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Trial record 1 of 1 for:    SYR-322_301
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Efficacy of Alogliptin and With Pioglitazone in Patients With Type 2 Diabetes.

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ClinicalTrials.gov Identifier: NCT00655863
Recruitment Status : Completed
First Posted : April 10, 2008
Results First Posted : May 27, 2013
Last Update Posted : May 27, 2013
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Diabetes Mellitus
Interventions Drug: Alogliptin and Pioglitazone
Drug: Alogliptin
Drug: Placebo
Enrollment 71
Recruitment Details Participants enrolled at 2 investigative sites in The Netherlands and Sweden from 16 July 2007 to 17 December 2009.
Pre-assignment Details Participants with a historical diagnosis of type 2 diabetes mellitus were enrolled in one of three, once-daily (QD) treatment groups.
Arm/Group Title Placebo QD Alogliptin 25 mg QD Alogliptin 25 mg QD + Pioglitazone 30 mg QD
Hide Arm/Group Description Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks. Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks. Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
Period Title: Overall Study
Started 24 25 22
Completed 24 25 21
Not Completed 0 0 1
Reason Not Completed
Lost to Follow-up             0             0             1
Arm/Group Title Placebo QD Alogliptin 25 mg QD Alogliptin 25 mg QD + Pioglitazone 30 mg QD Total
Hide Arm/Group Description Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks. Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks. Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks. Total of all reporting groups
Overall Number of Baseline Participants 24 25 22 71
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 25 participants 22 participants 71 participants
59.1  (6.23) 58.7  (6.47) 59.1  (6.94) 59.0  (6.45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 25 participants 22 participants 71 participants
Female
4
  16.7%
10
  40.0%
7
  31.8%
21
  29.6%
Male
20
  83.3%
15
  60.0%
15
  68.2%
50
  70.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 25 participants 22 participants 71 participants
Netherlands 9 10 9 28
Sweden 15 15 13 43
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 25 participants 22 participants 71 participants
24
 100.0%
25
 100.0%
22
 100.0%
71
 100.0%
[1]
Measure Description: White
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 24 participants 25 participants 22 participants 71 participants
101.83  (11.989) 93.68  (10.816) 93.05  (13.160) 96.24  (12.471)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 24 participants 25 participants 22 participants 71 participants
178.3  (6.74) 173.9  (8.17) 172.8  (10.97) 175.0  (8.91)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 24 participants 25 participants 22 participants 71 participants
32.12  (3.997) 31.09  (4.196) 31.15  (3.503) 31.46  (3.898)
Diabetes duration  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 25 participants 22 participants 71 participants
5.55  (3.243) 6.40  (3.622) 5.03  (3.791) 5.69  (3.548)
1.Primary Outcome
Title Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 16.
Hide Description The change in postprandial (after eating a meal) incremental area under the plasma concentration-time curve from 0 to 8 hours (AUC (0-8h)) postdose at week 16 relative to baseline.
Time Frame Baseline and Week 16.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
Arm/Group Title Placebo QD Alogliptin 25 mg QD Alogliptin 25 mg QD + Pioglitazone 30 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
Overall Number of Participants Analyzed 24 25 21
Least Squares Mean (Standard Error)
Unit of Measure: mg.h/dL
-39.728  (48.2481) -346.957  (47.2251) -293.439  (51.1271)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 25 mg QD
Comments The null hypothesis that there was no difference between Alogliptin 25 mg QD and placebo groups was tested at a 2-sided 0.05 significance level. The ANCOVA model used for the change in postprandial incremental area the curver for total triglycerides includes treatment and statin use as fixed effects and baseline AUC(0-8h) for total triglycerides as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-value and confidence interval presented without multiplicity adjustment.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -307.229
Confidence Interval (2-Sided) 95%
-443.168 to -171.290
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo QD, Alogliptin 25 mg QD + Pioglitazone 30 mg QD
Comments The null hypothesis that there was no difference between Alogliptin 25 mg QD + Pioglitazone 30 mg QD and placebo QD groups was tested at a 2-sided 0.05 significance level. The ANCOVA model used for the change in postprandial incremental area the curve for total triglycerides includes treatment and statin use as fixed effects and baseline AUC(0-8h) for total triglycerides as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-value and confidence interval presented without multiplicity adjustment.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -253.711
Confidence Interval 95%
-394.161 to -113.262
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 4.
Hide Description The change in postprandial incremental area under the plasma concentration-time curve from 0 to 8 hours (AUC(0-8h)) postdose at week 4 relative to baseline.
Time Frame Baseline and Week 4.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
Arm/Group Title Placebo QD Alogliptin 25 mg QD Alogliptin 25 mg QD + Pioglitazone 30 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
Overall Number of Participants Analyzed 24 21 19
Least Squares Mean (Standard Error)
Unit of Measure: mg.h/dL
-16.291  (61.1286) -288.490  (65.4530) -279.116  (68.4947)
3.Secondary Outcome
Title Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters.
Hide Description The change in postprandial incremental area under the plasma concentration-time curve for very-low-density lipoprotein (VLDL) cholesterol, VLDL triglycerides, VLDL2 cholesterol, VLDL2 triglycerides, chylomicron cholesterol, chylomicron triglycerides, intermediate-density lipoprotein (IDL) cholesterol, and IDL triglycerides from 0 to 8 hours postdose at week 4 and week 16 relative to baseline.
Time Frame Baseline, Week 4 and Week 16.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
Arm/Group Title Placebo QD Alogliptin 25 mg QD Alogliptin 25 mg QD + Pioglitazone 30 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
Overall Number of Participants Analyzed 24 25 22
Least Squares Mean (Standard Error)
Unit of Measure: mg.h/dL
VLDL triglycerides Week 4 (n=23; n=21; n=19) -9.488  (35.4108) -119.009  (37.0255) -98.758  (38.9818)
VLDL triglycerides Week 16 (n=23; n=25; n=21) 25.194  (29.4896) -130.459  (28.2397) -85.709  (30.7867)
VLDL cholesterol Week 4 (n=23; n=21; n=19) -6.914  (4.3110) -14.760  (4.4843) -10.760  (4.7065)
VLDL cholesterol Week 16 (n=23; n=25; n=21) -4.561  (3.4790) -16.365  (3.3125) -8.747  (3.5984)
VLDL 2 triglycerides Week 4 (n=23; n=20; n=19) -5.221  (7.8102) -17.960  (8.3710) -8.687  (8.6678)
VLDL 2 triglycerides Week 16 (n=23; n=25; n=21) -24.280  (3.4497) -18.986  (3.3104) -23.061  (3.6369)
VLDL 2 cholesterol Week 4 (n=23; n=20; n=19) -2.396  (0.8474) -0.709  (0.9059) -1.073  (0.9345)
VLDL 2 cholesterol Week 16 (n=23; n=25; n=21) -2.190  (0.7833) -1.445  (0.7506) -1.232  (0.8217)
Chylomicron triglycerides Week 4 (n=23; n=21; n=1 0.617  (26.1603) -115.093  (27.4280) -108.036  (28.6857)
Chylomicron triglycerides Week 16(n=23;n=25; n=21) -18.577  (15.2943) -136.626  (14.6683) -129.991  (15.9053)
Chylomicron cholesterol Week 4 (n=23; n=21; n=19) -0.091  (1.1845) -4.474  (1.2425) -3.628  (1.3039)
Chylomicron cholesterol Week 16 (n=23; n=25; n=21) -1.431  (0.6001) -5.566  (0.5769) -4.289  (0.6265)
IDL triglycerides Week 4 (n=22; n=18; n=17) 14.667  (12.9991) -6.771  (14.3964) -4.410  (14.9182)
IDL triglycerides Week 16 (n=22; n=23; n=19) -0.313  (2.9265) -4.045  (2.8759) -4.533  (3.1885)
IDL cholesterol Week 4 (n=22; n=18; n=17) 1.473  (1.5215) -0.808  (1.6835) 0.195  (1.7328)
IDL cholesterol Week 16 (n=22; n=23; n=19) 0.171  (0.6006) 0.249  (0.5893) 0.609  (0.6499)
4.Secondary Outcome
Title Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters.
Hide Description Postprandial incremental area under the curve changes for very-low-density lipoprotein (VLDL) Apo B-48, VLDL Apo B 100, VLDL2 Apo B-48, VLDL2 Apo B 100, chylomicron Apo B-48, chylomicron Apo B 100, and intermediate density lipoprotein (IDL) Apo B-48, IDL Apo B 100, and triglyceride-rich remnant (TRR) lipoproteins from 0 to 8 hours postdose at week 4 and week 16 relative to baseline.
Time Frame Baseline, Week 4 and Week 16.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
Arm/Group Title Placebo QD Alogliptin 25 mg QD Alogliptin 25 mg QD + Pioglitazone 30 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
Overall Number of Participants Analyzed 24 25 22
Least Squares Mean (Standard Error)
Unit of Measure: mg.h/dL
VLDL apo B-48 Week 4 (n=19; n=12; n=15) -0.020  (0.2902) -0.491  (0.3572) -0.312  (0.3180)
VLDL apo B-48 Week 16 (n=19; n=16; n=16) -0.055  (0.1956) -0.654  (0.2077) -0.266  (0.2044)
VLDL apo B 100 Week 4 (n=19; n=12; n=15) 0.568  (2.2981) -2.670  (2.8906) -2.977  (2.5811)
VLDL apo B 100 Week 16 (n=19; n=16; n=16) -0.453  (1.8388) -6.967  (2.0109) -3.265  (2.0025)
VLDL2 apo B-48 Week 4 (n=19; n=12; n=15) -0.075  (0.0776) -0.101  (0.0969) -0.022  (0.0870)
VLDL2 apo B-48 Week 16 (n=19; n=16; n=16) -0.079  (0.0674) -0.175  (0.0732) 0.002  (0.0737)
VLDL2 apo B 100 Week 4 (n=19; n=12; n=15) 0.464  (1.1846) 0.507  (1.4982) -0.781  (1.33287)
VLDL2 apo B 100 Week 16 (n=19; n=16; n=16) -1.155  (0.7985) -2.049  (0.8732) -1.793  (0.8707)
Chylomicron apo B-48 Week 4 (n=19; n=12; n=14) -0.051  (0.0236) -0.097  (0.0302) -0.071  (0.0272)
Chylomicron apo B-48 Week 16 (n=19; n=16; n=16) -0.051  (0.0180) -0.113  (0.0197) -0.084  (0.0191)
Chylomicron apo B 100 Week 4(n=19; n=12; n=14) -0.123  (0.0825) -0.417  (0.1041) -0.389  (0.0960)
Chylomicron apo B 100 Week 16 (n=19; n=16; n=16) -0.120  (0.0544) -0.419  (0.0594) -0.409  (0.0590)
IDL apo B-48 Week 4 (n=18; n=10; n=13) 0.002  (0.1254) -0.247  (0.1707) -0.223  (0.1476)
IDL apo B-48 Week 16 (n=18; n=14; n=14) 0.151  (0.1368) -0.188  (0.1580) 0.021  (0.1561)
IDL apo B 100 Week 4 (n=18; n=10; n=13) 0.952  (3.3778) -2.029  (4.5494) -2.769  (3.8565)
IDL apo B 100 Week 16 (n=18; n=14; n=14) 4.181  (3.4923) -2.876  (3.9944) 0.073  (3.8906)
TRR lipoproteins Week 4 (n=24; n=21; n=19) 16.147  (5.6739) -1.071  (6.0930) -5.673  (6.4428)
TRR lipoproteins Week 16 (n=24; n=25; n=21) 2.818  (3.1250) -12.719  (3.0884) -7.853  (3.3658)
5.Secondary Outcome
Title Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1)
Hide Description Postprandial changes over time at each week indicated relative to baseline.
Time Frame Baseline, Week 4 and Week 16.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
Arm/Group Title Placebo QD Alogliptin 25 mg QD Alogliptin 25 mg QD + Pioglitazone 30 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
Overall Number of Participants Analyzed 24 25 22
Least Squares Mean (Standard Error)
Unit of Measure: pmol/L
Week 4: 1 hour postprandial (n=20; n=17; n=15) 0.52  (1.167) -5.48  (1.249) -4.88  (1.330)
Week 4: 2 hours postprandial (n=21; n=17; n=16) 0.92  (1.524) -2.93  (1.702) -6.41  (1.732)
Week 4: 3 hours postprandial (n=21; n=17; n=16) 1.20  (1.619) -2.08  (1.789) -3.61  (1.848)
Week 4: 4 hours postprandial (n=21; n=17; n=16) 1.76  (1.823) 2.86  (2.027) -0.84  (2.077)
Week 4: 8 hours postprandial (n=19; n=16; n=16) -1.01  (0.955) -0.38  (1.039) -0.72  (1.040)
Week 16: 1 hour postprandial (n=21 ; n=20; n=16) -0.28  (1.304) -4.10  (1.326) -3.63  (1.462)
Week 16: 2 hours postprandial (n=21; n=21; n=17) -3.59  (1.451) -3.75  (1.457) -3.75  (1.599)
Week 16: 3 hours postprandial (n=21; n=21; n=17) -1.08  (1.206) -2.25  (1.202) -3.17  (1.326)
Week 16: 4 hours postprandial (n=21; n=21; n=17) -0.64  (1.263) -1.88  (1.271) -1.83  (1.393)
Week 16: 8 hours postprandial (n=21; n=21; n=17) -1.36  (0.820) 0.03  (0.819) -1.48  (0.910)
6.Secondary Outcome
Title Postprandial Changes Over Time From Baseline for Glucose
Hide Description Postprandial changes over time at each week indicated relative to baseline.
Time Frame Baseline, Week 4 and Week 16.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
Arm/Group Title Placebo QD Alogliptin 25 mg QD Alogliptin 25 mg QD + Pioglitazone 30 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
Overall Number of Participants Analyzed 24 25 22
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
Week 4: 1 hour postprandial (n=24; n=21; n=19) -5.957  (5.3970) -35.065  (5.7617) -65.905  (6.0315)
Week 4: 2 hours postprandial (n=23; n=21; n=19) -4.049  (5.9932) -24.721  (6.2299) -67.718  (6.5647)
Week 4: 3 hours postprandial (n=24; n=21; n=18) 3.200  (6.3047) -19.367  (6.7356) -54.345  (7.2106)
Week 4: 4 hours postprandial (n=24; n=21; n=19) 2.930  (5.3775) -13.907  (5.6699) -48.643  (6.0151)
Week 4: 8 hours postprandial (n=22; n=21; n=19) 0.046  (4.1120) -6.077  (4.2043) -27.856  (4.3961)
Week 16: 1 hour postprandial (n=24; n=25; n=21) 11.867  (8.1356) -36.189  (7.9793) -58.168  (8.6585)
Week 16: 2 hours postprandial (n=23; n=25; n=21) 17.324  (8.6572) -29.745  (8.2830) -61.899  (9.0248)
Week 16: 3 hours postprandial (n=24; n=25; n=20) 18.379  (7.8017) -16.996  (7.6465) -51.891  (8.4838)
Week 16: 4 hours postprandial (n=24; n=25; n=21) 10.849  (7.3084) -12.517  (7.1054) -41.943  (7.7396)
Week 16: 8 hours postprandial (n=24; n=25; n=21) 3.266  (5.0112) -5.737  (4.9335) -19.381  (5.3350)
7.Secondary Outcome
Title Postprandial Changes Over Time From Baseline for Insulin
Hide Description Postprandial changes over time at each week indicated relative to baseline.
Time Frame Baseline, Week 4 and Week 16.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
Arm/Group Title Placebo QD Alogliptin 25 mg QD Alogliptin 25 mg QD + Pioglitazone 30 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
Overall Number of Participants Analyzed 24 25 22
Least Squares Mean (Standard Error)
Unit of Measure: uIU/mL
Week 4: 1 hour postprandial (n=24; n=21; n=18) -5.047  (3.5562) -5.867  (3.7749) -18.287  (4.0906)
Week 4: 2 hours postprandial (n=24; n=21; n=19) 1.405  (6.3051) 3.161  (6.7294) -28.700  (7.0572)
Week 4: 3 hours postprandial (n=24; n=21; n=19) 0.637  (5.2789) 0.652  (5.6125) -18.842  (5.9301)
Week 4: 4 hours postprandial (n=24; n=21; n=19) 2.999  (3.5652) 5.092  (3.8075) -12.891  (4.0088)
Week 4: 8 hours postprandial (n=23; n=21; n=19) -1.174  (1.0270) 2.685  (1.0772) -6.000  (1.1301)
Week 16: 1 hour postprandial (n=24; n=25; n=21) -8.896  (4.8993) -14.368  (4.7784) -12.162  (5.2052)
Week 16: 2 hours postprandial (n=24; n=25; n=21) -9.258  (6.5119) -9.528  (6.4000) -24.777  (6.9371)
Week 16: 3 hours postprandial (n=24; n=25; n=21) 4.447  (4.8889) -9.848  (4.7800) -23.025  (5.2049)
Week 16: 4 hours postprandial (n=24; n=25; n=21) 8.405  (4.5090) -4.753  (4.4158) -19.329  (4.8159)
Week 16: 8 hours postprandial (n=24; n=25; n=21) 0.495  (1.2847) 3.163  (1.2637) -6.107  (1.3728)
8.Secondary Outcome
Title Postprandial Changes Over Time From Baseline for Glucagon
Hide Description Postprandial changes over time at each week indicated relative to baseline.
Time Frame Baseline, Week 4 and Week 16.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
Arm/Group Title Placebo QD Alogliptin 25 mg QD Alogliptin 25 mg QD + Pioglitazone 30 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
Overall Number of Participants Analyzed 24 25 22
Least Squares Mean (Standard Error)
Unit of Measure: pg/mL
Week 4: 1 hour postprandial (n=24; n=21; n=19) 7.222  (3.7636) -14.639  (4.0619) -17.704  (4.2418)
Week 4: 2 hours postprandial (n=24; n=21; n=19) 1.730  (3.3262) -17.015  (3.5627) -22.081  (3.7541)
Week 4: 3 hours postprandial (n=24; n=21; n=19) 6.637  (3.7141) -13.200  (3.9753) -15.987  (4.2015)
Week 4: 4 hours postprandial (n=24; n=20; n=18) 2.021  (4.1496) -4.679  (4.5627) -8.860  (4.7910)
Week 4: 8 hours postprandial (n=22; n=20; n=19) 1.081  (3.5000) -3.789  (3.6665) -5.150  (3.7592)
Week 16: 1 hour postprandial (n=24; n=25; n=21) 3.318  (3.1819) -16.955  (3.1477) -17.462  (3.4144)
Week 16: 2 hours postprandial (n=24; n=25; n=21) -1.047  (3.4159) -20.949  (3.3556) -20.662  (3.6653)
Week 16: 3 hours postprandial (n=24; n=25; n=21) 4.842  (3.4670) -13.602  (3.4048) 10.84  (3.7260)
Week 16: 4 hours postprandial (n=24; n=24; n=21) 2.801  (3.1830) -8.577  (3.1873) -10.326  (3.4011)
Week 16: 8 hours postprandial (n=24; n=25; n=21) 3.917  (2.5383) -5.818  (2.4876) -9.332  (2.7108)
9.Secondary Outcome
Title Change From Baseline in Glycosylated Hemoglobin
Hide Description The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each week indicated relative to baseline.
Time Frame Baseline, Week 8 and Week 16.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
Arm/Group Title Placebo QD Alogliptin 25 mg QD Alogliptin 25 mg QD + Pioglitazone 30 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
Overall Number of Participants Analyzed 24 25 21
Least Squares Mean (Standard Error)
Unit of Measure: percentage of glycosylated hemoglobin
Week 8: fasting (n=23; n=24; n=20) -0.12  (0.084) -0.55  (0.083) -1.01  (0.090)
Week 16: 5 minutes prior to meal (n=24;n=25; n=21) 0.38  (0.131) -0.39  (0.129) -0.95  (0.140)
10.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose
Hide Description The change in fasting plasma glucose collected at each week indicated relative to baseline.
Time Frame Baseline, Week 4, Week 8 and Week 16.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
Arm/Group Title Placebo QD Alogliptin 25 mg QD Alogliptin 25 mg QD + Pioglitazone 30 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
Overall Number of Participants Analyzed 24 25 22
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
Week 4 (n=24; n=20; n=19) -4.141  (3.0027) -20.669  (3.3024) -38.826  (3.3890)
Week 8 (n=24; n=25; n=21) 4.864  (5.3254) -16.293  (5.2451) -38.242  (5.7203)
Week 16 (n=24; n=25; n=21) 11.869  (6.4897) -17.052  (6.3918) -38.481  (6.9709)
11.Secondary Outcome
Title Change From Baseline in Postprandial C-Peptide
Hide Description The change in postprandial C-peptide collected at each week indicated relative to baseline.
Time Frame Baseline, Week 4 and Week 16.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
Arm/Group Title Placebo QD Alogliptin 25 mg QD Alogliptin 25 mg QD + Pioglitazone 30 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
Overall Number of Participants Analyzed 24 25 22
Least Squares Mean (Standard Error)
Unit of Measure: ng/mL
Week 4: 1 hour postprandial (n=24; n=21; n=19) -0.106  (0.2597) -0.300  (0.2775) -1.199  (0.2921)
Week 4: 2 hours postprandial (n=24; n=21; n=19) 0.311  (0.3789) -0.011  (0.4052) -1.379  (0.4262)
Week 4: 3 hours postprandial (n=24; n=21; n=19) 0.376  (0.4386) 0.116  (0.4684) -1.230  (0.4933)
Week 4: 4 hours postprandial (n=24; n=21; n=19) 0.256  (0.3674) 0.393  (0.3926) -1.173  (0.4140)
Week 4: 8 hours postprandial (n=23; n=20; n=19) -0.063  (0.1530) 0.421  (0.1643) -0.911  (0.1699)
Week 16: 1 hour postprandial (n=24; n=25; n=21) -0.176  (0.3474) -1.021  (0.3405) -0.646  (0.3712)
Week 16: 2 hours postprandial (n=24; n=25; n=21) -0.011  (0.4337) -1.006  (0.4259) -1.055  (0.4638)
Week 16: 3 hours postprandial (n=24; n=25; n=21) 0.492  (0.4570) -0.712  (0.4478) -1.269  (0.4882)
Week 16: 4 hours postprandial (n=24; n=25; n=21) 0.496  (0.4042) -0.068  (0.3961) -1.515  (0.4323)
Week 16: 8 hours postprandial (n=24; n=24; n=21) 0.151  (0.2042) 0.588  (0.2047) -0.761  (0.2194)
12.Secondary Outcome
Title Change From Baseline in Postprandial Proinsulin
Hide Description The change in postprandial proinsulin collected at each week indicated relative to baseline.
Time Frame Baseline, Week 4 and Week 16.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
Arm/Group Title Placebo QD Alogliptin 25 mg QD Alogliptin 25 mg QD + Pioglitazone 30 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
Overall Number of Participants Analyzed 24 25 22
Least Squares Mean (Standard Error)
Unit of Measure: pmol/L
Week 4: 1 hour postprandial (n=24; n=21; n=19) -4.555  (3.9248) -13.024  (4.2068) -41.192  (4.4562)
Week 4: 2 hours postprandial (n=24; n=21; n=19) -0.208  (5.5216) -12.568  (5.9505) -56.478  (6.3185)
Week 4: 3 hours postprandial (n=24; n=21; n=19) -6.735  (5.9547) -12.987  (6.4485) -59.573  (6.8034)
Week 4: 4 hours postprandial (n=24; n=21; n=19) -6.496  (5.9756) -6.848  (6.4875) -52.649  (6.8526)
Week 4: 8 hours postprandial (n=23; n=21; n=19) -5.082  (4.3735) -5.561  (4.6395) -35.159  (4.9287)
Week 16: 1 hour postprandial (n=24; n=25; n=21) 2.081  (5.3253) -22.812  (5.2274) -30.658  (5.7287)
Week 16: 2 hours postprandial (n=24; n=25; n=21) 3.336  (6.3373) -29.930  (6.2396) -45.487  (6.8516)
Week 16: 3 hours postprandial (n=24; n=25; n=21) 5.863  (6.2769) -27.768  (6.2041) -50.058  (6.7783)
Week 16: 4 hours postprandial (n=24; n=25; n=21) 8.671  (5.7153) -21.862  (5.6549) -48.757  (6.1834)
Week 16: 8 hours postprandial (n=24; n=25; n=21) 6.935  (5.2859) -6.898  (5.2307) -28.776  (5.7372)
13.Secondary Outcome
Title Change From Baseline in High-sensitive C-reactive Protein (Hs-CRP)
Hide Description The change in hs-CRP collected at each week indicated relative to baseline.
Time Frame Baseline, Week 4 and Week 16.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
Arm/Group Title Placebo QD Alogliptin 25 mg QD Alogliptin 25 mg QD + Pioglitazone 30 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
Overall Number of Participants Analyzed 24 25 22
Least Squares Mean (Standard Error)
Unit of Measure: mg/L
Week 4: 5 minutes prior to meal (n=24; n=21; n=19) -1.514  (1.0846) 0.631  (1.1693) 0.155  (1.2269)
Week 16: 5 minutes prior to meal (n=24; n=25;n=21) 4.338  (2.6070) -0.402  (2.5683) -0.402  (2.8000)
14.Secondary Outcome
Title Change From Baseline in Adiponectin
Hide Description The change in adiponectin collected at each week indicated relative to baseline.
Time Frame Baseline, Week 4 and Week 16.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
Arm/Group Title Placebo QD Alogliptin 25 mg QD Alogliptin 25 mg QD + Pioglitazone 30 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
Overall Number of Participants Analyzed 24 25 21
Least Squares Mean (Standard Error)
Unit of Measure: µg/mL
Week 4: 5 minutes prior to meal (n=24;n=21; n=19) 0.001  (0.0004) 0.000  (0.0005) 0.006  (0.0005)
Week 16: 5 minutes prior to meal (n=24;n=25;n=21) 0.000  (0.0005) 0.000  (0.0005) 0.007  (0.0005)
15.Secondary Outcome
Title Change From Baseline in Anti-Vascular Cell Adhesion Molecule (VCAM)
Hide Description The change in VCAM collected at each week indicated relative to baseline.
Time Frame Baseline, Week 4 and Week 16.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
Arm/Group Title Placebo QD Alogliptin 25 mg QD Alogliptin 25 mg QD + Pioglitazone 30 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
Overall Number of Participants Analyzed 24 25 21
Least Squares Mean (Standard Error)
Unit of Measure: ng/mL
Week 4: 5 minutes prior to meal (n=24;n=21; n=19) -37.351  (17.6828) 2.392  (18.8767) 4.849  (19.8297)
Week 16: 5 minutes prior to meal (n=24;n=25;n=21) 5.067  (16.6654) -1.441  (16.3094) 13.665  (17.7580)
16.Secondary Outcome
Title Change From Baseline in Anti-Intercellular Adhesion Molecule (ICAM)
Hide Description The change in ICAM collected at each week indicated relative to baseline.
Time Frame Baseline, Week 4 and Week 16.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
Arm/Group Title Placebo QD Alogliptin 25 mg QD Alogliptin 25 mg QD + Pioglitazone 30 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
Overall Number of Participants Analyzed 24 25 21
Least Squares Mean (Standard Error)
Unit of Measure: ng/mL
Week 4: 5 minutes prior to meal (n=24;n=21; n=19) -1.154  (6.7415) -0.294  (7.1785) -23.810  (7.6380)
Week 16: 5 minutes prior to meal (n=24; n=25;n=21) -2.495  (8.6653) -4.140  (8.4752) -16.556  (9.3414)
17.Secondary Outcome
Title Change From Baseline in e-Selectin
Hide Description The change in e-Selectin collected at each week indicated relative to baseline.
Time Frame Baseline, Week 4 and Week 16.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
Arm/Group Title Placebo QD Alogliptin 25 mg QD Alogliptin 25 mg QD + Pioglitazone 30 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
Overall Number of Participants Analyzed 24 25 22
Least Squares Mean (Standard Error)
Unit of Measure: ng/mL
Week 4: 5 minutes prior to meal (n=24;n=21; n=19) 1.041  (1.3484) 0.116  (1.4394) -6.437  (1.5137)
Week 16: 5 minutes prior to meal (n=24; n=25;n=21) 1.488  (2.0944) -1.671  (2.0480) -4.056  (2.2336)
18.Secondary Outcome
Title Change From Baseline in Endothelial Function Through Pulse Wave Tonometry
Hide Description Pulse wave tonometry performed before the meal and 2 hours postmeal using one recording consisting of 15 to 20 sequentially recorded radial artery waveforms collected at each assessment.
Time Frame Baseline and Week 16.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Participants who were in the full analysis set and had a baseline and at least 1 post-baseline assessment were included for this analysis. Missing values were imputed using last observation carried forward.
Arm/Group Title Placebo QD Alogliptin 25 mg QD Alogliptin 25 mg QD + Pioglitazone 30 mg QD
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
Overall Number of Participants Analyzed 24 25 22
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
Week 16: pre-meal (n=23;n=23;n=20) -3.6  (2.51) -4.7  (2.52) -4.2  (2.68)
Week 16: 2 hours postmeal (n=24;n=24;n=20) -1.6  (3.16) 0.1  (3.18) -1.3  (3.47)
Time Frame Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind study drug.
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory values or ECG findings. 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 QD Alogliptin 25 mg QD Alogliptin 25 mg QD + Pioglitazone 30 mg QD
Hide Arm/Group Description Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks. Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks. Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
All-Cause Mortality
Placebo QD Alogliptin 25 mg QD Alogliptin 25 mg QD + Pioglitazone 30 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo QD Alogliptin 25 mg QD Alogliptin 25 mg QD + Pioglitazone 30 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   2/25 (8.00%)   3/22 (13.64%) 
Gastrointestinal disorders       
Gastric ulcer  1  0/24 (0.00%)  1/25 (4.00%)  0/22 (0.00%) 
Injury, poisoning and procedural complications       
Concussion  1  0/24 (0.00%)  0/25 (0.00%)  1/22 (4.55%) 
Fall  1  0/24 (0.00%)  0/25 (0.00%)  1/22 (4.55%) 
Head injury  1  0/24 (0.00%)  0/25 (0.00%)  1/22 (4.55%) 
Renal and urinary disorders       
Nephrolithiasis  1  0/24 (0.00%)  1/25 (4.00%)  0/22 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Placebo QD Alogliptin 25 mg QD Alogliptin 25 mg QD + Pioglitazone 30 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/24 (62.50%)   19/25 (76.00%)   13/22 (59.09%) 
Blood and lymphatic system disorders       
Anaemia  1  1/24 (4.17%)  3/25 (12.00%)  0/22 (0.00%) 
Cardiac disorders       
Palpitations  1  0/24 (0.00%)  1/25 (4.00%)  0/22 (0.00%) 
Eye disorders       
Eye irritation  1  0/24 (0.00%)  0/25 (0.00%)  1/22 (4.55%) 
Eye pruritus  1  1/24 (4.17%)  0/25 (0.00%)  0/22 (0.00%) 
Gastrointestinal disorders       
Constipation  1  1/24 (4.17%)  2/25 (8.00%)  2/22 (9.09%) 
Dyspepsia  1  0/24 (0.00%)  0/25 (0.00%)  1/22 (4.55%) 
Frequent bowel movements  1  0/24 (0.00%)  0/25 (0.00%)  1/22 (4.55%) 
Nausea  1  0/24 (0.00%)  1/25 (4.00%)  1/22 (4.55%) 
Vomiting  1  0/24 (0.00%)  0/25 (0.00%)  1/22 (4.55%) 
Abdominal discomfort  1  0/24 (0.00%)  1/25 (4.00%)  0/22 (0.00%) 
Gastric ulcer  1  0/24 (0.00%)  1/25 (4.00%)  0/22 (0.00%) 
Gastrooesophageal reflux disease  1  1/24 (4.17%)  0/25 (0.00%)  0/22 (0.00%) 
Toothache  1  0/24 (0.00%)  1/25 (4.00%)  0/22 (0.00%) 
General disorders       
Fatigue  1  1/24 (4.17%)  0/25 (0.00%)  0/22 (0.00%) 
Feeling abnormal  1  1/24 (4.17%)  0/25 (0.00%)  0/22 (0.00%) 
Infections and infestations       
Nasopharyngitis  1  1/24 (4.17%)  5/25 (20.00%)  3/22 (13.64%) 
Asymptomatic bacteriuria  1  0/24 (0.00%)  1/25 (4.00%)  0/22 (0.00%) 
Gastroenteritis  1  1/24 (4.17%)  1/25 (4.00%)  0/22 (0.00%) 
Gastroenteritis viral  1  0/24 (0.00%)  1/25 (4.00%)  0/22 (0.00%) 
Influenza  1  0/24 (0.00%)  1/25 (4.00%)  0/22 (0.00%) 
Oral herpes  1  1/24 (4.17%)  0/25 (0.00%)  0/22 (0.00%) 
Urinary tract infection  1  1/24 (4.17%)  1/25 (4.00%)  0/22 (0.00%) 
Viral infection  1  1/24 (4.17%)  0/25 (0.00%)  0/22 (0.00%) 
Viral upper respiratory tract infection  1  0/24 (0.00%)  1/25 (4.00%)  0/22 (0.00%) 
Injury, poisoning and procedural complications       
Fall  1  0/24 (0.00%)  0/25 (0.00%)  2/22 (9.09%) 
Concussion  1  0/24 (0.00%)  0/25 (0.00%)  1/22 (4.55%) 
Contusion  1  0/24 (0.00%)  0/25 (0.00%)  1/22 (4.55%) 
Head injury  1  0/24 (0.00%)  0/25 (0.00%)  1/22 (4.55%) 
Subcutaneous haematoma  1  0/24 (0.00%)  0/25 (0.00%)  1/22 (4.55%) 
Wound  1  1/24 (4.17%)  0/25 (0.00%)  0/22 (0.00%) 
Investigations       
Blood potassium decreased  1  0/24 (0.00%)  1/25 (4.00%)  0/22 (0.00%) 
Blood potassium increased  1  1/24 (4.17%)  0/25 (0.00%)  0/22 (0.00%) 
Weight decreased  1  0/24 (0.00%)  1/25 (4.00%)  0/22 (0.00%) 
Metabolism and nutrition disorders       
Hypoglycaemia  1  0/24 (0.00%)  0/25 (0.00%)  3/22 (13.64%) 
Musculoskeletal and connective tissue disorders       
Myalgia  1  1/24 (4.17%)  0/25 (0.00%)  2/22 (9.09%) 
Pain in extremity  1  1/24 (4.17%)  0/25 (0.00%)  2/22 (9.09%) 
Arthralgia  1  0/24 (0.00%)  0/25 (0.00%)  1/22 (4.55%) 
Dupuytren's contracture  1  0/24 (0.00%)  1/25 (4.00%)  0/22 (0.00%) 
Musculoskeletal pain  1  1/24 (4.17%)  0/25 (0.00%)  0/22 (0.00%) 
Nervous system disorders       
Dizziness  1  2/24 (8.33%)  1/25 (4.00%)  2/22 (9.09%) 
Hypoaesthesia  1  0/24 (0.00%)  1/25 (4.00%)  0/22 (0.00%) 
Psychiatric disorders       
Anxiety  1  1/24 (4.17%)  0/25 (0.00%)  0/22 (0.00%) 
Renal and urinary disorders       
Nephrolithiasis  1  0/24 (0.00%)  1/25 (4.00%)  0/22 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Oropharyngeal pain  1  0/24 (0.00%)  1/25 (4.00%)  0/22 (0.00%) 
Skin and subcutaneous tissue disorders       
Alopecia  1  0/24 (0.00%)  1/25 (4.00%)  0/22 (0.00%) 
Blister  1  0/24 (0.00%)  1/25 (4.00%)  0/22 (0.00%) 
Rash  1  1/24 (4.17%)  0/25 (0.00%)  0/22 (0.00%) 
Vascular disorders       
Venous thrombosis limb  1  0/24 (0.00%)  0/25 (0.00%)  1/22 (4.55%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Sr. VP, Clinical Science
Organization: Takeda Global Research and Development Center, Inc.
Phone: 800-778-2860
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00655863     History of Changes
Other Study ID Numbers: SYR-322_301
2007-000486-38 ( EudraCT Number )
U1111-1113-2081 ( Registry Identifier: WHO )
NL22649.029.08 ( Registry Identifier: CCMO )
First Submitted: April 4, 2008
First Posted: April 10, 2008
Results First Submitted: February 17, 2013
Results First Posted: May 27, 2013
Last Update Posted: May 27, 2013