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Treatment Effect of Saxagliptin Compared With Placebo in Patients With Type 2 Diabetes and Renal Impairment

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00614939
First received: January 31, 2008
Last updated: May 16, 2011
Last verified: May 2011
Results First Received: June 7, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Interventions: Drug: Saxagliptin
Drug: Placebo

  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
A total of 572 participants were enrolled in the study; 561 entered the Lead-in period and 170 patients were randomized and treated.

Reporting Groups
  Description
Placebo Placebo
Saxa Saxagliptin 2.5 mg once daily oral dose

Participant Flow:   Overall Study
    Placebo     Saxa  
STARTED     85 [1]   85 [1]
COMPLETED     50 [2]   42 [2]
NOT COMPLETED     35     43  
Withdrawal by Subject                 10                 17  
Study specific discontinuation criteris                 13                 16  
Adverse Event                 2                 5  
Incorrect enrollment                 1                 2  
Death                 4                 3  
Poor/non-compliance                 4                 0  
Hospitalized due to kidney transplant                 1                 0  
[1] Randomized and treated
[2] Completed 52 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
Placebo Placebo
Saxa Saxagliptin 2.5 mg once daily oral dose
Total Total of all reporting groups

Baseline Measures
    Placebo     Saxa     Total  
Number of Participants  
[units: participants]
  85     85     170  
Age  
[units: years]
Mean ± Standard Deviation
  66.2  ± 9.08     66.8  ± 8.27     66.5  ± 8.66  
Gender  
[units: Participants]
     
Female     44     53     97  
Male     41     32     73  
Baseline Renal Impairment Category  
[units: Participants]
     
Moderate     42     48     90  
Severe     23     18     41  
End-Stage     20     19     39  
Baseline Diabetes Therapy  
[units: participants]
     
Diabetes Therapy     84     83     167  
Insulin     57     71     128  
Oral blood glucose lowering drug     30     23     53  



  Outcome Measures
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1.  Primary:   Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 12 Last Observation Carried Forward (LOCF)   [ Time Frame: Baseline , Week 12 (LOCF) ]

2.  Secondary:   Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF)- Moderate Renal Impairment Subgroup   [ Time Frame: Baseline, Week 12 (LOCF) ]

3.  Secondary:   Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Severe Renal Impairment Subgroup   [ Time Frame: Baseline, Week 12 (LOCF) ]

4.  Secondary:   Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - End-Stage Renal Impairment Subgroup   [ Time Frame: Baseline, Week 12 (LOCF) ]

5.  Secondary:   Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Moderate Renal Impairment Subgroup   [ Time Frame: Baseline, Week 12 (LOCF) ]

6.  Secondary:   Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Severe Renal Impairment Subgroup   [ Time Frame: Baseline, Week 12 (LOCF) ]

7.  Secondary:   Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - End-Stage Renal Impairment Subgroup   [ Time Frame: Baseline, Week 12 (LOCF) ]

8.  Secondary:   Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 52   [ Time Frame: Baseline , Week 52 ]
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Measure Type Secondary
Measure Title Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 52
Measure Description Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.
Time Frame Baseline , Week 52  
Safety Issue No  

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.
Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.

Reporting Groups
  Description
Placebo Placebo
Saxa Saxagliptin 2.5 mg once daily oral dose

Measured Values
    Placebo     Saxa  
Number of Participants Analyzed  
[units: participants]
  82     78  
Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 52  
[units: Percent]
Mean ± Standard Error
   
Baseline     8.10  ± 0.120     8.44  ± 0.134  
Week 52     7.93  ± 0.173     7.41  ± 0.138  
Adjusted mean change     -0.53  ± 0.154     -1.35  ± 0.174  


Statistical Analysis 1 for Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 52
Groups [1] All groups
Method [2] Repeated Measures
Mean Difference (Net) [3] -0.82
Standard Error of the mean ± 0.228
95% Confidence Interval ( -1.27 to -0.37 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
 

Number of subjects with observed values at Week 52 was n=26 for saxagliptin and n=34 for placebo

*Adjusted for baseline HbA1c

[3] Other relevant estimation information:
  No text entered.



9.  Secondary:   Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup   [ Time Frame: Baseline, Week 52 ]

10.  Secondary:   Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Severe Renal Impairment Subgroup   [ Time Frame: Baseline, Week 52 ]

11.  Secondary:   Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - End-Stage Renal Impairment Subgroup   [ Time Frame: Baseline, Week 52 ]

12.  Secondary:   Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup   [ Time Frame: Baseline, Week 52 ]

13.  Secondary:   Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Severe Renal Impairment Subgroup   [ Time Frame: Baseline, Week 52 ]

14.  Secondary:   Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - End-Stage Renal Impairment Subgroup   [ Time Frame: Baseline, Week 52 ]


  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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