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Safety and Efficacy Study of Alogliptin on Glycemic Control in Subjects With Type 2 Diabetes.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT00755846
First received: September 17, 2008
Last updated: February 1, 2012
Last verified: February 2012
Results First Received: June 8, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Diabetes Mellitus
Interventions: Drug: Alogliptin
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 enrolled at 62 sites in Chile and the United States from 17 March 2005 to 10 June 2005.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with a historical diagnosis of type 2 diabetes mellitus who were either receiving no current treatment or currently treated with diet and exercise, a sulfonylurea, metformin, or a combination of a sulfonylurea and metformin enrolled in once daily (QD) groups.

Reporting Groups
  Description
Placebo QD Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
Alogliptin 6.25 mg QD Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
Alogliptin 12.5 mg QD Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 25 mg QD Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 50 mg QD Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 100 mg QD Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.

Participant Flow:   Overall Study
    Placebo QD     Alogliptin 6.25 mg QD     Alogliptin 12.5 mg QD     Alogliptin 25 mg QD     Alogliptin 50 mg QD     Alogliptin 100 mg QD  
STARTED     43     44     44     45     44     45  
COMPLETED     18     27     32     32     27     31  
NOT COMPLETED     25     17     12     13     17     14  
Adverse Event                 0                 0                 0                 1                 3                 2  
Protocol Violation                 1                 1                 1                 1                 1                 1  
Lost to Follow-up                 0                 2                 1                 0                 4                 2  
Withdrawal by Subject                 2                 3                 5                 2                 0                 1  
Hyperglycemic Rescue                 21                 7                 5                 8                 8                 7  
Physician Decision                 1                 3                 0                 1                 0                 1  
Administrative Error                 0                 1                 0                 0                 0                 0  
Participant Non-compliance                 0                 0                 0                 0                 1                 0  



  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
Placebo QD Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
Alogliptin 6.25 mg QD Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
Alogliptin 12.5 mg QD Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 25 mg QD Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 50 mg QD Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 100 mg QD Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
Total Total of all reporting groups

Baseline Measures
    Placebo QD     Alogliptin 6.25 mg QD     Alogliptin 12.5 mg QD     Alogliptin 25 mg QD     Alogliptin 50 mg QD     Alogliptin 100 mg QD     Total  
Number of Participants  
[units: participants]
  43     44     44     45     44     45     265  
Age, Customized  
[units: participants]
             
<65 years     33     38     33     36     31     34     205  
≥65 years     10     6     11     9     13     11     60  
Gender  
[units: participants]
             
Female     24     25     22     17     26     25     139  
Male     19     19     22     28     18     20     126  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 85.   [ Time Frame: Baseline and Day 85. ]

2.  Secondary:   Change From Baseline in Glycosylated Hemoglobin at Day 43.   [ Time Frame: Baseline and Day 43. ]

3.  Secondary:   Change From Baseline in Fasting Plasma Glucose (Day 43).   [ Time Frame: Baseline and Day 43 ]

4.  Secondary:   Change From Baseline in Fasting Plasma Glucose (Day 85).   [ Time Frame: Baseline and Day 85. ]

5.  Secondary:   Change From Baseline in Fasting Fructosamine (Day 43).   [ Time Frame: Baseline and Day 43. ]

6.  Secondary:   Change From Baseline in Fasting Fructosamine (Day 85).   [ Time Frame: Baseline and Day 85. ]

7.  Secondary:   Change From Baseline in Total Cholesterol (Day 43).   [ Time Frame: Baseline and Day 43 ]

8.  Secondary:   Change From Baseline in Total Cholesterol (Day 85).   [ Time Frame: Baseline and Day 85. ]

9.  Secondary:   Change From Baseline in High-Density Lipoprotein Cholesterol (Day 43).   [ Time Frame: Baseline and Day 43. ]

10.  Secondary:   Change From Baseline in High-Density Lipoprotein Cholesterol (Day 85).   [ Time Frame: Baseline and Day 85. ]

11.  Secondary:   Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 43).   [ Time Frame: Baseline and Day 43. ]

12.  Secondary:   Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 85).   [ Time Frame: Baseline and Day 85. ]

13.  Secondary:   Change From Baseline in Triglycerides (Day 43).   [ Time Frame: Baseline and Day 43. ]

14.  Secondary:   Change From Baseline in Triglycerides (Day 85).   [ Time Frame: Baseline and Day 85. ]

15.  Secondary:   Mean Percent Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg/dL).   [ Time Frame: 85 Days. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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: NCT00755846     History of Changes
Other Study ID Numbers: SYR-322-003, U1111-1113-8352
Study First Received: September 17, 2008
Results First Received: June 8, 2011
Last Updated: February 1, 2012
Health Authority: United States: Food and Drug Administration