, 147, 155)
|
0.93 μIU/mL
Standard Error 0.811
|
-4.41 μIU/mL
Standard Error 0.834
|
-4.75 μIU/mL
Standard Error 0.818
|
-4.86 μIU/mL
Standard Error 0.797
|
|
Change From Baseline in Insulin
Week 12 (n=150, 142, 148, 155)
|
0.29 μIU/mL
Standard Error 0.883
|
-4.08 μIU/mL
Standard Error 0.907
|
-2.98 μIU/mL
Standard Error 0.887
|
-4.65 μIU/mL
Standard Error 0.867
|
|
Change From Baseline in Insulin
Week 16 (n=150, 142, 148, 155)
|
0.26 μIU/mL
Standard Error 0.829
|
-4.49 μIU/mL
Standard Error 0.852
|
-3.65 μIU/mL
Standard Error 0.833
|
-2.73 μIU/mL
Standard Error 0.814
|
|
Change From Baseline in Insulin
Week 20 (n=150, 142, 148, 155)
|
-1.02 μIU/mL
Standard Error 0.844
|
-4.56 μIU/mL
Standard Error 0.868
|
-4.61 μIU/mL
Standard Error 0.848
|
-3.06 μIU/mL
Standard Error 0.829
|
|
Change From Baseline in Insulin
Week 26 (n=150, 142, 148, 155)
|
-0.47 μIU/mL
Standard Error 0.755
|
-4.06 μIU/mL
Standard Error 0.776
|
-3.86 μIU/mL
Standard Error 0.759
|
-3.72 μIU/mL
Standard Error 0.742
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20 and 26.Population: The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (μIU/mL) at weeks 4, 8, 12, 16, 20 and 26 relative to the Baseline value. Least squares means were from an ANCOVA model with treatment and geographic region as class variables and Baseline proinsulin/insulin ratio as a covariate.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Proinsulin/Insulin Ratio
Week 4 (n=135, 133, 133, 145)
|
-0.073 ratio
Standard Error 0.0150
|
-0.047 ratio
Standard Error 0.0151
|
-0.080 ratio
Standard Error 0.0151
|
-0.056 ratio
Standard Error 0.0144
|
|
Change From Baseline in Proinsulin/Insulin Ratio
Week 8 (n=149, 142, 146, 155)
|
-0.041 ratio
Standard Error 0.0140
|
-0.085 ratio
Standard Error 0.0144
|
-0.094 ratio
Standard Error 0.0142
|
-0.102 ratio
Standard Error 0.0138
|
|
Change From Baseline in Proinsulin/Insulin Ratio
Week 12 (n=149, 142, 147, 155)
|
-0.062 ratio
Standard Error 0.0122
|
-0.098 ratio
Standard Error 0.0125
|
-0.123 ratio
Standard Error 0.0123
|
-0.095 ratio
Standard Error 0.0120
|
|
Change From Baseline in Proinsulin/Insulin Ratio
Week 16 (n=149, 142, 147, 155)
|
-0.049 ratio
Standard Error 0.0173
|
-0.081 ratio
Standard Error 0.0177
|
-0.115 ratio
Standard Error 0.0174
|
-0.090 ratio
Standard Error 0.0170
|
|
Change From Baseline in Proinsulin/Insulin Ratio
Week 20 (n=149, 142, 147, 155)
|
-0.057 ratio
Standard Error 0.0173
|
-0.076 ratio
Standard Error 0.0177
|
-0.124 ratio
Standard Error 0.0174
|
-0.119 ratio
Standard Error 0.0169
|
|
Change From Baseline in Proinsulin/Insulin Ratio
Week 26 (n=149, 142, 147, 155)
|
-0.051 ratio
Standard Error 0.0145
|
-0.076 ratio
Standard Error 0.0148
|
-0.107 ratio
Standard Error 0.0146
|
-0.102 ratio
Standard Error 0.0142
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20 and 26.Population: The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
C-peptide is a byproduct created when the hormone insulin is produced and is measured by a blood test. Change from Baseline was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline C-peptide as a covariate.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in C-peptide Levels
Week 4 (n=142, 141, 141, 146)
|
0.057 ng/mL
Standard Error 0.0740
|
-0.551 ng/mL
Standard Error 0.0741
|
-0.593 ng/mL
Standard Error 0.0741
|
-0.452 ng/mL
Standard Error 0.0729
|
|
Change From Baseline in C-peptide Levels
Week 8 (n=158, 150, 153, 156)
|
0.034 ng/mL
Standard Error 0.0701
|
-0.606 ng/mL
Standard Error 0.0718
|
-0.620 ng/mL
Standard Error 0.0711
|
-0.547 ng/mL
Standard Error 0.0704
|
|
Change From Baseline in C-peptide Levels
Week 12 (n=158, 150, 154, 156)
|
-0.040 ng/mL
Standard Error 0.0676
|
-0.612 ng/mL
Standard Error 0.0693
|
-0.534 ng/mL
Standard Error 0.0684
|
-0.536 ng/mL
Standard Error 0.0680
|
|
Change From Baseline in C-peptide Levels
Week 16 (n=158, 150, 154, 156)
|
0.037 ng/mL
Standard Error 0.0801
|
-0.604 ng/mL
Standard Error 0.0822
|
-0.424 ng/mL
Standard Error 0.0810
|
-0.353 ng/mL
Standard Error 0.0805
|
|
Change From Baseline in C-peptide Levels
Week 20 (n=158, 150, 154, 156)
|
-0.097 ng/mL
Standard Error 0.0783
|
-0.623 ng/mL
Standard Error 0.0803
|
-0.556 ng/mL
Standard Error 0.0792
|
-0.374 ng/mL
Standard Error 0.0787
|
|
Change From Baseline in C-peptide Levels
Week 26 (n=158, 150, 154, 156)
|
-0.068 ng/mL
Standard Error 0.0752
|
-0.577 ng/mL
Standard Error 0.0771
|
-0.541 ng/mL
Standard Error 0.0760
|
-0.444 ng/mL
Standard Error 0.0756
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12 and 26.Population: The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
The Homeostasis Model Assessment of insulin resistance (HOMA IR) measures insulin resistance based on fasting glucose and insulin measurements: HOMA IR = fasting plasma insulin (µIU/mL) \* fasting plasma glucose (mmol/L) / 22.5 A higher number indicates a greater degree of insulin resistance. The change from Baseline in HOMA IR was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HOMA IR as a covariate.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Calculated Homeostatic Model Assessment Insulin Resistance
Week 12 (n=139, 132, 137, 143)
|
-0.814 insulin resistance
Standard Error 0.5309
|
-3.479 insulin resistance
Standard Error 0.5458
|
-2.905 insulin resistance
Standard Error 0.5348
|
-3.877 insulin resistance
Standard Error 0.5236
|
|
Change From Baseline in Calculated Homeostatic Model Assessment Insulin Resistance
Week 26 (n=145, 134, 144, 148)
|
-1.353 insulin resistance
Standard Error 0.3566
|
-3.350 insulin resistance
Standard Error 0.3717
|
-3.646 insulin resistance
Standard Error 0.3579
|
-3.508 insulin resistance
Standard Error 0.3532
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12 and 26.Population: The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population. HOMA %B = 20 \* insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5 The change from Baseline in the homeostasis model assessment of beta cell function was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HOMA beta cell function as a covariate.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Homeostatic Model Assessment Beta Cell Function
Week 12 (n= 139, 132, 137, 143)
|
15.133 percentage beta cell function
Standard Error 4.2787
|
17.328 percentage beta cell function
Standard Error 4.3868
|
30.266 percentage beta cell function
Standard Error 4.3006
|
22.134 percentage beta cell function
Standard Error 4.2098
|
|
Change From Baseline in Homeostatic Model Assessment Beta Cell Function
Week 26 (n=145, 134, 144, 148)
|
10.472 percentage beta cell function
Standard Error 8.5306
|
17.500 percentage beta cell function
Standard Error 8.8718
|
39.153 percentage beta cell function
Standard Error 8.5455
|
24.887 percentage beta cell function
Standard Error 8.4285
|
SECONDARY outcome
Timeframe: Baseline and Weeks 8, 12, 20 and 26.Population: The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Change from Baseline in body weight was assessed at Weeks 8, 12, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and Baseline weight as a covariate.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Body Weight
Week 8 (n=155, 146, 152, 151)
|
-0.34 kg
Standard Error 0.184
|
0.58 kg
Standard Error 0.189
|
0.82 kg
Standard Error 0.185
|
0.70 kg
Standard Error 0.186
|
|
Change From Baseline in Body Weight
Week 12 (n=159, 147, 155, 154)
|
-0.78 kg
Standard Error 0.227
|
0.96 kg
Standard Error 0.236
|
1.35 kg
Standard Error 0.230
|
1.22 kg
Standard Error 0.230
|
|
Change From Baseline in Body Weight
Week 20 (n=159, 147, 155, 154)
|
-0.47 kg
Standard Error 0.265
|
1.56 kg
Standard Error 0.275
|
2.36 kg
Standard Error 0.268
|
1.86 kg
Standard Error 0.269
|
|
Change From Baseline in Body Weight
Week 26 (n=159, 147, 155, 154)
|
-0.29 kg
Standard Error 0.291
|
2.19 kg
Standard Error 0.302
|
3.14 kg
Standard Error 0.295
|
2.51 kg
Standard Error 0.296
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20 and 26.Population: The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Change from Baseline in total cholesterol level was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline total cholesterol as a covariate.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Total Cholesterol Level
Week 4 (n=146, 144, 142, 149)
|
-8.5 mg/dL
Standard Error 2.22
|
0.9 mg/dL
Standard Error 2.23
|
-0.4 mg/dL
Standard Error 2.25
|
-5.3 mg/dL
Standard Error 2.20
|
|
Change From Baseline in Total Cholesterol Level
Week 8 (n=160, 151, 154, 158)
|
-5.4 mg/dL
Standard Error 2.30
|
7.2 mg/dL
Standard Error 2.37
|
-0.3 mg/dL
Standard Error 2.34
|
-1.2 mg/dL
Standard Error 2.31
|
|
Change From Baseline in Total Cholesterol Level
Week 12 (n=160, 151, 155, 158)
|
-4.0 mg/dL
Standard Error 2.43
|
4.9 mg/dL
Standard Error 2.51
|
-0.6 mg/dL
Standard Error 2.47
|
4.4 mg/dL
Standard Error 2.45
|
|
Change From Baseline in Total Cholesterol Level
Week 16 (n=160, 151, 155, 158)
|
-4.3 mg/dL
Standard Error 2.42
|
4.6 mg/dL
Standard Error 2.49
|
3.8 mg/dL
Standard Error 2.46
|
4.7 mg/dL
Standard Error 2.44
|
|
Change From Baseline in Total Cholesterol Level
Week 20 (n=160, 151, 155, 158)
|
-2.9 mg/dL
Standard Error 2.67
|
4.5 mg/dL
Standard Error 2.75
|
-0.3 mg/dL
Standard Error 2.71
|
-0.6 mg/dL
Standard Error 2.69
|
|
Change From Baseline in Total Cholesterol Level
Week 26 (n=160, 151, 155, 158)
|
-0.5 mg/dL
Standard Error 2.61
|
6.5 mg/dL
Standard Error 2.68
|
3.7 mg/dL
Standard Error 2.65
|
4.0 mg/dL
Standard Error 2.62
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20 and 26.Population: The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Change from Baseline in low-density lipoprotein cholesterol (LDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline LDL cholesterol as a covariate.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Low-Density Lipoprotein Cholesterol
Week 4 (n=137, 130, 135, 142)
|
-3.5 mg/dL
Standard Error 1.88
|
2.8 mg/dL
Standard Error 1.93
|
2.2 mg/dL
Standard Error 1.89
|
-2.8 mg/dL
Standard Error 1.85
|
|
Change From Baseline in Low-Density Lipoprotein Cholesterol
Week 8 (n=152, 139, 147, 153)
|
-0.5 mg/dL
Standard Error 1.96
|
7.6 mg/dL
Standard Error 2.05
|
2.6 mg/dL
Standard Error 1.99
|
1.3 mg/dL
Standard Error 1.95
|
|
Change From Baseline in Low-Density Lipoprotein Cholesterol
Week 12 (n=154, 140, 148, 154)
|
0.8 mg/dL
Standard Error 2.02
|
5.8 mg/dL
Standard Error 2.12
|
1.4 mg/dL
Standard Error 2.06
|
3.9 mg/dL
Standard Error 2.02
|
|
Change From Baseline in Low-Density Lipoprotein Cholesterol
Week 16 (n=154, 140, 148, 154)
|
1.8 mg/dL
Standard Error 2.22
|
6.6 mg/dL
Standard Error 2.33
|
5.3 mg/dL
Standard Error 2.27
|
4.6 mg/dL
Standard Error 2.22
|
|
Change From Baseline in Low-Density Lipoprotein Cholesterol
Week 20 (n=154, 140, 148, 154)
|
0.9 mg/dL
Standard Error 2.27
|
7.4 mg/dL
Standard Error 2.38
|
2.1 mg/dL
Standard Error 2.32
|
0.5 mg/dL
Standard Error 2.27
|
|
Change From Baseline in Low-Density Lipoprotein Cholesterol
Week 26 (n=154, 140, 148, 154)
|
2.0 mg/dL
Standard Error 2.22
|
8.1 mg/dL
Standard Error 2.33
|
4.6 mg/dL
Standard Error 2.27
|
3.8 mg/dL
Standard Error 2.22
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20 and 26.Population: The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Change from Baseline in high-density lipoprotein cholesterol (HDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HDL cholesterol as a covariate.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in High-Density Lipoprotein Cholesterol
Week 4 (n=146, 144, 142, 149)
|
-0.2 mg/dL
Standard Error 0.54
|
3.0 mg/dL
Standard Error 0.54
|
3.8 mg/dL
Standard Error 0.55
|
3.0 mg/dL
Standard Error 0.54
|
|
Change From Baseline in High-Density Lipoprotein Cholesterol
Week 8 (n=160, 151, 154, 158)
|
0.5 mg/dL
Standard Error 0.56
|
4.7 mg/dL
Standard Error 0.58
|
5.0 mg/dL
Standard Error 0.57
|
4.8 mg/dL
Standard Error 0.57
|
|
Change From Baseline in High-Density Lipoprotein Cholesterol
Week 12 (n=160, 151, 155, 158)
|
0.9 mg/dL
Standard Error 0.64
|
6.0 mg/dL
Standard Error 0.66
|
6.4 mg/dL
Standard Error 0.65
|
6.5 mg/dL
Standard Error 0.65
|
|
Change From Baseline in High-Density Lipoprotein Cholesterol
Week 16 (n=160, 151, 155, 158)
|
0.9 mg/dL
Standard Error 0.57
|
5.2 mg/dL
Standard Error 0.58
|
6.0 mg/dL
Standard Error 0.58
|
5.9 mg/dL
Standard Error 0.57
|
|
Change From Baseline in High-Density Lipoprotein Cholesterol
Week 20 (n=160, 151, 155, 158)
|
0.5 mg/dL
Standard Error 0.59
|
4.7 mg/dL
Standard Error 0.60
|
5.6 mg/dL
Standard Error 0.60
|
5.6 mg/dL
Standard Error 0.59
|
|
Change From Baseline in High-Density Lipoprotein Cholesterol
Week 26 (n=160, 151, 155, 158)
|
0.8 mg/dL
Standard Error 0.64
|
5.7 mg/dL
Standard Error 0.66
|
6.2 mg/dL
Standard Error 0.65
|
6.2 mg/dL
Standard Error 0.64
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20 and 26.Population: The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Change from Baseline in triglycerides was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline triglycerides as a covariate.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Triglyceride Levels
Week 4 (n=146, 144, 142, 149)
|
-28.2 mg/dL
Standard Error 8.60
|
-43.2 mg/dL
Standard Error 8.63
|
-51.7 mg/dL
Standard Error 8.70
|
-32.1 mg/dL
Standard Error 8.51
|
|
Change From Baseline in Triglyceride Levels
Week 8 (n=160, 151, 154, 158)
|
-34.8 mg/dL
Standard Error 6.51
|
-38.2 mg/dL
Standard Error 6.69
|
-61.6 mg/dL
Standard Error 6.63
|
-51.9 mg/dL
Standard Error 6.56
|
|
Change From Baseline in Triglyceride Levels
Week 12 (n=160, 151, 155, 158)
|
-36.4 mg/dL
Standard Error 6.90
|
-47.9 mg/dL
Standard Error 7.09
|
-64.3 mg/dL
Standard Error 7.00
|
-45.4 mg/dL
Standard Error 6.95
|
|
Change From Baseline in Triglyceride Levels
Week 16 (n=160, 151, 155, 158)
|
-44.5 mg/dL
Standard Error 5.74
|
-48.3 mg/dL
Standard Error 5.90
|
-54.6 mg/dL
Standard Error 5.82
|
-43.9 mg/dL
Standard Error 5.78
|
|
Change From Baseline in Triglyceride Levels
Week 20 (n=160, 151, 155, 158)
|
-29.9 mg/dL
Standard Error 7.35
|
-46.6 mg/dL
Standard Error 7.56
|
-59.3 mg/dL
Standard Error 7.46
|
-46.5 mg/dL
Standard Error 7.41
|
|
Change From Baseline in Triglyceride Levels
Week 26 (n=160, 151, 155, 158)
|
-24.7 mg/dL
Standard Error 6.83
|
-46.6 mg/dL
Standard Error 7.02
|
-56.2 mg/dL
Standard Error 6.92
|
-43.1 mg/dL
Standard Error 6.88
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12 and 26.Population: The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Change from Baseline in free fatty acids (FFA) was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline free fatty acid as a covariate.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Free Fatty Acids
Week 12 (n=148, 136, 140, 147)
|
-0.0404 mmol/L
Standard Error 0.01643
|
-0.0990 mmol/L
Standard Error 0.01716
|
-0.1061 mmol/L
Standard Error 0.01690
|
-0.0805 mmol/L
Standard Error 0.01650
|
|
Change From Baseline in Free Fatty Acids
Week 26 (n=154, 136, 147, 150)
|
-0.0429 mmol/L
Standard Error 0.01624
|
-0.0680 mmol/L
Standard Error 0.01729
|
-0.0881 mmol/L
Standard Error 0.01662
|
-0.1013 mmol/L
Standard Error 0.01647
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12 and 26.Population: The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Change from Baseline in plasminogen activator inhibitor-1 was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline plasminogen activator inhibitor-1 as a covariate.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Plasminogen Activator Inhibitor-1
Week 12 (n=136, 127, 131, 133)
|
-1.58 ng/mL
Standard Error 2.815
|
-4.23 ng/mL
Standard Error 2.909
|
-9.63 ng/mL
Standard Error 2.870
|
-11.87 ng/mL
Standard Error 2.849
|
|
Change From Baseline in Plasminogen Activator Inhibitor-1
Week 26 (n=145, 129, 142, 137)
|
1.71 ng/mL
Standard Error 3.151
|
-5.45 ng/mL
Standard Error 3.341
|
-7.14 ng/mL
Standard Error 3.189
|
-8.38 ng/mL
Standard Error 3.246
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12 and 26.Population: The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Change from Baseline in high-sensitivity C-Reactive Protein (hsCRP) was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline hsCRP as a covariate.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in High-sensitivity C-Reactive Protein
Week 12 (n=147, 134, 138, 146)
|
-0.4497 mg/L
Standard Error 0.41497
|
-1.7446 mg/L
Standard Error 0.43493
|
-1.5346 mg/L
Standard Error 0.42831
|
-2.2771 mg/L
Standard Error 0.41646
|
|
Change From Baseline in High-sensitivity C-Reactive Protein
Week 26 (n=153, 135, 144, 149)
|
-0.1851 mg/L
Standard Error 0.42623
|
-1.0391 mg/L
Standard Error 0.45388
|
-1.9763 mg/L
Standard Error 0.43925
|
-1.9796 mg/L
Standard Error 0.43182
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12 and 26.Population: The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Change from Baseline in adiponectin was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline adiponectin as a covariate.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Adiponectin
Week 12 (n=148, 137, 141, 147)
|
-0.28 μg/mL
Standard Error 0.560
|
6.35 μg/mL
Standard Error 0.582
|
8.10 μg/mL
Standard Error 0.575
|
7.50 μg/mL
Standard Error 0.562
|
|
Change From Baseline in Adiponectin
Week 26 (n=154, 137, 147, 149)
|
-0.09 μg/mL
Standard Error 0.570
|
6.90 μg/mL
Standard Error 0.605
|
6.85 μg/mL
Standard Error 0.586
|
7.16 μg/mL
Standard Error 0.581
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12 and 26.Population: The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Change from Baseline in Apolipoprotein A1 was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and Baseline apolipoprotein A1 as a covariate.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Apolipoprotein A1
Week 12 (n=140, 138, 137, 144)
|
-1.6 mg/dL
Standard Error 1.57
|
2.3 mg/dL
Standard Error 1.58
|
1.0 mg/dL
Standard Error 1.59
|
1.7 mg/dL
Standard Error 1.55
|
|
Change From Baseline in Apolipoprotein A1
Week 26 (n=149, 139, 146, 146)
|
-4.5 mg/dL
Standard Error 1.59
|
1.2 mg/dL
Standard Error 1.64
|
0.8 mg/dL
Standard Error 1.60
|
1.6 mg/dL
Standard Error 1.60
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12 and 26.Population: The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Change from Baseline in apolipoprotein A2 was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline apolipoprotein A2 as a covariate.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Apolipoprotein A2
Week 12 (n=140, 138, 137, 144)
|
-0.1 mg/dL
Standard Error 0.41
|
3.4 mg/dL
Standard Error 0.41
|
2.8 mg/dL
Standard Error 0.41
|
3.2 mg/dL
Standard Error 0.40
|
|
Change From Baseline in Apolipoprotein A2
Week 26 (n=149, 139, 146, 146)
|
-0.3 mg/dL
Standard Error 0.41
|
2.9 mg/dL
Standard Error 0.43
|
2.5 mg/dL
Standard Error 0.42
|
2.6 mg/dL
Standard Error 0.42
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12 and 26.Population: The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Change from Baseline in apolipoprotein B was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline apolipoprotein B as a covariate.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Apolipoprotein B
Week 12 (n=140, 138, 137, 143)
|
-4.0 mg/dL
Standard Error 1.76
|
-5.0 mg/dL
Standard Error 1.78
|
-9.8 mg/dL
Standard Error 1.78
|
-5.9 mg/dL
Standard Error 1.74
|
|
Change From Baseline in Apolipoprotein B
Week 26 (n=149, 139, 146, 146)
|
-2.5 mg/dL
Standard Error 1.84
|
-3.7 mg/dL
Standard Error 1.91
|
-7.9 mg/dL
Standard Error 1.86
|
-6.4 mg/dL
Standard Error 1.86
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12 and 26.Population: The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Change from Baseline in apolipoprotein C-III was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline apolipoprotein C-III as a covariate.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Apolipoprotein C-III
Week 12 (n=140, 138, 138, 144)
|
-0.5 mg/dL
Standard Error 0.30
|
-0.3 mg/dL
Standard Error 0.30
|
-0.8 mg/dL
Standard Error 0.30
|
-0.3 mg/dL
Standard Error 0.30
|
|
Change From Baseline in Apolipoprotein C-III
Week 26 (n=149, 139, 147, 146)
|
-0.4 mg/dL
Standard Error 0.28
|
-0.2 mg/dL
Standard Error 0.29
|
-0.3 mg/dL
Standard Error 0.28
|
-0.4 mg/dL
Standard Error 0.28
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12 and 26.Population: The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Nuclear Magnetic Resonance (NMR) lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline NMR total triglycerides as a covariate.
Outcome measures
| Measure |
Alogliptin 25 mg
n=147 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=133 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=141 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=147 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Nuclear Magnetic Resonance Lipid Fractionation Total Triglycerides
Week 12 (n=139, 132, 132, 141)
|
-14.9 mg/dL
Standard Error 6.36
|
-25.0 mg/dL
Standard Error 6.52
|
-39.7 mg/dL
Standard Error 6.52
|
-23.7 mg/dL
Standard Error 6.32
|
|
Change From Baseline in Nuclear Magnetic Resonance Lipid Fractionation Total Triglycerides
Week 26 (n=147, 133, 141, 147)
|
-7.6 mg/dL
Standard Error 5.82
|
-20.2 mg/dL
Standard Error 6.11
|
-28.8 mg/dL
Standard Error 5.94
|
-22.6 mg/dL
Standard Error 5.82
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12 and 26.Population: The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline VLDL/chylomicron particles as a covariate.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Very Low Density Lipoprotein (VLDL) / Chylomicron Particles
Total Particles - Week 12 (n=139, 132, 132, 141)
|
-6.59 nmol/L
Standard Error 2.600
|
0.70 nmol/L
Standard Error 2.663
|
-9.63 nmol/L
Standard Error 2.664
|
-2.67 nmol/L
Standard Error 2.578
|
|
Change From Baseline in Very Low Density Lipoprotein (VLDL) / Chylomicron Particles
Total Particles - Week 26 (n=147, 133, 141, 147)
|
-4.97 nmol/L
Standard Error 2.831
|
4.94 nmol/L
Standard Error 2.976
|
-0.73 nmol/L
Standard Error 2.888
|
-1.17 nmol/L
Standard Error 2.828
|
|
Change From Baseline in Very Low Density Lipoprotein (VLDL) / Chylomicron Particles
Large Particles - Week 12 (n=139, 132, 132, 141)
|
-0.94 nmol/L
Standard Error 0.511
|
-1.83 nmol/L
Standard Error 0.525
|
-2.63 nmol/L
Standard Error 0.525
|
-2.06 nmol/L
Standard Error 0.508
|
|
Change From Baseline in Very Low Density Lipoprotein (VLDL) / Chylomicron Particles
Large Particles - Week 26 (n=147, 133, 141, 147)
|
-0.18 nmol/L
Standard Error 0.480
|
-1.96 nmol/L
Standard Error 0.505
|
-2.37 nmol/L
Standard Error 0.490
|
-2.11 nmol/L
Standard Error 0.480
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12 and 26.Population: The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
The change from Baseline in levels of VLDL/chylomicron triglycerides was assessed by NMR lipid fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline VLDL/chylomicron triglycerides as a covariate.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in VLDL / Chylomicron Triglycerides
Week 12 (n=139, 132, 132, 141)
|
-14.4 mg/dL
Standard Error 6.34
|
-25.6 mg/dL
Standard Error 6.50
|
-39.5 mg/dL
Standard Error 6.50
|
-24.2 mg/dL
Standard Error 6.30
|
|
Change From Baseline in VLDL / Chylomicron Triglycerides
Week 26 (n=147, 133, 141, 147)
|
-8.2 mg/dL
Standard Error 5.79
|
-22.0 mg/dL
Standard Error 6.08
|
-29.7 mg/dL
Standard Error 5.90
|
-23.3 mg/dL
Standard Error 5.79
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12 and 26.Population: The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline VLDL particles as a covariate.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in VLDL Particles
Medium Particles - Week 12 (n=139, 132, 132, 141)
|
-3.20 nmol/L
Standard Error 1.639
|
-2.30 nmol/L
Standard Error 1.678
|
-8.52 nmol/L
Standard Error 1.679
|
-4.69 nmol/L
Standard Error 1.625
|
|
Change From Baseline in VLDL Particles
Medium Particles - Week 26 (n=147, 133, 141, 147)
|
-0.23 nmol/L
Standard Error 1.784
|
-0.39 nmol/L
Standard Error 1.874
|
-3.76 nmol/L
Standard Error 1.819
|
-3.58 nmol/L
Standard Error 1.782
|
|
Change From Baseline in VLDL Particles
Small Particles - Week 12 (n=139, 132, 132, 141)
|
-1.74 nmol/L
Standard Error 1.617
|
4.77 nmol/L
Standard Error 1.662
|
1.18 nmol/L
Standard Error 1.660
|
3.71 nmol/L
Standard Error 1.607
|
|
Change From Baseline in VLDL Particles
Small Particles - Week 26 (n=147, 133, 141, 147)
|
-4.11 nmol/L
Standard Error 1.710
|
7.16 nmol/L
Standard Error 1.802
|
5.22 nmol/L
Standard Error 1.746
|
4.36 nmol/L
Standard Error 1.711
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12 and 26.Population: The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline mean VLDL particle size as a covariate.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Mean VLDL Particle Size
Week 26 (n=147, 133, 141, 147)
|
0.30 nm
Standard Error 0.607
|
-3.71 nm
Standard Error 0.640
|
-4.21 nm
Standard Error 0.620
|
-2.80 nm
Standard Error 0.607
|
|
Change From Baseline in Mean VLDL Particle Size
Week 12 (n=139, 132, 132, 141)
|
-0.97 nm
Standard Error 0.668
|
-3.97 nm
Standard Error 0.688
|
-2.92 nm
Standard Error 0.687
|
-2.85 nm
Standard Error 0.665
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12 and 26.Population: The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
The change from Baseline in levels of IDL particles was assessed by NMR fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline IDL particles as a covariate.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Intermediate Density Lipoprotein (IDL) Particles
Week 12 (n=139, 132, 132, 141)
|
-2.9 nmol/L
Standard Error 3.63
|
-1.0 nmol/L
Standard Error 3.72
|
-2.9 nmol/L
Standard Error 3.73
|
-4.0 nmol/L
Standard Error 3.61
|
|
Change From Baseline in Intermediate Density Lipoprotein (IDL) Particles
Week 26 (n=147, 133, 141, 147)
|
0.5 nmol/L
Standard Error 3.68
|
2.1 nmol/L
Standard Error 3.86
|
-1.0 nmol/L
Standard Error 3.75
|
-5.8 nmol/L
Standard Error 3.68
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12 and 26.Population: The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline LDL particles as a covariate.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Low Density Lipoprotein (LDL) Particles
Very Small - Week 12 (n=139, 132, 132, 141)
|
-20.9 nmol/L
Standard Error 26.22
|
-159.2 nmol/L
Standard Error 26.88
|
-265.7 nmol/L
Standard Error 26.90
|
-254.2 nmol/L
Standard Error 26.02
|
|
Change From Baseline in Low Density Lipoprotein (LDL) Particles
Medium-Small - Week 12 (n=139, 132, 132, 141)
|
-6.2 nmol/L
Standard Error 6.25
|
-41.4 nmol/L
Standard Error 6.41
|
-65.8 nmol/L
Standard Error 6.41
|
-65.8 nmol/L
Standard Error 6.20
|
|
Change From Baseline in Low Density Lipoprotein (LDL) Particles
Total Particles - Week 12 (n=139, 132, 132, 141)
|
-11.9 nmol/L
Standard Error 28.57
|
-104.1 nmol/L
Standard Error 29.34
|
-207.0 nmol/L
Standard Error 29.33
|
-181.8 nmol/L
Standard Error 28.40
|
|
Change From Baseline in Low Density Lipoprotein (LDL) Particles
Total Particles - Week 26 (n=147, 133, 141, 147)
|
60.9 nmol/L
Standard Error 30.67
|
-75.6 nmol/L
Standard Error 32.29
|
-169.9 nmol/L
Standard Error 31.31
|
-177.1 nmol/L
Standard Error 30.68
|
|
Change From Baseline in Low Density Lipoprotein (LDL) Particles
Large Particles - Week 12 (n=139, 132, 132, 141)
|
15.3 nmol/L
Standard Error 15.16
|
98.8 nmol/L
Standard Error 15.52
|
129.4 nmol/L
Standard Error 15.54
|
142.1 nmol/L
Standard Error 15.05
|
|
Change From Baseline in Low Density Lipoprotein (LDL) Particles
Large Particles - Week 26 (n=147, 133, 141, 147)
|
2.6 nmol/L
Standard Error 15.32
|
120.4 nmol/L
Standard Error 16.10
|
146.6 nmol/L
Standard Error 15.63
|
155.5 nmol/L
Standard Error 15.33
|
|
Change From Baseline in Low Density Lipoprotein (LDL) Particles
Medium-Small - Week 26 (n=147, 133, 141, 147)
|
9.9 nmol/L
Standard Error 6.42
|
-40.1 nmol/L
Standard Error 6.75
|
-63.0 nmol/L
Standard Error 6.55
|
-66.6 nmol/L
Standard Error 6.41
|
|
Change From Baseline in Low Density Lipoprotein (LDL) Particles
Total Small - Week 12 (n=139, 132, 132, 141)
|
-27.8 nmol/L
Standard Error 31.91
|
-200.3 nmol/L
Standard Error 32.71
|
-331.2 nmol/L
Standard Error 32.73
|
-320.0 nmol/L
Standard Error 31.66
|
|
Change From Baseline in Low Density Lipoprotein (LDL) Particles
Total Small - Week 26 (n=147, 133, 141, 147)
|
54.5 nmol/L
Standard Error 33.34
|
-195.8 nmol/L
Standard Error 35.04
|
-313.8 nmol/L
Standard Error 34.01
|
-327.4 nmol/L
Standard Error 33.30
|
|
Change From Baseline in Low Density Lipoprotein (LDL) Particles
Very Small - Week 26 (n=147, 133, 141, 147)
|
45.1 nmol/L
Standard Error 27.44
|
-156.0 nmol/L
Standard Error 28.83
|
-250.9 nmol/L
Standard Error 27.98
|
-260.8 nmol/L
Standard Error 27.40
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12 and 26.Population: The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline mean LDL particle size as a covariate.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Mean LDL Particle Size
Week 12 (n=139, 132, 132, 141)
|
0.09 nm
Standard Error 0.051
|
0.44 nm
Standard Error 0.053
|
0.63 nm
Standard Error 0.053
|
0.58 nm
Standard Error 0.051
|
|
Change From Baseline in Mean LDL Particle Size
Week 26 (n=147, 133, 141, 147)
|
-0.02 nm
Standard Error 0.052
|
0.44 nm
Standard Error 0.054
|
0.65 nm
Standard Error 0.053
|
0.61 nm
Standard Error 0.052
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12 and 26.Population: The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HDL particles as a covariate.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in High Density Lipoprotein (HDL) Particles
Total Particles - Week 12 (n=139, 132, 132, 141)
|
0.18 µmol/L
Standard Error 0.350
|
0.92 µmol/L
Standard Error 0.359
|
0.11 µmol/L
Standard Error 0.359
|
0.54 µmol/L
Standard Error 0.348
|
|
Change From Baseline in High Density Lipoprotein (HDL) Particles
Total Particles - Week 26 (n=147, 133, 141, 147)
|
0.81 µmol/L
Standard Error 0.359
|
1.67 µmol/L
Standard Error 0.377
|
1.01 µmol/L
Standard Error 0.367
|
1.03 µmol/L
Standard Error 0.359
|
|
Change From Baseline in High Density Lipoprotein (HDL) Particles
Large Particles - Week 12 (n=139, 132, 132, 141)
|
0.07 µmol/L
Standard Error 0.195
|
0.99 µmol/L
Standard Error 0.200
|
0.98 µmol/L
Standard Error 0.200
|
1.31 µmol/L
Standard Error 0.193
|
|
Change From Baseline in High Density Lipoprotein (HDL) Particles
Large Particles - Week 26 (n=147, 133, 141, 147)
|
-0.06 µmol/L
Standard Error 0.197
|
1.14 µmol/L
Standard Error 0.207
|
1.24 µmol/L
Standard Error 0.201
|
1.31 µmol/L
Standard Error 0.197
|
|
Change From Baseline in High Density Lipoprotein (HDL) Particles
Medium Particles - Week 12 (n=139, 132, 132, 141)
|
-0.26 µmol/L
Standard Error 0.311
|
0.72 µmol/L
Standard Error 0.319
|
1.60 µmol/L
Standard Error 0.320
|
1.61 µmol/L
Standard Error 0.308
|
|
Change From Baseline in High Density Lipoprotein (HDL) Particles
Medium Particles - Week 26 (n=147, 133, 141, 147)
|
-0.26 µmol/L
Standard Error 0.313
|
0.95 µmol/L
Standard Error 0.329
|
1.19 µmol/L
Standard Error 0.320
|
1.30 µmol/L
Standard Error 0.312
|
|
Change From Baseline in High Density Lipoprotein (HDL) Particles
Small Particles - Week 12 (n=139, 132, 132, 141)
|
0.50 µmol/L
Standard Error 0.412
|
-0.68 µmol/L
Standard Error 0.423
|
-2.65 µmol/L
Standard Error 0.423
|
-2.42 µmol/L
Standard Error 0.410
|
|
Change From Baseline in High Density Lipoprotein (HDL) Particles
Small Particles - Week 26 (n=147, 133, 141, 147)
|
1.24 µmol/L
Standard Error 0.412
|
-0.28 µmol/L
Standard Error 0.433
|
-1.58 µmol/L
Standard Error 0.421
|
-1.63 µmol/L
Standard Error 0.413
|
SECONDARY outcome
Timeframe: Baseline and Weeks 12 and 26.Population: The full analysis set where Baseline and at least 1 postbaseline value were available. Last observation carried forward (LOCF) imputation was utilized.
Change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline mean HDL particle size as a covariate.
Outcome measures
| Measure |
Alogliptin 25 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 Participants
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 Participants
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Mean HDL Particle Size
Week 12 (n=139, 132, 132, 141)
|
-0.02 nm
Standard Error 0.024
|
0.09 nm
Standard Error 0.025
|
0.17 nm
Standard Error 0.025
|
0.15 nm
Standard Error 0.024
|
|
Change From Baseline in Mean HDL Particle Size
Week 26 (n=147, 133, 141, 147)
|
-0.03 nm
Standard Error 0.024
|
0.08 nm
Standard Error 0.025
|
0.15 nm
Standard Error 0.024
|
0.14 nm
Standard Error 0.024
|
Adverse Events
Alogliptin 25 mg
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Pioglitazone 30 mg
Serious events: 6 serious events
Other events: 25 other events
Deaths: 0 deaths
Alogliptin 25 mg + Pioglitazone 30 mg
Serious events: 8 serious events
Other events: 37 other events
Deaths: 0 deaths
Alogliptin 12.5 mg + Pioglitazone 30 mg
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alogliptin 25 mg
n=164 participants at risk
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 participants at risk
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 participants at risk
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 participants at risk
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.00%
0/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.61%
1/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.00%
0/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
|
Cardiac disorders
Angina unstable
|
0.61%
1/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.00%
0/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.00%
0/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.00%
0/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.00%
0/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.61%
1/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.00%
0/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.00%
0/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.61%
1/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.00%
0/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.00%
0/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.61%
1/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.00%
0/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.61%
1/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.00%
0/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.00%
0/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.00%
0/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.61%
1/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.00%
0/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
|
Infections and infestations
Cervicitis
|
0.00%
0/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.00%
0/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.61%
1/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.00%
0/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.61%
1/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.00%
0/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.00%
0/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.61%
1/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.00%
0/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.00%
0/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.61%
1/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.00%
0/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.00%
0/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.61%
1/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.61%
1/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.00%
0/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.61%
1/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.00%
0/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.00%
0/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.00%
0/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.61%
1/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.00%
0/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.00%
0/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.00%
0/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.61%
1/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.00%
0/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.61%
1/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.00%
0/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.00%
0/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.61%
1/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
0.00%
0/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
Other adverse events
| Measure |
Alogliptin 25 mg
n=164 participants at risk
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Pioglitazone 30 mg
n=163 participants at risk
Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 25 mg + Pioglitazone 30 mg
n=164 participants at risk
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
Alogliptin 12.5 mg + Pioglitazone 30 mg
n=163 participants at risk
Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
6.7%
11/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
6.7%
11/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
12.2%
20/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
8.6%
14/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
|
Infections and infestations
Urinary tract infection
|
3.0%
5/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
2.5%
4/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
5.5%
9/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
3.7%
6/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.61%
1/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
1.8%
3/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
6.1%
10/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
1.8%
3/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
|
General disorders
Oedema peripheral
|
1.2%
2/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
5.5%
9/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
2.4%
4/164 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug treatment.
|
1.2%
2/163 • Adverse events were collected from the time of informed consent until the end of the study, and from spontaneous reporting for 30 days after the end of treatment.
At each study visit, the investigator assessed whether any events had occurred. Patients could report events at any other time during the study. All events, whether reported by the patient or observed by the investigator, were documented, whether or not the investigator concluded the event to be related to the drug 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 No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study at all study sites. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER