Does saxagliptin reduce the risk of cardiovascular events when used alone or added to other diabetes medications - SAVOR- TIMI 53

Study identifier:D1680C00003

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Type 2 Diabetes Mellitus

Phase

Phase 4

Healthy volunteers

No

Study drug

Saxagliptin, Placebo

Sex

All

Actual Enrollment

18206

Study type

Interventional

Age

40 Years - 150 Years

Date

Study Start Date: 01 May 2010
Primary Completion Date: 01 May 2013
Study Completion Date: 01 May 2013

Study design

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2014 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Bristol-Myers Squibb

Inclusion and exclusion criteria