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Efficacy and Safety Study of Alogliptin and Insulin in the Treatment of Type 2 Diabetes.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT00286429
First received: February 1, 2006
Last updated: February 1, 2012
Last verified: February 2012
Results First Received: June 8, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Diabetes Mellitus
Interventions: Drug: Alogliptin and insulin
Drug: Insulin

  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 110 investigative sites in Australia, Brazil, Chile, Guatemala, Germany, Hungary, India, Mexico, New Zealand, the Netherlands, Poland, South Africa, and the United States from 16 March 2006 to 18 September 2006

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 inadequately controlled while being treated with insulin with or without metformin were enrolled in one of three, once-daily (QD) treatment groups.

Reporting Groups
  Description
Placebo Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
Alogliptin 12.5 mg QD Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
Alogliptin 25 mg QD Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.

Participant Flow:   Overall Study
    Placebo   Alogliptin 12.5 mg QD   Alogliptin 25 mg QD
STARTED   130   131   129 
COMPLETED   55   83   77 
NOT COMPLETED   75   48   52 
Adverse Event                4                1                6 
Lack of Efficacy                52                27                25 
Lost to Follow-up                2                4                3 
Physician Decision                10                7                7 
Protocol Violation                3                5                4 
Withdrawal by Subject                3                2                6 
Administrative Error                1                1                1 
Administrative Decision                0                1                0 



  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 insulin for up to 26 weeks.
Alogliptin 12.5 mg QD Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
Alogliptin 25 mg QD Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
Total Total of all reporting groups

Baseline Measures
   Placebo   Alogliptin 12.5 mg QD   Alogliptin 25 mg QD   Total 
Overall Participants Analyzed 
[Units: Participants]
 130   131   129   390 
Age, Customized 
[Units: Participants]
       
<65 years   109   112   106   327 
≥65 years   21   19   23   63 
Gender 
[Units: Participants]
       
Female   68   76   85   229 
Male   62   55   44   161 


  Outcome Measures
  Show All Outcome Measures

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

2.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (Week 4).   [ Time Frame: Baseline and Week 4. ]

3.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (Week 8).   [ Time Frame: Baseline and Week 8. ]

4.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (Week 12).   [ Time Frame: Baseline and Week 12. ]

5.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (Week 16).   [ Time Frame: Baseline and Week 16. ]

6.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (Week 20).   [ Time Frame: Baseline and Week 20. ]

7.  Secondary:   Change From Baseline in Fasting Plasma Glucose (Week 1).   [ Time Frame: Baseline and Week 1. ]

8.  Secondary:   Change From Baseline in Fasting Plasma Glucose (Week 2).   [ Time Frame: Baseline and Week 2. ]

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

10.  Secondary:   Change From Baseline in Fasting Plasma Glucose (Week 8).   [ Time Frame: Baseline and Week 8. ]

11.  Secondary:   Change From Baseline in Fasting Plasma Glucose (Week 12).   [ Time Frame: Baseline and Week 12. ]

12.  Secondary:   Change From Baseline in Fasting Plasma Glucose (Week 16).   [ Time Frame: Baseline and Week 16. ]

13.  Secondary:   Change From Baseline in Fasting Plasma Glucose (Week 20).   [ Time Frame: Baseline and Week 20. ]

14.  Secondary:   Change From Baseline in Fasting Plasma Glucose (Week 26).   [ Time Frame: Baseline and Week 26. ]

15.  Secondary:   Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).   [ Time Frame: 26 Weeks. ]

16.  Secondary:   Number of Participants Requiring Rescue.   [ Time Frame: 26 Weeks. ]

17.  Secondary:   Change From Baseline in C-peptide (Week 4).   [ Time Frame: Baseline and Week 4. ]

18.  Secondary:   Change From Baseline in C-peptide (Week 8).   [ Time Frame: Baseline and Week 8. ]

19.  Secondary:   Change From Baseline in C-peptide (Week 12).   [ Time Frame: Baseline and Week 12. ]

20.  Secondary:   Change From Baseline in C-peptide (Week 16).   [ Time Frame: Baseline and Week 16. ]

21.  Secondary:   Change From Baseline in C-peptide (Week 20).   [ Time Frame: Baseline and Week 20. ]

22.  Secondary:   Change From Baseline in C-peptide (Week 26).   [ Time Frame: Baseline and Week 26. ]

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

24.  Secondary:   Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.   [ Time Frame: Baseline and Week 26. ]

25.  Secondary:   Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.   [ Time Frame: Baseline and Week 26. ]

26.  Secondary:   Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.   [ Time Frame: Baseline and Week 26. ]

27.  Secondary:   Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.   [ Time Frame: Baseline and Week 26. ]

28.  Secondary:   Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.   [ Time Frame: Baseline and Week 26. ]

29.  Secondary:   Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.   [ Time Frame: Baseline and Week 26. ]

30.  Secondary:   Change From Baseline in Body Weight (Week 8).   [ Time Frame: Baseline and Week 8. ]

31.  Secondary:   Change From Baseline in Body Weight (Week 12).   [ Time Frame: Baseline and Week 12. ]

32.  Secondary:   Change From Baseline in Body Weight (Week 20).   [ Time Frame: Baseline and Week 20. ]

33.  Secondary:   Change From Baseline in Body Weight (Week 26).   [ 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
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: NCT00286429     History of Changes
Other Study ID Numbers: SYR-322-INS-011
2005-004671-38 ( EudraCT Number )
U1111-1113-8369 ( Registry Identifier: WHO )
Study First Received: February 1, 2006
Results First Received: June 8, 2011
Last Updated: February 1, 2012