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52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00575588
First received: December 14, 2007
Last updated: March 20, 2012
Last verified: March 2012
History of Changes
Results First Received: August 10, 2010  
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: Type 2 Diabetes
Interventions: Drug: Metformin
Drug: Sulphonylurea
Drug: Saxagliptin

  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
891 participants were enrolled in the study; 33 participants did not enter the treatment period; 858 participants were randomized and treated.

Reporting Groups
  Description
Saxagliptin + Metformin Saxagliptin 5 mg tablets added on to open-label metformin
Glipizide + Metformin Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin

Participant Flow:   Overall Study
    Saxagliptin + Metformin     Glipizide + Metformin  
STARTED     428 [1]   430 [1]
COMPLETED     165 [2]   147 [2]
NOT COMPLETED     263     283  
Adverse Event                 11                 13  
Withdrawal by Subject                 27                 31  
Lost to Follow-up                 1                 3  
Death                 4                 2  
Incorrect enrollment                 8                 4  
Study specific discontinuation criteria                 203                 218  
Severe non-compliance to protocol                 5                 7  
Safety reasons                 2                 1  
Elevated triglyceride                 1                 0  
Patient moved                 1                 3  
Impossible to determine HbA1c                 0                 1  
[1] Randomized and treated
[2] Completed 104 weeks of treatment



  Baseline Characteristics
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Reporting Groups
  Description
Saxagliptin + Metformin Saxagliptin 5 mg tablets added on to open-label metformin
Glipizide + Metformin Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
Total Total of all reporting groups

Baseline Measures
    Saxagliptin + Metformin     Glipizide + Metformin     Total  
Number of Participants  
[units: participants]
 		  428     430     858  
Age  
[units: years]
Mean ± Standard Deviation 		  57.50  ± 10.26     57.59  ± 10.37     57.55  ± 10.31  
Gender  
[units: Participants]
 		     
Female     216     198     414  
Male     212     232     444  



  Outcome Measures
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1.  Primary:   Hemoglobin A1c (HbA1c) Change From Baseline to Week 52   [ Time Frame: Baseline to 52 Weeks ]
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2.  Secondary:   Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 52 Weeks   [ Time Frame: From Baseline to Week 52 ]
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3.  Secondary:   Body Weight Change From Baseline to Week 52   [ Time Frame: Baseline, Week 52 (Last Observation Carried Forward) ]
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4.  Secondary:   Mean Slope of the Regressions of Change From Week 24 to Week 52 in HbA1c   [ Time Frame: Week 24 to Week 52 ]
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5.  Other Pre-specified:   Hemoglobin A1c (HbA1c) Change From Baseline to Week 104   [ Time Frame: Baseline, Week 104 ]
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6.  Other Pre-specified:   Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 104 Weeks   [ Time Frame: Baseline, Week 104 ]
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7.  Other Pre-specified:   Body Weight Change From Baseline to Week 104   [ Time Frame: Baseline, Week 104 ]
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8.  Other Pre-specified:   Mean Slope of the Regressions of Change From Week 24 to Week 104 in HbA1c   [ Time Frame: Week 24 to Week 104 ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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