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

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ClinicalTrials.gov Identifier: NCT01107886
Recruitment Status : Completed
First Posted : April 21, 2010
Results First Posted : June 13, 2014
Last Update Posted : July 17, 2014
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE March 25, 2010
First Posted Date  ICMJE April 21, 2010
Results First Submitted Date  ICMJE May 15, 2014
Results First Posted Date  ICMJE June 13, 2014
Last Update Posted Date July 17, 2014
Study Start Date  ICMJE May 2010
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2014)
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 ]
Participants with CV death, non-fatal MI or non-fatal ischaemic stroke. If no event, censoring occurs at the patient withdrawal of consent, last contact, or death (when applicable)-whichever was later.
Original Primary Outcome Measures  ICMJE
 (submitted: April 20, 2010)
  • The primary efficacy outcome variable of the study is defined as the composite endpoint of cardiovascular death, non-fatal myocardial infarction or non-fatal ischaemic stroke [ Time Frame: Time to first event. Information collected during study period (anticipated to be 5 years). ]
  • The primary safety outcome variable of the study is defined as the composite endpoint of cardiovascular death, non-fatal myocardial infarction or non-fatal ischaemic stroke [ Time Frame: Time to first event. Information collected during study period (anticipated to be 5 years). ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2014)
  • 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 ]
    Participants with CV death, non-fatal MI, non-fatal ischaemic stroke, hospitalisation for heart failure, hospitalisation for unstable angina pectoris, or hospitalisation for coronary revascularisation. If no event, censoring occurs at the patient withdrawal of consent, last contact, or death (when applicable)-whichever was later.
  • Participants With Event of Death [ Time Frame: Randomization (day 0) up to 2.9 years ]
    Participants with event of death. If no event, censoring occurs at the patient withdrawal of consent, or last contact -whichever was later.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2010)
The composite endpoint of cardiovascular death, non-fatal myocardial infarction, non-fatal ischaemic stroke, hospitalisation for heart failure, unstable angina pectoris or coronary revascularisation [ Time Frame: Time to first event. Information collected during study period (anticipated to be 5 years). ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications
Official Title  ICMJE A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IV Trial to Evaluate the Effect of Saxagliptin on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischaemic Stroke in Patients With Type 2 Diabetes
Brief Summary The purpose of this study is to determine whether saxagliptin can reduce the risk of cardiovascular events when used alone or added to other diabetes medications
Detailed Description A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IV Trial to Evaluate the Effect of Saxagliptin on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischaemic Stroke in Patients with Type 2 Diabetes
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Saxagliptin
    5 mg or 2.5 mg once daily
    Other Name: Onglyza
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Saxagliptin
    Intervention: Drug: Saxagliptin
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 15, 2014)
18206
Original Estimated Enrollment  ICMJE
 (submitted: April 20, 2010)
12000
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with type 2 diabetes mellitus
  • HbA1c ≥6.5%. (based on the last measured and documented laboratory measurement within 6 months)
  • High risk for CV events -Established cardiovascular disease and/or multiple risk factors

Exclusion Criteria:

  • Current or previous (within 6 months) treatment with DPP4 inhibitors and/or GLP-1 mimetics
  • Acute vascular event <2months prior to randomisation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Brazil,   Canada,   Chile,   China,   Czech Republic,   France,   Germany,   Hong Kong,   Hungary,   India,   Israel,   Italy,   Mexico,   Netherlands,   Peru,   Poland,   Puerto Rico,   Russian Federation,   South Africa,   Spain,   Sweden,   Taiwan,   Thailand,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01107886
Other Study ID Numbers  ICMJE D1680C00003
EudraCT No 2009-017358-10
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Study Chair: Eugene Braunwald TIMI
Principal Investigator: Itamar Raz hadassah medical organisation
Principal Investigator: Deepak Bhatt TIMI
PRS Account AstraZeneca
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP