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Trial record 1 of 1 for:    01-06-TL-322OPI-002
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Efficacy of Alogliptin With Pioglitazone (Actos®) in Subjects With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00395512
First Posted: November 3, 2006
Last Update Posted: March 27, 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Diabetes Mellitus
Interventions: Drug: Alogliptin
Drug: Pioglitazone
Drug: Placebo

  Participant Flow
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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 268 investigative sites in 23 countries from 02 November 2006 to 13 February 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 with diet and exercise were randomized to 1 of 4 treatment groups in a 1:1:1:1 ratio as follows: Alogliptin alone, pioglitazone alone, alogliptin 25 mg + pioglitazone 30 mg and alogliptin 12.5 mg + pioglitazone 30 mg.

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

Participant Flow:   Overall Study
    Alogliptin 25 mg   Pioglitazone 30 mg   Alogliptin 25 mg + Pioglitazone 30 mg   Alogliptin 12.5 mg + Pioglitazone 30 mg
STARTED   164   163   164   164 
Safety Set   164   163   164   163 [1] 
COMPLETED   126   126   136   126 
NOT COMPLETED   38   37   28   38 
Adverse Event                3                8                6                6 
Protocol Violation                2                3                6                7 
Lost to Follow-up                2                6                5                5 
Withdrawal by Subject                6                5                5                12 
Physician Decision                6                4                2                2 
Other                1                1                0                0 
Hyperglycemic Rescue                18                10                4                6 
[1] 1 participant was lost to follow-up post visit 1. It is unknown if they took any study medication.



  Baseline Characteristics
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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
Alogliptin 25 mg Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
Pioglitazone 30 mg Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
Alogliptin 25 mg + Pioglitazone 30 mg Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Alogliptin 12.5 mg + Pioglitazone 30 mg Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
Total Total of all reporting groups

Baseline Measures
   Alogliptin 25 mg   Pioglitazone 30 mg   Alogliptin 25 mg + Pioglitazone 30 mg   Alogliptin 12.5 mg + Pioglitazone 30 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 164   163   164   164   655 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.6  (10.38)   51.5  (10.72)   52.8  (11.01)   53.5  (11.37)   52.6  (10.88) 
Age, Customized 
[Units: Participants]
         
< 65 years   144   143   140   130   557 
≥ 65 years   20   20   24   34   98 
Gender 
[Units: Participants]
         
Female   88   73   91   83   335 
Male   76   90   73   81   320 
Ethnicity (NIH/OMB) 
[Units: Participants]
         
Hispanic or Latino   63   65   58   62   248 
Not Hispanic or Latino   101   98   106   102   407 
Unknown or Not Reported   0   0   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
         
American Indian or Alaska Native   1   0   0   0   1 
Asian   14   15   12   16   57 
Native Hawaiian or Other Pacific Islander   0   0   0   1   1 
Black or African American   8   9   12   9   38 
White   135   130   129   132   526 
More than one race   0   0   0   0   0 
Unknown or Not Reported   6   9   11   6   32 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 86.72  (19.033)   85.53  (16.254)   85.39  (20.374)   84.38  (20.378)   85.50  (19.062) 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 31.61  (5.587)   30.87  (4.938)   31.32  (5.354)   30.71  (5.621)   31.13  (5.382) 
Duration of diabetes 
[Units: Years]
Mean (Standard Deviation)
 3.23  (3.559)   3.20  (3.739)   3.05  (3.328)   3.36  (4.166)   3.21  (3.704) 


  Outcome Measures
  Show All Outcome Measures

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

2.  Secondary:   Change From Baseline in HbA1c Over Time   [ Time Frame: Baseline and Weeks 4, 8, 12, 16 and 20. ]

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

4.  Secondary:   Percentage of Participants With Marked Hyperglycemia   [ Time Frame: Weeks 1, 2, 4, 8, 12, 16, 20 and 26. ]

5.  Secondary:   Percentage of Participants Meeting Rescue Criteria   [ Time Frame: Weeks 4, 8, 12, 16, 20 and 26. ]

6.  Secondary:   Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 6.5%   [ Time Frame: Week 26 ]

7.  Secondary:   Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.0%   [ Time Frame: Week 26 ]

8.  Secondary:   Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.5%   [ Time Frame: Week 26 ]

9.  Secondary:   Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 0.5%   [ Time Frame: Baseline and Week 26 ]

10.  Secondary:   Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 1.0%   [ Time Frame: Baseline and Week 26 ]

11.  Secondary:   Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 1.5%.   [ Time Frame: Baseline and Week 26 ]

12.  Secondary:   Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 2.0%   [ Time Frame: Baseline and Week 26 ]

13.  Secondary:   Change From Baseline in Fasting Proinsulin   [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20 and 26. ]

14.  Secondary:   Change From Baseline in Insulin   [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20 and 26. ]

15.  Secondary:   Change From Baseline in Proinsulin/Insulin Ratio   [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20 and 26. ]

16.  Secondary:   Change From Baseline in C-peptide Levels   [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20 and 26. ]

17.  Secondary:   Change From Baseline in Calculated Homeostatic Model Assessment Insulin Resistance   [ Time Frame: Baseline and Weeks 12 and 26. ]

18.  Secondary:   Change From Baseline in Homeostatic Model Assessment Beta Cell Function   [ Time Frame: Baseline and Weeks 12 and 26. ]

19.  Secondary:   Change From Baseline in Body Weight   [ Time Frame: Baseline and Weeks 8, 12, 20 and 26. ]

20.  Secondary:   Change From Baseline in Total Cholesterol Level   [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20 and 26. ]

21.  Secondary:   Change From Baseline in Low-Density Lipoprotein Cholesterol   [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20 and 26. ]

22.  Secondary:   Change From Baseline in High-Density Lipoprotein Cholesterol   [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20 and 26. ]

23.  Secondary:   Change From Baseline in Triglyceride Levels   [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20 and 26. ]

24.  Secondary:   Change From Baseline in Free Fatty Acids   [ Time Frame: Baseline and Weeks 12 and 26. ]

25.  Secondary:   Change From Baseline in Plasminogen Activator Inhibitor-1   [ Time Frame: Baseline and Weeks 12 and 26. ]

26.  Secondary:   Change From Baseline in High-sensitivity C-Reactive Protein   [ Time Frame: Baseline and Weeks 12 and 26. ]

27.  Secondary:   Change From Baseline in Adiponectin   [ Time Frame: Baseline and Weeks 12 and 26. ]

28.  Secondary:   Change From Baseline in Apolipoprotein A1   [ Time Frame: Baseline and Weeks 12 and 26. ]

29.  Secondary:   Change From Baseline in Apolipoprotein A2   [ Time Frame: Baseline and Weeks 12 and 26. ]

30.  Secondary:   Change From Baseline in Apolipoprotein B   [ Time Frame: Baseline and Weeks 12 and 26. ]

31.  Secondary:   Change From Baseline in Apolipoprotein C-III   [ Time Frame: Baseline and Weeks 12 and 26. ]

32.  Secondary:   Change From Baseline in Nuclear Magnetic Resonance Lipid Fractionation Total Triglycerides   [ Time Frame: Baseline and Weeks 12 and 26. ]

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

34.  Secondary:   Change From Baseline in VLDL / Chylomicron Triglycerides   [ Time Frame: Baseline and Weeks 12 and 26. ]

35.  Secondary:   Change From Baseline in VLDL Particles   [ Time Frame: Baseline and Weeks 12 and 26. ]

36.  Secondary:   Change From Baseline in Mean VLDL Particle Size   [ Time Frame: Baseline and Weeks 12 and 26. ]

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

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

39.  Secondary:   Change From Baseline in Mean LDL Particle Size   [ Time Frame: Baseline and Weeks 12 and 26. ]

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

41.  Secondary:   Change From Baseline in Mean HDL Particle Size   [ Time Frame: Baseline and Weeks 12 and 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
No text entered.


  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: NCT00395512     History of Changes
Other Study ID Numbers: 01-06-TL-322OPI-002
2006-005492-17 ( EudraCT Number )
U1111-1113-8616 ( Registry Identifier: WHO )
First Submitted: November 1, 2006
First Posted: November 3, 2006
Results First Submitted: February 19, 2013
Results First Posted: March 27, 2013
Last Update Posted: March 27, 2013