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

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

Sponsors

Lead Sponsor: AstraZeneca

Collaborator: Bristol-Myers Squibb
The TIMI Study Group
Hadassah Medical Organization

Source AstraZeneca
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.

Overall Status Completed
Start Date 2013-04-25
Completion Date 2018-09-11
Primary Completion Date 2018-09-11
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Subjects Included in the Composite Endpoint of CV Death, MI or Ischemic Stroke up to 5.2 years
Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure. up to 5.2 years
Secondary Outcome
Measure Time Frame
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
Enrollment 17190
Condition
Intervention

Intervention Type: Drug

Intervention Name: Dapagliflozin 10 mg

Description: Oral dose (od)

Arm Group Label: Dapagliflozin

Intervention Type: Drug

Intervention Name: Placebo tablet

Description: Oral dose (od)

Arm Group Label: Placebo

Eligibility

Criteria:

Inclusion Criteria: - 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 Exclusion Criteria: - 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

Gender:

All

Minimum Age:

40 Years

Maximum Age:

130 Years

Healthy Volunteers:

No

Overall Official
Location
Facility:
Research Site | Alexander City, Alabama, 35010, United States
Research Site | Athens, Alabama, 35611, United States
Research Site | Birmingham, Alabama, 35243, United States
Research Site | Birmingham, Alabama, 35294, United States
Research Site | Mobile, Alabama, 36608, United States
Research Site | Montgomery, Alabama, 36106, United States
Research Site | Mesa, Arizona, 85206, United States
Research Site | Mesa, Arizona, 85213, United States
Research Site | Phoenix, Arizona, 85018, United States
Research Site | Alhambra, California, 91801, United States
Research Site | Bakersfield, California, 93308, United States
Research Site | Greenbrae, California, 94904, United States
Research Site | Huntington Park, California, 90255, United States
Research Site | La Mesa, California, 91942, United States
Research Site | Lomita, California, 90717, United States
Research Site | Los Alamitos, California, 90720, United States
Research Site | Los Angeles, California, 90022, United States
Research Site | Los Angeles, California, 90067, United States
Research Site | Newport Beach, California, 92663, United States
Research Site | San Diego, California, 92103, United States
Research Site | San Marino, California, 91108, United States
Research Site | San Ramon, California, 94582, United States
Research Site | Torrance, California, 90502, United States
Research Site | Ventura, California, 93003, United States
Research Site | Vista, California, 92083, United States
Research Site | Fort Collins, Colorado, 80528, United States
Research Site | Golden, Colorado, 80401, United States
Research Site | Bridgeport, Connecticut, 06610, United States
Research Site | Bristol, Connecticut, 06010, United States
Research Site | Norwalk, Connecticut, 06851, United States
Research Site | Stamford, Connecticut, 06905, United States
Research Site | Trumbull, Connecticut, 06611, United States
Research Site | Waterbury, Connecticut, 06708, United States
Research Site | Newark, Delaware, 19713, United States
Research Site | Seaford, Delaware, 19973, United States
Research Site | Wilmington, Delaware, 19803, United States
Research Site | Washington, District of Columbia, 20037, United States
Research Site | Bradenton, Florida, 34201, United States
Research Site | Chiefland, Florida, 32626, United States
Research Site | Clearwater, Florida, 33756, United States
Research Site | Coral Springs, Florida, 33065, United States
Research Site | Daytona Beach, Florida, 32117, United States
Research Site | Fort Lauderdale, Florida, 33308, United States
Research Site | Fort Lauderdale, Florida, 33312, United States
Research Site | Green Cove Springs, Florida, 32043, United States
Research Site | Hollywood, Florida, 33021, United States
Research Site | Jacksonville Beach, Florida, 32250, United States
Research Site | Jacksonville, Florida, 32258, United States
Research Site | Lake Worth, Florida, 33461, United States
Research Site | Lakeland, Florida, 33805, United States
Research Site | Largo, Florida, 33770, United States
Research Site | Miami Beach, Florida, 33140, United States
Research Site | Miami, Florida, 33125, United States
Research Site | Miami, Florida, 33126, United States
Research Site | Miami, Florida, 33144, United States
Research Site | Miami, Florida, 33155, United States
Research Site | Miami, Florida, 33175, United States
Research Site | Miami, Florida, 33186, United States
Research Site | Naples, Florida, 34102, United States
Research Site | New Port Richey, Florida, 34653, United States
Research Site | Ocala, Florida, 34471, United States
Research Site | Palm Beach Gardens, Florida, 33410, United States
Research Site | Pembroke Pines, Florida, 33025, United States
Research Site | Pembroke Pines, Florida, 33029, United States
Research Site | Pensacola, Florida, 32501, United States
Research Site | Saint Petersburg, Florida, 33709, United States
Research Site | Saint Petersburg, Florida, 33713, United States
Research Site | Spring Hill, Florida, 34609, United States
Research Site | Stuart, Florida, 34996, United States
Research Site | Tampa, Florida, 33634, United States
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Research Site | Rock Island, Illinois, 61201, United States
Research Site | Anderson, Indiana, 46011, United States
Research Site | Avon, Indiana, 46123, United States
Research Site | Bloomington, Indiana, 47403, United States
Research Site | Evansville, Indiana, 47713, United States
Research Site | Evansville, Indiana, 47715, United States
Research Site | Evansville, Indiana, 47725, United States
Research Site | Greenfield, Indiana, 46140, United States
Research Site | Muncie, Indiana, 47304, United States
Research Site | Newburgh, Indiana, 47630, United States
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Research Site | Topeka, Kansas, 66606, United States
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Research Site | Portland, Maine, 04101, United States
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Research Site | Fall River, Massachusetts, 02720, United States
Research Site | Haverhill, Massachusetts, 01830, United States
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Research Site | Natick, Massachusetts, 01760, United States
Research Site | Alpena, Michigan, 49707, United States
Research Site | Flint, Michigan, 48504, United States
Research Site | Flint, Michigan, 48532, United States
Research Site | Grand Blanc, Michigan, 48439, United States
Research Site | Jackson, Michigan, 49201, United States
Research Site | Kalamazoo, Michigan, 49009, United States
Research Site | Petoskey, Michigan, 49770, United States
Research Site | Troy, Michigan, 48085, United States
Research Site | Duluth, Minnesota, 55805, United States
Research Site | Eagan, Minnesota, 55123, United States
Research Site | Saint Cloud, Minnesota, 56303, United States
Research Site | Kansas City, Missouri, 64111, United States
Research Site | Lee's Summit, Missouri, 64064, United States
Research Site | Saint Louis, Missouri, 63117, United States
Research Site | Billings, Montana, 59102, United States
Research Site | Great Falls, Montana, 59405, United States
Research Site | Kalispell, Montana, 59901, United States
Research Site | Grand Island, Nebraska, 68803, United States
Research Site | Lincoln, Nebraska, 68526, United States
Research Site | Omaha, Nebraska, 68105, United States
Research Site | Omaha, Nebraska, 68124, United States
Research Site | Reno, Nevada, 89502, United States
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Research Site | Somerset, New Jersey, 08873, United States
Research Site | Voorhees, New Jersey, 08043, United States
Research Site | Albuquerque, New Mexico, 87102, United States
Research Site | Buffalo, New York, 14215, United States
Research Site | New Hyde Park, New York, 11042, United States
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Research Site | Northport, New York, 11768, United States
Research Site | Poughkeepsie, New York, 12601, United States
Research Site | Southampton, New York, 11968, United States
Research Site | Stony Brook, New York, 11794, United States
Research Site | Westfield, New York, 14787, United States
Research Site | Asheville, North Carolina, 28803, United States
Research Site | Burlington, North Carolina, 27215, United States
Research Site | Charlotte, North Carolina, 28209, United States
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Research Site | Lenoir, North Carolina, 28645, United States
Research Site | Monroe, North Carolina, 28110, United States
Research Site | Rocky Mount, North Carolina, 27804, United States
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Research Site | Bismarck, North Dakota, 58501, United States
Research Site | Fargo, North Dakota, 58103, United States
Research Site | Canal Fulton, Ohio, 44614, United States
Research Site | Cincinnati, Ohio, 45219, United States
Research Site | Cleveland, Ohio, 44126, United States
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Research Site | Elyria, Ohio, 44035, United States
Research Site | Parma Hts., Ohio, 44130, United States
Research Site | Sandusky, Ohio, 44870, United States
Research Site | Springfield, Ohio, 45504, United States
Research Site | Toledo, Ohio, 43606, United States
Research Site | Oklahoma City, Oklahoma, 73104, United States
Research Site | Oklahoma City, Oklahoma, 73120, United States
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Research Site | Tulsa, Oklahoma, 74104, United States
Research Site | Altoona, Pennsylvania, 16602, United States
Research Site | Bethlehem, Pennsylvania, 18015, United States
Research Site | Camp Hill, Pennsylvania, 17011, United States
Research Site | Doylestown, Pennsylvania, 18901, United States
Research Site | Erie, Pennsylvania, 16508, United States
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Research Site | Langhorne, Pennsylvania, 19047, United States
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Research Site | Pittsburgh, Pennsylvania, 15240, United States
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Research Site | Charleston, South Carolina, 29425, United States
Research Site | Greer, South Carolina, 29651, United States
Research Site | Sioux Falls, South Dakota, 57108, United States
Research Site | Bristol, Tennessee, 37620, United States
Research Site | Kingsport, Tennessee, 37660, United States
Research Site | Knoxville, Tennessee, 37912, United States
Research Site | Memphis, Tennessee, 38163, United States
Research Site | Arlington, Texas, 76014, United States
Research Site | Carrollton, Texas, 75101, United States
Research Site | Dallas, Texas, 75220, United States
Research Site | Dallas, Texas, 75243, United States
Research Site | Fort Worth, Texas, 76107, United States
Research Site | Georgetown, Texas, 78626, United States
Research Site | Houston, Texas, 77025, United States
Research Site | Houston, Texas, 77030, United States
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Research Site | Irving, Texas, 75039, United States
Research Site | Katy, Texas, 77450, United States
Research Site | Kingwood, Texas, 77339, United States
Research Site | McAllen, Texas, 78503, United States
Research Site | Midland, Texas, 79707, United States
Research Site | Odessa, Texas, 79761, United States
Research Site | Plano, Texas, 75023, United States
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Research Site | Verona, 37126, Italy
Research Site | Bunkyo-ku, 113-8655, Japan
Research Site | Daito-shi, 574-0074, Japan
Research Site | Kasuga-shi, 816-0864, Japan
Research Site | Kobe-shi, 655-0017, Japan
Research Site | Kumamoto-shi, 860-8556, Japan
Research Site | Matsubara-shi, 580-0032, Japan
Research Site | Saga-shi, 849-8501, Japan
Research Site | Ube-shi, 755-8505, Japan
Research Site | Uji-shi, 611-0041, Japan
Research Site | Yao-shi, 581-0011, Japan
Research Site | Yokohama-shi, 236-0004, Japan
Research Site | Bucheon-si, 420-717, Korea, Republic of
Research Site | Busan, 47392, Korea, Republic of
Research Site | Cheongju-si, 28644, Korea, Republic of
Research Site | Daegu, 705-718, Korea, Republic of
Research Site | Daejeon, 301721, Korea, Republic of
Research Site | Goyang-si, 10444, Korea, Republic of
Research Site | Gyeonggi-do, 11923, Korea, Republic of
Research Site | Jeonju-si, Jeollabuk-do, 561-71, Korea, Republic of
Research Site | Jung-gu, 41944, Korea, Republic of
Research Site | Seongnam-si, 13620, Korea, Republic of
Research Site | Seoul, 02841, Korea, Republic of
Research Site | Seoul, 03080, Korea, Republic of
Research Site | Seoul, 03722, Korea, Republic of
Research Site | Seoul, 05505, Korea, Republic of
Research Site | Seoul, 06591, Korea, Republic of
Research Site | Seoul, 110746, Korea, Republic of
Research Site | Seoul, 135710, Korea, Republic of
Research Site | Suwon-si, 16499, Korea, Republic of
Research Site | Uijeongbu-si, 480717, Korea, Republic of
Research Site | Acapulco, 39670, Mexico
Research Site | Culiacan, 80230, Mexico
Research Site | Del. Cuauhtemoc, 06700, Mexico
Research Site | Distrito Federal, 07760, Mexico
Research Site | Distrito Federal, 14000, Mexico
Research Site | Guadalajara, 44150, Mexico
Research Site | Guadalajara, 44160, Mexico
Research Site | Guadalajara, 44600, Mexico
Research Site | Guadalajara, 44670, Mexico
Research Site | Meridas, 97070, Mexico
Research Site | Mexico, 11560, Mexico
Research Site | Mexico, 11850, Mexico
Research Site | Monterey, 64060, Mexico
Research Site | Monterrey, 64460, Mexico
Research Site | Monterrey, 64465, Mexico
Research Site | Pachuca de Soto, 42090, Mexico
Research Site | Queretaro, 76000, Mexico
Research Site | San Luis Potosi, 78200, Mexico
Research Site | Tijuana, 22210, Mexico
Research Site | Veracruz, 91900, Mexico
Research Site | Xalapa, 91193, Mexico
Research Site | Zapopan, Jalisco, 45200, Mexico
Research Site | Zapopan, 45116, Mexico
Research Site | Alkmaar, 1815JD, Netherlands
Research Site | Amsterdam, 1105 AZ, Netherlands
Research Site | Apeldoorn, 7334 DZ, Netherlands
Research Site | Arnhem, 6815 AD, Netherlands
Research Site | Breda, 4818 CK, Netherlands
Research Site | Delft, 2625 AD, Netherlands
Research Site | Den Haag, 2597 AX, Netherlands
Research Site | EDE, 6716 RP, Netherlands
Research Site | Eindhoven, 5631 BM, Netherlands
Research Site | Gouda, 2803 HH, Netherlands
Research Site | Groningen, 9728 NT, Netherlands
Research Site | Haarlem, 2035 RC, Netherlands
Research Site | Hardenberg, 7772 SE, Netherlands
Research Site | Heerlen, 6419 PC, Netherlands
Research Site | Hoogeveen, 7909 AA, Netherlands
Research Site | Nijmegen, 6532 SZ, Netherlands
Research Site | Rotterdam, 3039 BD, Netherlands
Research Site | Rotterdam, 3045 PM, Netherlands
Research Site | Sliedrecht, 3361 XV, Netherlands
Research Site | Sneek, 8601 ZR, Netherlands
Research Site | Utrecht, 3584 CX, Netherlands
Research Site | Venlo, 5912 BL, Netherlands
Research Site | Zutphen, 7207 AE, Netherlands
Research Site | Bacolod, 6100, Philippines
Research Site | Cebu City, 6000, Philippines
Research Site | Dasmarinas City, 4114, Philippines
Research Site | Iloilo City, 5000, Philippines
Research Site | Lipa City, 4217, Philippines
Research Site | Makati City, 1218, Philippines
Research Site | Mandaluyong City, 1554, Philippines
Research Site | Manila, 1000, Philippines
Research Site | Manila, 1003, Philippines
Research Site | Manila, 1008, Philippines
Research Site | Marikina City, 1810, Philippines
Research Site | Pasay City, 1300, Philippines
Research Site | Pasig City, 1605, Philippines
Research Site | Quezon City, 1100, Philippines
Research Site | Quezon City, 1101, Philippines
Research Site | Quezon City, 1104, Philippines
Research Site | Quezon City, 1112, Philippines
Research Site | Tanauan City, 4232, Philippines
Research Site | Biała Rawska, 96-230, Poland
Research Site | Bydgoszcz, 85-681, Poland
Research Site | ChrzanÓw, 32-500, Poland
Research Site | Gdansk, 80-858, Poland
Research Site | Gdańsk, 80-952, Poland
Research Site | Gdynia, 81-423, Poland
Research Site | Giżycko, 11-500, Poland
Research Site | Katowice, 40-081, Poland
Research Site | Koluszki, 95-040, Poland
Research Site | Krakow, 31-121, Poland
Research Site | Kraków, 31-156, Poland
Research Site | Legnica, 59-220, Poland
Research Site | Lublin, 20-044, Poland
Research Site | Mrągowo, 11-700, Poland
Research Site | Nakło nad Notecią, 89-100, Poland
Research Site | Poznan, 61-289, Poland
Research Site | Poznan, 61655, Poland
Research Site | Płock, 09-402, Poland
Research Site | Ruda Śląska, 41-709, Poland
Research Site | Skierniewice, 96-100, Poland
Research Site | Sobótka, 55-050, Poland
Research Site | Sokółka, 16-100, Poland
Research Site | Torun, 87-100, Poland
Research Site | Toruń, 87-100, Poland
Research Site | Warszawa, 02-679, Poland
Research Site | Warszawa, 03-973, Poland
Research Site | Wierzchosławice, 33-122, Poland
Research Site | Wrocław, 50-403, Poland
Research Site | Wrocław, 50-981, Poland
Research Site | Węgrów, 07-100, Poland
Research Site | Włocławek, 87-800, Poland
Research Site | Zabrze, 41-800, Poland
Research Site | Łęczna, 21-010, Poland
Research Site | Bacau, 600114, Romania
Research Site | Bacau, 600164, Romania
Research Site | Bucharest, 010507, Romania
Research Site | Bucharest, 020475, Romania
Research Site | Bucharest, 020614, Romania
Research Site | Bucuresti, 011234, Romania
Research Site | Bucuresti, 020042, Romania
Research Site | Bucuresti, 020359, Romania
Research Site | Bucuresti, 20048, Romania
Research Site | Cluj Napoca, 400006, Romania
Research Site | Cluj Napoca, 400353, Romania
Research Site | Constanta, 900675, Romania
Research Site | Galati, 800371, Romania
Research Site | Iasi, 700400, Romania
Research Site | Iasi, 700515, Romania
Research Site | Iasi, 700613, Romania
Research Site | Iasi, 700732, Romania
Research Site | Ploiesti, 100163, Romania
Research Site | Sibiu, 550371, Romania
Research Site | Timisoara, 300125, Romania
Research Site | Tirgu Mures, 540013, Romania
Research Site | Târgu Mures, 540136, Romania
Research Site | Zalau, 450129, Romania
Research Site | Arkhangelsk, 163001, Russian Federation
Research Site | Chelyabinsk, 454091, Russian Federation
Research Site | Chelyabinsk, 454106, Russian Federation
Research Site | Ivanovo, 153012, Russian Federation
Research Site | Izhevsk, 426063, Russian Federation
Research Site | Kazan, 420012, Russian Federation
Research Site | Kazan, 420029, Russian Federation
Research Site | Moscow, 117292, Russian Federation
Research Site | Moscow, 119034, Russian Federation
Research Site | Moscow, 121552, Russian Federation
Research Site | Moscow, 125367, Russian Federation
Research Site | Moscow, 127473, Russian Federation
Research Site | Moscow, 129110, Russian Federation
Research Site | Moscow, 129301, Russian Federation
Research Site | Nizhnii Novgorod, 603018, Russian Federation
Research Site | Novosibirsk, 630008, Russian Federation
Research Site | Perm, 6144090, Russian Federation
Research Site | Rostov-on-Don, 344022, Russian Federation
Research Site | Saint Petersburg, 193312, Russian Federation
Research Site | Saint Petersburg, 194044, Russian Federation
Research Site | Saint Petersburg, 194354, Russian Federation
Research Site | Saint Petersburg, 195257, Russian Federation
Research Site | Saint Petersburg, 198217, Russian Federation
Research Site | Saint Petersburg, 198328, Russian Federation
Research Site | Saint- Petersburg, 192148, Russian Federation
Research Site | Saint-Petersburg, 199106, Russian Federation
Research Site | Saratov, 410053, Russian Federation
Research Site | Tver, 170036, Russian Federation
Research Site | Ufa, 450071, Russian Federation
Research Site | Vladikavkaz, 362027, Russian Federation
Research Site | Volgograd, 400005, Russian Federation
Research Site | Yekaterinburg, 620039, Russian Federation
Research Site | Banská Bystrica, 97401, Slovakia
Research Site | Bratislava, 81108, Slovakia
Research Site | Bratislava, 83301, Slovakia
Research Site | Dolný Kubín, 02601, Slovakia
Research Site | Kosice, 04011, Slovakia
Research Site | Kosice, 04022, Slovakia
Research Site | Košice, 04001, Slovakia
Research Site | Levice, 934 01, Slovakia
Research Site | Lučenec, 98401, Slovakia
Research Site | Nove Zamky, 94001, Slovakia
Research Site | Námestovo, 02901, Slovakia
Research Site | Piešťany, 92101, Slovakia
Research Site | Poprad, 058 01, Slovakia
Research Site | Povazska Bystrica, 01701, Slovakia
Research Site | Prievidza, 97101, Slovakia
Research Site | Rimavská Sobota, 97901, Slovakia
Research Site | Sabinov, 083 01, Slovakia
Research Site | Sala, 927 01, Slovakia
Research Site | Trebišov, 07501, Slovakia
Research Site | Trenčín, 91101, Slovakia
Research Site | Vrutky, 038 61, Slovakia
Research Site | Žilina, 01001, Slovakia
Research Site | Alberton, 1450, South Africa
Research Site | Benoni, 1500, South Africa
Research Site | Cape Town, 7405, South Africa
Research Site | Cape Town, 7500, South Africa
Research Site | Cape Town, 7505, South Africa
Research Site | Diepkloof, Soweto, 2013, South Africa
Research Site | Durban, 4001, South Africa
Research Site | Durban, 4052, South Africa
Research Site | Goodwood, 7460, South Africa
Research Site | Houghton, 2198, South Africa
Research Site | Muckleneuk, 0002, South Africa
Research Site | Parktown West, 2193, South Africa
Research Site | Parktown, 2193, South Africa
Research Site | Phoenix, 4068, South Africa
Research Site | Somerset West, 7130, South Africa
Research Site | Verulam, 4345, South Africa
Research Site | Worcester, 6850, South Africa
Research Site | Almeria, 04120, Spain
Research Site | Barcelona, 08003, Spain
Research Site | Barcelona, 08041, Spain
Research Site | L'Hospitalet de Llobregat, 08907, Spain
Research Site | Madrid, 28046, Spain
Research Site | Madrid, 28049, Spain
Research Site | Oviedo, 33011, Spain
Research Site | Sant Joan Despi, 08970, Spain
Research Site | Santiago de Compostela, 15706, Spain
Research Site | Sevilla, 41071, Spain
Research Site | Borås, 506 30, Sweden
Research Site | Eksjö, 57535, Sweden
Research Site | Finspång, 612 37, Sweden
Research Site | Gothenburg, 41345, Sweden
Research Site | Gothenburg, 41685, Sweden
Research Site | Järfälla, 177 30, Sweden
Research Site | Linköping, 589 29, Sweden
Research Site | Lund, 222 21, Sweden
Research Site | Malmo, 21152, Sweden
Research Site | Ostersund, 831 83, Sweden
Research Site | Rättvik, 79530, Sweden
Research Site | Stockholm, 111 57, Sweden
Research Site | Stockholm, 117 28, Sweden
Research Site | Stockholm, 171 76, Sweden
Research Site | Umeå, 907 36, Sweden
Research Site | Vällingby, 162 68, Sweden
Research Site | Changhua, 50006, Taiwan
Research Site | Kaohsiung City, 83301, Taiwan
Research Site | Kaohsiung, 80756, Taiwan
Research Site | Taichung City, 40201, Taiwan
Research Site | Taichung, 40705, Taiwan
Research Site | Taipei, 11217, Taiwan
Research Site | Bangkok, 10330, Thailand
Research Site | Bangkok, 10400, Thailand
Research Site | Bangkok, 10700, Thailand
Research Site | Chiang Mai, 50200, Thailand
Research Site | Muang, 40002, Thailand
Research Site | Nakhon Ratchasima, 30000, Thailand
Research Site | Pathumthani, 12120, Thailand
Research Site | Phisanulok, 65000, Thailand
Research Site | Rajthevi, 10400, Thailand
Research Site | Ratchaburi, 70000, Thailand
Research Site | Ratchathewi, 10400, Thailand
Research Site | Antalya, 07058, Turkey
Research Site | Istanbul, 34093, Turkey
Research Site | Istanbul, 34360, Turkey
Research Site | Istanbul, 34730, Turkey
Research Site | Istanbul, 34865, Turkey
Research Site | Izmir, 35100, Turkey
Research Site | İzmir, 35210, Turkey
Research Site | Dnepropetrovsk, 49006, Ukraine
Research Site | Dnipropetrovsk, 49038, Ukraine
Research Site | Donetsk, 83003, Ukraine
Research Site | Kharkiv, 61176, Ukraine
Research Site | Kharkov, 61018, Ukraine
Research Site | Kiev, 02176, Ukraine
Research Site | Kiev, 03015, Ukraine
Research Site | Kyiv, 01601, Ukraine
Research Site | Kyiv, 04114, Ukraine
Research Site | Vinnytsia, 21001, Ukraine
Research Site | Vynnitsa, 21018, Ukraine
Research Site | Zaporizhzhya, 69118, Ukraine
Research Site | Zaporozhye, 69001, Ukraine
Research Site | Addlestone, KT15 2BH, United Kingdom
Research Site | Aylesbury, HP22 5LB, United Kingdom
Research Site | Bath, BA3 2UH, United Kingdom
Research Site | Belfast, BT13 3BW, United Kingdom
Research Site | Belfast, BT7 2EB, United Kingdom
Research Site | Blackpool, FY4 3AD, United Kingdom
Research Site | Canterbury, CT1 3HX, United Kingdom
Research Site | Corsham, SN13 9DL, United Kingdom
Research Site | Coventry, CV6 4DD, United Kingdom
Research Site | Glasgow, G69 7AD, United Kingdom
Research Site | Irvine, KA12 0AY, United Kingdom
Research Site | Leicester, LE10 2SE, United Kingdom
Research Site | Mortimer Reading, RG7 3SQ, United Kingdom
Research Site | Sheffield, S35 9XQ, United Kingdom
Research Site | Whitstable, CT5 3SE, United Kingdom
Research Site | Hanoi, 100000, Vietnam
Research Site | Ho Chi Minh City, 700000, Vietnam
Research Site | Ho Chi Minh City, 70000, Vietnam
Research Site | Ho Chi Minh City, 9000, Vietnam
Location Countries

Argentina

Australia

Belgium

Brazil

Bulgaria

Canada

China

Czechia

France

Germany

Hong Kong

Hungary

India

Israel

Italy

Japan

Korea, Republic of

Mexico

Netherlands

Philippines

Poland

Romania

Russian Federation

Slovakia

South Africa

Spain

Sweden

Taiwan

Thailand

Turkey

Ukraine

United Kingdom

United States

Vietnam

Verification Date

2019-11-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Dapagliflozin

Type: Experimental

Description: Dapagliflozin + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors

Label: Placebo

Type: Placebo Comparator

Description: Placebo + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors

Acronym DECLARE-TIMI58
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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