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

Completed

Phase 4 Results

Trial Description

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

Conditions

Interventions

  • Placebo Drug
    ARM 1: Kind: Experimental
    Label: Placebo
  • Saxagliptin Drug
    Other Names: Onglyza
    Intervention Desc: 5 mg or 2.5 mg once daily
    ARM 1: Kind: Experimental
    Label: Saxagliptin

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary 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 to first event. Information collected during study period (anticipated to be 5 years). No
Primary 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 to first event. Information collected during study period (anticipated to be 5 years). Yes
Secondary 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 to first event. Information collected during study period (anticipated to be 5 years). No
Secondary The next secondary efficacy variable is any documented death Time to event. Information collected during study period (anticipated to be 4 years) No
Primary Participants With Any Event From the Composite of Cardiovascular Death (CV Death), Non-fatal Myocardial Infarction (MI), or Non-fatal Ischaemic Stroke Randomization (day 0) up to 2.9 years No
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 Randomization (day 0) up to 2.9 years No
Secondary Participants With Event of Death Randomization (day 0) up to 2.9 years No

Sponsors