A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00313313
First received: April 10, 2006
Last updated: August 4, 2010
Last verified: June 2010
Results First Received: August 17, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Diabetes
Interventions: Drug: Saxagliptin
Drug: Glyburide
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Saxagliptin 2.5 mg + Glyburide 7.5 mg The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
Saxagliptin 5 mg + Glyburide 7.5 mg The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
Placebo + Glyburide 7.5 mg The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.

Participant Flow:   Overall Study
    Saxagliptin 2.5 mg + Glyburide 7.5 mg     Saxagliptin 5 mg + Glyburide 7.5 mg     Placebo + Glyburide 7.5 mg  
STARTED     248     253     267  
COMPLETED     185 [1]   187 [2]   185 [3]
NOT COMPLETED     63     66     82  
Lack of Efficacy                 14                 9                 20  
Withdrawal of consent by subject                 18                 17                 31  
Lost to Follow-up                 10                 7                 9  
Adverse Event                 15                 16                 12  
Physician Decision                 2                 6                 4  
Poor/Noncompliance                 3                 6                 2  
Pregnancy                 1                 2                 0  
Death                 0                 0                 2  
Subject No Longer Meets Study Criteria                 0                 3                 2  
[1] 61 subjects completed the study without being rescued
[2] 55 subjects completed the study without being rescued
[3] 26 subjects completed the study without being rescued



  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
Saxagliptin 2.5 mg + Glyburide 7.5 mg The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
Saxagliptin 5 mg + Glyburide 7.5 mg The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
Placebo + Glyburide 7.5 mg The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
Total Total of all reporting groups

Baseline Measures
    Saxagliptin 2.5 mg + Glyburide 7.5 mg     Saxagliptin 5 mg + Glyburide 7.5 mg     Placebo + Glyburide 7.5 mg     Total  
Number of Participants  
[units: participants]
  248     253     267     768  
Age  
[units: years]
Mean ± Standard Deviation
  55.36  ± 9.58     54.85  ± 9.96     55.06  ± 10.69     55.09  ± 10.09  
Gender  
[units: participants]
       
Female     135     143     144     422  
Male     113     110     123     346  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Hemoglobin A1c (A1C) at Week 24   [ Time Frame: Baseline, Week 24 ]

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

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

4.  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


  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.


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.  


Results Point of Contact:  
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: clinical.trials@bms.com


Publications:
Publications automatically indexed to this study:

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00313313     History of Changes
Other Study ID Numbers: CV181-040
Study First Received: April 10, 2006
Results First Received: August 17, 2009
Last Updated: August 4, 2010
Health Authority: United States: Food and Drug Administration