Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events
DECLARE-TIMI58
Dapagliflozin Effect on Cardiovascular Events A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Dapagliflozin 10 mg Once Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischemic Stroke in Patients With Type 2 Diabetes
1 other identifier
interventional
17,190
34 countries
805
Brief Summary
This study is being carried out to determine the effect of dapagliflozin on cardiovacular outcomes when added to current background therapy in patients with type 2 diabetes with either established cardiovacular disease or cardiovascular risk factors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2013
Longer than P75 for phase_3
805 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2012
CompletedFirst Posted
Study publicly available on registry
November 21, 2012
CompletedStudy Start
First participant enrolled
April 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 11, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 11, 2018
CompletedResults Posted
Study results publicly available
December 26, 2019
CompletedDecember 26, 2019
November 1, 2019
5.4 years
November 15, 2012
September 6, 2019
December 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Subjects Included in the Composite Endpoint of CV Death, MI or Ischemic Stroke
Safety and co-primary efficacy
up to 5.2 years
Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.
Co-primary efficacy
up to 5.2 years
Secondary Outcomes (2)
Subjects Included in the Renal Composite Endpoint: Confirmed Sustained ≥40% Decrease in eGFR to eGFR <60 ml/Min/1.73m2 and/or ESRD and/or Renal or CV Death.
up to 5.2 years
Subjects Included in the Endpoint of All-cause Mortality.
up to 5.2 years
Study Arms (2)
Dapagliflozin
EXPERIMENTALDapagliflozin + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors
Placebo
PLACEBO COMPARATORPlacebo + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors
Interventions
Eligibility Criteria
You may qualify if:
- Provision of informed consent prior to any study specific procedures
- Female or male aged ≥40 years
- Diagnosed with Type 2 Diabetes
- High Risk for Cardiovascular events
You may not qualify if:
- Diagnosis of Type 1 diabetes mellitus History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
- Chronic cystitis and/or recurrent urinary tract infections
- Pregnant or breast-feeding patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Bristol-Myers Squibbcollaborator
- The TIMI Study Groupcollaborator
- Hadassah Medical Organizationcollaborator
Study Sites (805)
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Alexander City, Alabama, 35010, United States
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Athens, Alabama, 35611, United States
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Birmingham, Alabama, 35243, United States
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Birmingham, Alabama, 35294, United States
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Mobile, Alabama, 36608, United States
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Montgomery, Alabama, 36106, United States
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Mesa, Arizona, 85206, United States
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Mesa, Arizona, 85213, United States
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Phoenix, Arizona, 85018, United States
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Alhambra, California, 91801, United States
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Bakersfield, California, 93308, United States
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Greenbrae, California, 94904, United States
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Huntington Park, California, 90255, United States
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La Mesa, California, 91942, United States
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Lomita, California, 90717, United States
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Los Alamitos, California, 90720, United States
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Los Angeles, California, 90022, United States
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Los Angeles, California, 90067, United States
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Newport Beach, California, 92663, United States
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San Diego, California, 92103, United States
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San Marino, California, 91108, United States
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San Ramon, California, 94582, United States
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Torrance, California, 90502, United States
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Ventura, California, 93003, United States
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Vista, California, 92083, United States
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Fort Collins, Colorado, 80528, United States
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Golden, Colorado, 80401, United States
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Bridgeport, Connecticut, 06610, United States
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Bristol, Connecticut, 06010, United States
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Norwalk, Connecticut, 06851, United States
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Stamford, Connecticut, 06905, United States
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Trumbull, Connecticut, 06611, United States
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Waterbury, Connecticut, 06708, United States
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Newark, Delaware, 19713, United States
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Seaford, Delaware, 19973, United States
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Wilmington, Delaware, 19803, United States
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Washington D.C., District of Columbia, 20037, United States
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Bradenton, Florida, 34201, United States
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Chiefland, Florida, 32626, United States
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Clearwater, Florida, 33756, United States
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Coral Springs, Florida, 33065, United States
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Daytona Beach, Florida, 32117, United States
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Fort Lauderdale, Florida, 33308, United States
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Fort Lauderdale, Florida, 33312, United States
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Green Cove Springs, Florida, 32043, United States
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Hollywood, Florida, 33021, United States
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Jacksonville, Florida, 32258, United States
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Jacksonville Beach, Florida, 32250, United States
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Lake Worth, Florida, 33461, United States
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Lakeland, Florida, 33805, United States
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Largo, Florida, 33770, United States
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Miami, Florida, 33125, United States
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Miami, Florida, 33126, United States
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Miami, Florida, 33144, United States
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Miami, Florida, 33155, United States
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Miami, Florida, 33175, United States
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Miami, Florida, 33186, United States
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Miami Beach, Florida, 33140, United States
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Naples, Florida, 34102, United States
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New Port Richey, Florida, 34653, United States
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Ocala, Florida, 34471, United States
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Palm Beach Gardens, Florida, 33410, United States
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Pembroke Pines, Florida, 33025, United States
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Pembroke Pines, Florida, 33029, United States
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Pensacola, Florida, 32501, United States
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Spring Hill, Florida, 34609, United States
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St. Petersburg, Florida, 33709, United States
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St. Petersburg, Florida, 33713, United States
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Stuart, Florida, 34996, United States
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Tampa, Florida, 33634, United States
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Trinity, Florida, 34655, United States
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Vero Beach, Florida, 32960, United States
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Wellington, Florida, 33449, United States
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Atlanta, Georgia, 30308, United States
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Calhoun, Georgia, 30701, United States
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Cumming, Georgia, 30041, United States
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Savannah, Georgia, 31406, United States
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Honolulu, Hawaii, 96814, United States
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Coeur d'Alene, Idaho, 83814, United States
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Arlington Heights, Illinois, 60005, United States
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Chicago, Illinois, 60607, United States
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Chicago, Illinois, 60611, United States
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Rock Island, Illinois, 61201, United States
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Anderson, Indiana, 46011, United States
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Avon, Indiana, 46123, United States
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Bloomington, Indiana, 47403, United States
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Evansville, Indiana, 47713, United States
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Evansville, Indiana, 47715, United States
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Evansville, Indiana, 47725, United States
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Greenfield, Indiana, 46140, United States
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Muncie, Indiana, 47304, United States
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Newburgh, Indiana, 47630, United States
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Iowa City, Iowa, 52242, United States
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Topeka, Kansas, 66606, United States
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Louisville, Kentucky, 40205, United States
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Alexandria, Louisiana, 71301, United States
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Hammond, Louisiana, 70403, United States
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Shreveport, Louisiana, 71103, United States
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Slidell, Louisiana, 70458, United States
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Auburn, Maine, 04210, United States
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Bangor, Maine, 04401, United States
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Biddeford, Maine, 04005, United States
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Portland, Maine, 04101, United States
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Baltimore, Maryland, 21218, United States
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Baltimore, Maryland, 21229, United States
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Beltsville, Maryland, 20705, United States
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Columbia, Maryland, 21044, United States
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Boston, Massachusetts, 02115, United States
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Fall River, Massachusetts, 02720, United States
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Haverhill, Massachusetts, 01830, United States
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Methuen, Massachusetts, 01844, United States
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Natick, Massachusetts, 01760, United States
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Alpena, Michigan, 49707, United States
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Flint, Michigan, 48504, United States
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Flint, Michigan, 48532, United States
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Grand Blanc, Michigan, 48439, United States
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Jackson, Michigan, 49201, United States
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Kalamazoo, Michigan, 49009, United States
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Petoskey, Michigan, 49770, United States
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Troy, Michigan, 48085, United States
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Duluth, Minnesota, 55805, United States
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Eagan, Minnesota, 55123, United States
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Saint Cloud, Minnesota, 56303, United States
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Kansas City, Missouri, 64111, United States
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Lee's Summit, Missouri, 64064, United States
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St Louis, Missouri, 63117, United States
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Billings, Montana, 59102, United States
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Great Falls, Montana, 59405, United States
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Kalispell, Montana, 59901, United States
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Grand Island, Nebraska, 68803, United States
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Lincoln, Nebraska, 68526, United States
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Omaha, Nebraska, 68105, United States
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Omaha, Nebraska, 68124, United States
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Reno, Nevada, 89502, United States
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Edison, New Jersey, 08837, United States
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Newark, New Jersey, 07103, United States
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Somerset, New Jersey, 08873, United States
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Voorhees Township, New Jersey, 08043, United States
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Albuquerque, New Mexico, 87102, United States
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Buffalo, New York, 14215, United States
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New Hyde Park, New York, 11042, United States
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New York, New York, 10036, United States
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Northport, New York, 11768, United States
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Poughkeepsie, New York, 12601, United States
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Southampton, New York, 11968, United States
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Stony Brook, New York, 11794, United States
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Westfield, New York, 14787, United States
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Asheville, North Carolina, 28803, United States
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Burlington, North Carolina, 27215, United States
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Charlotte, North Carolina, 28209, United States
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Hickory, North Carolina, 28601, United States
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Lenoir, North Carolina, 28645, United States
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Monroe, North Carolina, 28110, United States
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Rocky Mount, North Carolina, 27804, United States
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Salisbury, North Carolina, 28144, United States
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Winston-Salem, North Carolina, 27103, United States
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Bismarck, North Dakota, 58501, United States
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Fargo, North Dakota, 58103, United States
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Canal Fulton, Ohio, 44614, United States
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Cincinnati, Ohio, 45219, United States
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Cleveland, Ohio, 44126, United States
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Delaware, Ohio, 43015, United States
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Elyria, Ohio, 44035, United States
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Parma Hts., Ohio, 44130, United States
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Sandusky, Ohio, 44870, United States
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Springfield, Ohio, 45504, United States
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Toledo, Ohio, 43606, United States
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Oklahoma City, Oklahoma, 73104, United States
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Oklahoma City, Oklahoma, 73120, United States
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Oklahoma City, Oklahoma, 73135, United States
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Tulsa, Oklahoma, 74104, United States
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Altoona, Pennsylvania, 16602, United States
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Bethlehem, Pennsylvania, 18015, United States
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Camp Hill, Pennsylvania, 17011, United States
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Doylestown, Pennsylvania, 18901, United States
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Erie, Pennsylvania, 16508, United States
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Indiana, Pennsylvania, 15701, United States
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Johnstown, Pennsylvania, 15905, United States
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Kittanning, Pennsylvania, 16201, United States
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Langhorne, Pennsylvania, 19047, United States
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Philadelphia, Pennsylvania, 19152, United States
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Philadelphia, Pennsylvania, 19153, United States
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Pittsburgh, Pennsylvania, 15240, United States
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Sellersville, Pennsylvania, 18960, United States
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Tyrone, Pennsylvania, 16686, United States
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York, Pennsylvania, 17405, United States
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Charleston, South Carolina, 29425, United States
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Greer, South Carolina, 29651, United States
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Sioux Falls, South Dakota, 57108, United States
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Bristol, Tennessee, 37620, United States
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Kingsport, Tennessee, 37660, United States
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Knoxville, Tennessee, 37912, United States
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Memphis, Tennessee, 38163, United States
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Arlington, Texas, 76014, United States
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Carrollton, Texas, 75101, United States
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Dallas, Texas, 75220, United States
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Dallas, Texas, 75243, United States
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Fort Worth, Texas, 76107, United States
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Georgetown, Texas, 78626, United States
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Houston, Texas, 77025, United States
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Houston, Texas, 77030, United States
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Houston, Texas, 77074, United States
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Houston, Texas, 77095, United States
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Irving, Texas, 75039, United States
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Katy, Texas, 77450, United States
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Kingwood, Texas, 77339, United States
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McAllen, Texas, 78503, United States
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Midland, Texas, 79707, United States
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Odessa, Texas, 79761, United States
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Plano, Texas, 75023, United States
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San Antonio, Texas, 78249, United States
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Tomball, Texas, 77375, United States
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Tyler, Texas, 75701, United States
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Ogden, Utah, 84405, United States
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Salt Lake City, Utah, 84102, United States
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Salt Lake City, Utah, 84124, United States
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Bennington, Vermont, 05201, United States
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Burke, Virginia, 22015, United States
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Danville, Virginia, 24541, United States
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Manassas, Virginia, 20109, United States
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Manassas, Virginia, 20110, United States
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Norfolk, Virginia, 23502, United States
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Richmond, Virginia, 23249, United States
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Richmond, Virginia, 23836, United States
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Burien, Washington, 98166, United States
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Puyallup, Washington, 98372, United States
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Seattle, Washington, 98104, United States
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Spokane, Washington, 99204, United States
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Spokane, Washington, 99218, United States
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Tacoma, Washington, 98405, United States
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Madison, Wisconsin, 52713, United States
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Madison, Wisconsin, 53719, United States
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Milwaukee, Wisconsin, 53295, United States
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Wausau, Wisconsin, 54401, United States
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Buenos Aires, 1205, Argentina
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Buenos Aires, C1425AGC, Argentina
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CABA, C1093AAS, Argentina
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Ciudad Autonoma Buenos Aires, C1181ACH, Argentina
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Ciudad Autonoma de Buenos Aire, C1120AAC, Argentina
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Córdoba, 5000, Argentina
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Córdoba, X5006CBI, Argentina
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Córdoba, X5008HHW, Argentina
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La Plata, 1900, Argentina
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La Plata, B1902COS, Argentina
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Lanús, B1824KAJ, Argentina
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Mar del Plata, 7600, Argentina
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Mar del Plata, B7600FZN, Argentina
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Ramos Mejía, B1704ETD, Argentina
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Rosario, S2000CVD, Argentina
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Rosario, S2000DNM, Argentina
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San Nicolás, B2900DMH, Argentina
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Santa Fe, S3000FWO, Argentina
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Adelaide - Oaklands Park, 5046, Australia
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Ashford, 5035, Australia
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Box Hill, 3128, Australia
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Camperdown, 2050, Australia
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Darlinghurst, 2010, Australia
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Fullarton, 5063, Australia
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Garran, 2605, Australia
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Geelong, 3220, Australia
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Heidelberg West, 3081, Australia
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Herston, 4029, Australia
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Joondalup, 6027, Australia
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Maroubra, 2035, Australia
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Melbourne, 3004, Australia
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Milton, 4064, Australia
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Murdoch, 6150, Australia
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Wollongong, 2500, Australia
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Aalst, 9300, Belgium
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Antwerp, 2060, Belgium
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Bonheiden, 2820, Belgium
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Brasschaat, 2930, Belgium
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Bruges, 8000, Belgium
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Brussels, 1070, Belgium
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Edegem, 2650, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Mechelen, 2800, Belgium
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Merksem, 2170, Belgium
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Roeselare, 8800, Belgium
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Tienen, 3300, Belgium
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Turnhout, 2300, Belgium
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Belo Horizonte, 30150-240, Brazil
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Brasília, 71625-175, Brazil
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Campina Grande do Sul, 83430000, Brazil
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Campinas, 13010-001, Brazil
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Campinas, 13060-904, Brazil
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Marília, 17515-000, Brazil
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Porto Alegre, 90035-003, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São José dos Campos, 12243-280, Brazil
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São Paulo, 01228-000, Brazil
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São Paulo, 01228-200, Brazil
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São Paulo, 05403-000, Brazil
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Blagoevgrad, 2700, Bulgaria
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Botevgrad, 2140, Bulgaria
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Dimitrovgrad, 6400, Bulgaria
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Dupnitsa, 2600, Bulgaria
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Gotse Delchev, 2900, Bulgaria
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Kozloduy, 3320, Bulgaria
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Kyustendil, 2500, Bulgaria
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Lukovit, 5770, Bulgaria
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Petrich, 2900, Bulgaria
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Pleven, 5800, Bulgaria
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Plovdiv, 4000, Bulgaria
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Rousse, 7002, Bulgaria
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Sandanski, 2800, Bulgaria
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Sevlievo, 5400, Bulgaria
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Sliven, 8800, Bulgaria
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Smolyan, 4700, Bulgaria
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Sofia, 1202, Bulgaria
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Sofia, 1223, Bulgaria
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Sofia, 1303, Bulgaria
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Sofia, 1324, Bulgaria
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Sofia, 1407, Bulgaria
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Sofia, 1431, Bulgaria
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Sofia, 1606, Bulgaria
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Sofia, 1632, Bulgaria
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Sofia, Bulgaria
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Stara Zagora, 6000, Bulgaria
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Yambol, 8600, Bulgaria
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Calgary, Alberta, T2H 2G4, Canada
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Calgary, Alberta, T2T 5C7, Canada
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New Westminster, British Columbia, V3L 3W5, Canada
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Surrey, British Columbia, V3V 0C6, Canada
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Winnipeg, Manitoba, R3E 3P4, Canada
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Moncton, New Brunswick, E1G 1A7, Canada
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Mount Pearl, Newfoundland and Labrador, A1N 1W7, Canada
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St. John's, Newfoundland and Labrador, A1A 3R5, Canada
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Halifax, Nova Scotia, B3H 1V7, Canada
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Sydney Mines, Nova Scotia, B1V 2L2, Canada
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Brampton, Ontario, L6S 0C6, Canada
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Brampton, Ontario, L6W 2X7, Canada
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Brampton, Ontario, L6Z 4N5, Canada
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Cambridge, Ontario, N1R 6V6, Canada
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Cambridge, Ontario, N1R 7L6, Canada
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Concord, Ontario, L4K 4M2, Canada
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London, Ontario, N5W 6A2, Canada
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London, Ontario, N6A 4V2, Canada
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London, Ontario, N6A 5A5, Canada
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London, Ontario, N6G 2M1, Canada
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North York, Ontario, M3J 1N2, Canada
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Oakville, Ontario, L6M 1M1, Canada
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Oshawa, Ontario, L1J 2K1, Canada
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Scarborough Village, Ontario, M1E 5E9, Canada
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Smiths Falls, Ontario, K7A 4W8, Canada
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Toronto, Ontario, M4G 3E8, Canada
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Toronto, Ontario, M5C 2T2, Canada
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Toronto, Ontario, M5T 3L9, Canada
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Chicoutimi, Quebec, G7H 7K9, Canada
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Laval, Quebec, H7T 2P5, Canada
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Lévis, Quebec, G6V 4Z5, Canada
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Longueuil, Quebec, J4M 2X1, Canada
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Montreal, Quebec, H1M 1B1, Canada
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Montreal, Quebec, H1T 1C8, Canada
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Montreal, Quebec, H2W 1R7, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Pointe-Claire, Quebec, H9R 3J1, Canada
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Québec, Quebec, G1G 3Y8, Canada
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Québec, Quebec, G1N 4V3, Canada
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Québec, Quebec, G1V 4G2, Canada
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Québec, Quebec, G1V 4G5, Canada
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Saint-Charles-Borromée, Quebec, J6E 6J2, Canada
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Saint-Georges, Quebec, G5Y 4T8, Canada
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Sherbrooke, Quebec, J1G 5K2, Canada
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Sherbrooke, Quebec, J1H 5N4, Canada
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Sherbrooke, Quebec, J1J 2E3, Canada
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Terrebonne, Quebec, J6V 2H2, Canada
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Regina, Saskatchewan, S4P 0W5, Canada
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Saskatoon, Saskatchewan, S7H 5M3, Canada
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Laval, H7M3L9, Canada
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Beijing, 100044, China
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Beijing, 100096, China
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Changsha, 410011, China
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Guangzhou, 510080, China
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Guangzhou, 510630, China
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Hefei, 230022, China
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Jinan, 250013, China
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Nanchang, 330006, China
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Nanjing, 210012, China
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Shanghai, 200065, China
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Shijiazhuang, 050051, China
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Tianjin, 300211, China
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Beroun, 266 01, Czechia
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Brno, 603 00, Czechia
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Brno, 615 00, Czechia
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Brno, 62500, Czechia
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Brno, 656 91, Czechia
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Cheb, 350 02, Czechia
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Chomutov, 430 02, Czechia
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Chrudim III, 537 01, Czechia
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Hodonín, 695 01, Czechia
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Hořovice, 268 01, Czechia
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Hradec Králové, 500 05, Czechia
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Jílové u Prahy, 254 01, Czechia
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Kroměříž, 767 01, Czechia
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Ostrava - Belsky Les, 700 30, Czechia
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Ostrava - Dubina, 700 30, Czechia
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Ostrava-Kunčice, 707 02, Czechia
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Ostrava-Moravska, 702 00, Czechia
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Pilsen, 30100, Czechia
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Plzen - Severni Predmesti, 301 00, Czechia
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Prague, 140 46, Czechia
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Prague, 152 00, Czechia
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Prague, 154 00, Czechia
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Prague, 163 00, Czechia
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Přelouč, 535 01, Czechia
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Rakovník, 269 01, Czechia
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Slaný, 274 01, Czechia
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Teplice, 415 01, Czechia
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Uherské Hradiště, 686 01, Czechia
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Ústí nad Labem, 400 01, Czechia
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Zlín, 760 01, Czechia
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Angers, 49033, France
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Corbeil-Essonnes, 91100, France
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Dijon, 21079, France
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La Rochelle, 17019, France
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Le Creusot, 71206, France
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Nantes, 44093, France
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Nantes, 44277, France
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Pessac, 33604, France
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Poitiers, 86021, France
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Toulouse, 31059, France
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Aschaffenburg, 63739, Germany
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Bad Mergentheim, 97980, Germany
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Bad Oeynhausen, 32545, Germany
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Berlin, 10115, Germany
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Berlin, 12559, Germany
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Berlin, 13347, Germany
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Cologne, 51069, Germany
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Dippoldiswalde, 01744, Germany
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Freiburg im Breisgau, 79106, Germany
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Hamburg, 22391, Germany
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Kassel, 34121, Germany
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Leipzig, 04103, Germany
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München, 80333, Germany
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Related Publications (26)
Haller PM, Wiviott SD, Berg DD, Jarolim P, Goodrich EL, Bhatt DL, Gause-Nilsson I, Leiter LA, McGuire DK, Wilding JPH, Raz I, Sabatine MS, Morrow DA. Galectin-3 and kidney function in type 2 diabetes treated with dapagliflozin: Analysis from DECLARE-TIMI 58. ESC Heart Fail. 2025 Dec;12(6):3981-3986. doi: 10.1002/ehf2.15415. Epub 2025 Sep 15.
PMID: 40952180DERIVEDNatale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
PMID: 38770818DERIVEDSchechter M, Wiviott SD, Raz I, Goodrich EL, Rozenberg A, Yanuv I, Murphy SA, Zelniker TA, Fredriksson M, Johansson PA, Leiter LA, Bhatt DL, McGuire DK, Wilding JPH, Gause-Nilsson IAM, Cahn A, Langkilde AM, Sabatine MS, Mosenzon O. Effects of dapagliflozin on hospitalisations in people with type 2 diabetes: post-hoc analyses of the DECLARE-TIMI 58 trial. Lancet Diabetes Endocrinol. 2023 Apr;11(4):233-241. doi: 10.1016/S2213-8587(23)00009-8. Epub 2023 Mar 3.
PMID: 36878239DERIVEDZelniker TA, Wiviott SD, Mosenzon O, Goodrich EL, Jarolim P, Cahn A, Bhatt DL, Leiter LA, McGuire DK, Wilding J, Averkov O, Budaj A, Parkhomenko A, Ray KK, Gause-Nilsson I, Langkilde AM, Fredriksson M, Raz I, Sabatine MS, Morrow DA. Association of Cardiac Biomarkers With Major Adverse Cardiovascular Events in High-risk Patients With Diabetes: A Secondary Analysis of the DECLARE-TIMI 58 Trial. JAMA Cardiol. 2023 May 1;8(5):503-509. doi: 10.1001/jamacardio.2023.0019.
PMID: 36857035DERIVEDMosenzon O, Raz I, Wiviott SD, Schechter M, Goodrich EL, Yanuv I, Rozenberg A, Murphy SA, Zelniker TA, Langkilde AM, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Wilding JPH, McGuire DK, Bhatt DL, Leiter LA, Cahn A, Dwyer JP, Heerspink HJL, Sabatine MS. Dapagliflozin and Prevention of Kidney Disease Among Patients With Type 2 Diabetes: Post Hoc Analyses From the DECLARE-TIMI 58 Trial. Diabetes Care. 2022 Oct 1;45(10):2350-2359. doi: 10.2337/dc22-0382.
PMID: 35997319DERIVEDOyama K, Raz I, Cahn A, Goodrich EL, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Gause-Nilsson IAM, Mosenzon O, Sabatine MS, Wiviott SD. Efficacy and Safety of Dapagliflozin According to Background Use of Cardiovascular Medications in Patients With Type 2 Diabetes: A Prespecified Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2022 Sep 1;7(9):914-923. doi: 10.1001/jamacardio.2022.2006.
PMID: 35857296DERIVEDFurtado RHM, Raz I, Goodrich EL, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Aylward P, Dalby AJ, Dellborg M, Dimulescu D, Nicolau JC, Oude Ophuis AJM, Cahn A, Mosenzon O, Gause-Nilsson I, Langkilde AM, Sabatine MS, Wiviott SD. Efficacy and Safety of Dapagliflozin in Type 2 Diabetes According to Baseline Blood Pressure: Observations From DECLARE-TIMI 58 Trial. Circulation. 2022 May 24;145(21):1581-1591. doi: 10.1161/CIRCULATIONAHA.121.058103. Epub 2022 May 5.
PMID: 35510542DERIVEDCahn A, Wiviott SD, Mosenzon O, Goodrich EL, Murphy SA, Yanuv I, Rozenberg A, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Gause-Nilsson IAM, Langkilde AM, Sabatine MS, Raz I. Association of Baseline HbA1c With Cardiovascular and Renal Outcomes: Analyses From DECLARE-TIMI 58. Diabetes Care. 2022 Apr 1;45(4):938-946. doi: 10.2337/dc21-1744.
PMID: 35015847DERIVEDOyama K, Raz I, Cahn A, Kuder J, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Park KS, Goudev A, Diaz R, Spinar J, Gause-Nilsson IAM, Mosenzon O, Sabatine MS, Wiviott SD. Obesity and effects of dapagliflozin on cardiovascular and renal outcomes in patients with type 2 diabetes mellitus in the DECLARE-TIMI 58 trial. Eur Heart J. 2022 Aug 14;43(31):2958-2967. doi: 10.1093/eurheartj/ehab530.
PMID: 34427295DERIVEDMosenzon O, Wiviott SD, Heerspink HJL, Dwyer JP, Cahn A, Goodrich EL, Rozenberg A, Schechter M, Yanuv I, Murphy SA, Zelniker TA, Gause-Nilsson IAM, Langkilde AM, Fredriksson M, Johansson PA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Sabatine MS, Raz I. The Effect of Dapagliflozin on Albuminuria in DECLARE-TIMI 58. Diabetes Care. 2021 Aug;44(8):1805-1815. doi: 10.2337/dc21-0076. Epub 2021 Jul 7.
PMID: 34233928DERIVEDCherney DZI, Dagogo-Jack S, McGuire DK, Cosentino F, Pratley R, Shih WJ, Frederich R, Maldonado M, Liu J, Wang S, Cannon CP; VERTIS CV Investigators. Kidney outcomes using a sustained >/=40% decline in eGFR: A meta-analysis of SGLT2 inhibitor trials. Clin Cardiol. 2021 Aug;44(8):1139-1143. doi: 10.1002/clc.23665. Epub 2021 Jun 15.
PMID: 34129237DERIVEDZelniker TA, Raz I, Mosenzon O, Dwyer JP, Heerspink HHJL, Cahn A, Goodrich EL, Im K, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Gause-Nilsson I, Langkilde AM, Sabatine MS, Wiviott SD. Effect of Dapagliflozin on Cardiovascular Outcomes According to Baseline Kidney Function and Albuminuria Status in Patients With Type 2 Diabetes: A Prespecified Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2021 Jul 1;6(7):801-810. doi: 10.1001/jamacardio.2021.0660.
PMID: 33851953DERIVEDCahn A, Raz I, Leiter LA, Mosenzon O, Murphy SA, Goodrich EL, Yanuv I, Rozenberg A, Bhatt DL, McGuire DK, Wilding JPH, Gause-Nilsson IAM, Langkilde AM, Sabatine MS, Wiviott SD. Cardiovascular, Renal, and Metabolic Outcomes of Dapagliflozin Versus Placebo in a Primary Cardiovascular Prevention Cohort: Analyses From DECLARE-TIMI 58. Diabetes Care. 2021 May;44(5):1159-1167. doi: 10.2337/dc20-2492. Epub 2021 Mar 2.
PMID: 33653824DERIVEDO'Donoghue ML, Kato ET, Mosenzon O, Murphy SA, Cahn A, Herrera M, Tankova T, Smahelova A, Merlini P, Gause-Nilsson I, Langkilde AM, McGuire DK, Wilding JPH, Leiter LA, Bhatt DL, Raz I, Sabatine MS, Wiviott SD. The efficacy and safety of dapagliflozin in women and men with type 2 diabetes mellitus. Diabetologia. 2021 Jun;64(6):1226-1234. doi: 10.1007/s00125-021-05399-2. Epub 2021 Feb 20.
PMID: 33611623DERIVEDBonaca MP, Wiviott SD, Zelniker TA, Mosenzon O, Bhatt DL, Leiter LA, McGuire DK, Goodrich EL, De Mendonca Furtado RH, Wilding JPH, Cahn A, Gause-Nilsson IAM, Johanson P, Fredriksson M, Johansson PA, Langkilde AM, Raz I, Sabatine MS. Dapagliflozin and Cardiac, Kidney, and Limb Outcomes in Patients With and Without Peripheral Artery Disease in DECLARE-TIMI 58. Circulation. 2020 Aug 25;142(8):734-747. doi: 10.1161/CIRCULATIONAHA.119.044775. Epub 2020 Aug 3.
PMID: 32795086DERIVEDZelniker TA, Bonaca MP, Furtado RHM, Mosenzon O, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Budaj A, Kiss RG, Padilla F, Gause-Nilsson I, Langkilde AM, Raz I, Sabatine MS, Wiviott SD. Effect of Dapagliflozin on Atrial Fibrillation in Patients With Type 2 Diabetes Mellitus: Insights From the DECLARE-TIMI 58 Trial. Circulation. 2020 Apr 14;141(15):1227-1234. doi: 10.1161/CIRCULATIONAHA.119.044183. Epub 2020 Jan 27.
PMID: 31983236DERIVEDCahn A, Mosenzon O, Wiviott SD, Rozenberg A, Yanuv I, Goodrich EL, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS, Raz I. Efficacy and Safety of Dapagliflozin in the Elderly: Analysis From the DECLARE-TIMI 58 Study. Diabetes Care. 2020 Feb;43(2):468-475. doi: 10.2337/dc19-1476. Epub 2019 Dec 16.
PMID: 31843945DERIVEDBerg 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.
PMID: 31474116DERIVEDMosenzon O, Wiviott SD, Cahn A, Rozenberg A, Yanuv I, Goodrich EL, Murphy SA, Heerspink HJL, Zelniker TA, Dwyer JP, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Kato ET, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS, Raz I. Effects of dapagliflozin on development and progression of kidney disease in patients with type 2 diabetes: an analysis from the DECLARE-TIMI 58 randomised trial. Lancet Diabetes Endocrinol. 2019 Aug;7(8):606-617. doi: 10.1016/S2213-8587(19)30180-9. Epub 2019 Jun 10.
PMID: 31196815DERIVEDFurtado RHM, Bonaca MP, Raz I, Zelniker TA, Mosenzon O, Cahn A, Kuder J, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Nicolau JC, Gause-Nilsson IAM, Fredriksson M, Langkilde AM, Sabatine MS, Wiviott SD. Dapagliflozin and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus and Previous Myocardial Infarction. Circulation. 2019 May 28;139(22):2516-2527. doi: 10.1161/CIRCULATIONAHA.119.039996. Epub 2019 Mar 18.
PMID: 30882239DERIVEDKato ET, Silverman MG, Mosenzon O, Zelniker TA, Cahn A, Furtado RHM, Kuder J, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Bonaca MP, Ruff CT, Desai AS, Goto S, Johansson PA, Gause-Nilsson I, Johanson P, Langkilde AM, Raz I, Sabatine MS, Wiviott SD. Effect of Dapagliflozin on Heart Failure and Mortality in Type 2 Diabetes Mellitus. Circulation. 2019 May 28;139(22):2528-2536. doi: 10.1161/CIRCULATIONAHA.119.040130. Epub 2019 Mar 18.
PMID: 30882238DERIVEDWiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Zelniker TA, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS; DECLARE-TIMI 58 Investigators. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2019 Jan 24;380(4):347-357. doi: 10.1056/NEJMoa1812389. Epub 2018 Nov 10.
PMID: 30415602DERIVEDWiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Bansilal S, Bhatt DL, Leiter LA, McGuire DK, Wilding JP, Gause-Nilsson IA, Langkilde AM, Johansson PA, Sabatine MS. The design and rationale for the Dapagliflozin Effect on Cardiovascular Events (DECLARE)-TIMI 58 Trial. Am Heart J. 2018 Jun;200:83-89. doi: 10.1016/j.ahj.2018.01.012. Epub 2018 Feb 7.
PMID: 29898853DERIVEDWittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Eligibility varies among the 4 sodium-glucose cotransporter-2 inhibitor cardiovascular outcomes trials: implications for the general type 2 diabetes US population. Am J Manag Care. 2018 Apr;24(8 Suppl):S138-S145.
PMID: 29693360DERIVEDBloch MJ. Blood pressure effects of SGLT2 inhibitors make them an attractive option in diabetic patients with hypertension. J Am Soc Hypertens. 2016 Mar;10(3):186-7. doi: 10.1016/j.jash.2016.01.001. No abstract available.
PMID: 27408945DERIVEDLeiter LA, Cefalu WT, de Bruin TW, Xu J, Parikh S, Johnsson E, Gause-Nilsson I. Long-term maintenance of efficacy of dapagliflozin in patients with type 2 diabetes mellitus and cardiovascular disease. Diabetes Obes Metab. 2016 Aug;18(8):766-74. doi: 10.1111/dom.12666. Epub 2016 May 12.
PMID: 27009868DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Study Leader
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Anna Maria Langkilde, MD
AstraZeneca Sweden
- STUDY CHAIR
Marc S Sabatine, MD, MPH
TIMI Study Group, Boston, MA, USA
- PRINCIPAL INVESTIGATOR
Itamar Raz, MD
Hadassah Medical Organization
- PRINCIPAL INVESTIGATOR
Stephen D Wiviott, MD
TIMI Study Group, MA, USA
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2012
First Posted
November 21, 2012
Study Start
April 25, 2013
Primary Completion
September 11, 2018
Study Completion
September 11, 2018
Last Updated
December 26, 2019
Results First Posted
December 26, 2019
Record last verified: 2019-11