Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of Alogliptin Combined With Sulfonylurea in Subjects With Type 2 Diabetes Mellitus.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT00286468
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;   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 and glyburide
Drug: Glyburide

  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 125 investigative sites in Argentina, Australia, Brazil, Chile, Dominican Republic, Germany, Guatemala, India, Mexico, New Zealand, The Netherlands, Poland, South Africa, Spain, and the United States from 04 April 2006 to 20 June 2007.

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 receiving a stable dose of glyburide monotherapy were enrolled in one of 3, once-daily (QD) treatment groups.

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

Participant Flow:   Overall Study
    Placebo     Alogliptin 12.5 mg QD     Alogliptin 25 mg QD  
STARTED     99     203     198  
COMPLETED     62     153     148  
NOT COMPLETED     37     50     50  
Hyperglycemic Rescue                 28                 30                 31  
Adverse Event                 2                 6                 4  
Protocol Violation                 0                 3                 1  
Lost to Follow-up                 1                 1                 2  
Withdrawal by Subject                 3                 8                 11  
Physician Decision                 3                 2                 1  



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

Baseline Measures
    Placebo     Alogliptin 12.5 mg QD     Alogliptin 25 mg QD     Total  
Number of Participants  
[units: participants]
  99     203     198     500  
Age, Customized  
[units: participants]
       
<65 years     72     153     145     370  
Between 65 and 74 years     23     42     47     112  
≥75 years     4     8     6     18  
Gender  
[units: participants]
       
Female     48     92     99     239  
Male     51     111     99     261  



  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 Fasting Proinsulin (Week 4).   [ Time Frame: Baseline and Week 4. ]

18.  Secondary:   Change From Baseline in Fasting Proinsulin (Week 8).   [ Time Frame: Baseline and Week 8. ]

19.  Secondary:   Change From Baseline in Fasting Proinsulin (Week 12).   [ Time Frame: Baseline and Week 12. ]

20.  Secondary:   Change From Baseline in Fasting Proinsulin (Week 16).   [ Time Frame: Baseline and Week 16. ]

21.  Secondary:   Change From Baseline in Fasting Proinsulin (Week 20).   [ Time Frame: Baseline and Week 20. ]

22.  Secondary:   Change From Baseline in Fasting Proinsulin (Week 26).   [ Time Frame: Baseline and Week 26. ]

23.  Secondary:   Change From Baseline in Insulin (Week 4).   [ Time Frame: Baseline and Week 4. ]

24.  Secondary:   Change From Baseline in Insulin (Week 8).   [ Time Frame: Baseline and Week 8. ]

25.  Secondary:   Change From Baseline in Insulin (Week 12).   [ Time Frame: Baseline and Week 12. ]

26.  Secondary:   Change From Baseline in Insulin (Week 16).   [ Time Frame: Baseline and Week 16. ]

27.  Secondary:   Change From Baseline in Insulin (Week 20).   [ Time Frame: Baseline and Week 20. ]

28.  Secondary:   Change From Baseline in Insulin (Week 26).   [ Time Frame: Baseline and Week 26. ]

29.  Secondary:   Change From Baseline in Proinsulin/Insulin Ratio (Week 4).   [ Time Frame: Baseline and Week 4. ]

30.  Secondary:   Change From Baseline in Proinsulin/Insulin Ratio (Week 8).   [ Time Frame: Baseline and Week 8. ]

31.  Secondary:   Change From Baseline in Proinsulin/Insulin Ratio (Week 12).   [ Time Frame: Baseline and Week 12. ]

32.  Secondary:   Change From Baseline in Proinsulin/Insulin Ratio (Week 16).   [ Time Frame: Baseline and Week 16. ]

33.  Secondary:   Change From Baseline in Proinsulin/Insulin Ratio (Week 20).   [ Time Frame: Baseline and Week 20. ]

34.  Secondary:   Change From Baseline in Proinsulin/Insulin Ratio (Week 26).   [ Time Frame: Baseline and Week 26. ]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

51.  Secondary:   Change From Baseline in Body Weight (Week 26).   [ Time Frame: Baseline and Week 26. ]


  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: NCT00286468     History of Changes
Other Study ID Numbers: SYR-322-SULF-007, 2005-004667-36, U1111-1113-8506
Study First Received: February 1, 2006
Results First Received: June 8, 2011
Last Updated: February 1, 2012
Health Authority: United States: Food and Drug Administration