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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
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
No text entered.

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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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 + 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 ]

2.  Secondary:   Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 52 Weeks   [ Time Frame: From Baseline to Week 52 ]

3.  Secondary:   Body Weight Change From Baseline to Week 52   [ Time Frame: Baseline, Week 52 (Last Observation Carried Forward) ]

4.  Secondary:   Mean Slope of the Regressions of Change From Week 24 to Week 52 in HbA1c   [ Time Frame: Week 24 to Week 52 ]

5.  Other Pre-specified:   Hemoglobin A1c (HbA1c) Change From Baseline to Week 104   [ Time Frame: Baseline, Week 104 ]

6.  Other Pre-specified:   Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 104 Weeks   [ Time Frame: Baseline, Week 104 ]

7.  Other Pre-specified:   Body Weight Change From Baseline to Week 104   [ Time Frame: Baseline, Week 104 ]

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 ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided by AstraZeneca

Publications automatically indexed to this study:

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00575588     History of Changes
Other Study ID Numbers: D1680C00001, EudraCT number 2007-003998-55
Study First Received: December 14, 2007
Results First Received: August 10, 2010
Last Updated: March 20, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency