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Trial record 1 of 1 for:    01-05-TL-322OPI-001
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Efficacy and Safety of Alogliptin Combined With Pioglitazone in Treating Subjects With Type 2 Diabetes Mellitus.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00328627
First Posted: May 22, 2006
Last Update Posted: April 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Takeda
Results First Submitted: February 19, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Alogliptin
Drug: Alogliptin placebo
Drug: Pioglitazone
Drug: Pioglitazone placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants took part in the study at 327 investigative sites in 20 countries from 31 May 2006 to 17 March 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with a diagnosis of type 2 diabetes who were inadequately controlled on a regimen of metformin alone were equally randomized to 1 of 12 double-blind treatment groups.

Reporting Groups
  Description
Placebo Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 + Placebo Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 + Placebo Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Placebo + Pioglitazone 15 Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 + Pioglitazone 15 Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 + Pioglitazone 15 Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
Placebo + Pioglitazone 30 Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 + Pioglitazone 30 Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 + Pioglitazone 30 Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Placebo + Pioglitazone 45 Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 + Pioglitazone 45 Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 + Pioglitazone 45 Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.

Participant Flow:   Overall Study
    Placebo   Alogliptin 12.5 + Placebo   Alogliptin 25 + Placebo   Placebo + Pioglitazone 15   Alogliptin 12.5 + Pioglitazone 15   Alogliptin 25 + Pioglitazone 15   Placebo + Pioglitazone 30   Alogliptin 12.5 + Pioglitazone 30   Alogliptin 25 + Pioglitazone 30   Placebo + Pioglitazone 45   Alogliptin 12.5 + Pioglitazone 45   Alogliptin 25 + Pioglitazone 45
STARTED   129   128   129   130   130   130   129   130   130   129   130   130 
Safety Set   129 [1]   128   129   129   130   130   129   130   130   129   130   130 
COMPLETED   70   97   101   93   115   110   94   116   113   97   112   114 
NOT COMPLETED   59   31   28   37   15   20   35   14   17   32   18   16 
Hyperglycemic Rescue                41                18                16                13                6                5                19                6                6                11                3                2 
Adverse Event                3                1                2                3                1                2                1                2                0                7                5                4 
Protocol Violation                2                2                2                8                5                5                6                2                1                4                6                2 
Lost to Follow-up                4                2                2                4                0                2                3                0                3                2                0                1 
Withdrawal by Subject                5                4                5                6                2                5                4                4                4                5                2                7 
Pregnancy                0                1                0                0                0                0                0                0                0                0                0                0 
Physician Decision                4                3                1                2                1                1                1                0                3                2                1                0 
Other                0                0                0                1                0                0                1                0                0                1                1                0 
[1] All patients who took at least 1 dose of double-blind study drug.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 + Placebo Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 + Placebo Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Placebo + Pioglitazone 15 Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 + Pioglitazone 15 Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 + Pioglitazone 15 Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
Placebo + Pioglitazone 30 Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 + Pioglitazone 30 Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 + Pioglitazone 30 Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Placebo + Pioglitazone 45 Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 + Pioglitazone 45 Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 + Pioglitazone 45 Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
Total Total of all reporting groups

Baseline Measures
   Placebo   Alogliptin 12.5 + Placebo   Alogliptin 25 + Placebo   Placebo + Pioglitazone 15   Alogliptin 12.5 + Pioglitazone 15   Alogliptin 25 + Pioglitazone 15   Placebo + Pioglitazone 30   Alogliptin 12.5 + Pioglitazone 30   Alogliptin 25 + Pioglitazone 30   Placebo + Pioglitazone 45   Alogliptin 12.5 + Pioglitazone 45   Alogliptin 25 + Pioglitazone 45   Total 
Overall Participants Analyzed 
[Units: Participants]
 129   128   129   130   130   130   129   130   130   129   130   130   1554 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.2  (9.89)   53.1  (9.59)   53.7  (9.31)   54.1  (9.54)   53.6  (9.91)   54.9  (9.18)   56.1  (9.43)   55.0  (9.07)   54.4  (9.69)   54.5  (9.70)   54.0  (9.82)   54.2  (8.86)   54.4  (9.50) 
Age, Customized 
[Units: Participants]
                         
<65 years   106   116   112   113   109   112   101   111   107   112   111   112   1322 
≥65 years   23   12   17   17   21   18   28   19   23   17   19   18   232 
Gender 
[Units: Participants]
                         
Female   68   61   79   69   70   69   66   76   75   76   70   78   857 
Male   61   67   50   61   60   61   63   54   55   53   60   52   697 
Ethnicity (NIH/OMB) 
[Units: Participants]
                         
Hispanic or Latino   63   60   63   63   55   57   67   66   62   61   63   65   745 
Not Hispanic or Latino   66   68   66   67   75   73   62   64   68   68   67   65   809 
Unknown or Not Reported   0   0   0   0   0   0   0   0   0   0   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
                         
American Indian or Alaska Native   0   0   0   0   2   2   0   1   0   0   0   0   5 
Asian   5   14   15   11   9   7   10   5   12   12   8   12   120 
Native Hawaiian or Other Pacific Islander   0   0   0   0   0   0   0   0   0   0   0   0   0 
Black or African American   8   6   5   8   4   3   6   2   5   9   9   3   68 
White   93   89   80   85   95   96   96   107   85   85   92   93   1096 
More than one race   0   0   0   0   0   0   0   0   0   0   0   0   0 
Unknown or Not Reported   23   19   29   26   20   22   17   15   28   23   21   22   265 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 83.38  (18.378)   84.63  (19.378)   83.25  (18.326)   84.68  (18.634)   85.95  (18.498)   82.90  (16.570)   85.86  (20.347)   83.68  (18.340)   85.77  (18.844)   82.10  (17.019)   85.01  (18.536)   82.79  (18.768)   84.17  (18.470) 
Height 
[Units: Cm]
Mean (Standard Deviation)
 164.48  (10.157)   164.61  (10.614)   162.38  (9.790)   164.25  (11.007)   164.59  (10.841)   163.74  (10.456)   164.59  (9.724)   163.63  (11.036)   163.64  (9.548)   163.14  (10.961)   163.82  (10.708)   163.73  (11.432)   163.88  (10.522) 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 30.59  (4.808)   30.96  (5.133)   31.48  (5.733)   31.25  (5.280)   31.53  (4.979)   30.78  (4.723)   31.41  (5.391)   31.09  (5.054)   31.86  (5.585)   30.69  (4.721)   31.51  (5.206)   30.62  (4.751)   31.15  (5.122) 
Diabetes Duration 
[Units: Years]
Mean (Standard Deviation)
 6.01  (4.958)   6.17  (5.614)   5.55  (4.879)   5.70  (4.767)   6.08  (5.485)   6.86  (5.489)   7.63  (7.069)   5.81  (5.054)   6.63  (6.005)   5.68  (4.232)   6.59  (5.273)   6.22  (5.014)   6.24  (5.375) 
Baseline metformin dose 
[Units: Mg]
Mean (Standard Deviation)
 1936.8  (428.41)   1902.0  (450.17)   1851.2  (413.85)   1892.6  (410.70)   1909.6  (418.98)   1880.0  (413.65)   1853.5  (435.72)   1822.3  (444.22)   1867.1  (455.48)   1918.6  (417.91)   1919.6  (421.22)   1884.6  (439.47)   1886.5  (429.08) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline to Week 26 in Glycosylated Hemoglobin (HbA1c) (Grouped Analysis)   [ Time Frame: Baseline and Week 26 ]

2.  Primary:   Change From Baseline to Week 26 in HbA1c   [ Time Frame: Baseline and Week 26 ]

3.  Secondary:   Change From Baseline in HbA1c Over Time (Grouped Analysis)   [ Time Frame: Baseline and Weeks 4, 8, 12, 16 and 20. ]

4.  Secondary:   Change From Baseline to Week 4 in HbA1c   [ Time Frame: Baseline and Week 4 ]

5.  Secondary:   Change From Baseline to Week 8 in HbA1c   [ Time Frame: Baseline and Week 8 ]

6.  Secondary:   Change From Baseline to Week 12 in HbA1c   [ Time Frame: Baseline and Week 12 ]

7.  Secondary:   Change From Baseline to Week 16 in HbA1c   [ Time Frame: Baseline and Week 16 ]

8.  Secondary:   Change From Baseline to Week 20 in HbA1c   [ Time Frame: Baseline and Week 20 ]

9.  Secondary:   Change From Baseline in Fasting Plasma Glucose Over Time (Grouped Analysis)   [ Time Frame: Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26. ]

10.  Secondary:   Change From Baseline to Week 1 in Fasting Plasma Glucose   [ Time Frame: Baseline and Week 1 ]

11.  Secondary:   Change From Baseline to Week 2 in Fasting Plasma Glucose   [ Time Frame: Baseline and Week 2 ]

12.  Secondary:   Change From Baseline to Week 4 in Fasting Plasma Glucose   [ Time Frame: Baseline and Week 4 ]

13.  Secondary:   Change From Baseline to Week 8 in Fasting Plasma Glucose   [ Time Frame: Baseline and Week 8 ]

14.  Secondary:   Change From Baseline to Week 12 in Fasting Plasma Glucose   [ Time Frame: Baseline and Week 12 ]

15.  Secondary:   Change From Baseline to Week 16 in Fasting Plasma Glucose   [ Time Frame: Baseline and Week 16 ]

16.  Secondary:   Change From Baseline to Week 20 in Fasting Plasma Glucose   [ Time Frame: Baseline and Week 20 ]

17.  Secondary:   Change From Baseline to Week 26 in Fasting Plasma Glucose   [ Time Frame: Baseline and Week 26 ]

18.  Secondary:   Percentage of Participants With Marked Hyperglycemia (Grouped Analysis)   [ Time Frame: From Week 1 to Week 26 ]

19.  Secondary:   Percentage of Participants With Marked Hyperglycemia   [ Time Frame: From Week 1 to Week 26 ]

20.  Secondary:   Percentage of Participants Meeting Rescue Criteria (Grouped Analysis)   [ Time Frame: From Week 1 to Week 26. ]

21.  Secondary:   Percentage of Participants Meeting Rescue Criteria   [ Time Frame: From Week 1 to Week 26 ]

22.  Secondary:   Percentage of Participants With Glycosylated Hemoglobin ≤ 6.5% (Grouped Analysis)   [ Time Frame: Week 26 ]

23.  Secondary:   Percentage of Participants With Glycosylated Hemoglobin ≤ 6.5%   [ Time Frame: Week 26 ]

24.  Secondary:   Percentage of Participants With Glycosylated Hemoglobin ≤ 7.0% (Grouped Analysis)   [ Time Frame: Week 26 ]

25.  Secondary:   Percentage of Participants With Glycosylated Hemoglobin ≤ 7%   [ Time Frame: Week 26 ]

26.  Secondary:   Percentage of Participants With Glycosylated Hemoglobin ≤ 7.5% (Grouped Analysis)   [ Time Frame: Week 26 ]

27.  Secondary:   Percentage of Participants With Glycosylated Hemoglobin ≤ 7.5%   [ Time Frame: Week 26 ]

28.  Secondary:   Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 0.5% (Grouped Analysis)   [ Time Frame: Baseline and Week 26 ]

29.  Secondary:   Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 0.5%   [ Time Frame: Baseline and Week 26 ]

30.  Secondary:   Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1% (Grouped Analysis)   [ Time Frame: Baseline and Week 26 ]

31.  Secondary:   Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1%   [ Time Frame: Baseline and Week 26 ]

32.  Secondary:   Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1.5% (Grouped Analysis)   [ Time Frame: Baseline and Week 26 ]

33.  Secondary:   Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1.5%   [ Time Frame: Baseline and Week 26 ]

34.  Secondary:   Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 2.0% (Grouped Analysis)   [ Time Frame: Baseline and Week 26. ]

35.  Secondary:   Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 2%   [ Time Frame: Baseline and Week 26 ]

36.  Secondary:   Change From Baseline in Fasting Proinsulin Over Time (Grouped Analysis)   [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20 and 26. ]

37.  Secondary:   Change From Baseline to Week 4 in Fasting Proinsulin   [ Time Frame: Baseline and Week 4 ]

38.  Secondary:   Change From Baseline to Week 8 in Fasting Proinsulin   [ Time Frame: Baseline and Week 8 ]

39.  Secondary:   Change From Baseline to Week 12 in Fasting Proinsulin   [ Time Frame: Baseline and Week 12 ]

40.  Secondary:   Change From Baseline to Week 16 in Fasting Proinsulin   [ Time Frame: Baseline and Week 16 ]

41.  Secondary:   Change From Baseline to Week 20 in Fasting Proinsulin   [ Time Frame: Baseline and Week 20 ]

42.  Secondary:   Change From Baseline to Week 26 in Fasting Proinsulin   [ Time Frame: Baseline and Week 26 ]

43.  Secondary:   Change From Baseline in Insulin Over Time (Grouped Analysis)   [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20 and 26. ]

44.  Secondary:   Change From Baseline to Week 4 in Insulin Levels   [ Time Frame: Baseline and Week 4 ]

45.  Secondary:   Change From Baseline to Week 8 in Insulin Levels   [ Time Frame: Baseline and Week 8 ]

46.  Secondary:   Change From Baseline to Week 12 in Insulin Levels   [ Time Frame: Baseline and Week 12 ]

47.  Secondary:   Change From Baseline to Week 16 in Insulin Levels   [ Time Frame: Baseline and Week 16 ]

48.  Secondary:   Change From Baseline to Week 20 in Insulin Levels   [ Time Frame: Baseline and Week 20 ]

49.  Secondary:   Change From Baseline to Week 26 in Insulin Levels   [ Time Frame: Baseline and Week 26 ]

50.  Secondary:   Change From Baseline in Proinsulin/Insulin Ratio Over Time (Grouped Analysis)   [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20 and 26. ]

51.  Secondary:   Change From Baseline to Week 4 in Proinsulin/Insulin Ratio   [ Time Frame: Baseline and Week 4 ]

52.  Secondary:   Change From Baseline to Week 8 in Proinsulin/Insulin Ratio   [ Time Frame: Baseline and Week 8 ]

53.  Secondary:   Change From Baseline to Week 12 in Proinsulin/Insulin Ratio   [ Time Frame: Baseline and Week 12 ]

54.  Secondary:   Change From Baseline to Week 16 in Proinsulin/Insulin Ratio   [ Time Frame: Baseline and Week 16 ]

55.  Secondary:   Change From Baseline to Week 20 in Proinsulin/Insulin Ratio   [ Time Frame: Baseline and Week 20 ]

56.  Secondary:   Change From Baseline to Week 26 in Proinsulin/Insulin Ratio   [ Time Frame: Baseline and Week 26 ]

57.  Secondary:   Change From Baseline in C-peptide Over Time (Grouped Analysis)   [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20 and 26. ]

58.  Secondary:   Change From Baseline to Week 4 in C-peptide Levels   [ Time Frame: Baseline and Week 4 ]

59.  Secondary:   Change From Baseline to Week 8 in C-peptide Levels   [ Time Frame: Baseline and Week 8 ]

60.  Secondary:   Change From Baseline to Week 12 in C-peptide Levels   [ Time Frame: Baseline and Week 12 ]

61.  Secondary:   Change From Baseline to Week 16 in C-peptide Levels   [ Time Frame: Baseline and Week 16 ]

62.  Secondary:   Change From Baseline to Week 20 in C-peptide Levels   [ Time Frame: Baseline and Week 20 ]

63.  Secondary:   Change From Baseline to Week 26 in C-peptide Levels   [ Time Frame: Baseline and Week 26 ]

64.  Secondary:   Change From Baseline in Total Cholesterol Over Time (Grouped Analysis)   [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20 and 26. ]

65.  Secondary:   Change From Baseline to Week 4 in Total Cholesterol Levels   [ Time Frame: Baseline and Week 4 ]

66.  Secondary:   Change From Baseline to Week 8 in Total Cholesterol Levels   [ Time Frame: Baseline and Week 8 ]

67.  Secondary:   Change From Baseline to Week 12 in Total Cholesterol Levels   [ Time Frame: Baseline and Week 12 ]

68.  Secondary:   Change From Baseline to Week 16 in Total Cholesterol Levels   [ Time Frame: Baseline and Week 16 ]

69.  Secondary:   Change From Baseline to Week 20 in Total Cholesterol Levels   [ Time Frame: Baseline and Week 20 ]

70.  Secondary:   Change From Baseline to Week 26 in Total Cholesterol Levels   [ Time Frame: Baseline and Week 26 ]

71.  Secondary:   Change From Baseline in Low-Density Lipoprotein Cholesterol Over Time (Grouped Analysis)   [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20 and 26. ]

72.  Secondary:   Change From Baseline to Week 4 in Low-Density Lipoprotein Cholesterol   [ Time Frame: Baseline and Week 4 ]

73.  Secondary:   Change From Baseline to Week 8 in Low-Density Lipoprotein Cholesterol   [ Time Frame: Baseline and Week 8 ]

74.  Secondary:   Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol   [ Time Frame: Baseline and Week 12 ]

75.  Secondary:   Change From Baseline to Week 16 in Low-Density Lipoprotein Cholesterol   [ Time Frame: Baseline and Week 16 ]

76.  Secondary:   Change From Baseline to Week 20 in Low-Density Lipoprotein Cholesterol   [ Time Frame: Baseline and Week 20 ]

77.  Secondary:   Change From Baseline to Week 26 in Low-Density Lipoprotein Cholesterol   [ Time Frame: Baseline and Week 26 ]

78.  Secondary:   Change From Baseline in High-Density Lipoprotein Cholesterol Over Time (Grouped Analysis)   [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20 and 26. ]

79.  Secondary:   Change From Baseline to Week 4 in High-Density Lipoprotein Cholesterol   [ Time Frame: Baseline and Week 4 ]

80.  Secondary:   Change From Baseline to Week 8 in High-Density Lipoprotein Cholesterol   [ Time Frame: Baseline and Week 8 ]

81.  Secondary:   Change From Baseline to Week 12 in High-Density Lipoprotein Cholesterol   [ Time Frame: Baseline and Week 12 ]

82.  Secondary:   Change From Baseline to Week 16 in High-Density Lipoprotein Cholesterol   [ Time Frame: Baseline and Week 16 ]

83.  Secondary:   Change From Baseline to Week 20 in High-Density Lipoprotein Cholesterol   [ Time Frame: Baseline and Week 20 ]

84.  Secondary:   Change From Baseline to Week 26 in High-Density Lipoprotein Cholesterol   [ Time Frame: Baseline and Week 26 ]

85.  Secondary:   Change From Baseline in Triglycerides Over Time (Grouped Analysis)   [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20 and 26. ]

86.  Secondary:   Change From Baseline to Week 4 in Triglyceride Levels   [ Time Frame: Baseline and Week 4 ]

87.  Secondary:   Change From Baseline to Week 8 in Triglyceride Levels   [ Time Frame: Baseline and Week 8 ]

88.  Secondary:   Change From Baseline to Week 12 in Triglyceride Levels   [ Time Frame: Baseline and Week 12 ]

89.  Secondary:   Change From Baseline to Week 16 in Triglyceride Levels   [ Time Frame: Baseline and Week 16 ]

90.  Secondary:   Change From Baseline to Week 20 in Triglyceride Levels   [ Time Frame: Baseline and Week 20 ]

91.  Secondary:   Change From Baseline to Week 26 in Triglyceride Levels   [ Time Frame: Baseline and Week 26 ]

92.  Secondary:   Change From Baseline in Free Fatty Acids Over Time (Grouped Analysis)   [ Time Frame: Baseline and Weeks 12 and 26. ]

93.  Secondary:   Change From Baseline to Week 12 in Free Fatty Acids   [ Time Frame: Baseline and Week 12 ]

94.  Secondary:   Change From Baseline to Week 26 in Free Fatty Acids   [ Time Frame: Baseline and Week 26 ]

95.  Secondary:   Change From Baseline in Plasminogen Activator Inhibitor-1 Over Time (Grouped Analysis)   [ Time Frame: Baseline and Weeks 12 and 26. ]

96.  Secondary:   Change From Baseline to Week 12 in Plasminogen Activator Inhibitor-1   [ Time Frame: Baseline and Week 12 ]

97.  Secondary:   Change From Baseline to Week 26 in Plasminogen Activator Inhibitor-1   [ Time Frame: Baseline and Week 26 ]

98.  Secondary:   Change From Baseline in High-sensitivity C-Reactive Protein Over Time (Grouped Analysis)   [ Time Frame: Baseline and Weeks 12 and 26. ]

99.  Secondary:   Change From Baseline to Week 12 in High-sensitivity C-Reactive Protein   [ Time Frame: Baseline and Week 12 ]

100.  Secondary:   Change From Baseline to Week 26 in High-sensitivity C-Reactive Protein   [ Time Frame: Baseline and Week 26 ]

101.  Secondary:   Change From Baseline in Adiponectin Over Time (Grouped Analysis)   [ Time Frame: Baseline and Weeks 12 and 26. ]

102.  Secondary:   Change From Baseline to Week 12 in Adiponectin   [ Time Frame: Baseline and Week 12 ]

103.  Secondary:   Change From Baseline to Week 26 in Adiponectin   [ Time Frame: Baseline and Week 26 ]

104.  Secondary:   Change From Baseline in Body Weight Over Time (Grouped Analysis)   [ Time Frame: Baseline and Weeks 8, 12, 20 and 26. ]

105.  Secondary:   Change From Baseline to Week 8 in Body Weight   [ Time Frame: Baseline and Week 8 ]

106.  Secondary:   Change From Baseline to Week 12 in Body Weight   [ Time Frame: Baseline and Week 12 ]

107.  Secondary:   Change From Baseline to Week 20 in Body Weight   [ Time Frame: Baseline and Week 20 ]

108.  Secondary:   Change From Baseline to Week 26 in Body Weight   [ Time Frame: Baseline and Week 26 ]

109.  Secondary:   Change From Baseline in Calculated Homeostatic Model Assessment Insulin Resistance (HOMA IR) (Grouped Analysis)   [ Time Frame: Baseline and Weeks 12 and 26. ]

110.  Secondary:   Change From Baseline to Week 12 in Calculated HOMA Insulin Resistance   [ Time Frame: Baseline and Week 12 ]

111.  Secondary:   Change From Baseline to Week 26 in Calculated HOMA Insulin Resistance   [ Time Frame: Baseline and Week 26 ]

112.  Secondary:   Change From Baseline in Homeostatic Model Assessment Beta Cell Function (Grouped Analysis)   [ Time Frame: Baseline and Weeks 12 and 26 ]

113.  Secondary:   Change From Baseline to Week 12 in Calculated HOMA Beta-cell Function   [ Time Frame: Baseline and Week 12 ]

114.  Secondary:   Change From Baseline to Week 26 in Calculated HOMA Beta-cell Function   [ Time Frame: Baseline and Week 26 ]

115.  Secondary:   Change From Baseline in Apolipoprotein A1 Over Time (Grouped Analysis)   [ Time Frame: Baseline and Weeks 12 and 26. ]

116.  Secondary:   Change From Baseline to Week 12 in Apolipoprotein A1   [ Time Frame: Baseline and Week 12 ]

117.  Secondary:   Change From Baseline to Week 26 in Apolipoprotein A1   [ Time Frame: Baseline and Week 26 ]

118.  Secondary:   Change From Baseline in Apolipoprotein A2 Over Time (Grouped Analysis)   [ Time Frame: Baseline and Weeks 12 and 26 ]

119.  Secondary:   Change From Baseline to Week 12 in Apolipoprotein A2   [ Time Frame: Baseline and Week 12 ]

120.  Secondary:   Change From Baseline to Week 26 in Apolipoprotein A2   [ Time Frame: Baseline and Week 26 ]

121.  Secondary:   Change From Baseline in Apolipoprotein B Over Time (Grouped Analysis)   [ Time Frame: Baseline and Weeks 12 and 26 ]

122.  Secondary:   Change From Baseline to Week 12 in Apolipoprotein B   [ Time Frame: Baseline and Week 12 ]

123.  Secondary:   Change From Baseline to Week 26 in Apolipoprotein B   [ Time Frame: Baseline and Week 26 ]

124.  Secondary:   Change From Baseline in Apolipoprotein C-III Over Time (Grouped Analysis)   [ Time Frame: Baseline and Weeks 12 and 26 ]

125.  Secondary:   Change From Baseline to Week 12 in Apolipoprotein C-III   [ Time Frame: Baseline and Week 12 ]

126.  Secondary:   Change From Baseline to Week 26 in Apolipoprotein C-III   [ Time Frame: Baseline and Week 26 ]

127.  Secondary:   Change From Baseline in Nuclear Magnetic Resonance Lipid Fractionation Total Triglycerides Over Time (Grouped Analysis)   [ Time Frame: Baseline and Weeks 12 and 26. ]

128.  Secondary:   Change From Baseline to Week 12 in NMR Lipid Fractionation Total Triglycerides   [ Time Frame: Baseline and Week 12 ]

129.  Secondary:   Change From Baseline to Week 26 in NMR Lipid Fractionation Total Triglycerides   [ Time Frame: Baseline and Week 26 ]

130.  Secondary:   Change From Baseline in Very Low Density Lipoprotein (VLDL) / Chylomicron Particles Over Time (Grouped Analysis)   [ Time Frame: Baseline and Weeks 12 and 26 ]

131.  Secondary:   Change From Baseline to Week 12 in VLDL / Chylomicron Particles   [ Time Frame: Baseline and Week 12 ]

132.  Secondary:   Change From Baseline to Week 26 in VLDL / Chylomicron Particles   [ Time Frame: Baseline and Week 26 ]

133.  Secondary:   Change From Baseline in VLDL / Chylomicron Triglycerides Over Time (Grouped Analysis)   [ Time Frame: Baseline and Weeks 12 and 26 ]

134.  Secondary:   Change From Baseline to Week 12 in VLDL / Chylomicron Triglycerides   [ Time Frame: Baseline and Week 12 ]

135.  Secondary:   Change From Baseline to Week 26 in VLDL / Chylomicron Triglycerides   [ Time Frame: Baseline and Week 26 ]

136.  Secondary:   Change From Baseline in VLDL Particles Over Time (Grouped Analysis)   [ Time Frame: Baseline and Weeks 12 and 26 ]

137.  Secondary:   Change From Baseline to Week 12 in VLDL Particles   [ Time Frame: Baseline and Week 12 ]

138.  Secondary:   Change From Baseline to Week 26 in VLDL Particles   [ Time Frame: Baseline and Week 26 ]

139.  Secondary:   Change From Baseline in Mean VLDL Particle Size Over Time (Grouped Analysis)   [ Time Frame: Baseline and Weeks 12 and 26 ]

140.  Secondary:   Change From Baseline to Week 12 in Mean VLDL Particle Size   [ Time Frame: Baseline and Week 12 ]

141.  Secondary:   Change From Baseline to Week 26 in Mean VLDL Particle Size   [ Time Frame: Baseline and Week 26 ]

142.  Secondary:   Change From Baseline in Intermediate Density Lipoprotein (IDL) Particles Over Time (Grouped Analysis)   [ Time Frame: Baseline and Weeks 12 and 26 ]

143.  Secondary:   Change From Baseline to Week 12 in IDL Particles   [ Time Frame: Baseline and Week 12 ]

144.  Secondary:   Change From Baseline to Week 26 in IDL Particles   [ Time Frame: Baseline and Week 26 ]

145.  Secondary:   Change From Baseline in Low Density Lipoprotein (LDL) Particles Over Time (Grouped Analysis)   [ Time Frame: Baseline and Weeks 12 and 26 ]

146.  Secondary:   Change From Baseline to Week 12 in LDL Particles   [ Time Frame: Baseline and Week 12 ]

147.  Secondary:   Change From Baseline to Week 26 in LDL Particles   [ Time Frame: Baseline and Week 26 ]

148.  Secondary:   Change From Baseline in Mean LDL Particle Size Over Time (Grouped Analysis)   [ Time Frame: Baseline and Weeks 12 and 26 ]

149.  Secondary:   Change From Baseline to Week 12 in Mean LDL Particle Size   [ Time Frame: Baseline and Week 12 ]

150.  Secondary:   Change From Baseline to Week 26 in Mean LDL Particle Size   [ Time Frame: Baseline and Week 26 ]

151.  Secondary:   Change From Baseline in High Density Lipoprotein (HDL) Particles Over Time (Grouped Analysis)   [ Time Frame: Baseline and Weeks 12 and 26. ]

152.  Secondary:   Change From Baseline to Week 12 in HDL Particles   [ Time Frame: Baseline and Week 12 ]

153.  Secondary:   Change From Baseline to Week 26 in HDL Particles   [ Time Frame: Baseline and Week 26 ]

154.  Secondary:   Change From Baseline in Mean HDL Particle Size Over Time (Grouped Analysis)   [ Time Frame: Baseline and Weeks 12 and 26 ]

155.  Secondary:   Change From Baseline to Week 12 in Mean HDL Particle Size   [ Time Frame: Baseline and Week 12 ]

156.  Secondary:   Change From Baseline to Week 26 in Mean HDL Particle Size   [ Time Frame: Baseline and Week 26 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Sr. VP, Clinical Science
Organization: Takeda Global Research and Development Center, Inc.
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com


Publications of Results:

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00328627     History of Changes
Other Study ID Numbers: 01-05-TL-322OPI-001
2006-000694-30 ( EudraCT Number )
U1111-1113-8587 ( Registry Identifier: WHO )
First Submitted: May 19, 2006
First Posted: May 22, 2006
Results First Submitted: February 19, 2013
Results First Posted: April 4, 2013
Last Update Posted: April 4, 2013



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