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

March 25, 2010
July 9, 2014
May 2010
May 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
  • 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). ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01107886 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Participants with event of death. If no event, censoring occurs at the patient withdrawal of consent, or last contact —whichever was later.
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). ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications
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

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

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Saxagliptin
    5 mg or 2.5 mg once daily
    Other Name: Onglyza
  • Drug: Placebo
  • Experimental: Saxagliptin
    Intervention: Drug: Saxagliptin
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18206
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom,   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
 
NCT01107886
D1680C00003, EudraCT No 2009-017358-10
Yes
AstraZeneca
AstraZeneca
Bristol-Myers Squibb
Study Chair: Eugene Braunwald TIMI
Principal Investigator: Itamar Raz Hadassah Medical Organisation
Principal Investigator: Deepak Bhatt TIMI
AstraZeneca
July 2014

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