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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Saxagliptin
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Risk of cardiovascular disease and death in patients with type 2 diabetes mellitus

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Saxagliptin

Placebo

Arm Description

Placebo

Outcomes

Primary Outcome Measures

Participants With Any Event From the Composite of Cardiovascular Death (CV Death), Non-fatal Myocardial Infarction (MI), or Non-fatal Ischaemic Stroke
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.

Secondary Outcome Measures

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
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
Participants with event of death. If no event, censoring occurs at the patient withdrawal of consent, or last contact -whichever was later.

Full Information

First Posted
March 25, 2010
Last Updated
July 9, 2014
Sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01107886
Brief Title
Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications
Acronym
SAVOR- TIMI 53
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Risk of cardiovascular disease and death in patients with type 2 diabetes mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18206 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Saxagliptin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Saxagliptin
Other Intervention Name(s)
Onglyza
Intervention Description
5 mg or 2.5 mg once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Participants With Any Event From the Composite of Cardiovascular Death (CV Death), Non-fatal Myocardial Infarction (MI), or Non-fatal Ischaemic Stroke
Description
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.
Time Frame
Randomization (day 0) up to 2.9 years
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Randomization (day 0) up to 2.9 years
Title
Participants With Event of Death
Description
Participants with event of death. If no event, censoring occurs at the patient withdrawal of consent, or last contact -whichever was later.
Time Frame
Randomization (day 0) up to 2.9 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Braunwald
Organizational Affiliation
TIMI
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Itamar Raz
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Deepak Bhatt
Organizational Affiliation
TIMI
Official's Role
Principal Investigator
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Facility Name
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City
Pontiac
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Michigan
Country
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City
Rochester
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Waterford
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Minnesota
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Chaska
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City
Duluth
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City
Eagan
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Minnesota
Country
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City
Minneapolis
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Minnesota
Country
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City
Robbinsdale
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Minnesota
Country
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City
Kansas City
State/Province
Missouri
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City
St Louis
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Missouri
Country
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City
St. Louis
State/Province
Missouri
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City
Billings
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Montana
Country
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City
Bellevue
State/Province
Nebraska
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City
Fremont
State/Province
Nebraska
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City
Grand Island
State/Province
Nebraska
Country
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City
Omaha
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Country
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City
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State/Province
Nevada
Country
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City
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Nevada
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City
Reno
State/Province
Nevada
Country
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City
Elizabeth
State/Province
New Jersey
Country
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City
Elmer
State/Province
New Jersey
Country
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City
Voorhees
State/Province
New Jersey
Country
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City
Albuquerque
State/Province
New Mexico
Country
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City
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State/Province
New York
Country
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City
Bronx
State/Province
New York
Country
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City
Buffalo
State/Province
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Country
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City
Cortlandt Manor
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New York
Country
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Endwell
State/Province
New York
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City
New Hyde Park
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New York
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City
Northport
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City
Saratoga Springs
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City
Syracuse
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Westfield
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New York
Country
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City
Charlotte
State/Province
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Country
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City
Durham
State/Province
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Country
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City
Hickory
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Monroe
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City
Morganton
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North Carolina
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City
Rocky Mount
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City
Smithfield
State/Province
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City
Winston-Salem
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Grand Forks
State/Province
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Beachwood
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Ohio
Country
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Cadiz
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Ohio
Country
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City
Canal Fulton
State/Province
Ohio
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City
Canton
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Ohio
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City
Cincinnati
State/Province
Ohio
Country
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City
Columbus
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Ohio
Country
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City
Dayton
State/Province
Ohio
Country
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City
Delaware
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Ohio
Country
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City
Elyria
State/Province
Ohio
Country
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City
Kettering
State/Province
Ohio
Country
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City
Lorain
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Ohio
Country
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City
Middleburg Hights
State/Province
Ohio
Country
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City
Sandusky
State/Province
Ohio
Country
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Facility Name
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City
Toledo
State/Province
Ohio
Country
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Facility Name
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City
Oklahoma City
State/Province
Oklahoma
Country
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Facility Name
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City
Tulsa
State/Province
Oklahoma
Country
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City
Portland
State/Province
Oregon
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City
Altoona
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City
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Clymer
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Doylestown
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Hermitage
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Indiana
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City
Jersey Shore
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City
Johnstown
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City
Philadelphia
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City
Pittsburgh
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City
Sayre
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City
Tyrone
State/Province
Pennsylvania
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City
Providence
State/Province
Rhode Island
Country
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City
Charleston
State/Province
South Carolina
Country
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City
Columbia
State/Province
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Country
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City
Greer
State/Province
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Country
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City
Spartenburg
State/Province
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City
Rapid City
State/Province
South Dakota
Country
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City
Bristol
State/Province
Tennessee
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City
Jackson
State/Province
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Country
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City
Memphis
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City
Nashville
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City
Amarillo
State/Province
Texas
Country
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Arlington
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Austin
State/Province
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Country
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City
Colleyville
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Country
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City
Dallas
State/Province
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Country
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City
Edinburg
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Country
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City
Fort Worth
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Country
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City
Georgetown
State/Province
Texas
Country
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City
Grapevine
State/Province
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Country
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City
Houston
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Country
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City
Irving
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Country
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City
Katy
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Country
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City
MC Allen
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Country
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City
Midland
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Country
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City
Mission
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Country
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City
Odessa
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Texas
Country
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City
Plano
State/Province
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Country
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City
Richardson
State/Province
Texas
Country
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City
San Antonio
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Texas
Country
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City
San Marcos
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Country
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City
Southlake
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Texas
Country
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City
Tomball
State/Province
Texas
Country
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City
Victoria
State/Province
Texas
Country
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City
Burke
State/Province
Virginia
Country
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City
Manassas
State/Province
Virginia
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City
Midlothian
State/Province
Virginia
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City
Norfolk
State/Province
Virginia
Country
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City
Richmond
State/Province
Virginia
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City
Burien
State/Province
Washington
Country
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City
Federal Way
State/Province
Washington
Country
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City
Tacoma
State/Province
Washington
Country
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City
Wenatchee
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Washington
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City
Milwaukee
State/Province
Wisconsin
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City
Buenos Aires
Country
Argentina
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Ciudad Autonom de Buenos Aires
Country
Argentina
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CiudadAutonoma de Buenos Aires
Country
Argentina
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City
Cordoba
Country
Argentina
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Corrientes
Country
Argentina
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La Plata
Country
Argentina
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Lanus Buenos Aires
Country
Argentina
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City
Mar del Plata
Country
Argentina
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City
Mendoza
Country
Argentina
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City
Morón
Country
Argentina
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City
Ramos Mejía
Country
Argentina
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City
Rosario Santa Fe
Country
Argentina
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City
Rosario
Country
Argentina
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City
Santa Fe
Country
Argentina
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City
Sarandi Buenos Aires
Country
Argentina
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Villa Ballester
Country
Argentina
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Ashford
Country
Australia
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Fitzroy
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Australia
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Frankston
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Australia
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Garran
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Australia
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City
Geelong
Country
Australia
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City
Launceston
Country
Australia
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City
Maroubra
Country
Australia
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City
Milton
Country
Australia
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City
Sherwood
Country
Australia
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City
Southport
Country
Australia
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Windsor
Country
Australia
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City
Belem
Country
Brazil
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Country
Brazil
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Brazil
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Goiânia
Country
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Marilia
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Brazil
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Porto Alegre
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Brazil
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Recife
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Brazil
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City
Rio de Janeiro
Country
Brazil
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Sao Paulo
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São Paulo
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Brazil
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Red Deer
State/Province
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Country
Canada
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Spruce Grove
State/Province
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Country
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New Westminster
State/Province
British Columbia
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Surrey
State/Province
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City
Victoria
State/Province
British Columbia
Country
Canada
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City
Winnipeg
State/Province
Manitoba
Country
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St. John's
State/Province
Newfoundland and Labrador
Country
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Halifax
State/Province
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Country
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Brampton
State/Province
Ontario
Country
Canada
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Courtice
State/Province
Ontario
Country
Canada
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City
Hamilton
State/Province
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Country
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City
Kingston
State/Province
Ontario
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Canada
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City
Kitchener
State/Province
Ontario
Country
Canada
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London
State/Province
Ontario
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Canada
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City
Mississauga
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Country
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Newmarket
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Country
Canada
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City
Oshawa
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Canada
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City
Scarborough
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Country
Canada
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City
Smiths Falls
State/Province
Ontario
Country
Canada
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City
Sudbury
State/Province
Ontario
Country
Canada
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City
Toronto
State/Province
Ontario
Country
Canada
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City
Brossard
State/Province
Quebec
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Chicoutimi
State/Province
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Country
Canada
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Greenfield Park
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Country
Canada
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Laval
State/Province
Quebec
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Canada
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City
Longueuil
State/Province
Quebec
Country
Canada
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Montreal
State/Province
Quebec
Country
Canada
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City
Saint-Charles-Borromee
State/Province
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Country
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Sherbrooke
State/Province
Quebec
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Canada
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City
St-Lambert
State/Province
Quebec
Country
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City
Regina
State/Province
Saskatchewan
Country
Canada
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City
Saskatoon
State/Province
Saskatchewan
Country
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Quebec
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Canada
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Santiago
Country
Chile
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Temuco
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Chile
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Beijing
Country
China
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Changsha
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China
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Guangzhou
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China
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Hong Kong
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Nanjing
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Shanghai
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Suzhou
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Tianjin
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Beroun
Country
Czech Republic
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Blansko
Country
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Breclav
Country
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Brno
Country
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Caslav
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Cheb
Country
Czech Republic
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Chrudim III
Country
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Havirov
Country
Czech Republic
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Hodonin
Country
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Horovice
Country
Czech Republic
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Hradec Kralove
Country
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Jablonec nad Nisou
Country
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Kromeriz
Country
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Olomouc-Lazce
Country
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Ostrava - Belsky les
Country
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Ostrava - Kuncice
Country
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Ostrava-Vitkovice
Country
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Ostrava
Country
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Pardubice
Country
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Plzen
Country
Czech Republic
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Praha 2
Country
Czech Republic
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Praha 6
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Czech Republic
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Praha
Country
Czech Republic
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Prelouc
Country
Czech Republic
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Slany
Country
Czech Republic
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Uherske Hradiste
Country
Czech Republic
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Valaske Klobouky
Country
Czech Republic
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Zlin
Country
Czech Republic
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Amiens
Country
France
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Bron
Country
France
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Colmar Cedex
Country
France
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Corbeil Essonnes
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France
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Nantes cedex 1
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France
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Paris Cedex 10
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France
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Pessac
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France
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Poitiers Cedex
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France
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Reims Cedex
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France
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Toulouse Cedex
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France
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Aschaffenburg
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Germany
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Bad Nauheim
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Germany
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Bad Oeynhausen
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Berlin
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Germany
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Deggingen
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Germany
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Dippoldiswalde
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Dortmund
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Dresden
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Eschweiler
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Gießen
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Goch
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Germany
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Gueglingen
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Germany
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Hamburg
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Germany
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Hohenmölsen
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Kassel
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Germany
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Leipzig
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Germany
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Mayen
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Germany
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Rehlingen Siersburg
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Germany
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Rotenburg
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Germany
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Hong Kong
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Country
Hong Kong
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Hong Kong
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Hong Kong
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Balatonfüred
Country
Hungary
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Budapest
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Békéscsaba
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Hungary
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Cegled
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Csongrad
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Eger
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Gyor
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Gyula
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Gyöngyös
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Miskolc
Country
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Nagykanizsa
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Pecs
Country
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Siofok
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Szolnok
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Veszprém
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Ahmedabad
Country
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India
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India
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Ernakulam District
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Indore
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Mumbai
Country
India
Facility Name
Research Site
City
Mysore
Country
India
Facility Name
Research Site
City
Nagpur
Country
India
Facility Name
Research Site
City
New Delhi
Country
India
Facility Name
Research Site
City
Pune
Country
India
Facility Name
Research Site
City
Vadodara
Country
India
Facility Name
Research Site
City
Ashkelon
Country
Israel
Facility Name
Research Site
City
Beer Sheva
Country
Israel
Facility Name
Research Site
City
Dimona
Country
Israel
Facility Name
Research Site
City
Givatayim
Country
Israel
Facility Name
Research Site
City
Haifa
Country
Israel
Facility Name
Research Site
City
Holon
Country
Israel
Facility Name
Research Site
City
Jerusalem
Country
Israel
Facility Name
Research Site
City
Kfar-Saba
Country
Israel
Facility Name
Research Site
City
Nahariya
Country
Israel
Facility Name
Research Site
City
Petach Tikva
Country
Israel
Facility Name
Research Site
City
Rehovot
Country
Israel
Facility Name
Research Site
City
Tel Aviv
Country
Israel
Facility Name
Research Site
City
Tel-Aviv
Country
Israel
Facility Name
Research Site
City
Zefat
Country
Israel
Facility Name
Research Site
City
Zerifin
Country
Israel
Facility Name
Research Site
City
Bergamo
Country
Italy
Facility Name
Research Site
City
Catania
Country
Italy
Facility Name
Research Site
City
Firenze
Country
Italy
Facility Name
Research Site
City
Mercato San Severino
Country
Italy
Facility Name
Research Site
City
Milano
Country
Italy
Facility Name
Research Site
City
Napoli
Country
Italy
Facility Name
Research Site
City
Negrar - VR
Country
Italy
Facility Name
Research Site
City
Padova
Country
Italy
Facility Name
Research Site
City
Parma
Country
Italy
Facility Name
Research Site
City
Pavia
Country
Italy
Facility Name
Research Site
City
Pozzuoli
Country
Italy
Facility Name
Research Site
City
Prato
Country
Italy
Facility Name
Research Site
City
Ravenna
Country
Italy
Facility Name
Research Site
City
Roma
Country
Italy
Facility Name
Research Site
City
Rozzano
Country
Italy
Facility Name
Research Site
City
S Maria Capua Vetere
Country
Italy
Facility Name
Research Site
City
San Giovanni Rotondo
Country
Italy
Facility Name
Research Site
City
Sessa Aurunca
Country
Italy
Facility Name
Research Site
City
Taormina
Country
Italy
Facility Name
Research Site
City
Terni
Country
Italy
Facility Name
Research Site
City
Aguascalientes
Country
Mexico
Facility Name
Research Site
City
Culiacan
Country
Mexico
Facility Name
Research Site
City
Durango
Country
Mexico
Facility Name
Research Site
City
Guadalajara
Country
Mexico
Facility Name
Research Site
City
Mexico
Country
Mexico
Facility Name
Research Site
City
Monclova
Country
Mexico
Facility Name
Research Site
City
Monterrey
Country
Mexico
Facility Name
Research Site
City
México
Country
Mexico
Facility Name
Research Site
City
Nuevo Leon
Country
Mexico
Facility Name
Research Site
City
Oaxaca
Country
Mexico
Facility Name
Research Site
City
Queretaro
Country
Mexico
Facility Name
Research Site
City
San Luis Potosi
Country
Mexico
Facility Name
Research Site
City
San Luis Potosí
Country
Mexico
Facility Name
Research Site
City
Tijuana
Country
Mexico
Facility Name
Research Site
City
Xalapa
Country
Mexico
Facility Name
Research Site
City
Almelo
Country
Netherlands
Facility Name
Research Site
City
Amersfoort
Country
Netherlands
Facility Name
Research Site
City
Amsterdam
Country
Netherlands
Facility Name
Research Site
City
Apeldoorn
Country
Netherlands
Facility Name
Research Site
City
Arnhem
Country
Netherlands
Facility Name
Research Site
City
Breda
Country
Netherlands
Facility Name
Research Site
City
Delft
Country
Netherlands
Facility Name
Research Site
City
Eindhoven
Country
Netherlands
Facility Name
Research Site
City
Goes
Country
Netherlands
Facility Name
Research Site
City
Gouda
Country
Netherlands
Facility Name
Research Site
City
Groningen
Country
Netherlands
Facility Name
Research Site
City
Hardenberg
Country
Netherlands
Facility Name
Research Site
City
Hoogeveen
Country
Netherlands
Facility Name
Research Site
City
Hoorn
Country
Netherlands
Facility Name
Research Site
City
Leiderdorp
Country
Netherlands
Facility Name
Research Site
City
Nijmegen
Country
Netherlands
Facility Name
Research Site
City
Rotterdam
Country
Netherlands
Facility Name
Research Site
City
Sneek
Country
Netherlands
Facility Name
Research Site
City
Utrecht
Country
Netherlands
Facility Name
Research Site
City
Velp
Country
Netherlands
Facility Name
Research Site
City
Waalwijk
Country
Netherlands
Facility Name
Research Site
City
Zoetermeer
Country
Netherlands
Facility Name
Research Site
City
Callao
Country
Peru
Facility Name
Research Site
City
Lima
Country
Peru
Facility Name
Research Site
City
San Isidro
Country
Peru
Facility Name
Research Site
City
Bydgoszcz
Country
Poland
Facility Name
Research Site
City
Gdansk
Country
Poland
Facility Name
Research Site
City
Kamieniec Ząbkowicki
Country
Poland
Facility Name
Research Site
City
Koluszki
Country
Poland
Facility Name
Research Site
City
Krakow
Country
Poland
Facility Name
Research Site
City
Lodz
Country
Poland
Facility Name
Research Site
City
Mrgowo
Country
Poland
Facility Name
Research Site
City
Nakso nad Noteci
Country
Poland
Facility Name
Research Site
City
Opole
Country
Poland
Facility Name
Research Site
City
Oława
Country
Poland
Facility Name
Research Site
City
Poznan
Country
Poland
Facility Name
Research Site
City
Przemyśl
Country
Poland
Facility Name
Research Site
City
Sieradz
Country
Poland
Facility Name
Research Site
City
Skierniewice
Country
Poland
Facility Name
Research Site
City
Toruń
Country
Poland
Facility Name
Research Site
City
Warszawa
Country
Poland
Facility Name
Research Site
City
Wroclaw
Country
Poland
Facility Name
Research Site
City
Wrocław
Country
Poland
Facility Name
Research Site
City
Wąbrzeźno
Country
Poland
Facility Name
Research Site
City
Zabrze
Country
Poland
Facility Name
Research Site
City
Łęczna
Country
Poland
Facility Name
Research Site
City
Aguas Buneas
Country
Puerto Rico
Facility Name
Research Site
City
Bayamon
Country
Puerto Rico
Facility Name
Research Site
City
Cidra
Country
Puerto Rico
Facility Name
Research Site
City
Hato Rey
Country
Puerto Rico
Facility Name
Research Site
City
Jardines de Loiza, Loiza
Country
Puerto Rico
Facility Name
Research Site
City
Juncos
Country
Puerto Rico
Facility Name
Research Site
City
Ponce
Country
Puerto Rico
Facility Name
Research Site
City
Rio Piedras
Country
Puerto Rico
Facility Name
Research Site
City
San Juan
Country
Puerto Rico
Facility Name
Research Site
City
Toa Baja
Country
Puerto Rico
Facility Name
Research Site
City
Ekaterinburg
Country
Russian Federation
Facility Name
Research Site
City
Kazan
Country
Russian Federation
Facility Name
Research Site
City
Moscow
Country
Russian Federation
Facility Name
Research Site
City
Novosibirsk
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Saratov
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
Country
Russian Federation
Facility Name
Research Site
City
St.-Petersburg
Country
Russian Federation
Facility Name
Research Site
City
St.Petersburg
Country
Russian Federation
Facility Name
Research Site
City
StPetersburg
Country
Russian Federation
Facility Name
Research Site
City
Benoni
Country
South Africa
Facility Name
Research Site
City
Cape Town
Country
South Africa
Facility Name
Research Site
City
Durban
Country
South Africa
Facility Name
Research Site
City
Johannesburg
Country
South Africa
Facility Name
Research Site
City
Parow
Country
South Africa
Facility Name
Research Site
City
Pretoria
Country
South Africa
Facility Name
Research Site
City
Umkomaas
Country
South Africa
Facility Name
Research Site
City
Verulam
Country
South Africa
Facility Name
Research Site
City
Alicante
Country
Spain
Facility Name
Research Site
City
Barcelona
Country
Spain
Facility Name
Research Site
City
Granada
Country
Spain
Facility Name
Research Site
City
Jerez de la Frontera Cadiz
Country
Spain
Facility Name
Research Site
City
Lérida
Country
Spain
Facility Name
Research Site
City
Madrid
Country
Spain
Facility Name
Research Site
City
Majadahonda
Country
Spain
Facility Name
Research Site
City
Oviedo
Country
Spain
Facility Name
Research Site
City
Palma de Mallorca
Country
Spain
Facility Name
Research Site
City
Santiago de Compostela
Country
Spain
Facility Name
Research Site
City
Sevilla
Country
Spain
Facility Name
Research Site
City
Valencia
Country
Spain
Facility Name
Research Site
City
Brämhult
Country
Sweden
Facility Name
Research Site
City
Eksjö
Country
Sweden
Facility Name
Research Site
City
Goteborg
Country
Sweden
Facility Name
Research Site
City
Göteborg
Country
Sweden
Facility Name
Research Site
City
Helsingborg
Country
Sweden
Facility Name
Research Site
City
Jönköping
Country
Sweden
Facility Name
Research Site
City
Malmo
Country
Sweden
Facility Name
Research Site
City
Rättvik
Country
Sweden
Facility Name
Research Site
City
Stockholm
Country
Sweden
Facility Name
Research Site
City
Söråker
Country
Sweden
Facility Name
Research Site
City
Umeå
Country
Sweden
Facility Name
Research Site
City
Örebro
Country
Sweden
Facility Name
Research Site
City
Östersund
Country
Sweden
Facility Name
Research Site
City
Kaohsiung Hsien
Country
Taiwan
Facility Name
Research Site
City
Kaohsiung
Country
Taiwan
Facility Name
Research Site
City
Taichung
Country
Taiwan
Facility Name
Research Site
City
Taipei
Country
Taiwan
Facility Name
Research Site
City
Yong-Kang City
Country
Taiwan
Facility Name
Research Site
City
Bangkoknoi
Country
Thailand
Facility Name
Research Site
City
Bangkok
Country
Thailand
Facility Name
Research Site
City
Chiang Mai
Country
Thailand
Facility Name
Research Site
City
Khon Kaen
Country
Thailand
Facility Name
Research Site
City
Ratchaburi
Country
Thailand
Facility Name
Research Site
City
Aylesbury
Country
United Kingdom
Facility Name
Research Site
City
Bath
Country
United Kingdom
Facility Name
Research Site
City
Belfast
Country
United Kingdom
Facility Name
Research Site
City
Blackpool
Country
United Kingdom
Facility Name
Research Site
City
Corsham
Country
United Kingdom
Facility Name
Research Site
City
Coventry
Country
United Kingdom
Facility Name
Research Site
City
Fowey
Country
United Kingdom
Facility Name
Research Site
City
Kenton
Country
United Kingdom
Facility Name
Research Site
City
Leicester
Country
United Kingdom
Facility Name
Research Site
City
Mortimer Reading
Country
United Kingdom
Facility Name
Research Site
City
Plymouth
Country
United Kingdom
Facility Name
Research Site
City
Sheffield
Country
United Kingdom
Facility Name
Research Site
City
Sunbury on Thames
Country
United Kingdom
Facility Name
Research Site
City
Swindon
Country
United Kingdom
Facility Name
Research Site
City
Wansford
Country
United Kingdom
Facility Name
Research Site
City
Warminster
Country
United Kingdom
Facility Name
Research Site
City
Whitstable
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33832610
Citation
Cavallari I, Bhatt DL, Steg PG, Leiter LA, McGuire DK, Mosenzon O, Im K, Raz I, Braunwald E, Scirica BM. Causes and Risk Factors for Death in Diabetes: A Competing-Risk Analysis From the SAVOR-TIMI 53 Trial. J Am Coll Cardiol. 2021 Apr 13;77(14):1837-1840. doi: 10.1016/j.jacc.2021.02.030. No abstract available.
Results Reference
derived
PubMed Identifier
31474116
Citation
Berg DD, Wiviott SD, Scirica BM, Gurmu Y, Mosenzon O, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Johanson P, Johansson PA, Langkilde AM, Raz I, Braunwald E, Sabatine MS. Heart Failure Risk Stratification and Efficacy of Sodium-Glucose Cotransporter-2 Inhibitors in Patients With Type 2 Diabetes Mellitus. Circulation. 2019 Nov 5;140(19):1569-1577. doi: 10.1161/CIRCULATIONAHA.119.042685. Epub 2019 Aug 31.
Results Reference
derived
PubMed Identifier
31362530
Citation
Bergmark BA, Bhatt DL, McGuire DK, Cahn A, Mosenzon O, Steg PG, Im K, Kanevsky E, Gurmu Y, Raz I, Braunwald E, Scirica BM; SAVOR-TIMI 53 Steering Committee and Investigators. Metformin Use and Clinical Outcomes Among Patients With Diabetes Mellitus With or Without Heart Failure or Kidney Dysfunction: Observations From the SAVOR-TIMI 53 Trial. Circulation. 2019 Sep 17;140(12):1004-1014. doi: 10.1161/CIRCULATIONAHA.119.040144. Epub 2019 Jul 31.
Results Reference
derived
PubMed Identifier
29214305
Citation
Scirica BM, Mosenzon O, Bhatt DL, Udell JA, Steg PG, McGuire DK, Im K, Kanevsky E, Stahre C, Sjostrand M, Raz I, Braunwald E. Cardiovascular Outcomes According to Urinary Albumin and Kidney Disease in Patients With Type 2 Diabetes at High Cardiovascular Risk: Observations From the SAVOR-TIMI 53 Trial. JAMA Cardiol. 2018 Feb 1;3(2):155-163. doi: 10.1001/jamacardio.2017.4228.
Results Reference
derived
PubMed Identifier
28417296
Citation
Xia C, Goud A, D'Souza J, Dahagam C, Rao X, Rajagopalan S, Zhong J. DPP4 inhibitors and cardiovascular outcomes: safety on heart failure. Heart Fail Rev. 2017 May;22(3):299-304. doi: 10.1007/s10741-017-9617-4.
Results Reference
derived
PubMed Identifier
27797925
Citation
Mosenzon O, Leibowitz G, Bhatt DL, Cahn A, Hirshberg B, Wei C, Im K, Rozenberg A, Yanuv I, Stahre C, Ray KK, Iqbal N, Braunwald E, Scirica BM, Raz I. Effect of Saxagliptin on Renal Outcomes in the SAVOR-TIMI 53 Trial. Diabetes Care. 2017 Jan;40(1):69-76. doi: 10.2337/dc16-0621. Epub 2016 Oct 17.
Results Reference
derived
PubMed Identifier
27681000
Citation
Scirica BM, Bhatt DL, Braunwald E, Raz I, Cavender MA, Im K, Mosenzon O, Udell JA, Hirshberg B, Pollack PS, Steg PG, Jarolim P, Morrow DA. Prognostic Implications of Biomarker Assessments in Patients With Type 2 Diabetes at High Cardiovascular Risk: A Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2016 Dec 1;1(9):989-998. doi: 10.1001/jamacardio.2016.3030.
Results Reference
derived
PubMed Identifier
26524706
Citation
Cavender MA, Scirica BM, Raz I, Steg PG, McGuire DK, Leiter LA, Hirshberg B, Davidson J, Cahn A, Mosenzon O, Im K, Braunwald E, Bhatt DL. Cardiovascular Outcomes of Patients in SAVOR-TIMI 53 by Baseline Hemoglobin A1c. Am J Med. 2016 Mar;129(3):340.e1-8. doi: 10.1016/j.amjmed.2015.09.022. Epub 2015 Oct 31.
Results Reference
derived
PubMed Identifier
26358285
Citation
Mosenzon O, Wei C, Davidson J, Scirica BM, Yanuv I, Rozenberg A, Hirshberg B, Cahn A, Stahre C, Strojek K, Bhatt DL, Raz I. Incidence of Fractures in Patients With Type 2 Diabetes in the SAVOR-TIMI 53 Trial. Diabetes Care. 2015 Nov;38(11):2142-50. doi: 10.2337/dc15-1068. Epub 2015 Sep 10.
Results Reference
derived
PubMed Identifier
25758769
Citation
Leiter LA, Teoh H, Braunwald E, Mosenzon O, Cahn A, Kumar KM, Smahelova A, Hirshberg B, Stahre C, Frederich R, Bonnici F, Scirica BM, Bhatt DL, Raz I; SAVOR-TIMI 53 Steering Committee and Investigators. Efficacy and safety of saxagliptin in older participants in the SAVOR-TIMI 53 trial. Diabetes Care. 2015 Jun;38(6):1145-53. doi: 10.2337/dc14-2868. Epub 2015 Mar 10.
Results Reference
derived
PubMed Identifier
25552421
Citation
Udell JA, Bhatt DL, Braunwald E, Cavender MA, Mosenzon O, Steg PG, Davidson JA, Nicolau JC, Corbalan R, Hirshberg B, Frederich R, Im K, Umez-Eronini AA, He P, McGuire DK, Leiter LA, Raz I, Scirica BM; SAVOR-TIMI 53 Steering Committee and Investigators. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes and moderate or severe renal impairment: observations from the SAVOR-TIMI 53 Trial. Diabetes Care. 2015 Apr;38(4):696-705. doi: 10.2337/dc14-1850. Epub 2014 Dec 31.
Results Reference
derived
PubMed Identifier
25189213
Citation
Scirica BM, Braunwald E, Raz I, Cavender MA, Morrow DA, Jarolim P, Udell JA, Mosenzon O, Im K, Umez-Eronini AA, Pollack PS, Hirshberg B, Frederich R, Lewis BS, McGuire DK, Davidson J, Steg PG, Bhatt DL; SAVOR-TIMI 53 Steering Committee and Investigators*. Heart failure, saxagliptin, and diabetes mellitus: observations from the SAVOR-TIMI 53 randomized trial. Circulation. 2014 Oct 28;130(18):1579-88. doi: 10.1161/CIRCULATIONAHA.114.010389. Epub 2014 Sep 4. Erratum In: Circulation. 2015 Oct 13;132(15):e198.
Results Reference
derived
PubMed Identifier
23992601
Citation
Scirica BM, Bhatt DL, Braunwald E, Steg PG, Davidson J, Hirshberg B, Ohman P, Frederich R, Wiviott SD, Hoffman EB, Cavender MA, Udell JA, Desai NR, Mosenzon O, McGuire DK, Ray KK, Leiter LA, Raz I; SAVOR-TIMI 53 Steering Committee and Investigators. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med. 2013 Oct 3;369(14):1317-26. doi: 10.1056/NEJMoa1307684. Epub 2013 Sep 2.
Results Reference
derived
PubMed Identifier
23564755
Citation
Mosenzon O, Raz I, Scirica BM, Hirshberg B, Stahre CI, Steg PG, Davidson J, Ohman P, Price DL, Frederich B, Udell JA, Braunwald E, Bhatt DL. Baseline characteristics of the patient population in the Saxagliptin Assessment of Vascular Outcomes Recorded in patients with diabetes mellitus (SAVOR)-TIMI 53 trial. Diabetes Metab Res Rev. 2013 Jul;29(5):417-26. doi: 10.1002/dmrr.2413. Epub 2013 May 21.
Results Reference
derived
PubMed Identifier
22093196
Citation
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. doi: 10.1016/j.ahj.2011.08.006.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1185&filename=D1680C00003_CSP.pdf
Description
D1680C00003 Clinical Study Protocol
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1185&filename=D1680C00003_Study_Synopsis_for_CTW.pdf
Description
Related Info
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1185&filename=D1680C00003_Study_Synopsis.pdf
Description
D1680C00003_CSR_Synopsis

Learn more about this trial

Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications

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