Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes
Sponsor
Takeda (Industry)
Overall Status
Completed
CT.gov ID
NCT01289119
Collaborator
(none)
506
21
6
12
24.1
2
Study Details
Study Description
Brief Summary
The purpose of the study is to determine the efficacy of alogliptin compared to placebo when given alone or as add-on therapy to metformin or add-on to pioglitazone (with or without metformin).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Diabetes is a chronic illness associated with microvascular complications such as nephropathy (kidney disease), retinopathy (eye damage) and neuropathy (nervous system damage). Diabetes is also associated with macrovascular complications including cardiovascular disease (heart disease), stroke and peripheral vascular disease (narrowing or blockage of blood vessels). These complications are associated with reduced quality of life and increased morbidity and mortality.
Takeda is developing SYR-322 (alogliptin) for improvement of glycemic control in patients with Type 2 diabetes mellitus.
Evaluations of alogliptin and its clinical efficacy have been conducted in multiple countries including the United States and Japan. This study will be conducted as a multi-center clinical trial in order to validate the efficacy and safety of alogliptin on type 2 diabetes population within Asia.
Participants who qualified for the study were stratified into 1 of the 3 therapy groups based upon their background antidiabetic therapy before being randomized 1:1 to receive either alogliptin 25 mg once daily or matching placebo once daily.
-
Monotherapy group - patients who had been treated with diet and exercise for at least 2 months prior to screening.
-
Add-on to metformin therapy group - patients who had been treated with metformin for at least 3 months and at a stable dose (≥1000 mg/day) for at least 8 weeks prior to screening.
-
Add-on to pioglitazone therapy group - patients who had been treated with a stable dose of pioglitazone alone or in combination with metformin at a stable dose for at least 8 weeks prior to screening.
Study Design
Study Type:
Interventional
Actual Enrollment
:
506 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
An International, Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Determine the Efficacy and Safety of SYR-322 When Used in Subjects With Type 2 Diabetes
Study Start Date
:
Dec 1, 2010
Actual Primary Completion Date
:
Dec 1, 2011
Actual Study Completion Date
:
Dec 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. |
Drug: Placebo to alogliptin
Alogliptin placebo-matching tablets.
|
| Experimental: Alogliptin Monotherapy Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. |
Drug: Alogliptin
Alogliptin tablets
Other Names:
|
| Other: Metformin Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. |
Drug: Placebo to alogliptin
Alogliptin placebo-matching tablets.
Drug: Metformin
Stable metformin dose
Other Names:
|
| Experimental: Metformin + Alogliptin Add-on Therapy Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. |
Drug: Alogliptin
Alogliptin tablets
Other Names:
Drug: Metformin
Stable metformin dose
Other Names:
|
| Other: Pioglitazone Participants continued to receive their stable dose of pioglitazone with or without metformin, and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. |
Drug: Placebo to alogliptin
Alogliptin placebo-matching tablets.
Drug: Pioglitazone
Stable pioglitazone dose
Other Names:
|
| Experimental: Pioglitazone + Alogliptin Add-on Therapy Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks. |
Drug: Alogliptin
Alogliptin tablets
Other Names:
Drug: Pioglitazone
Stable pioglitazone dose
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) [Baseline and Week 16.]
The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 16. Least squares means are derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect, and baseline HbA1c as a covariate for the monotherapy, baseline HbA1c with baseline metformin dose as covariates for the metformin therapy, baseline HbA1c with baseline metformin therapy status and baseline pioglitazone dose as covariates for the pioglitazone therapy.
Secondary Outcome Measures
- Change From Baseline in HbA1c Over Time [Baseline and Weeks 4, 8 and 12.]
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 Weeks 4, 8 and 12. Least squares means are derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect, and baseline HbA1c as a covariate for the monotherapy, baseline HbA1c with baseline metformin dose as covariates for the metformin therapy, baseline HbA1c with baseline metformin therapy status and baseline pioglitazone dose as covariates for the pioglitazone therapy.
- Change From Baseline in Fasting Plasma Glucose Over Time [Baseline and Weeks 4, 8, 12 and 16.]
The change from Baseline in fasting plasma glucose (FPG) at Weeks 4, 8, 12 and 16. Least squares means are derived from an ANCOVA model with treatment as a fixed effect, and baseline FPG as a covariate for the monotherapy, baseline FPG with baseline metformin dose as covariates for the metformin therapy, baseline FPG with baseline metformin therapy status and baseline pioglitazone dose as covariates for the pioglitazone therapy.
- Percentage of Participants With Marked Hyperglycemia [Randomization to Week 16.]
Marked Hyperglycemia was defined as fasting plasma glucose greater than or equal to 200 mg/dL (11.1 mmol/L).
- Change From Baseline in Body Weight [Baseline and Weeks 8 and 16.]
The change between body weight measured at Baseline and body weight measured at Weeks 8 and 16. The least squares means are derived from an ANCOVA model with treatment as a fixed effect, and baseline body weight as a covariate for the monotherapy, baseline body weight with baseline metformin dose as covariates for the add-on to metformin therapy, baseline body weight with baseline metformin therapy status and baseline pioglitazone dose as covariates for the add-on to pioglitazone therapy.
- Percentage of Participants With HbA1c ≤6.5% at Week 16 [Week 16]
Clinical response was assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) less than or equal to 6.5% at Week 16.
- Percentage of Participants With HbA1c ≤7.0% at Week 16 [Week 16]
Clinical response was assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) less than or equal to 7.0% at Week 16.
- Percentage of Participants With HbA1c ≤7.5% at Week 16 [Week 16]
Clinical response was assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) less than or equal to 7.5% at Week 16.
- Percentage of Participants With a Decrease in HbA1c ≥ 0.5% [Baseline and Week 16]
Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 0.5% at Week 16.
- Percentage of Participants With a Decrease in HbA1c ≥1.0% [Baseline and Week 16]
Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.0% at Week 16.
- Percentage of Participants With a Decrease in HbA1c ≥1.5% [Baseline and Week 16.]
Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.5% at Week 16.
- Percentage of Participants With a Decrease in HbA1c ≥2.0% [Baseline and Week 16.]
Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 2.0% at Week 16.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Has a historical diagnosis of Type 2 Diabetes Mellitus.
-
Has a body mass index between acceptable range.
-
Is experiencing inadequate glycemic control.
-
Body weight keeps constant.
-
Females of childbearing potential and males who are sexually active agree to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after last dose.
Exclusion Criteria:
-
Has participated in another clinical study within the past 90 days or has received any investigational compound within 30 days prior to randomization.
-
Has a systolic blood pressure beyond the acceptable range at Screening visit.
-
Has New York Heart Association Class III or IV heart failure regardless of therapy.
-
Has any major illness or debility that in the investigator's opinion prohibits the subject from completing the study.
-
Has a history of hypersensitivity or allergies to any DPP-4 inhibitor.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing | Beijing | China | ||
| 2 | Fuzhou | Fujian | China | ||
| 3 | Xiamen | Fujian | China | ||
| 4 | Guangzhou | Guangdong | China | ||
| 5 | Haikou | Hainan | China | ||
| 6 | Ha'erbin | Heilongjiang | China | ||
| 7 | Jingzhou | Hubei | China | ||
| 8 | Shiyan | Hubei | China | ||
| 9 | Changsha | Hunan | China | ||
| 10 | Wuxi | Jiangsu | China | ||
| 11 | Nanchang | Jiangxi | China | ||
| 12 | Changchun | Jilin | China | ||
| 13 | Shenyang | Liaoning | China | ||
| 14 | Jinan | Shandong | China | ||
| 15 | Shanghai | Shanghai | China | ||
| 16 | Xi'an | Shanxi | China | ||
| 17 | Tianjin | Tianjin | China | ||
| 18 | Kunming | Yunnan | China | ||
| 19 | Hangzhou | Zhejiang | China | ||
| 20 | Hong Kong | Hong Kong | |||
| 21 | Taipei County | Taiwan |
Sponsors and Collaborators
- Takeda
Investigators
- Study Chair: Professor Study Chair, Takeda
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Takeda
ClinicalTrials.gov Identifier:
NCT01289119
Other Study ID Numbers:
- SYR-322_02
- U1111-1118-3681
- SYR-322_308
First Posted:
Feb 3, 2011
Last Update Posted:
Mar 22, 2013
Last Verified:
Feb 1, 2013
Keywords provided by Takeda
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants took part in the study at 30 investigative sites in China, Taiwan province and Hong Kong from 23 December 2010 to 19 December 2011. |
|---|---|
| Pre-assignment Detail | Participants with a historical diagnosis of Type 2 diabetes mellitus who were experiencing inadequate glycemic control were stratified into 1 of the 3 therapy groups based upon their background antidiabetic therapy before being randomized 1:1 to receive either alogliptin 25 mg once daily or matching placebo once daily. |
| Arm/Group Title | Placebo | Alogliptin Monotherapy | Metformin | Metformin + Alogliptin Add-on Therapy | Pioglitazone | Pioglitazone + Alogliptin Add-on Therapy |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks | Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. | Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. | Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. | Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. | Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks. |
| Period Title: Overall Study | ||||||
| STARTED | 93 | 92 | 98 | 99 | 63 | 61 |
| Treated | 92 | 92 | 98 | 99 | 63 | 61 |
| COMPLETED | 84 | 83 | 89 | 93 | 58 | 57 |
| NOT COMPLETED | 9 | 9 | 9 | 6 | 5 | 4 |
Baseline Characteristics
| Arm/Group Title | Placebo | Alogliptin Monotherapy | Metformin | Metformin + Alogliptin Add-on Therapy | Pioglitazone | Pioglitazone + Alogliptin Add-on Therapy | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks | Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. | Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. | Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. | Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. | Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks. | Total of all reporting groups |
| Overall Participants | 93 | 92 | 98 | 99 | 63 | 61 | 506 |
| Age (years) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [years] |
53.1
(8.88)
|
51.6
(10.41)
|
53.2
(9.46)
|
53.0
(9.88)
|
51.8
(10.37)
|
52.6
(9.44)
|
52.6
(9.71)
|
| Age, Customized (participants) [Number] | |||||||
| <65 Years |
81
87.1%
|
80
87%
|
86
87.8%
|
85
85.9%
|
56
88.9%
|
52
85.2%
|
440
87%
|
| ≥65 years |
12
12.9%
|
12
13%
|
12
12.2%
|
14
14.1%
|
7
11.1%
|
9
14.8%
|
66
13%
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
39
41.9%
|
37
40.2%
|
50
51%
|
48
48.5%
|
24
38.1%
|
33
54.1%
|
231
45.7%
|
| Male |
54
58.1%
|
55
59.8%
|
48
49%
|
51
51.5%
|
39
61.9%
|
28
45.9%
|
275
54.3%
|
| Race/Ethnicity, Customized (participants) [Number] | |||||||
| Number [participants] |
93
100%
|
92
100%
|
98
100%
|
99
100%
|
63
100%
|
61
100%
|
506
100%
|
| Region of Enrollment (participants) [Number] | |||||||
| Taiwan |
1
1.1%
|
0
0%
|
2
2%
|
3
3%
|
0
0%
|
0
0%
|
6
1.2%
|
| Hong Kong |
1
1.1%
|
2
2.2%
|
2
2%
|
4
4%
|
0
0%
|
0
0%
|
9
1.8%
|
| China |
91
97.8%
|
90
97.8%
|
94
95.9%
|
92
92.9%
|
63
100%
|
61
100%
|
491
97%
|
| Height (cm) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [cm] |
165.4
(7.19)
|
165.9
(8.61)
|
164.8
(8.47)
|
165.7
(9.06)
|
166.2
(8.87)
|
163.0
(7.06)
|
165.2
(8.31)
|
| Weight (kg) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [kg] |
70.86
(10.464)
|
71.16
(11.065)
|
69.67
(11.792)
|
71.20
(13.473)
|
72.44
(11.989)
|
67.59
(11.989)
|
70.55
(11.856)
|
| Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [kg/m^2] |
25.86
(3.002)
|
25.79
(3.086)
|
25.54
(2.876)
|
25.75
(3.122)
|
26.13
(3.031)
|
25.32
(3.223)
|
25.73
(3.042)
|
| Diabetes duration (years) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [years] |
2.12
(2.845)
|
1.86
(2.369)
|
5.33
(3.873)
|
5.38
(4.335)
|
4.85
(4.724)
|
5.80
(5.300)
|
4.11
(4.215)
|
| HbA1c (participants) [Number] | |||||||
| <8.0% |
47
50.5%
|
48
52.2%
|
54
55.1%
|
55
55.6%
|
34
54%
|
32
52.5%
|
270
53.4%
|
| ≥8.0% |
46
49.5%
|
44
47.8%
|
44
44.9%
|
44
44.4%
|
29
46%
|
29
47.5%
|
236
46.6%
|
| Stable Daily Dose of Metformin (mg) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [mg] |
NA
(NA)
|
NA
(NA)
|
1484.2
(451.09)
|
1472.2
(417.31)
|
1355.0
(431.80)
|
1295.0
(506.82)
|
1426.6
(450.90)
|
| Stable Daily Dose of Pioglitazone (mg) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [mg] |
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
21.9
(11.37)
|
20.2
(7.19)
|
21.0
(9.55)
|
Outcome Measures
| Title | Change From Baseline in Glycosylated Hemoglobin (HbA1c) |
|---|---|
| Description | The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 16. Least squares means are derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect, and baseline HbA1c as a covariate for the monotherapy, baseline HbA1c with baseline metformin dose as covariates for the metformin therapy, baseline HbA1c with baseline metformin therapy status and baseline pioglitazone dose as covariates for the pioglitazone therapy. |
| Time Frame | Baseline and Week 16. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized. |
| Arm/Group Title | Placebo | Alogliptin Monotherapy | Metformin | Metformin + Alogliptin Add-on Therapy | Pioglitazone | Pioglitazone + Alogliptin Add-on Therapy |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks | Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. | Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. | Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. | Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. | Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks. |
| Measure Participants | 90 | 90 | 97 | 98 | 63 | 60 |
| Least Squares Mean (Standard Error) [percentage glycosylated hemoglobin] |
-0.42
(0.074)
|
-0.99
(0.074)
|
-0.22
(0.065)
|
-0.91
(0.065)
|
-0.25
(0.097)
|
-0.76
(0.101)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Alogliptin Monotherapy |
|---|---|---|
| Comments | The analysis was conducted at the 2-sided 5% significance level without a multiplicity adjustment. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ANCOVA model with treatment as a fixed effect, and baseline HbA1c as a covariate. | |
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.58 | |
| Confidence Interval |
(2-Sided) 95% -0.78 to -0.37 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Metformin, Metformin + Alogliptin Add-on Therapy |
|---|---|---|
| Comments | The analysis was conducted at the 2-sided 5% significance level without a multiplicity adjustment. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ANCOVA model with treatment as a fixed effect, and baseline HbA1c with baseline metformin dose as covariates. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.69 | |
| Confidence Interval |
(2-Sided) 95% -0.87 to -0.51 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Pioglitazone, Pioglitazone + Alogliptin Add-on Therapy |
|---|---|---|
| Comments | The analysis was conducted at the 2-sided 5% significance level without a multiplicity adjustment. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ANCOVA model with treatment as a fixed effect, and baseline HbA1c with baseline metformin therapy status and baseline pioglitazone dose as covariates. | |
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.52 | |
| Confidence Interval |
(2-Sided) 95% -0.75 to -0.28 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in HbA1c Over Time |
|---|---|
| Description | 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 Weeks 4, 8 and 12. Least squares means are derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect, and baseline HbA1c as a covariate for the monotherapy, baseline HbA1c with baseline metformin dose as covariates for the metformin therapy, baseline HbA1c with baseline metformin therapy status and baseline pioglitazone dose as covariates for the pioglitazone therapy. |
| Time Frame | Baseline and Weeks 4, 8 and 12. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized. |
| Arm/Group Title | Placebo | Alogliptin Monotherapy | Metformin | Metformin + Alogliptin Add-on Therapy | Pioglitazone | Pioglitazone + Alogliptin Add-on Therapy |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks | Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. | Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. | Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. | Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. | Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks. |
| Measure Participants | 92 | 92 | 98 | 99 | 63 | 61 |
| Week 4 (n=90, 88, 97, 98, 63, 60) |
-0.24
(0.059)
|
-0.56
(0.059)
|
-0.15
(0.036)
|
-0.43
(0.036)
|
-0.09
(0.064)
|
-0.44
(0.066)
|
| Week 8 (n=90, 90, 97, 98, 63, 60) |
-0.39
(0.068)
|
-0.86
(0.068)
|
-0.15
(0.057)
|
-0.66
(0.057)
|
-0.31
(0.094)
|
-0.70
(0.098)
|
| Week 12 (n=90, 90, 97, 98, 63, 60) |
-0.41
(0.078)
|
-0.99
(0.078)
|
-0.24
(0.069)
|
-0.86
(0.068)
|
-0.25
(0.102)
|
-0.77
(0.106)
|
| Title | Change From Baseline in Fasting Plasma Glucose Over Time |
|---|---|
| Description | The change from Baseline in fasting plasma glucose (FPG) at Weeks 4, 8, 12 and 16. Least squares means are derived from an ANCOVA model with treatment as a fixed effect, and baseline FPG as a covariate for the monotherapy, baseline FPG with baseline metformin dose as covariates for the metformin therapy, baseline FPG with baseline metformin therapy status and baseline pioglitazone dose as covariates for the pioglitazone therapy. |
| Time Frame | Baseline and Weeks 4, 8, 12 and 16. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline FPG assessment. Last observation carried forward was utilized. |
| Arm/Group Title | Placebo | Alogliptin Monotherapy | Metformin | Metformin + Alogliptin Add-on Therapy | Pioglitazone | Pioglitazone + Alogliptin Add-on Therapy |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks | Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. | Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. | Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. | Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. | Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks. |
| Measure Participants | 92 | 92 | 98 | 99 | 63 | 61 |
| Week 4 (n=89, 87, 97, 97, 63, 60) |
-0.331
(0.1221)
|
-0.719
(0.1235)
|
-0.251
(0.1454)
|
-0.985
(0.1454)
|
0.284
(0.2505)
|
-0.985
(0.2603)
|
| Week 8 (n=89, 89, 97, 97, 63, 60) |
-0.330
(0.1224)
|
-1.015
(0.1224)
|
-0.235
(0.1397)
|
-1.265
(0.1397)
|
-0.038
(0.2503)
|
-0.924
(0.2600)
|
| Week 12 (n=89, 89, 97, 97, 63, 60) |
-0.411
(0.1515)
|
-1.123
(0.1515)
|
-0.335
(0.1600)
|
-1.270
(0.1600)
|
-0.187
(0.2484)
|
-1.177
(0.2581)
|
| Week 16 (n=89, 89, 97, 97, 63, 60) |
-0.317
(0.1556)
|
-1.243
(0.1556)
|
-0.512
(0.1565)
|
-1.240
(0.1565)
|
-0.114
(0.2579)
|
-1.070
(0.2679)
|
| Title | Percentage of Participants With Marked Hyperglycemia |
|---|---|
| Description | Marked Hyperglycemia was defined as fasting plasma glucose greater than or equal to 200 mg/dL (11.1 mmol/L). |
| Time Frame | Randomization to Week 16. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline assessment. |
| Arm/Group Title | Placebo | Alogliptin Monotherapy | Metformin | Metformin + Alogliptin Add-on Therapy | Pioglitazone | Pioglitazone + Alogliptin Add-on Therapy |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks | Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. | Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. | Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. | Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. | Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks. |
| Measure Participants | 89 | 89 | 97 | 97 | 63 | 60 |
| Number [percentage of participants] |
16.9
18.2%
|
4.5
4.9%
|
25.8
26.3%
|
13.4
13.5%
|
23.8
37.8%
|
8.3
13.6%
|
| Title | Change From Baseline in Body Weight |
|---|---|
| Description | The change between body weight measured at Baseline and body weight measured at Weeks 8 and 16. The least squares means are derived from an ANCOVA model with treatment as a fixed effect, and baseline body weight as a covariate for the monotherapy, baseline body weight with baseline metformin dose as covariates for the add-on to metformin therapy, baseline body weight with baseline metformin therapy status and baseline pioglitazone dose as covariates for the add-on to pioglitazone therapy. |
| Time Frame | Baseline and Weeks 8 and 16. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline weight assessment. Last observation carried forward was utilized. |
| Arm/Group Title | Placebo | Alogliptin Monotherapy | Metformin | Metformin + Alogliptin Add-on Therapy | Pioglitazone | Pioglitazone + Alogliptin Add-on Therapy |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks | Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. | Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. | Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. | Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. | Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks. |
| Measure Participants | 92 | 92 | 98 | 99 | 63 | 61 |
| Week 8 (n=87, 86, 94, 96, 63, 59) |
-1.04
(0.210)
|
-0.71
(0.211)
|
-0.82
(0.170)
|
-0.43
(0.168)
|
-0.74
(0.286)
|
-0.15
(0.304)
|
| Week 16 (n=88, 87, 94, 96, 63, 59) |
-1.55
(0.244)
|
-0.89
(0.245)
|
-1.06
(0.219)
|
-0.76
(0.217)
|
-0.68
(0.364)
|
-0.10
(0.388)
|
| Title | Percentage of Participants With HbA1c ≤6.5% at Week 16 |
|---|---|
| Description | Clinical response was assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) less than or equal to 6.5% at Week 16. |
| Time Frame | Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized. |
| Arm/Group Title | Placebo | Alogliptin Monotherapy | Metformin | Metformin + Alogliptin Add-on Therapy | Pioglitazone | Pioglitazone + Alogliptin Add-on Therapy |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks | Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. | Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. | Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. | Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. | Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks. |
| Measure Participants | 90 | 90 | 97 | 98 | 63 | 60 |
| Number [percentage of participants] |
12.2
13.1%
|
36.7
39.9%
|
4.1
4.2%
|
21.4
21.6%
|
9.5
15.1%
|
30.0
49.2%
|
| Title | Percentage of Participants With HbA1c ≤7.0% at Week 16 |
|---|---|
| Description | Clinical response was assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) less than or equal to 7.0% at Week 16. |
| Time Frame | Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized. |
| Arm/Group Title | Placebo | Alogliptin Monotherapy | Metformin | Metformin + Alogliptin Add-on Therapy | Pioglitazone | Pioglitazone + Alogliptin Add-on Therapy |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks | Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. | Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. | Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. | Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. | Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks. |
| Measure Participants | 90 | 90 | 97 | 98 | 63 | 60 |
| Number [percentage of participants] |
30.0
32.3%
|
63.3
68.8%
|
25.8
26.3%
|
55.1
55.7%
|
31.7
50.3%
|
61.7
101.1%
|
| Title | Percentage of Participants With HbA1c ≤7.5% at Week 16 |
|---|---|
| Description | Clinical response was assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) less than or equal to 7.5% at Week 16. |
| Time Frame | Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized. |
| Arm/Group Title | Placebo | Alogliptin Monotherapy | Metformin | Metformin + Alogliptin Add-on Therapy | Pioglitazone | Pioglitazone + Alogliptin Add-on Therapy |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks | Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. | Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. | Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. | Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. | Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks. |
| Measure Participants | 90 | 90 | 97 | 98 | 63 | 60 |
| Number [percentage of participants] |
53.3
57.3%
|
81.1
88.2%
|
50.5
51.5%
|
80.6
81.4%
|
47.6
75.6%
|
85.0
139.3%
|
| Title | Percentage of Participants With a Decrease in HbA1c ≥ 0.5% |
|---|---|
| Description | Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 0.5% at Week 16. |
| Time Frame | Baseline and Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized. |
| Arm/Group Title | Placebo | Alogliptin Monotherapy | Metformin | Metformin + Alogliptin Add-on Therapy | Pioglitazone | Pioglitazone + Alogliptin Add-on Therapy |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks | Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. | Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. | Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. | Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. | Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks. |
| Measure Participants | 90 | 90 | 97 | 98 | 63 | 60 |
| Number [percentage of participants] |
41.1
44.2%
|
84.4
91.7%
|
37.1
37.9%
|
70.4
71.1%
|
42.9
68.1%
|
76.7
125.7%
|
| Title | Percentage of Participants With a Decrease in HbA1c ≥1.0% |
|---|---|
| Description | Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.0% at Week 16. |
| Time Frame | Baseline and Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized. |
| Arm/Group Title | Placebo | Alogliptin Monotherapy | Metformin | Metformin + Alogliptin Add-on Therapy | Pioglitazone | Pioglitazone + Alogliptin Add-on Therapy |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks | Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. | Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. | Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. | Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. | Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks. |
| Measure Participants | 90 | 90 | 97 | 98 | 63 | 60 |
| Number [percentage of participants] |
20.0
21.5%
|
50.0
54.3%
|
9.3
9.5%
|
45.9
46.4%
|
19.0
30.2%
|
46.7
76.6%
|
| Title | Percentage of Participants With a Decrease in HbA1c ≥1.5% |
|---|---|
| Description | Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.5% at Week 16. |
| Time Frame | Baseline and Week 16. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized. |
| Arm/Group Title | Placebo | Alogliptin Monotherapy | Metformin | Metformin + Alogliptin Add-on Therapy | Pioglitazone | Pioglitazone + Alogliptin Add-on Therapy |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks | Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. | Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. | Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. | Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. | Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks. |
| Measure Participants | 90 | 90 | 97 | 98 | 63 | 60 |
| Number [percentage of participants] |
7.8
8.4%
|
23.3
25.3%
|
1.0
1%
|
22.4
22.6%
|
7.9
12.5%
|
8.3
13.6%
|
| Title | Percentage of Participants With a Decrease in HbA1c ≥2.0% |
|---|---|
| Description | Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 2.0% at Week 16. |
| Time Frame | Baseline and Week 16. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized. |
| Arm/Group Title | Placebo | Alogliptin Monotherapy | Metformin | Metformin + Alogliptin Add-on Therapy | Pioglitazone | Pioglitazone + Alogliptin Add-on Therapy |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks | Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. | Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. | Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. | Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. | Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks. |
| Measure Participants | 90 | 90 | 97 | 98 | 63 | 60 |
| Number [percentage of participants] |
2.2
2.4%
|
8.9
9.7%
|
0.0
0%
|
9.2
9.3%
|
1.6
2.5%
|
3.3
5.4%
|
Adverse Events
| Time Frame | Treatment-emergent adverse events (TEAE) were defined as any adverse events that started on or after the date of the first dose of double-blind study drug and within 14 days after the date of the last dose of double-blind study drug. | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The investigator had to document any occurrence of adverse events at each visit, and the occurrence of abnormal laboratory findings at applicable visits. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. | |||||||||||
| Arm/Group Title | Placebo | Alogliptin Monotherapy | Metformin | Metformin + Alogliptin Add-on Therapy | Pioglitazone | Pioglitazone + Alogliptin Add-on Therapy | ||||||
| Arm/Group Description | Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks | Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. | Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. | Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. | Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. | Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks. | ||||||
All Cause Mortality |
||||||||||||
| Placebo | Alogliptin Monotherapy | Metformin | Metformin + Alogliptin Add-on Therapy | Pioglitazone | Pioglitazone + Alogliptin Add-on Therapy | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||
Serious Adverse Events |
||||||||||||
| Placebo | Alogliptin Monotherapy | Metformin | Metformin + Alogliptin Add-on Therapy | Pioglitazone | Pioglitazone + Alogliptin Add-on Therapy | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/92 (2.2%) | 2/92 (2.2%) | 3/98 (3.1%) | 0/99 (0%) | 0/63 (0%) | 1/61 (1.6%) | ||||||
| Cardiac disorders | ||||||||||||
| Atrial fibrillation | 0/92 (0%) | 0/92 (0%) | 1/98 (1%) | 0/99 (0%) | 0/63 (0%) | 0/61 (0%) | ||||||
| Coronary artery disease | 0/92 (0%) | 0/92 (0%) | 1/98 (1%) | 0/99 (0%) | 0/63 (0%) | 0/61 (0%) | ||||||
| Gastrointestinal disorders | ||||||||||||
| Pancreatitis acute | 1/92 (1.1%) | 0/92 (0%) | 0/98 (0%) | 0/99 (0%) | 0/63 (0%) | 0/61 (0%) | ||||||
| Hepatobiliary disorders | ||||||||||||
| Cholangitis acute | 0/92 (0%) | 1/92 (1.1%) | 0/98 (0%) | 0/99 (0%) | 0/63 (0%) | 0/61 (0%) | ||||||
| Infections and infestations | ||||||||||||
| Cellulitis | 1/92 (1.1%) | 0/92 (0%) | 0/98 (0%) | 0/99 (0%) | 0/63 (0%) | 0/61 (0%) | ||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Intervertebral disc protrusion | 0/92 (0%) | 0/92 (0%) | 1/98 (1%) | 0/99 (0%) | 0/63 (0%) | 0/61 (0%) | ||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||
| Intraductal papilloma of breast | 0/92 (0%) | 1/92 (1.1%) | 0/98 (0%) | 0/99 (0%) | 0/63 (0%) | 0/61 (0%) | ||||||
| Nervous system disorders | ||||||||||||
| Lacunar infarction | 0/92 (0%) | 0/92 (0%) | 0/98 (0%) | 0/99 (0%) | 0/63 (0%) | 1/61 (1.6%) | ||||||
| Vascular disorders | ||||||||||||
| Hypertension | 0/92 (0%) | 0/92 (0%) | 1/98 (1%) | 0/99 (0%) | 0/63 (0%) | 0/61 (0%) | ||||||
Other (Not Including Serious) Adverse Events |
||||||||||||
| Placebo | Alogliptin Monotherapy | Metformin | Metformin + Alogliptin Add-on Therapy | Pioglitazone | Pioglitazone + Alogliptin Add-on Therapy | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 11/92 (12%) | 12/92 (13%) | 8/98 (8.2%) | 7/99 (7.1%) | 14/63 (22.2%) | 18/61 (29.5%) | ||||||
| Infections and infestations | ||||||||||||
| Upper respiratory tract infection | 3/92 (3.3%) | 5/92 (5.4%) | 5/98 (5.1%) | 3/99 (3%) | 6/63 (9.5%) | 2/61 (3.3%) | ||||||
| Urinary tract infection | 6/92 (6.5%) | 2/92 (2.2%) | 2/98 (2%) | 2/99 (2%) | 1/63 (1.6%) | 4/61 (6.6%) | ||||||
| Investigations | ||||||||||||
| Blood triglycerides increased | 1/92 (1.1%) | 2/92 (2.2%) | 2/98 (2%) | 2/99 (2%) | 4/63 (6.3%) | 0/61 (0%) | ||||||
| Metabolism and nutrition disorders | ||||||||||||
| Hyperlipidaemia | 1/92 (1.1%) | 6/92 (6.5%) | 0/98 (0%) | 0/99 (0%) | 4/63 (6.3%) | 13/61 (21.3%) | ||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
| Name/Title | Sr. VP, Clinical Science |
|---|---|
| Organization | Takeda Global Research and Development Center, Inc. |
| Phone | 800-778-2860 |
| clinicaltrialregistry@tpna.com |
Responsible Party:
Takeda
ClinicalTrials.gov Identifier:
NCT01289119
Other Study ID Numbers:
- SYR-322_02
- U1111-1118-3681
- SYR-322_308
First Posted:
Feb 3, 2011
Last Update Posted:
Mar 22, 2013
Last Verified:
Feb 1, 2013