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Trial record 72 of 115 for:    centurion

Efficacy and Safety of Alogliptin Plus Metformin in Patients With Type 2 Diabetes (AM7D)

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ClinicalTrials.gov Identifier: NCT01023581
Recruitment Status : Completed
First Posted : December 2, 2009
Results First Posted : March 26, 2013
Last Update Posted : March 26, 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, Type 2
Interventions Drug: Alogliptin
Drug: Metformin
Drug: Alogliptin Placebo
Drug: Metformin Placebo
Enrollment 784
Recruitment Details Participants took part in the study at 198 investigative sites worldwide from 16 November 2009 to 30 June 2011.
Pre-assignment Details Participants with a diagnosis of type 2 diabetes and glycemia inadequately controlled on diet and exercise alone were randomly assigned with equal probability to 1 of 7 treatment groups, including placebo, alogliptin alone, metformin alone or a combination of alogliptin and metformin.
Arm/Group Title Placebo Alogliptin 25 QD Alogliptin 12.5 BID Metformin 500 BID Metformin 1000 BID Alogliptin 12.5 BID + Metformin 500 BID Alogliptin 12.5 BID + Metformin 1000 BID
Hide Arm/Group Description Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks. Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks. Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks. Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks. Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks. Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks. Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
Period Title: Overall Study
Started 109 112 113 114 111 111 114
Received Study Treatment 106 112 110 109 111 106 114
Completed 74 [1] 89 71 94 95 92 94
Not Completed 35 23 42 20 16 19 20
Reason Not Completed
Adverse Event             4             4             7             3             2             5             11
Major protocol deviation             2             0             3             0             0             0             0
Lost to Follow-up             4             8             7             2             5             2             2
Withdrawal by Subject             13             8             16             10             6             8             5
Pregnancy             0             0             0             2             0             1             0
Lack of Efficacy             9             3             6             2             1             2             1
Physician Decision             2             0             2             1             1             1             1
Other             1             0             1             0             1             0             0
[1]
The number of completed patients represents those who completed study drug.
Arm/Group Title Placebo Alogliptin 25 QD Alogliptin 12.5 BID Metformin 500 BID Metformin 1000 BID Alogliptin 12.5 BID + Metformin 500 BID Alogliptin 12.5 BID + Metformin 1000 BID Total
Hide Arm/Group Description Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks. Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks. Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks. Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks. Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks. Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks. Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks. Total of all reporting groups
Overall Number of Baseline Participants 109 112 113 114 111 111 114 784
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 109 participants 112 participants 113 participants 114 participants 111 participants 111 participants 114 participants 784 participants
53.1  (9.60) 52.6  (9.38) 53.7  (9.70) 54.6  (10.20) 52.6  (11.30) 53.7  (11.59) 54.6  (10.42) 53.5  (10.33)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 109 participants 112 participants 113 participants 114 participants 111 participants 111 participants 114 participants 784 participants
<65 years 100 103 96 95 94 91 96 675
≥65 years 9 9 17 19 17 20 18 109
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants 112 participants 113 participants 114 participants 111 participants 111 participants 114 participants 784 participants
Female
54
  49.5%
64
  57.1%
50
  44.2%
67
  58.8%
60
  54.1%
63
  56.8%
52
  45.6%
410
  52.3%
Male
55
  50.5%
48
  42.9%
63
  55.8%
47
  41.2%
51
  45.9%
48
  43.2%
62
  54.4%
374
  47.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 109 participants 112 participants 113 participants 114 participants 111 participants 111 participants 114 participants 784 participants
Hispanic or Latino 45 43 43 45 42 45 39 302
Not Hispanic or Latino 64 69 70 69 69 66 75 482
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 109 participants 112 participants 113 participants 114 participants 111 participants 111 participants 114 participants 784 participants
American Indian or Alaska Native 5 8 5 3 6 9 5 41
Asian 20 17 21 19 20 20 26 143
Native Hawaiian or Other Pacific Islander 0 0 1 0 0 0 0 1
Black or African American 8 3 3 6 6 6 5 37
White 76 84 83 85 79 76 78 561
Multiracial 0 0 0 1 0 0 0 1
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 109 participants 112 participants 113 participants 114 participants 111 participants 111 participants 114 participants 784 participants
31.15  (5.269) 30.81  (5.219) 30.36  (5.159) 30.19  (4.842) 30.51  (5.043) 30.92  (5.353) 31.04  (5.375) 30.71  (5.173)
Diabetes Duration  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 109 participants 112 participants 113 participants 114 participants 111 participants 111 participants 114 participants 784 participants
4.25  (4.778) 3.65  (4.119) 3.97  (4.800) 3.78  (3.904) 4.08  (4.587) 4.13  (4.777) 4.22  (4.972) 4.01  (4.563)
Baseline HbA1c   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 109 participants 112 participants 113 participants 114 participants 111 participants 111 participants 114 participants 784 participants
≤8.5% 65 67 67 67 66 66 67 465
>8.5% 44 45 46 47 45 45 47 319
[1]
Measure Description: The count for baseline HbA1c category is based on HbA1c value used in randomization for stratification.
1.Primary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
Hide Description The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).
Time Frame Baseline and Week 26.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (patients who took at least 1 dose of study medication) where baseline and at least 1 postbaseline assessment were available. Analysis includes only data collected on or after baseline and within 7 days after last dose of study medication or hyperglycemic rescue, whichever came first. Last observation carried forward was utilized.
Arm/Group Title Placebo Alogliptin 25 QD Alogliptin 12.5 BID Metformin 500 BID Metformin 1000 BID Alogliptin 12.5 BID + Metformin 500 BID Alogliptin 12.5 BID + Metformin 1000 BID
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
Overall Number of Participants Analyzed 102 104 104 103 108 102 111
Least Squares Mean (Standard Error)
Unit of Measure: percentage glycosylated hemoglobin
0.15  (0.094) -0.52  (0.094) -0.56  (0.093) -0.65  (0.094) -1.11  (0.092) -1.22  (0.094) -1.55  (0.090)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 BID, Alogliptin 12.5 BID + Metformin 500 BID
Comments The primary efficacy analysis consisted of 2 separate sets of comparisons between each BID combination of alogliptin and metformin (alogliptin/metformin 12.5/500 mg BID and 12.5/1000 mg BID) and its constituent doses of alogliptin and metformin. The null hypothesis was that the combination of alogliptin and metformin had no additional effect on glycemic control at Week 26 either when compared with the constituent dose of alogliptin or with the constituent dose of metformin.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments For each set of comparisons in the primary analysis, the null hypothesis was rejected only if both comparisons between a combination and its constituent doses were statistically significant at the 2-sided 2.5% level.
Method ANCOVA
Comments ANCOVA model with treatment and geographic region as fixed effects and baseline HbA1c as a covariate.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.67
Confidence Interval (2-Sided) 95%
-0.96 to -0.37
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Metformin 500 BID, Alogliptin 12.5 BID + Metformin 500 BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model with treatment and geographic region as fixed effects and baseline HbA1c as a covariate
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.57
Confidence Interval (2-Sided) 95%
-0.87 to -0.27
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Alogliptin 12.5 BID, Alogliptin 12.5 BID + Metformin 1000 BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model with treatment and geographic region as fixed effects and baseline HbA1c as a covariate.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.00
Confidence Interval (2-Sided) 95%
-1.29 to -0.71
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Metformin 1000 BID, Alogliptin 12.5 BID + Metformin 1000 BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model with treatment and geographic region as fixed effects and baseline HbA1c as a covariate.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.44
Confidence Interval (2-Sided) 95%
-0.73 to -0.16
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in HbA1c Over Time
Hide 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) was assessed at Weeks 4, 8, 12, 16 and 20.

Least squares means are from an analysis of covariance (ANCOVA) model with treatment and geographic region as fixed effects, and baseline HbA1c as a covariate.

Time Frame Baseline and Weeks 4, 8, 12, 16, and 20.
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set where a baseline assessment and at least 1 valid postbaseline assessment were available. The analysis includes only data collected on or after baseline and within 7 days after the last dose of study medication or hyperglycemic rescue, whichever came first. Last observation carried forward was utilized.
Arm/Group Title Placebo Alogliptin 25 QD Alogliptin 12.5 BID Metformin 500 BID Metformin 1000 BID Alogliptin 12.5 BID + Metformin 500 BID Alogliptin 12.5 BID + Metformin 1000 BID
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
Overall Number of Participants Analyzed 106 112 110 109 111 106 114
Least Squares Mean (Standard Error)
Unit of Measure: percentage glycosylated hemoglobin
Week 4 (n=95, 97, 89, 94, 102, 94, 101) 0.09  (0.058) -0.34  (0.057) -0.42  (0.060) -0.37  (0.058) -0.58  (0.056) -0.70  (0.058) -0.75  (0.056)
Week 8 (n=102, 104, 104, 103, 108, 102, 111) 0.08  (0.073) -0.51  (0.073) -0.58  (0.072) -0.59  (0.073) -0.86  (0.071) -1.08  (0.073) -1.17  (0.070)
Week 12 (n=102, 104, 104, 103, 108, 102, 111) 0.12  (0.081) -0.53  (0.080) -0.62  (0.080) -0.68  (0.081) -1.02  (0.079) -1.22  (0.081) -1.40  (0.078)
Week 16 (n=102, 104, 104, 103, 108, 102, 111) 0.13  (0.087) -0.58  (0.087) -0.63  (0.086) -0.72  (0.087) -1.09  (0.085) -1.26  (0.087) -1.50  (0.084)
Week 20 (n=102, 104, 104, 103, 108, 102, 111) 0.12  (0.092) -0.57  (0.091) -0.59  (0.091) -0.68  (0.092) -1.14  (0.089) -1.25  (0.092) -1.54  (0.088)
3.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose Over Time
Hide Description The change from Baseline in fasting plasma glucose was assessed at Weeks 1, 2, 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as fixed effects, and baseline fasting plasma glucose as a covariate.
Time Frame Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26.
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set where a baseline assessment and at least 1 valid postbaseline assessment were available. Includes only data collected on or after baseline and within 1 day after the last dose of study medication or hyperglycemic rescue, whichever came first. Last observation carried forward was utilized.
Arm/Group Title Placebo Alogliptin 25 QD Alogliptin 12.5 BID Metformin 500 BID Metformin 1000 BID Alogliptin 12.5 BID + Metformin 500 BID Alogliptin 12.5 BID + Metformin 1000 BID
Hide Arm/Group Description:
Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
Overall Number of Participants Analyzed 106 112 110 109 111 106 114
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
Week 1 (n=102, 103, 94, 95, 104, 101, 109) 5.7  (3.40) -3.9  (3.38) -11.9  (3.54) -12.6  (3.52) -23.1  (3.36) -32.7  (3.41) -36.3  (3.29)
Week 2 (n=105, 112, 105, 102, 108, 106, 111) 4.6  (3.58) -7.4  (3.46) -11.6  (3.58) -14.5  (3.63) -22.2  (3.53) -34.5  (3.56) -43.6  (3.48)
Week 4 (n=105, 112, 106, 106, 110, 106, 111) 7.2  (3.69) -11.5  (3.57) -16.6  (3.67) -16.9  (3.67) -29.0  (3.60) -37.6  (3.67) -44.1  (3.58)
Week 8 (n=105, 112, 106, 106, 110, 106, 112) 7.1  (4.00) -10.9  (3.87) -12.1  (3.98) -11.8  (3.98) -30.7  (3.91) -32.9  (3.98) -43.8  (3.87)
Week 12 (n=105, 112, 106, 106, 110, 106, 112) 11.6  (4.16) -9.7  (4.03) -14.7  (4.14) -14.0  (4.14) -30.7  (4.06) -31.6  (4.14) -44.7  (4.03)
Week 16 (n=105, 112, 106, 106, 110, 106, 112) 10.1  (4.17) -7.1  (4.04) -14.7  (4.15) -13.3  (4.15) -33.5  (4.07) -35.9  (4.15) -47.7  (4.04)
Week 20 (n=105, 112, 106, 106, 110, 106, 112) 8.7  (4.36) -9.2  (4.22) -12.3  (4.34) -10.9  (4.34) -35.1  (4.25) -33.8  (4.34) -44.6  (4.22)
Week 26 (n=105, 112, 106, 106, 110, 106, 112) 12.4  (4.52) -6.1  (4.37) -9.7  (4.49) -11.5  (4.49) -31.9  (4.41) -31.7  (4.49) -45.9  (4.37)
Time Frame Adverse events that occurred after the first dose of double-blind study medication and within 14 days after the last dose of double-blind study medication.
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory 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 Alogliptin 25 QD Alogliptin 12.5 BID Metformin 500 BID Metformin 1000 BID Alogliptin 12.5 BID + Metformin 500 BID Alogliptin 12.5 BID + Metformin 1000 BID
Hide Arm/Group Description Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks. Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks. Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks. Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks. Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks. Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks. Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
All-Cause Mortality
Placebo Alogliptin 25 QD Alogliptin 12.5 BID Metformin 500 BID Metformin 1000 BID Alogliptin 12.5 BID + Metformin 500 BID Alogliptin 12.5 BID + Metformin 1000 BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Alogliptin 25 QD Alogliptin 12.5 BID Metformin 500 BID Metformin 1000 BID Alogliptin 12.5 BID + Metformin 500 BID Alogliptin 12.5 BID + Metformin 1000 BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/106 (2.83%)   1/112 (0.89%)   4/110 (3.64%)   3/109 (2.75%)   2/111 (1.80%)   2/106 (1.89%)   2/114 (1.75%) 
Cardiac disorders               
Angina pectoris  1  0/106 (0.00%)  0/112 (0.00%)  0/110 (0.00%)  1/109 (0.92%)  0/111 (0.00%)  0/106 (0.00%)  0/114 (0.00%) 
Myocardial ischaemia  1  1/106 (0.94%)  0/112 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/111 (0.00%)  0/106 (0.00%)  0/114 (0.00%) 
Wandering pacemaker  1  0/106 (0.00%)  0/112 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  1/111 (0.90%)  0/106 (0.00%)  0/114 (0.00%) 
General disorders               
Non-cardiac chest pain  1  0/106 (0.00%)  0/112 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/111 (0.00%)  1/106 (0.94%)  0/114 (0.00%) 
Hepatobiliary disorders               
Cholecystitis  1  0/106 (0.00%)  0/112 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/111 (0.00%)  0/106 (0.00%)  1/114 (0.88%) 
Infections and infestations               
Gallbladder empyema  1  0/106 (0.00%)  0/112 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/111 (0.00%)  0/106 (0.00%)  1/114 (0.88%) 
Pneumonia  1  0/106 (0.00%)  0/112 (0.00%)  1/110 (0.91%)  0/109 (0.00%)  0/111 (0.00%)  0/106 (0.00%)  0/114 (0.00%) 
Urinary tract infection  1  0/106 (0.00%)  1/112 (0.89%)  0/110 (0.00%)  0/109 (0.00%)  0/111 (0.00%)  0/106 (0.00%)  0/114 (0.00%) 
Injury, poisoning and procedural complications               
Ankle fracture  1  0/106 (0.00%)  0/112 (0.00%)  0/110 (0.00%)  1/109 (0.92%)  0/111 (0.00%)  0/106 (0.00%)  0/114 (0.00%) 
Multiple drug overdose intentional  1  0/106 (0.00%)  0/112 (0.00%)  1/110 (0.91%)  0/109 (0.00%)  0/111 (0.00%)  0/106 (0.00%)  0/114 (0.00%) 
Metabolism and nutrition disorders               
Hyperglycaemia  1  1/106 (0.94%)  0/112 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/111 (0.00%)  0/106 (0.00%)  0/114 (0.00%) 
Nervous system disorders               
Cerebrovascular accident  1  0/106 (0.00%)  0/112 (0.00%)  1/110 (0.91%)  0/109 (0.00%)  0/111 (0.00%)  0/106 (0.00%)  0/114 (0.00%) 
Ischaemic stroke  1  0/106 (0.00%)  0/112 (0.00%)  1/110 (0.91%)  0/109 (0.00%)  0/111 (0.00%)  0/106 (0.00%)  0/114 (0.00%) 
Tremor  1  1/106 (0.94%)  0/112 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/111 (0.00%)  0/106 (0.00%)  0/114 (0.00%) 
Psychiatric disorders               
Delusion  1  0/106 (0.00%)  0/112 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/111 (0.00%)  1/106 (0.94%)  0/114 (0.00%) 
Renal and urinary disorders               
Urinary retention  1  0/106 (0.00%)  0/112 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  1/111 (0.90%)  0/106 (0.00%)  0/114 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Alveolitis allergic  1  0/106 (0.00%)  0/112 (0.00%)  0/110 (0.00%)  1/109 (0.92%)  0/111 (0.00%)  0/106 (0.00%)  0/114 (0.00%) 
Pulmonary fibrosis  1  0/106 (0.00%)  0/112 (0.00%)  0/110 (0.00%)  1/109 (0.92%)  0/111 (0.00%)  0/106 (0.00%)  0/114 (0.00%) 
Vascular disorders               
Hypotension  1  0/106 (0.00%)  0/112 (0.00%)  0/110 (0.00%)  0/109 (0.00%)  0/111 (0.00%)  0/106 (0.00%)  1/114 (0.88%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Alogliptin 25 QD Alogliptin 12.5 BID Metformin 500 BID Metformin 1000 BID Alogliptin 12.5 BID + Metformin 500 BID Alogliptin 12.5 BID + Metformin 1000 BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   50/106 (47.17%)   38/112 (33.93%)   34/110 (30.91%)   44/109 (40.37%)   43/111 (38.74%)   40/106 (37.74%)   37/114 (32.46%) 
Gastrointestinal disorders               
Diarrhoea  1  3/106 (2.83%)  1/112 (0.89%)  3/110 (2.73%)  4/109 (3.67%)  10/111 (9.01%)  6/106 (5.66%)  8/114 (7.02%) 
Nausea  1  2/106 (1.89%)  0/112 (0.00%)  3/110 (2.73%)  4/109 (3.67%)  6/111 (5.41%)  3/106 (2.83%)  6/114 (5.26%) 
Dyspepsia  1  3/106 (2.83%)  0/112 (0.00%)  1/110 (0.91%)  0/109 (0.00%)  2/111 (1.80%)  0/106 (0.00%)  8/114 (7.02%) 
Infections and infestations               
Upper respiratory tract infection  1  3/106 (2.83%)  3/112 (2.68%)  3/110 (2.73%)  4/109 (3.67%)  3/111 (2.70%)  8/106 (7.55%)  2/114 (1.75%) 
Nasopharyngitis  1  2/106 (1.89%)  7/112 (6.25%)  1/110 (0.91%)  2/109 (1.83%)  4/111 (3.60%)  3/106 (2.83%)  2/114 (1.75%) 
Investigations               
Creatinine renal clearance decreased  1  4/106 (3.77%)  1/112 (0.89%)  4/110 (3.64%)  0/109 (0.00%)  6/111 (5.41%)  5/106 (4.72%)  9/114 (7.89%) 
Metabolism and nutrition disorders               
Hyperglycaemia  1  28/106 (26.42%)  19/112 (16.96%)  13/110 (11.82%)  19/109 (17.43%)  9/111 (8.11%)  8/106 (7.55%)  1/114 (0.88%) 
Dyslipidaemia  1  6/106 (5.66%)  1/112 (0.89%)  2/110 (1.82%)  7/109 (6.42%)  6/111 (5.41%)  6/106 (5.66%)  2/114 (1.75%) 
Hypertriglyceridaemia  1  3/106 (2.83%)  3/112 (2.68%)  1/110 (0.91%)  3/109 (2.75%)  6/111 (5.41%)  6/106 (5.66%)  1/114 (0.88%) 
Musculoskeletal and connective tissue disorders               
Back pain  1  1/106 (0.94%)  0/112 (0.00%)  1/110 (0.91%)  6/109 (5.50%)  1/111 (0.90%)  4/106 (3.77%)  0/114 (0.00%) 
Nervous system disorders               
Headache  1  3/106 (2.83%)  6/112 (5.36%)  5/110 (4.55%)  8/109 (7.34%)  4/111 (3.60%)  7/106 (6.60%)  6/114 (5.26%) 
Vascular disorders               
Hypertension  1  5/106 (4.72%)  3/112 (2.68%)  2/110 (1.82%)  6/109 (5.50%)  1/111 (0.90%)  5/106 (4.72%)  8/114 (7.02%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
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.
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
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01023581     History of Changes
Other Study ID Numbers: SYR-322MET_302
2009-012652-24 ( Registry Identifier: EudraCT )
U1111-1112-1912 ( Registry Identifier: WHO )
DOH-27-0910-3155 ( Registry Identifier: SANCTR )
CTRI/2010/091/000253 ( Registry Identifier: CTRI )
First Submitted: December 1, 2009
First Posted: December 2, 2009
Results First Submitted: February 17, 2013
Results First Posted: March 26, 2013
Last Update Posted: March 26, 2013