A Study Assessing Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00374907
First received: September 7, 2006
Last updated: June 3, 2011
Last verified: June 2011
Results First Received: December 26, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Interventions: Drug: Saxagliptin
Drug: Placebo
Drug: Metformin (blinded)
Drug: Metformin (open-label)

  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
156 participants were enrolled in the study; 110 participants failed screening; 10 subjects entered lead-in and discontinued prior to randomization.

Reporting Groups
  Description
Saxagliptin 5 mg Tablet, Oral, 5 mg, once daily, up to 12 weeks (short-term) and up to 104 weeks (long-term). Metformin 500-1500 mg (open-label, as needed for rescue in LT).
Placebo / Metformin Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks; Metformin Tablet, Oral, 500 mg/1000 mg, once daily, up to 104 weeks starting at Week 12 (end of ST period). Metformin 500-1500 mg (open-label, as needed for rescue in LT).

Participant Flow for 2 periods

Period 1:   12-Week Short-term Period
    Saxagliptin 5 mg     Placebo / Metformin  
STARTED     20     16  
COMPLETED     17     15  
NOT COMPLETED     3     1  
Subject Withdrew Consent                 3                 1  

Period 2:   116-Week Short-term + Long-term Period
    Saxagliptin 5 mg     Placebo / Metformin  
STARTED     20     16  
Completed 12-week Short Term Period     17     15  
COMPLETED     7     2  
NOT COMPLETED     13     14  
Subject Withdrew Consent                 8                 9  
Lack of Efficacy                 4                 2  
Adverse Event                 0                 2  
Lost to Follow-up                 1                 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
Saxagliptin 5 mg Tablet, Oral, 5 mg, once daily, up to 12 weeks (short-term) and up to 104 weeks (long-term)
Placebo / Metformin Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks; Metformin Tablet, Oral, 500 mg/1000 mg, once daily, starting at Week 12 and up to 104 weeks
Total Total of all reporting groups

Baseline Measures
    Saxagliptin 5 mg     Placebo / Metformin     Total  
Number of Participants  
[units: participants]
  20     16     36  
Age  
[units: years]
Median ( Full Range )
  58  
  ( 43 to 69 )  
  55  
  ( 45 to 69 )  
  55.5  
  ( 43 to 69 )  
Gender  
[units: participants]
     
Female     12     10     22  
Male     8     6     14  
Race/Ethnicity, Customized  
[units: participants]
     
White     16     12     28  
Black/African American     3     4     7  
Other     1     0     1  
Region of Enrollment  
[units: participants]
     
North America     20     16     36  
Body Mass Index (BMI)  
[units: kg/m^2]
Median ( Full Range )
  33.36  
  ( 24.67 to 39.35 )  
  32.31  
  ( 25.56 to 38.55 )  
  33.01  
  ( 24.67 to 39.35 )  



  Outcome Measures
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1.  Primary:   Insulin Secretion Rate Area Under the Curve (AUC) During Intravenous (IV)-Oral Hyperglycemic Clamp - Percent Change From Baseline at Week 12   [ Time Frame: Baseline, Week 12 ]

2.  Secondary:   Insulin Secretion Rate AUC During IV Hyperglycemic Clamp - Percent Change From Baseline at Week 12   [ Time Frame: Baseline, Week 12 ]

3.  Other Pre-specified:   Overall Summary of Adverse Events (AEs) Serious AEs (SAEs), Discontinuations, and Deaths During the ST + LT Treatment Period   [ Time Frame: 116 weeks ]

4.  Other Pre-specified:   Marked Laboratory Abnormalities - During ST + LT Treatment Period   [ Time Frame: 116 weeks ]


  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


No publications provided


Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00374907     History of Changes
Other Study ID Numbers: CV181-041
Study First Received: September 7, 2006
Results First Received: December 26, 2010
Last Updated: June 3, 2011
Health Authority: United States: Food and Drug Administration