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Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications (SAVOR- TIMI 53)

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01107886
First received: March 25, 2010
Last updated: July 9, 2014
Last verified: July 2014
Results First Received: May 15, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
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
The first participant was enrolled on 10 May 2010 and the last participant completed the study on 16 May 2013. A total of 18206 subjects were enrolled in the study of which 16492 were randomised. Study participants were randomized from 790 centers in 26 countries.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects meeting all inclusion criteria and with no exclusion criteria were randomised in a 1:1 ratio to receive either saxagliptin or matching placebo (Day 0).

Reporting Groups
  Description
Saxagliptin 5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR >50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
Placebo Matching Placebo

Participant Flow:   Overall Study
    Saxagliptin   Placebo
STARTED   8280 [1]   8212 [1] 
COMPLETED   8078 [2]   7998 [2] 
NOT COMPLETED   202   214 
Lost to Follow-up                15                13 
Withdrawal by Subject                180                196 
Administrative withdrawal of consent                7                5 
[1] Randomized subjects
[2] Completed subjects



  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 once daily in subjects with normal renal function or mild impaired renal function (eGFR >50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
Placebo Matching Placebo
Total Total of all reporting groups

Baseline Measures
   Saxagliptin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 8280   8212   16492 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.1  (8.52)   65.0  (8.58)   65.0  (8.55) 
Gender 
[Units: Participants]
     
Female   2768   2687   5455 
Male   5512   5525   11037 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   1778   1763   3541 
Not Hispanic or Latino   6502   6449   12951 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   18   33   51 
Asian   896   884   1780 
Native Hawaiian or Other Pacific Islander   11   11   22 
Black or African American   278   290   568 
White   6241   6166   12407 
More than one race   768   758   1526 
Unknown or Not Reported   68   70   138 
Cardiovascular Risk Category: Cardiovascular disease/Multiple risk factors (CVD/MRF) [1] 
[Units: Participants]
     
CVD   6494   6465   12959 
MRF   1786   1747   3533 
[1] CVD subjects were defined as subjects with history of established CV disease. MRF subjects were defined as subjects with MRF for vascular disease without established CV disease.
Renal Functione Categor: Normal or Mild impairment/Moderate impairment/Severe impairment [1] 
[Units: Participants]
     
Normal or Mild impairment   6986   6930   13916 
Moderate impairment   1122   1118   2240 
Severe impairment   172   164   336 
[1] Renal function categories Normal function – Mild impairment defined as: eGFR >50 mL/min; Moderate impairment defined as: eGFR 30 to 50 mL/min; Severe impairment defined as: eGFR eGFR <30 mL/min.


  Outcome Measures
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1.  Primary:   Participants With Any Event From the Composite of Cardiovascular Death (CV Death), Non-fatal Myocardial Infarction (MI), or Non-fatal Ischaemic Stroke   [ Time Frame: Randomization (day 0) up to 2.9 years ]

2.  Secondary:   Participants With Any Event From the Composite of CV Death, Non-fatal MI, Non-fatal Ischaemic Stroke, Hospitalisation for Heart Failure, Hospitalisation for Unstable Angina Pectoris, or Hospitalisation for Coronary Revascularisation   [ Time Frame: Randomization (day 0) up to 2.9 years ]

3.  Secondary:   Participants With Event of Death   [ Time Frame: Randomization (day 0) up to 2.9 years ]


  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 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.


Results Point of Contact:  
Name/Title: Boaz Hirshberg MD, MBA
Organization: AstraZeneca LP
phone: 1 302 885 4997
e-mail: ClinicalTrialTransparency@astrazeneca.com


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


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01107886     History of Changes
Other Study ID Numbers: D1680C00003
EudraCT No 2009-017358-10
Study First Received: March 25, 2010
Results First Received: May 15, 2014
Last Updated: July 9, 2014
Health Authority: Argentina: Ministry of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
Brazil: Ministry of Health
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control
France: Ministry of Health
Germany: Ethics Commission
Hungary: National Institute of Pharmacy
India: Drugs Controller General of India
Israel: Ministry of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Mexico: Federal Commission for Protection Against Health Risks
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Peru: Instituto Nacional de Salud
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
South Africa: Medicines Control Council
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Taiwan: Department of Health
Thailand: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration