Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events
Part of paid clinical trials in Alexander City, Alabama.
- Sponsor
- AstraZeneca
- Study ID
- NCT01730534
- Phase
- PHASE3
- Status
- Completed
Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- High Risk for Cardiovascular Event
Eligibility Criteria
- Sex
- ALL
- Age
- 40 Years - 130 Years
- Healthy Volunteers
- Not accepted
Interventions
- Dapagliflozin 10 mg — DRUGOral dose (od)
- Placebo tablet — DRUGOral dose (od)
Study Details
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.
Key Dates
- Start date
- Apr 25, 2013
- Status verified
- Nov 2019
- Primary completion
- Sep 11, 2018
- Completion
- Sep 11, 2018
Study Design
- Enrollment
- 17,190 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: DapagliflozinDapagliflozin + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors
- Placebo Comparator: PlaceboPlacebo + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors
Primary Outcome Measure
Subjects Included in the Composite Endpoint of CV Death, MI or Ischemic Stroke [ Time Frame: up to 5.2 years ]
Locations (234)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Research Site | Alexander City | Alabama | 35010 | - |
| Research Site | Athens | Alabama | 35611 | - |
| Research Site | Birmingham | Alabama | 35243 | - |
| Research Site | Birmingham | Alabama | 35294 | - |
| Research Site | Mobile | Alabama | 36608 | - |
| Research Site | Montgomery | Alabama | 36106 | - |
| Research Site | Mesa | Arizona | 85206 | - |
| Research Site | Mesa | Arizona | 85213 | - |
| Research Site | Phoenix | Arizona | 85018 | - |
| Research Site | Alhambra | California | 91801 | - |
| Research Site | Bakersfield | California | 93308 | - |
| Research Site | Greenbrae | California | 94904 | - |
| Research Site | Huntington Park | California | 90255 | - |
| Research Site | La Mesa | California | 91942 | - |
| Research Site | Lomita | California | 90717 | - |
| Research Site | Los Alamitos | California | 90720 | - |
| Research Site | Los Angeles | California | 90022 | - |
| Research Site | Los Angeles | California | 90067 | - |
| Research Site | Newport Beach | California | 92663 | - |
| Research Site | San Diego | California | 92103 | - |
| Research Site | San Marino | California | 91108 | - |
| Research Site | San Ramon | California | 94582 | - |
| Research Site | Torrance | California | 90502 | - |
| Research Site | Ventura | California | 93003 | - |
| Research Site | Vista | California | 92083 | - |
| Research Site | Fort Collins | Colorado | 80528 | - |
| Research Site | Golden | Colorado | 80401 | - |
| Research Site | Bridgeport | Connecticut | 06610 | - |
| Research Site | Bristol | Connecticut | 06010 | - |
| Research Site | Norwalk | Connecticut | 06851 | - |
| Research Site | Stamford | Connecticut | 06905 | - |
| Research Site | Trumbull | Connecticut | 06611 | - |
| Research Site | Waterbury | Connecticut | 06708 | - |
| Research Site | Newark | Delaware | 19713 | - |
| Research Site | Seaford | Delaware | 19973 | - |
| Research Site | Wilmington | Delaware | 19803 | - |
| Research Site | Washington D.C. | District of Columbia | 20037 | - |
| Research Site | Bradenton | Florida | 34201 | - |
| Research Site | Chiefland | Florida | 32626 | - |
| Research Site | Clearwater | Florida | 33756 | - |
| Research Site | Coral Springs | Florida | 33065 | - |
| Research Site | Daytona Beach | Florida | 32117 | - |
| Research Site | Fort Lauderdale | Florida | 33308 | - |
| Research Site | Fort Lauderdale | Florida | 33312 | - |
| Research Site | Green Cove Springs | Florida | 32043 | - |
| Research Site | Hollywood | Florida | 33021 | - |
| Research Site | Jacksonville | Florida | 32258 | - |
| Research Site | Jacksonville Beach | Florida | 32250 | - |
| Research Site | Lake Worth | Florida | 33461 | - |
| Research Site | Lakeland | Florida | 33805 | - |
| Research Site | Largo | Florida | 33770 | - |
| 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 | - |
| Research Site | Naples | Florida | 34102 | - |
| Research Site | New Port Richey | Florida | 34653 | - |
| Research Site | Ocala | Florida | 34471 | - |
| Research Site | Palm Beach Gardens | Florida | 33410 | - |
| Research Site | Pembroke Pines | Florida | 33025 | - |
| Research Site | Pembroke Pines | Florida | 33029 | - |
| Research Site | Pensacola | Florida | 32501 | - |
| Research Site | Spring Hill | Florida | 34609 | - |
| Research Site | St. Petersburg | Florida | 33709 | - |
| Research Site | St. Petersburg | Florida | 33713 | - |
| Research Site | Stuart | Florida | 34996 | - |
| Research Site | Tampa | Florida | 33634 | - |
| Research Site | Trinity | Florida | 34655 | - |
| Research Site | Vero Beach | Florida | 32960 | - |
| Research Site | Wellington | Florida | 33449 | - |
| Research Site | Atlanta | Georgia | 30308 | - |
| Research Site | Calhoun | Georgia | 30701 | - |
| Research Site | Cumming | Georgia | 30041 | - |
| Research Site | Savannah | Georgia | 31406 | - |
| Research Site | Honolulu | Hawaii | 96814 | - |
| Research Site | Coeur d'Alene | Idaho | 83814 | - |
| Research Site | Arlington Heights | Illinois | 60005 | - |
| Research Site | Chicago | Illinois | 60607 | - |
| Research Site | Chicago | Illinois | 60611 | - |
| Research Site | Rock Island | Illinois | 61201 | - |
| Research Site | Anderson | Indiana | 46011 | - |
| Research Site | Avon | Indiana | 46123 | - |
| Research Site | Bloomington | Indiana | 47403 | - |
| Research Site | Evansville | Indiana | 47713 | - |
| Research Site | Evansville | Indiana | 47715 | - |
| Research Site | Evansville | Indiana | 47725 | - |
| Research Site | Greenfield | Indiana | 46140 | - |
| Research Site | Muncie | Indiana | 47304 | - |
| Research Site | Newburgh | Indiana | 47630 | - |
| Research Site | Iowa City | Iowa | 52242 | - |
| Research Site | Topeka | Kansas | 66606 | - |
| Research Site | Louisville | Kentucky | 40205 | - |
| Research Site | Alexandria | Louisiana | 71301 | - |
| Research Site | Hammond | Louisiana | 70403 | - |
| Research Site | Shreveport | Louisiana | 71103 | - |
| Research Site | Slidell | Louisiana | 70458 | - |
| Research Site | Auburn | Maine | 04210 | - |
| Research Site | Bangor | Maine | 04401 | - |
| Research Site | Biddeford | Maine | 04005 | - |
| Research Site | Portland | Maine | 04101 | - |
| Research Site | Baltimore | Maryland | 21218 | - |
| Research Site | Baltimore | Maryland | 21229 | - |
| Research Site | Beltsville | Maryland | 20705 | - |
| Research Site | Columbia | Maryland | 21044 | - |
| Research Site | Boston | Massachusetts | 02115 | - |
| Research Site | Fall River | Massachusetts | 02720 | - |
| Research Site | Haverhill | Massachusetts | 01830 | - |
| Research Site | Methuen | Massachusetts | 01844 | - |
| Research Site | Natick | Massachusetts | 01760 | - |
| Research Site | Alpena | Michigan | 49707 | - |
| Research Site | Flint | Michigan | 48504 | - |
| Research Site | Flint | Michigan | 48532 | - |
| Research Site | Grand Blanc | Michigan | 48439 | - |
| Research Site | Jackson | Michigan | 49201 | - |
| Research Site | Kalamazoo | Michigan | 49009 | - |
| Research Site | Petoskey | Michigan | 49770 | - |
| Research Site | Troy | Michigan | 48085 | - |
| Research Site | Duluth | Minnesota | 55805 | - |
| Research Site | Eagan | Minnesota | 55123 | - |
| Research Site | Saint Cloud | Minnesota | 56303 | - |
| Research Site | Kansas City | Missouri | 64111 | - |
| Research Site | Lee's Summit | Missouri | 64064 | - |
| Research Site | St Louis | Missouri | 63117 | - |
| Research Site | Billings | Montana | 59102 | - |
| Research Site | Great Falls | Montana | 59405 | - |
| Research Site | Kalispell | Montana | 59901 | - |
| Research Site | Grand Island | Nebraska | 68803 | - |
| Research Site | Lincoln | Nebraska | 68526 | - |
| Research Site | Omaha | Nebraska | 68105 | - |
| Research Site | Omaha | Nebraska | 68124 | - |
| Research Site | Reno | Nevada | 89502 | - |
| Research Site | Edison | New Jersey | 08837 | - |
| Research Site | Newark | New Jersey | 07103 | - |
| Research Site | Somerset | New Jersey | 08873 | - |
| Research Site | Voorhees Township | New Jersey | 08043 | - |
| Research Site | Albuquerque | New Mexico | 87102 | - |
| Research Site | Buffalo | New York | 14215 | - |
| Research Site | New Hyde Park | New York | 11042 | - |
| Research Site | New York | New York | 10036 | - |
| Research Site | Northport | New York | 11768 | - |
| Research Site | Poughkeepsie | New York | 12601 | - |
| Research Site | Southampton | New York | 11968 | - |
| Research Site | Stony Brook | New York | 11794 | - |
| Research Site | Westfield | New York | 14787 | - |
| Research Site | Asheville | North Carolina | 28803 | - |
| Research Site | Burlington | North Carolina | 27215 | - |
| Research Site | Charlotte | North Carolina | 28209 | - |
| Research Site | Hickory | North Carolina | 28601 | - |
| Research Site | Lenoir | North Carolina | 28645 | - |
| Research Site | Monroe | North Carolina | 28110 | - |
| Research Site | Rocky Mount | North Carolina | 27804 | - |
| Research Site | Salisbury | North Carolina | 28144 | - |
| Research Site | Winston-Salem | North Carolina | 27103 | - |
| Research Site | Bismarck | North Dakota | 58501 | - |
| Research Site | Fargo | North Dakota | 58103 | - |
| Research Site | Canal Fulton | Ohio | 44614 | - |
| Research Site | Cincinnati | Ohio | 45219 | - |
| Research Site | Cleveland | Ohio | 44126 | - |
| Research Site | Delaware | Ohio | 43015 | - |
| Research Site | Elyria | Ohio | 44035 | - |
| Research Site | Parma Hts. | Ohio | 44130 | - |
| Research Site | Sandusky | Ohio | 44870 | - |
| Research Site | Springfield | Ohio | 45504 | - |
| Research Site | Toledo | Ohio | 43606 | - |
| Research Site | Oklahoma City | Oklahoma | 73104 | - |
| Research Site | Oklahoma City | Oklahoma | 73120 | - |
| Research Site | Oklahoma City | Oklahoma | 73135 | - |
| Research Site | Tulsa | Oklahoma | 74104 | - |
| Research Site | Altoona | Pennsylvania | 16602 | - |
| Research Site | Bethlehem | Pennsylvania | 18015 | - |
| Research Site | Camp Hill | Pennsylvania | 17011 | - |
| Research Site | Doylestown | Pennsylvania | 18901 | - |
| Research Site | Erie | Pennsylvania | 16508 | - |
| Research Site | Indiana | Pennsylvania | 15701 | - |
| Research Site | Johnstown | Pennsylvania | 15905 | - |
| Research Site | Kittanning | Pennsylvania | 16201 | - |
| Research Site | Langhorne | Pennsylvania | 19047 | - |
| Research Site | Philadelphia | Pennsylvania | 19152 | - |
| Research Site | Philadelphia | Pennsylvania | 19153 | - |
| Research Site | Pittsburgh | Pennsylvania | 15240 | - |
| Research Site | Sellersville | Pennsylvania | 18960 | - |
| Research Site | Tyrone | Pennsylvania | 16686 | - |
| Research Site | York | Pennsylvania | 17405 | - |
| Research Site | Charleston | South Carolina | 29425 | - |
| Research Site | Greer | South Carolina | 29651 | - |
| Research Site | Sioux Falls | South Dakota | 57108 | - |
| Research Site | Bristol | Tennessee | 37620 | - |
| Research Site | Kingsport | Tennessee | 37660 | - |
| Research Site | Knoxville | Tennessee | 37912 | - |
| Research Site | Memphis | Tennessee | 38163 | - |
| Research Site | Arlington | Texas | 76014 | - |
| Research Site | Carrollton | Texas | 75101 | - |
| Research Site | Dallas | Texas | 75220 | - |
| Research Site | Dallas | Texas | 75243 | - |
| Research Site | Fort Worth | Texas | 76107 | - |
| Research Site | Georgetown | Texas | 78626 | - |
| Research Site | Houston | Texas | 77025 | - |
| Research Site | Houston | Texas | 77030 | - |
| Research Site | Houston | Texas | 77074 | - |
| Research Site | Houston | Texas | 77095 | - |
| Research Site | Irving | Texas | 75039 | - |
| Research Site | Katy | Texas | 77450 | - |
| Research Site | Kingwood | Texas | 77339 | - |
| Research Site | McAllen | Texas | 78503 | - |
| Research Site | Midland | Texas | 79707 | - |
| Research Site | Odessa | Texas | 79761 | - |
| Research Site | Plano | Texas | 75023 | - |
| Research Site | San Antonio | Texas | 78249 | - |
| Research Site | Tomball | Texas | 77375 | - |
| Research Site | Tyler | Texas | 75701 | - |
| Research Site | Ogden | Utah | 84405 | - |
| Research Site | Salt Lake City | Utah | 84102 | - |
| Research Site | Salt Lake City | Utah | 84124 | - |
| Research Site | Bennington | Vermont | 05201 | - |
| Research Site | Burke | Virginia | 22015 | - |
| Research Site | Danville | Virginia | 24541 | - |
| Research Site | Manassas | Virginia | 20109 | - |
| Research Site | Manassas | Virginia | 20110 | - |
| Research Site | Norfolk | Virginia | 23502 | - |
| Research Site | Richmond | Virginia | 23249 | - |
| Research Site | Richmond | Virginia | 23836 | - |
| Research Site | Burien | Washington | 98166 | - |
| Research Site | Puyallup | Washington | 98372 | - |
| Research Site | Seattle | Washington | 98104 | - |
| Research Site | Spokane | Washington | 99204 | - |
| Research Site | Spokane | Washington | 99218 | - |
| Research Site | Tacoma | Washington | 98405 | - |
| Research Site | Madison | Wisconsin | 52713 | - |
| Research Site | Madison | Wisconsin | 53719 | - |
| Research Site | Milwaukee | Wisconsin | 53295 | - |
| Research Site | Wausau | Wisconsin | 54401 | - |