Diabetes Mellitus, Non-Insulin-DependentPhase 3DECLARE-TIMI58NCT01730534

Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events

A Phase 3 study testing Dapagliflozin 10 mg in people with Diabetes Mellitus, Non-Insulin-Dependent and High Risk for Cardiovascular Event, run by AstraZeneca at 805 sites in 34 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 40 to 130 years
Conditions the study is for: Diabetes Mellitus, Non-Insulin-Dependent, High Risk for Cardiovascular Event
What is being tested?: Dapagliflozin 10 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 17,190 participants
Where: 805 sitesin 34 countries
Study dates: 25 Apr 2013to 11 Sep 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

805 sites in 34 countries.

Country

City, postcode or hospital

805 sites in 34 countries

United States234 sites

Research Site
Albuquerque, New Mexico, 87102
Research Site
Alexander City, Alabama, 35010
Research Site
Alexandria, Louisiana, 71301
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Alhambra, California, 91801
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Alpena, Michigan, 49707
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Altoona, Pennsylvania, 16602
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Anderson, Indiana, 46011
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Arlington, Texas, 76014
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Arlington Heights, Illinois, 60005
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Asheville, North Carolina, 28803
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Athens, Alabama, 35611
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Atlanta, Georgia, 30308
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Auburn, Maine, 04210
Research Site
Avon, Indiana, 46123
Research Site
Bakersfield, California, 93308
Research Site
Baltimore, Maryland, 21218
Research Site
Baltimore, Maryland, 21229
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Bangor, Maine, 04401
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Beltsville, Maryland, 20705
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Bennington, Vermont, 05201
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Bethlehem, Pennsylvania, 18015
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Biddeford, Maine, 04005
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Billings, Montana, 59102
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Birmingham, Alabama, 35243
Research Site
Birmingham, Alabama, 35294
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Bismarck, North Dakota, 58501
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Bloomington, Indiana, 47403
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Boston, Massachusetts, 02115
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Bradenton, Florida, 34201
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Bridgeport, Connecticut, 06610
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Bristol, Connecticut, 06010
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Bristol, Tennessee, 37620
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Buffalo, New York, 14215
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Burien, Washington, 98166
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Burke, Virginia, 22015
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Burlington, North Carolina, 27215
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Calhoun, Georgia, 30701
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Camp Hill, Pennsylvania, 17011
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Canal Fulton, Ohio, 44614
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Carrollton, Texas, 75101
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Charleston, South Carolina, 29425
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Charlotte, North Carolina, 28209
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Chicago, Illinois, 60607
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Chicago, Illinois, 60611
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Chiefland, Florida, 32626
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Cincinnati, Ohio, 45219
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Clearwater, Florida, 33756
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Cleveland, Ohio, 44126
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Coeur d'Alene, Idaho, 83814
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Columbia, Maryland, 21044
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Coral Springs, Florida, 33065
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Cumming, Georgia, 30041
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Dallas, Texas, 75220
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Dallas, Texas, 75243
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Danville, Virginia, 24541
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Daytona Beach, Florida, 32117
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Delaware, Ohio, 43015
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Doylestown, Pennsylvania, 18901
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Duluth, Minnesota, 55805
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Eagan, Minnesota, 55123
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Edison, New Jersey, 08837
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Elyria, Ohio, 44035
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Erie, Pennsylvania, 16508
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Evansville, Indiana, 47713
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Evansville, Indiana, 47715
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Evansville, Indiana, 47725
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Fall River, Massachusetts, 02720
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Fargo, North Dakota, 58103
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Flint, Michigan, 48504
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Flint, Michigan, 48532
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Fort Collins, Colorado, 80528
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Fort Lauderdale, Florida, 33308
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Fort Lauderdale, Florida, 33312
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Fort Worth, Texas, 76107
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Georgetown, Texas, 78626
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Golden, Colorado, 80401
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Grand Blanc, Michigan, 48439
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Grand Island, Nebraska, 68803
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Great Falls, Montana, 59405
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Green Cove Springs, Florida, 32043
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Greenbrae, California, 94904
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Greenfield, Indiana, 46140
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Greer, South Carolina, 29651
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Hammond, Louisiana, 70403
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Haverhill, Massachusetts, 01830
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Hickory, North Carolina, 28601
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Hollywood, Florida, 33021
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Honolulu, Hawaii, 96814
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Houston, Texas, 77025
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Houston, Texas, 77030
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Houston, Texas, 77074
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Houston, Texas, 77095
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Huntington Park, California, 90255
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Indiana, Pennsylvania, 15701
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Iowa City, Iowa, 52242
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Irving, Texas, 75039
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Jackson, Michigan, 49201
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Jacksonville, Florida, 32258
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Jacksonville Beach, Florida, 32250
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Johnstown, Pennsylvania, 15905
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Kalamazoo, Michigan, 49009
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Kalispell, Montana, 59901
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Kansas City, Missouri, 64111
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Katy, Texas, 77450
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Kingsport, Tennessee, 37660
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Kingwood, Texas, 77339
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Kittanning, Pennsylvania, 16201
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Knoxville, Tennessee, 37912
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La Mesa, California, 91942
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Lake Worth, Florida, 33461
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Lakeland, Florida, 33805
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Langhorne, Pennsylvania, 19047
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Largo, Florida, 33770
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Lee's Summit, Missouri, 64064
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Lenoir, North Carolina, 28645
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Lincoln, Nebraska, 68526
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Lomita, California, 90717
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Los Alamitos, California, 90720
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Los Angeles, California, 90022
Research Site
Los Angeles, California, 90067
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Louisville, Kentucky, 40205
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Madison, Wisconsin, 52713
Research Site
Madison, Wisconsin, 53719
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Manassas, Virginia, 20109
Research Site
Manassas, Virginia, 20110
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McAllen, Texas, 78503
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Memphis, Tennessee, 38163
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Mesa, Arizona, 85206
Research Site
Mesa, Arizona, 85213
Research Site
Methuen, Massachusetts, 01844
Research Site
Miami, Florida, 33125
Research Site
Miami, Florida, 33126
Research Site
Miami, Florida, 33144
Research Site
Miami, Florida, 33155
Research Site
Miami, Florida, 33175
Research Site
Miami, Florida, 33186
Research Site
Miami Beach, Florida, 33140
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Midland, Texas, 79707
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Milwaukee, Wisconsin, 53295
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Mobile, Alabama, 36608
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Monroe, North Carolina, 28110
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Montgomery, Alabama, 36106
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Muncie, Indiana, 47304
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Naples, Florida, 34102
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Natick, Massachusetts, 01760
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New Hyde Park, New York, 11042
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New Port Richey, Florida, 34653
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New York, New York, 10036
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Newark, Delaware, 19713
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Newark, New Jersey, 07103
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Newburgh, Indiana, 47630
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Newport Beach, California, 92663
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Norfolk, Virginia, 23502
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Northport, New York, 11768
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Norwalk, Connecticut, 06851
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Ocala, Florida, 34471
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Odessa, Texas, 79761
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Ogden, Utah, 84405
Research Site
Oklahoma City, Oklahoma, 73104
Research Site
Oklahoma City, Oklahoma, 73120
Research Site
Oklahoma City, Oklahoma, 73135
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Omaha, Nebraska, 68105
Research Site
Omaha, Nebraska, 68124
Research Site
Palm Beach Gardens, Florida, 33410
Research Site
Parma Hts., Ohio, 44130
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Pembroke Pines, Florida, 33025
Research Site
Pembroke Pines, Florida, 33029
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Pensacola, Florida, 32501
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Petoskey, Michigan, 49770
Research Site
Philadelphia, Pennsylvania, 19152
Research Site
Philadelphia, Pennsylvania, 19153
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Phoenix, Arizona, 85018
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Pittsburgh, Pennsylvania, 15240
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Plano, Texas, 75023
Research Site
Portland, Maine, 04101
Research Site
Poughkeepsie, New York, 12601
Research Site
Puyallup, Washington, 98372
Research Site
Reno, Nevada, 89502
Research Site
Richmond, Virginia, 23249
Research Site
Richmond, Virginia, 23836
Research Site
Rock Island, Illinois, 61201
Research Site
Rocky Mount, North Carolina, 27804
Research Site
Saint Cloud, Minnesota, 56303
Research Site
Salisbury, North Carolina, 28144
Research Site
Salt Lake City, Utah, 84102
Research Site
Salt Lake City, Utah, 84124
Research Site
San Antonio, Texas, 78249
Research Site
San Diego, California, 92103
Research Site
San Marino, California, 91108
Research Site
San Ramon, California, 94582
Research Site
Sandusky, Ohio, 44870
Research Site
Savannah, Georgia, 31406
Research Site
Seaford, Delaware, 19973
Research Site
Seattle, Washington, 98104
Research Site
Sellersville, Pennsylvania, 18960
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Shreveport, Louisiana, 71103
Research Site
Sioux Falls, South Dakota, 57108
Research Site
Slidell, Louisiana, 70458
Research Site
Somerset, New Jersey, 08873
Research Site
Southampton, New York, 11968
Research Site
Spokane, Washington, 99204
Research Site
Spokane, Washington, 99218
Research Site
Spring Hill, Florida, 34609
Research Site
Springfield, Ohio, 45504
Research Site
St Louis, Missouri, 63117
Research Site
St. Petersburg, Florida, 33709
Research Site
St. Petersburg, Florida, 33713
Research Site
Stamford, Connecticut, 06905
Research Site
Stony Brook, New York, 11794
Research Site
Stuart, Florida, 34996
Research Site
Tacoma, Washington, 98405
Research Site
Tampa, Florida, 33634
Research Site
Toledo, Ohio, 43606
Research Site
Tomball, Texas, 77375
Research Site
Topeka, Kansas, 66606
Research Site
Torrance, California, 90502
Research Site
Trinity, Florida, 34655
Research Site
Troy, Michigan, 48085
Research Site
Trumbull, Connecticut, 06611
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Tulsa, Oklahoma, 74104
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Tyler, Texas, 75701
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Tyrone, Pennsylvania, 16686
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Ventura, California, 93003
Research Site
Vero Beach, Florida, 32960
Research Site
Vista, California, 92083
Research Site
Voorhees Township, New Jersey, 08043
Research Site
Washington D.C., District of Columbia, 20037
Research Site
Waterbury, Connecticut, 06708
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Wausau, Wisconsin, 54401
Research Site
Wellington, Florida, 33449
Research Site
Westfield, New York, 14787
Research Site
Wilmington, Delaware, 19803
Research Site
Winston-Salem, North Carolina, 27103
Research Site
York, Pennsylvania, 17405

Other trials in United States

Canada50 sites

Research Site
Brampton, Ontario, L6S 0C6
Research Site
Brampton, Ontario, L6W 2X7
Research Site
Brampton, Ontario, L6Z 4N5
Research Site
Calgary, Alberta, T2H 2G4
Research Site
Calgary, Alberta, T2T 5C7
Research Site
Cambridge, Ontario, N1R 6V6
Research Site
Cambridge, Ontario, N1R 7L6
Research Site
Chicoutimi, Quebec, G7H 7K9
Research Site
Concord, Ontario, L4K 4M2
Research Site
Halifax, Nova Scotia, B3H 1V7
Research Site
Laval, Quebec, H7T 2P5
Research Site
Laval, H7M3L9
Research Site
Lévis, Quebec, G6V 4Z5
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London, Ontario, N5W 6A2
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London, Ontario, N6A 4V2
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London, Ontario, N6A 5A5
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London, Ontario, N6G 2M1
Research Site
Longueuil, Quebec, J4M 2X1
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Moncton, New Brunswick, E1G 1A7
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Montreal, Quebec, H1M 1B1
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Montreal, Quebec, H1T 1C8
Research Site
Montreal, Quebec, H2W 1R7
Research Site
Montreal, Quebec, H4A 3J1
Research Site
Mount Pearl, Newfoundland and Labrador, A1N 1W7
Research Site
New Westminster, British Columbia, V3L 3W5
Research Site
North York, Ontario, M3J 1N2
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Oakville, Ontario, L6M 1M1
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Oshawa, Ontario, L1J 2K1
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Pointe-Claire, Quebec, H9R 3J1
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Québec, Quebec, G1G 3Y8
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Québec, Quebec, G1N 4V3
Research Site
Québec, Quebec, G1V 4G2
Research Site
Québec, Quebec, G1V 4G5
Research Site
Regina, Saskatchewan, S4P 0W5
Research Site
Saint-Charles-Borromée, Quebec, J6E 6J2
Research Site
Saint-Georges, Quebec, G5Y 4T8
Research Site
Saskatoon, Saskatchewan, S7H 5M3
Research Site
Scarborough Village, Ontario, M1E 5E9
Research Site
Sherbrooke, Quebec, J1G 5K2
Research Site
Sherbrooke, Quebec, J1H 5N4
Research Site
Sherbrooke, Quebec, J1J 2E3
Research Site
Smiths Falls, Ontario, K7A 4W8
Research Site
St. John's, Newfoundland and Labrador, A1A 3R5
Research Site
Surrey, British Columbia, V3V 0C6
Research Site
Sydney Mines, Nova Scotia, B1V 2L2
Research Site
Terrebonne, Quebec, J6V 2H2
Research Site
Toronto, Ontario, M4G 3E8
Research Site
Toronto, Ontario, M5C 2T2
Research Site
Toronto, Ontario, M5T 3L9
Research Site
Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

Poland32 sites

Research Site
Biała Rawska, 96-230
Research Site
Bydgoszcz, 85-681
Research Site
Chrzanów, 32-500
Research Site
Gdansk, 80-858
Research Site
Gdansk, 80-952
Research Site
Gdynia, 81-423
Research Site
Giżycko, 11-500
Research Site
Katowice, 40-081
Research Site
Koluszki, 95-040
Research Site
Krakow, 31-121
Research Site
Krakow, 31-156
Research Site
Łęczna, 21-010
Research Site
Legnica, 59-220
Research Site
Lublin, 20-044
Research Site
Mrągowo, 11-700
Research Site
Nakło nad Notecią, 89-100
Research Site
Płock, 09-402
Research Site
Poznan, 61-289
Research Site
Poznan, 61655
Research Site
Ruda Śląska, 41-709
Research Site
Skierniewice, 96-100
Research Site
Sobótka, 55-050
Research Site
Sokółka, 16-100
Research Site
Torun, 87-100
Research Site
Warsaw, 02-679
Research Site
Warsaw, 03-973
Research Site
Węgrów, 07-100
Research Site
Wierzchosławice, 33-122
Research Site
Włocławek, 87-800
Research Site
Wroclaw, 50-403
Research Site
Wroclaw, 50-981
Research Site
Zabrze, 41-800

Other trials in Poland

Russia32 sites

Research Site
Arkhangelsk, 163001
Research Site
Chelyabinsk, 454091
Research Site
Chelyabinsk, 454106
Research Site
Ivanovo, 153012
Research Site
Izhevsk, 426063
Research Site
Kazan', 420012
Research Site
Kazan', 420029
Research Site
Moscow, 117292
Research Site
Moscow, 119034
Research Site
Moscow, 121552
Research Site
Moscow, 125367
Research Site
Moscow, 127473
Research Site
Moscow, 129110
Research Site
Moscow, 129301
Research Site
Nizhny Novgorod, 603018
Research Site
Novosibirsk, 630008
Research Site
Perm, 6144090
Research Site
Rostov-on-Don, 344022
Research Site
Saint Petersburg, 192148
Research Site
Saint Petersburg, 193312
Research Site
Saint Petersburg, 194044
Research Site
Saint Petersburg, 194354
Research Site
Saint Petersburg, 195257
Research Site
Saint Petersburg, 198217
Research Site
Saint Petersburg, 198328
Research Site
Saint Petersburg, 199106
Research Site
Saratov, 410053
Research Site
Tver', 170036
Research Site
Ufa, 450071
Research Site
Vladikavkaz, 362027
Research Site
Volgograd, 400005
Research Site
Yekaterinburg, 620039

Other trials in Russia

Hungary31 sites

Research Site
Ács, 2941
Research Site
Balatonfüred, 8230
Research Site
Ballasagyarmat, 2660
Research Site
Berettyóújfalu, 4100
Research Site
Budapest, 1032
Research Site
Budapest, 1096
Research Site
Budapest, 1106
Research Site
Budapest, 1125
Research Site
Budapest, 1135
Research Site
Budapest, 1171
Research Site
Budapest, 1212
Research Site
Cegléd, 2700
Research Site
Csongrád, 6640
Research Site
Debrecen, 4025
Research Site
Debrecen, 4031
Research Site
Debrecen, 4032
Research Site
Eger, 3300
Research Site
Esztergom, 2500
Research Site
Gyöngyös, 3200
Research Site
Győr, 9024
Research Site
Kecskemét, 6000
Research Site
Kistarcsa, 2143
Research Site
Komárom, 2921
Research Site
Mórahalom, 6782
Research Site
Nyíregyháza, 4400
Research Site
Polgár, 4090
Research Site
Sopron, 9400
Research Site
Székesfehérvár, 8000
Research Site
Szolnok, 5004
Research Site
Tát, 2534
Research Site
Zalaegerszeg, 8900

Other trials in Hungary

Czechia30 sites

Research Site
Beroun, 266 01
Research Site
Brno, 603 00
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Brno, 615 00
Research Site
Brno, 62500
Research Site
Brno, 656 91
Research Site
Cheb, 350 02
Research Site
Chomutov, 430 02
Research Site
Chrudim III, 537 01
Research Site
Hodonín, 695 01
Research Site
Hořovice, 268 01
Research Site
Hradec Králové, 500 05
Research Site
Jílové u Prahy, 254 01
Research Site
Kroměříž, 767 01
Research Site
Ostrava - Belsky Les, 700 30
Research Site
Ostrava - Dubina, 700 30
Research Site
Ostrava-Kunčice, 707 02
Research Site
Ostrava-Moravska, 702 00
Research Site
Pilsen, 30100
Research Site
Plzen - Severni Predmesti, 301 00
Research Site
Prague, 140 46
Research Site
Prague, 152 00
Research Site
Prague, 154 00
Research Site
Prague, 163 00
Research Site
Přelouč, 535 01
Research Site
Rakovník, 269 01
Research Site
Slaný, 274 01
Research Site
Teplice, 415 01
Research Site
Uherské Hradiště, 686 01
Research Site
Ústí nad Labem, 400 01
Research Site
Zlín, 760 01

Other trials in Czechia

Bulgaria27 sites

Research Site
Blagoevgrad, 2700
Research Site
Botevgrad, 2140
Research Site
Dimitrovgrad, 6400
Research Site
Dupnitsa, 2600
Research Site
Gotse Delchev, 2900
Research Site
Kozloduy, 3320
Research Site
Kyustendil, 2500
Research Site
Lukovit, 5770
Research Site
Petrich, 2900
Research Site
Pleven, 5800
Research Site
Plovdiv, 4000
Research Site
Rousse, 7002
Research Site
Sandanski, 2800
Research Site
Sevlievo, 5400
Research Site
Sliven, 8800
Research Site
Smolyan, 4700
Research Site
Sofia, 1202
Research Site
Sofia, 1223
Research Site
Sofia, 1303
Research Site
Sofia, 1324
Research Site
Sofia, 1407
Research Site
Sofia, 1431
Research Site
Sofia, 1606
Research Site
Sofia, 1632
Research Site
Sofia
Research Site
Stara Zagora, 6000
Research Site
Yambol, 8600

Other trials in Bulgaria

Mexico23 sites

Research Site
Acapulco, 39670
Research Site
Culiacán, 80230
Research Site
Del. Cuauhtemoc, 06700
Research Site
Distrito Federal, 07760
Research Site
Distrito Federal, 14000
Research Site
Guadalajara, 44150
Research Site
Guadalajara, 44160
Research Site
Guadalajara, 44600
Research Site
Guadalajara, 44670
Research Site
Meridas, 97070
Research Site
México, 11560
Research Site
México, 11850
Research Site
Monterrey, 64060
Research Site
Monterrey, 64460
Research Site
Monterrey, 64465
Research Site
Pachuca, 42090
Research Site
Querétaro, 76000
Research Site
San Luis Potosí City, 78200
Research Site
Tijuana, 22210
Research Site
Veracruz, 91900
Research Site
Xalapa, 91193
Research Site
Zapopan, 45116
Research Site
Zapopan, Jalisco, 45200

Other trials in Mexico

Netherlands23 sites

Research Site
Alkmaar, 1815JD
Research Site
Amsterdam, 1105 AZ
Research Site
Apeldoorn, 7334 DZ
Research Site
Arnhem, 6815 AD
Research Site
Breda, 4818 CK
Research Site
Delft, 2625 AD
Research Site
Ede, 6716 RP
Research Site
Eindhoven, 5631 BM
Research Site
Gouda, 2803 HH
Research Site
Groningen, 9728 NT
Research Site
Haarlem, 2035 RC
Research Site
Hardenberg, 7772 SE
Research Site
Heerlen, 6419 PC
Research Site
Hoogeveen, 7909 AA
Research Site
Nijmegen, 6532 SZ
Research Site
Rotterdam, 3039 BD
Research Site
Rotterdam, 3045 PM
Research Site
Sliedrecht, 3361 XV
Research Site
Sneek, 8601 ZR
Research Site
The Hague, 2597 AX
Research Site
Utrecht, 3584 CX
Research Site
Venlo, 5912 BL
Research Site
Zutphen, 7207 AE

Other trials in Netherlands

Romania23 sites

Research Site
Bacau, 600114
Research Site
Bacau, 600164
Research Site
Bucharest, 010507
Research Site
Bucharest, 011234
Research Site
Bucharest, 020042
Research Site
Bucharest, 020359
Research Site
Bucharest, 020475
Research Site
Bucharest, 020614
Research Site
Bucharest, 20048
Research Site
Cluj-Napoca, 400006
Research Site
Cluj-Napoca, 400353
Research Site
Constanța, 900675
Research Site
Galati, 800371
Research Site
Iași, 700400
Research Site
Iași, 700515
Research Site
Iași, 700613
Research Site
Iași, 700732
Research Site
Ploieşti, 100163
Research Site
Sibiu, 550371
Research Site
Târgu Mures, 540136
Research Site
Târgu Mureş, 540013
Research Site
Timișoara, 300125
Research Site
Zalău, 450129

Other trials in Romania

Slovakia22 sites

Research Site
Banská Bystrica, 97401
Research Site
Bratislava, 81108
Research Site
Bratislava, 83301
Research Site
Dolný Kubín, 02601
Research Site
Košice, 04001
Research Site
Košice, 04011
Research Site
Košice, 04022
Research Site
Levice, 934 01
Research Site
Lučenec, 98401
Research Site
Námestovo, 02901
Research Site
Nové Zámky, 94001
Research Site
Piešťany, 92101
Research Site
Poprad, 058 01
Research Site
Považská Bystrica, 01701
Research Site
Prievidza, 97101
Research Site
Rimavská Sobota, 97901
Research Site
Sabinov, 083 01
Research Site
Šaľa, 927 01
Research Site
Trebišov, 07501
Research Site
Trenčín, 91101
Research Site
Vrútky, 038 61
Research Site
Žilina, 01001

Other trials in Slovakia

South Korea19 sites

Research Site
Bucheon-si, 420-717
Research Site
Busan, 47392
Research Site
Cheongju-si, 28644
Research Site
Daegu, 705-718
Research Site
Daejeon, 301721
Research Site
Goyang-si, 10444
Research Site
Gyeonggi-do, 11923
Research Site
Jeonju-si, Jeollabuk-do, 561-71
Research Site
Junggu, 41944
Research Site
Seongnam-si, 13620
Research Site
Seoul, 02841
Research Site
Seoul, 03080
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Seoul, 03722
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Seoul, 05505
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Seoul, 06591
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Seoul, 110746
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Seoul, 135710
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Suwon, 16499
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Uijeongbu-si, 480717

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Argentina18 sites

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Buenos Aires, 1205
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Buenos Aires, C1425AGC
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CABA, C1093AAS
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Ciudad Autonoma Buenos Aires, C1181ACH
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Ciudad Autonoma de Buenos Aire, C1120AAC
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Córdoba, 5000
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Córdoba, X5006CBI
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Córdoba, X5008HHW
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La Plata, 1900
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La Plata, B1902COS
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Lanus, B1824KAJ
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Mar del Plata, 7600
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Mar del Plata, B7600FZN
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Ramos Mejía, B1704ETD
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Rosario, S2000CVD
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Rosario, S2000DNM
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San Nicolás, B2900DMH
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Santa Fe, S3000FWO

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Philippines18 sites

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Bacolod, 6100
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Cebu City, 6000
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Dasmariñas, 4114
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Iloilo City, 5000
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Lipa City, 4217
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Makati City, 1218
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Mandaluyong, 1554
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Manila, 1000
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Manila, 1003
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Manila, 1008
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Marikina City, 1810
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Pasay, 1300
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Pasig, 1605
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Quezon City, 1100
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Quezon City, 1101
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Quezon City, 1104
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Quezon City, 1112
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Tanauan, 4232

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South Africa17 sites

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Alberton, 1450
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Benoni, 1500
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Cape Town, 7405
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Cape Town, 7500
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Cape Town, 7505
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Diepkloof, Soweto, 2013
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Durban, 4001
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Durban, 4052
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Goodwood, 7460
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Houghton Estate, 2198
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Muckleneuk, 0002
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Parktown, 2193
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Phoenix, 4068
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Somerset West, 7130
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Verulam, 4345
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Worcester, 6850

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Australia16 sites

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Adelaide - Oaklands Park, 5046
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Ashford, 5035
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Box Hill, 3128
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Camperdown, 2050
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Darlinghurst, 2010
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Fullarton, 5063
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Garran, 2605
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Geelong, 3220
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Heidelberg West, 3081
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Herston, 4029
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Joondalup, 6027
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Maroubra, 2035
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Melbourne, 3004
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Milton, 4064
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Murdoch, 6150
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Wollongong, 2500

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Sweden16 sites

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Borås, 506 30
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Eksjö, 57535
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Finspång, 612 37
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Gothenburg, 41345
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Gothenburg, 41685
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Järfälla, 177 30
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Linköping, 589 29
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Lund, 222 21
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Malmö, 21152
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Östersund, 831 83
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Rättvik, 79530
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Stockholm, 111 57
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Stockholm, 117 28
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Stockholm, 171 76
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Umeå, 907 36
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Vällingby, 162 68

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United Kingdom15 sites

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Addlestone, KT15 2BH
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Aylesbury, HP22 5LB
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Bath, BA3 2UH
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Belfast, BT13 3BW
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Belfast, BT7 2EB
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Blackpool, FY4 3AD
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Canterbury, CT1 3HX
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Corsham, SN13 9DL
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Coventry, CV6 4DD
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Glasgow, G69 7AD
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Irvine, KA12 0AY
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Leicester, LE10 2SE
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Mortimer Reading, RG7 3SQ
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Sheffield, S35 9XQ
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Whitstable, CT5 3SE

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Belgium14 sites

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Aalst, 9300
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Antwerp, 2060
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Bonheiden, 2820
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Brasschaat, 2930
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Bruges, 8000
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Brussels, 1070
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Edegem, 2650
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Leuven, 3000
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Liège, 4000
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Mechelen, 2800
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Merksem, 2170
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Roeselare, 8800
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Tienen, 3300
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Turnhout, 2300

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Germany14 sites

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Aschaffenburg, 63739
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Bad Mergentheim, 97980
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Bad Oeynhausen, 32545
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Berlin, 10115
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Berlin, 12559
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Berlin, 13347
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Cologne, 51069
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Dippoldiswalde, 01744
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Freiburg im Breisgau, 79106
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Hamburg, 22391
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Kassel, 34121
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Leipzig, 04103
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München, 80333
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Villingen-Schwenningen, 78048

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Italy14 sites

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Bergamo, 24100
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Florence, 50141
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Milan, 20132
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Milan, 20138
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Milan, 20162
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Naples, 80131
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Negrar - VR, 37024
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Padova, 35128
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Parma, 43100
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Pavia, 27100
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Rozzano, 20089
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S Maria Capua Vetere, 81055
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Sessa Aurunca, 81037
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Verona, 37126

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Israel13 sites

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Afula, 18101
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Ashkelon, 78278
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Beersheba, 84350
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Bnei Barak, 5136166
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Hadera, 38100
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Haifa, 31096
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Haifa, 34362
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Haifa, 35152
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Holon, 58100
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Jerusalem, 91120
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Jerusalem, 93106
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Nahariya, 22100
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Petah Tikva, 49100

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Ukraine13 sites

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Dnipro, 49006
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Dnipropetrovsk, 49038
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Donetsk, 83003
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Kharkiv, 61018
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Kharkiv, 61176
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Kiev, 02176
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Kiev, 03015
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Kyiv, 01601
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Kyiv, 04114
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Vinnytsia, 21001
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Vynnitsa, 21018
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Zaporizhzhya, 69001
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Zaporizhzhya, 69118

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Brazil12 sites

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Belo Horizonte, 30150-240
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Brasília, 71625-175
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Campina Grande do Sul, 83430000
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Campinas, 13010-001
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Campinas, 13060-904
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Marília, 17515-000
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Porto Alegre, 90035-003
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São José do Rio Preto, 15090-000
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São José dos Campos, 12243-280
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São Paulo, 01228-000
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São Paulo, 01228-200
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São Paulo, 05403-000

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China12 sites

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Beijing, 100044
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Beijing, 100096
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Changsha, 410011
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Guangzhou, 510080
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Guangzhou, 510630
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Hefei, 230022
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Jinan, 250013
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Nanchang, 330006
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Nanjing, 210012
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Tianjin, 300211

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Japan11 sites

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Bunkyō City, 113-8655
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Daito-shi, 574-0074
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Kasuga-shi, 816-0864
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Kobe, 655-0017
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Kumamoto, 860-8556
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Matsubara-shi, 580-0032
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Saga, 849-8501
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Uji-shi, 611-0041
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Yokohama, 236-0004

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Thailand11 sites

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Nakhon Ratchasima, 30000
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Rajthevi, 10400
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Ratchaburi, 70000
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Ratchathewi, 10400

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France10 sites

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Dijon, 21079
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Le Creusot, 71206
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Spain10 sites

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Turkey (Türkiye)7 sites

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Taiwan6 sites

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India5 sites

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Vietnam4 sites

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Hanoi, 100000
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Ho Chi Minh City, 700000
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Ho Chi Minh City, 70000
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Hong Kong3 sites

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Causeway Bay
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About this study

Official title: 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

Conditions: Diabetes Mellitus, Non-Insulin-Dependent, High Risk for Cardiovascular Event
Being tested: Dapagliflozin 10 mg, Placebo tablet
Keywords: Phase IIIb, T2DM, cardiovascular events
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dapagliflozin 10 mgDrug
Oral dose (od)
Placebo tabletDrug
Oral dose (od)

Study groups in NCT01730534
Study group	Role	What they receive
Dapagliflozin	Experimental	Dapagliflozin + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors Receives: Drug: Dapagliflozin 10 mg
Placebo	Placebo comparator	Placebo + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors Receives: Drug: Placebo tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Subjects Included in the Composite Endpoint of CV Death, MI or Ischemic Stroke
Safety and co-primary efficacy
Measured: up to 5.2 years
Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.
Co-primary efficacy
Measured: 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.
Secondary
Measured: up to 5.2 years
Subjects Included in the Endpoint of All-cause Mortality.
Secondary
Measured: up to 5.2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Apr 201311 Sep 2018

First posted21 Nov 2012 (estimated)
Study start25 Apr 2013
Primary completion11 Sep 2018
Study completion11 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (27)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Non-Insulin-DependentStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 17,190 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01730534
Sponsor's protocol ID: D1693C00001
Acronym: DECLARE-TIMI58
Status last verified: Nov 2019
First submitted: 15 Nov 2012
Last updated: 26 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Small AM, Berg DD, Raz I, Jarolim P, Goodrich EL, Moura FA, Mosenzon O, Cahn A, Bhatt DL, Dwyer JP, Leiter LA, Wilding JPH, Gause-Nilsson I, Sabatine MS, Morrow DA, Wiviott SD. Comparative risk assessment of cardiovascular and kidney outcomes in patients with type 2 diabetes using cystatin C and creatinine in DECLARE-TIMI 58. Am Heart J Plus. 2026 Oct 5;71:100929. doi: 10.1016/j.ahjo.2026.100929. eCollection 2026 Nov.
PubMed 42935495
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.
PubMed 40952180
Natale 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.
PubMed 38770818
Schechter 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.
PubMed 36878239
Zelniker 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.
PubMed 36857035
Mosenzon 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.
PubMed 35997319
Oyama 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.
PubMed 35857296
Furtado 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.
PubMed 35510542
Cahn 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.
PubMed 35015847
Oyama 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.
PubMed 34427295
Mosenzon 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.
PubMed 34233928
Cherney 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.
PubMed 34129237
Zelniker 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.
PubMed 33851953
Cahn 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.
PubMed 33653824
O'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.
PubMed 33611623

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01730534
Acronym / sponsor ID: DECLARE-TIMI58 / D1693C00001
Conditions: Diabetes Mellitus, Non-Insulin-Dependent, High Risk for Cardiovascular Event
Keywords: Phase IIIb, T2DM, cardiovascular events
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 17,190 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Bristol-Myers Squibb, The TIMI Study Group, Hadassah Medical Organization
Study start: 25 Apr 2013 (actual)
Primary completion: 11 Sep 2018 (actual)
Study completion: 11 Sep 2018 (actual)
First posted: 21 Nov 2012 (estimated)
Results: Posted 26 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Dapagliflozin	Experimental	Drug: Dapagliflozin 10 mgDapagliflozin + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors
Placebo	Placebo comparator	Drug: Placebo tabletPlacebo + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors

Who may qualify

Ages: 40 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dapagliflozin 10 mgOral dose (od)	Drug	Dapagliflozin
Placebo tabletOral dose (od)	Drug	Placebo

Primary outcome

Subjects Included in the Composite Endpoint of CV Death, MI or Ischemic Stroke
Time frame: up to 5.2 years
Safety and co-primary efficacy
Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.
Time frame: up to 5.2 years
Co-primary efficacy

2 secondary outcomes

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.
Time frame: up to 5.2 years
Subjects Included in the Endpoint of All-cause Mortality.
Time frame: up to 5.2 years

Results and safety

Results posted to the registry on 26 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dapa 10 mg	8,582	8,473
Placebo	8,578	8,433

Primary outcome: Subjects Included in the Composite Endpoint of CV Death, MI or Ischemic Stroke

Time frame: up to 5.2 years. Count of participants. Unit: Participants

Measure	Dapa 10 mg n = 8582	Placebo n = 8578
Number of patients with an event	756	803

Dapa 10 mg vs Placebo: Hazard Ratio (HR): 0.93 (95% CI 0.84 to 1.03), p = 0.172, Regression, Cox

Primary outcome: Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.

Time frame: up to 5.2 years. Count of participants. Unit: Participants

Measure	Dapa 10 mg n = 8582	Placebo n = 8578
Number of patients with an event	417	496

Dapa 10 mg vs Placebo: Hazard Ratio (HR): 0.83 (95% CI 0.73 to 0.95), p = 0.005, Regression, Cox

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 5.2 years. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dapa 10 mg	3,205 of 8,574 (37.4%)	268 of 8,574 (3.1%)	529 of 8,582
Placebo	3,418 of 8,569 (39.9%)	342 of 8,569 (4%)	570 of 8,578

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42935495Small AM, Berg DD, Raz I, Jarolim P, Goodrich EL, Moura FA, Mosenzon O, Cahn A, Bhatt DL, Dwyer JP, Leiter LA, Wilding JPH, Gause-Nilsson I, Sabatine MS, Morrow DA, Wiviott SD. Comparative risk assessment of cardiovascular and kidney outcomes in patients with type 2 diabetes using cystatin C and creatinine in DECLARE-TIMI 58. Am Heart J Plus. 2026 Oct 5;71:100929. doi: 10.1016/j.ahjo.2026.100929. eCollection 2026 Nov.
Derived from this study: PubMed 40952180Haller 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.
Derived from this study: PubMed 38770818Natale 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.
Derived from this study: PubMed 36878239Schechter 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.
Derived from this study: PubMed 36857035Zelniker 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.
Derived from this study: PubMed 35997319Mosenzon 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.
Derived from this study: PubMed 35857296Oyama 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.
Derived from this study: PubMed 35510542Furtado 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.
Derived from this study: PubMed 35015847Cahn 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.
Derived from this study: PubMed 34427295Oyama 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.
Derived from this study: PubMed 34233928Mosenzon 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.
Derived from this study: PubMed 34129237Cherney 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.
CSP redactedLink provided by the sponsor.
SAP redactedLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anna Maria Langkilde, MD study director

AstraZeneca Sweden

Marc S Sabatine, MD, MPH study chair

TIMI Study Group, Boston, MA, USA

Itamar Raz, MD principal investigator

Hadassah Medical Organization

805 sites in 34 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dapagliflozin 10 mg in people with Diabetes Mellitus, Non-Insulin-Dependent and High Risk for Cardiovascular Event, run by AstraZeneca at 805 sites in 34 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 805 sites in United States, Canada, Poland, Russia, Hungary and 29 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjects Included in the Composite Endpoint of CV Death, MI or Ischemic Stroke (time frame: up to 5.2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01730534, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2019.