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

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ClinicalTrials.gov Identifier: NCT00575588
Recruitment Status : Completed
First Posted : December 18, 2007
Results First Posted : September 6, 2010
Last Update Posted : March 21, 2012
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Interventions: Drug: Metformin
Drug: Sulphonylurea
Drug: Saxagliptin

  Participant Flow

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

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 
Overall Participants Analyzed 
[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

1.  Primary:   Hemoglobin A1c (HbA1c) Change From Baseline to Week 52   [ Time Frame: Baseline to 52 Weeks ]
  Show Outcome Measure 1

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

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

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

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

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

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

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 ]
  Show Outcome Measure 8


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00575588     History of Changes
Other Study ID Numbers: D1680C00001
EudraCT number 2007-003998-55
First Submitted: December 14, 2007
First Posted: December 18, 2007
Results First Submitted: August 10, 2010
Results First Posted: September 6, 2010
Last Update Posted: March 21, 2012