Study of BMS-477118 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00316082
First received: April 18, 2006
Last updated: June 4, 2014
Last verified: June 2014
Results First Received: August 17, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Diabetes
Interventions: Drug: Saxagliptin
Drug: Placebo
Drug: metformin

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Saxagliptin 2.5 mg Once in the Morning (QAM) The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
Saxagliptin 5 mg QAM The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
Saxagliptin 2.5/5 mg QAM The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
Saxagliptin 5 mg Once in the Evening (QPM) The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
Placebo The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.

Participant Flow:   Overall Study
    Saxagliptin 2.5 mg Once in the Morning (QAM)     Saxagliptin 5 mg QAM     Saxagliptin 2.5/5 mg QAM     Saxagliptin 5 mg Once in the Evening (QPM)     Placebo  
STARTED     74     74     71     72     74  
Completed Study Without Being Rescued     25     35     29     27     31  
COMPLETED     41     52     44     46     48  
NOT COMPLETED     33     22     27     26     26  
Lack of Efficacy                 2                 3                 3                 4                 6  
Withdrawal of Consent by Subject                 10                 8                 2                 9                 5  
Lost to Follow-up                 7                 6                 7                 8                 6  
Poor/noncompliance                 6                 1                 4                 1                 4  
Adverse Event                 4                 2                 5                 1                 3  
Subject no longer meets study criteria                 3                 1                 2                 2                 1  
Physician Decision                 1                 1                 2                 1                 1  
Death                 0                 0                 1                 0                 0  
Administrative reason by sponsor                 0                 0                 1                 0                 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.
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Reporting Groups
  Description
Saxagliptin 2.5 mg Once in the Morning (QAM) The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
Saxagliptin 5 mg QAM The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
Saxagliptin 2.5/5 mg QAM The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
Saxagliptin 5 mg Once in the Evening (QPM) The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
Placebo The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
Total Total of all reporting groups

Baseline Measures
    Saxagliptin 2.5 mg Once in the Morning (QAM)     Saxagliptin 5 mg QAM     Saxagliptin 2.5/5 mg QAM     Saxagliptin 5 mg Once in the Evening (QPM)     Placebo     Total  
Number of Participants  
[units: participants]
  74     74     71     72     74     365  
Age  
[units: years]
Mean ± Standard Deviation
  55.24  ± 10.44     54.66  ± 9.71     54.28  ± 10.93     55.11  ± 10.35     55.57  ± 10.32     54.98  ± 10.31  
Gender  
[units: participants]
           
Female     49     36     34     39     39     197  
Male     25     38     37     33     35     168  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Hemoglobin A1 (A1C) at Week 24   [ Time Frame: Baseline, Week 24 ]

2.  Secondary:   Change From Baseline in A1C at Week 24 - Saxagliptin 5 mg QPM   [ Time Frame: Baseline, Week 24 ]

3.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24   [ Time Frame: Baseline, Week 24 ]

4.  Secondary:   Percentage of Participants Achieving A1C < 7% at Week 24   [ Time Frame: Week 24 ]

5.  Secondary:   Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24   [ Time Frame: Baseline, Week 24 ]


  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
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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: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: clinical.trials@bms.com


No publications provided


Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00316082     History of Changes
Other Study ID Numbers: CV181-038
Study First Received: April 18, 2006
Results First Received: August 17, 2009
Last Updated: June 4, 2014
Health Authority: United States: Food and Drug Administration