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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 is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01107886
First received: March 25, 2010
Last updated: November 19, 2012
Last verified: November 2012
History of Changes

March 25, 2010
November 19, 2012
May 2010
July 2013   (final data collection date for primary outcome measure)
  • 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 4 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 4 years). ] [ Designated as safety issue: Yes ]
  • 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
  • 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 4 years). ] [ Designated as safety issue: No ]
  • The next secondary efficacy variable is any documented death [ Time Frame: Time to event. Information collected during study period (anticipated to be 4 years) ] [ Designated as safety issue: No ]
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
    Intervention: Drug: Placebo
Scirica BM, Bhatt DL, Braunwald E, Steg PG, Davidson J, Hirshberg B, Ohman P, Price DL, Chen R, Udell J, Raz I. The design and rationale of the saxagliptin assessment of vascular outcomes recorded in patients with diabetes mellitus-thrombolysis in myocardial infarction (SAVOR-TIMI) 53 study. Am Heart J. 2011 Nov;162(5):818-825.e6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
16500
July 2013
July 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,   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
 
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
November 2012

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