Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events (DECLARE-TIMI58)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by AstraZeneca
Sponsor:
Collaborators:
Bristol-Myers Squibb
The TIMI Study Group
Hadassah Medical Organization
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01730534
First received: November 15, 2012
Last updated: April 2, 2015
Last verified: April 2015
  Purpose

This study is being carried out to see if dapagliflozin when added to a patients current anti-diabetes therapy is effective in reducing cardiovascular events such as myocardial infarction (MI) (heart attack), ischemic stroke, and cardiovascular (CV) related death, compared with placebo (inactive study medication).


Condition Intervention Phase
Diabetes Mellitus, Non-Insulin-Dependent
High Risk for Cardiovascular Event
Drug: Dapagliflozin 10 mg
Drug: Placebo tablet
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Time to first event included in the composite endpoint of CV death, MI or ischemic stroke [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first event of Hospitalization for Congestive Heart Failure [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
  • Time to first event included in the composite endpoint of CV death, MI, ischemic stroke, hospitalization for heart failure, hospitalization for unstable angina pectoris, or hospitalization for any revascularization [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
  • Time to All-cause mortality [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]
  • Body weight change from baseline [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 17150
Study Start Date: April 2013
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dapagliflozin
Dapagliflozin + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors
Drug: Dapagliflozin 10 mg
Oral dose (od)
Placebo Comparator: Placebo
Placebo + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors
Drug: Placebo tablet
Oral dose (od)

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01730534

Contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

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Locations
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Research Site Active, not recruiting
Lukovit, Bulgaria
Research Site Active, not recruiting
Petrich, Bulgaria
Research Site Active, not recruiting
Pleven, Bulgaria
Research Site Active, not recruiting
Plovdiv, Bulgaria
Research Site Withdrawn
Razlog, Bulgaria
Research Site Active, not recruiting
Russe, Bulgaria
Research Site Active, not recruiting
Sandanski, Bulgaria
Research Site Active, not recruiting
Sevlievo, Bulgaria
Research Site Active, not recruiting
Sliven, Bulgaria
Research Site Active, not recruiting
Smolyan, Bulgaria
Research Site Withdrawn
Sofia, Bulgaria
Research Site Active, not recruiting
Sofia, Bulgaria
Research Site Active, not recruiting
Stara Zagora, Bulgaria
Research Site Active, not recruiting
Yambol, Bulgaria
Canada, Alberta
Research Site Active, not recruiting
Calgary, Alberta, Canada
Canada, British Columbia
Research Site Active, not recruiting
New Westminster, British Columbia, Canada
Research Site Active, not recruiting
Surrey, British Columbia, Canada
Canada, Manitoba
Research Site Active, not recruiting
Winnipeg, Manitoba, Canada
Canada, New Brunswick
Research Site Active, not recruiting
Moncton, New Brunswick, Canada
Canada, Newfoundland and Labrador
Research Site Withdrawn
Bay Roberts, Newfoundland and Labrador, Canada
Research Site Active, not recruiting
Mount Pearl, Newfoundland and Labrador, Canada
Research Site Active, not recruiting
St. John's, Newfoundland and Labrador, Canada
Canada, Nova Scotia
Research Site Active, not recruiting
Halifax, Nova Scotia, Canada
Research Site Active, not recruiting
Sydney Mines, Nova Scotia, Canada
Canada, Ontario
Research Site Active, not recruiting
Brampton, Ontario, Canada
Research Site Active, not recruiting
Cambridge, Ontario, Canada
Research Site Active, not recruiting
London, Ontario, Canada
Research Site Active, not recruiting
North York, Ontario, Canada
Research Site Active, not recruiting
Oakville, Ontario, Canada
Research Site Active, not recruiting
Oshawa, Ontario, Canada
Research Site Withdrawn
Ottawa, Ontario, Canada
Research Site Active, not recruiting
Scarborough, Ontario, Canada
Research Site Active, not recruiting
Smiths Falls, Ontario, Canada
Research Site Active, not recruiting
Thornhill, Ontario, Canada
Research Site Active, not recruiting
Toronto, Ontario, Canada
Canada, Quebec
Research Site Active, not recruiting
Chicoutimi, Quebec, Canada
Research Site Active, not recruiting
Laval, Quebec, Canada
Research Site Active, not recruiting
Levis, Quebec, Canada
Research Site Active, not recruiting
Longueuil, Quebec, Canada
Research Site Active, not recruiting
Montreal, Quebec, Canada
Research Site Withdrawn
Montreal, Quebec, Canada
Research Site Active, not recruiting
Montréal, Quebec, Canada
Research Site Active, not recruiting
Pointe-Claire, Quebec, Canada
Research Site Active, not recruiting
Saint-Charles-Borromee, Quebec, Canada
Research Site Active, not recruiting
Saint-Georges, Quebec, Canada
Research Site Active, not recruiting
Sherbrooke, Quebec, Canada
Research Site Active, not recruiting
Terrebonne, Quebec, Canada
Canada, Saskatchewan
Research Site Active, not recruiting
Regina, Saskatchewan, Canada
Research Site Active, not recruiting
Saskatoon, Saskatchewan, Canada
Canada
Research Site Active, not recruiting
Quebec, Canada
China
Research Site Not yet recruiting
Beijing, China
Research Site Not yet recruiting
Changsha, China
Research Site Not yet recruiting
Guang Zhou, China
Research Site Not yet recruiting
Guangzhou, China
Research Site Not yet recruiting
Hefei, China
Research Site Not yet recruiting
Jinan, China
Research Site Not yet recruiting
Nanchang, China
Research Site Not yet recruiting
Nanjing, China
Research Site Not yet recruiting
Shanghai, China
Research Site Not yet recruiting
Shenyang, China
Research Site Not yet recruiting
ShiJiazhuang, China
Research Site Not yet recruiting
Tianjin, China
Research Site Not yet recruiting
Xian, China
Czech Republic
Research Site Active, not recruiting
Beroun, Czech Republic
Research Site Active, not recruiting
Brno, Czech Republic
Research Site Withdrawn
Caslav, Czech Republic
Research Site Active, not recruiting
Cheb, Czech Republic
Research Site Active, not recruiting
Chomutov, Czech Republic
Research Site Active, not recruiting
Chrudim III, Czech Republic
Research Site Active, not recruiting
Hodonin, Czech Republic
Research Site Active, not recruiting
Horovice, Czech Republic
Research Site Active, not recruiting
Hradec Kralove, Czech Republic
Research Site Active, not recruiting
Jilove u Prahy, Czech Republic
Research Site Active, not recruiting
Kromeriz, Czech Republic
Research Site Withdrawn
Mlada Boleslav, Czech Republic
Research Site Active, not recruiting
Ostrava - Belsky les, Czech Republic
Research Site Active, not recruiting
Ostrava - Kuncice, Czech Republic
Research Site Active, not recruiting
Ostrava - Vitkovice, Czech Republic
Research Site Active, not recruiting
Ostrava-Moravska, Czech Republic
Research Site Withdrawn
Pelhrimov, Czech Republic
Research Site Active, not recruiting
Plzen, Czech Republic
Research Site Active, not recruiting
Plzen - Severni Predmesti, Czech Republic
Research Site Active, not recruiting
Praha, Czech Republic
Research Site Withdrawn
Praha - Klanovice, Czech Republic
Research Site Active, not recruiting
Praha 4, Czech Republic
Research Site Withdrawn
Praha 4, Czech Republic
Research Site Active, not recruiting
Praha 5, Czech Republic
Research Site Withdrawn
Praha 5, Czech Republic
Research Site Active, not recruiting
Praha 6, Czech Republic
Research Site Active, not recruiting
Prelouc, Czech Republic
Research Site Active, not recruiting
Rakovnik, Czech Republic
Research Site Active, not recruiting
Slany, Czech Republic
Research Site Active, not recruiting
Teplice, Czech Republic
Research Site Active, not recruiting
Uherske Hradiste, Czech Republic
Research Site Active, not recruiting
Usti nad Labem, Czech Republic
Research Site Active, not recruiting
Zlin, Czech Republic
France
Research Site Active, not recruiting
Angers cedex 9, France
Research Site Active, not recruiting
Corbeil-Essonnes, France
Research Site Active, not recruiting
Dijon, France
Research Site Active, not recruiting
Dijon Cedex, France
Research Site Active, not recruiting
La Rochelle, France
Research Site Active, not recruiting
Le Creusot, France
Research Site Active, not recruiting
Nantes Cedex 1, France
Research Site Active, not recruiting
Nantes Cedex 2, France
Research Site Withdrawn
Orleans, France
Research Site Active, not recruiting
Pessac, France
Research Site Active, not recruiting
Poitiers Cedex, France
Research Site Active, not recruiting
TOULOUSE Cedex 9, France
Germany
Research Site Active, not recruiting
Aschaffenburg, Germany
Research Site Active, not recruiting
Bad Lauterberg, Germany
Research Site Active, not recruiting
Bad Mergentheim, Germany
Research Site Active, not recruiting
Bad Oeynhausen, Germany
Research Site Withdrawn
Berlin, Germany
Research Site Active, not recruiting
Berlin, Germany
Research Site Withdrawn
Damme, Germany
Research Site Active, not recruiting
Dippoldiswalde, Germany
Research Site Withdrawn
Dresden, Germany
Research Site Withdrawn
Falkensee, Germany
Research Site Active, not recruiting
Freiburg, Germany
Research Site Withdrawn
Hamburg, Germany
Research Site Active, not recruiting
Hamburg, Germany
Research Site Withdrawn
Karlsbad, Germany
Research Site Active, not recruiting
Kassel, Germany
Research Site Active, not recruiting
Köln, Germany
Research Site Active, not recruiting
Leipzig, Germany
Research Site Active, not recruiting
München, Germany
Research Site Withdrawn
Münster, Germany
Research Site Active, not recruiting
Villingen-Schwenningen, Germany
Hong Kong
Research Site Recruiting
Causeway Bay, Hong Kong
Research Site Withdrawn
Hong Kong, Hong Kong
Research Site Recruiting
Hongkong, Hong Kong
Research Site Recruiting
Tai Po, Hong Kong
Hungary
Research Site Active, not recruiting
Acs, Hungary
Research Site Active, not recruiting
Balatonfüred, Hungary
Research Site Active, not recruiting
Ballasagyarmat, Hungary
Research Site Active, not recruiting
Berettyóújfalu, Hungary
Research Site Active, not recruiting
Budapest, Hungary
Research Site Withdrawn
Budapest, Hungary
Research Site Active, not recruiting
Cegléd, Hungary
Research Site Active, not recruiting
Csongrád, Hungary
Research Site Active, not recruiting
Debrecen, Hungary
Research Site Active, not recruiting
Eger, Hungary
Research Site Active, not recruiting
Esztergom, Hungary
Research Site Active, not recruiting
Gyor, Hungary
Research Site Active, not recruiting
Gyöngyös, Hungary
Research Site Active, not recruiting
Kecskemét, Hungary
Research Site Active, not recruiting
Kistarcsa, Hungary
Research Site Active, not recruiting
Komárom, Hungary
Research Site Withdrawn
Miskolc, Hungary
Research Site Active, not recruiting
Morahalom, Hungary
Research Site Active, not recruiting
Nyíregyháza, Hungary
Research Site Active, not recruiting
Polgar, Hungary
Research Site Active, not recruiting
Sopron, Hungary
Research Site Active, not recruiting
Szolnok, Hungary
Research Site Active, not recruiting
Székesfehérvár, Hungary
Research Site Active, not recruiting
Tát, Hungary
Research Site Active, not recruiting
Zalaegerszeg, Hungary
India
Research Site Recruiting
Ahmedabad, India
Research Site Withdrawn
Bangalore, India
Research Site Recruiting
Bangalore, India
Research Site Withdrawn
Indore, India
Research Site Withdrawn
Jaipur, India
Research Site Not yet recruiting
Jaipur, India
Research Site Not yet recruiting
Kolkatta, India
Research Site Withdrawn
Lucknow, India
Research Site Withdrawn
Mumbai, India
Research Site Not yet recruiting
New Delhi, India
Research Site Recruiting
Pune, India
Research Site Recruiting
Vellore, India
Israel
Research Site Active, not recruiting
Afula, Israel
Research Site Active, not recruiting
Ashkelon, Israel
Research Site Active, not recruiting
Bat Yam, Israel
Research Site Active, not recruiting
Beer Sheva, Israel
Research Site Active, not recruiting
Hadera, Israel
Research Site Active, not recruiting
Haifa, Israel
Research Site Active, not recruiting
Holon, Israel
Research Site Active, not recruiting
Jerusalem, Israel
Research Site Active, not recruiting
Naharia, Israel
Research Site Active, not recruiting
Petach Tikva, Israel
Italy
Research Site Withdrawn
Ascoli Piceno, Italy
Research Site Active, not recruiting
Bergamo, Italy
Research Site Withdrawn
Catanzaro, Italy
Research Site Active, not recruiting
Firenze, Italy
Research Site Withdrawn
Mercato San Severino, Italy
Research Site Active, not recruiting
Milano, Italy
Research Site Withdrawn
Monza, Italy
Research Site Active, not recruiting
Napoli, Italy
Research Site Active, not recruiting
Negrar - VR, Italy
Research Site Active, not recruiting
Padova, Italy
Research Site Completed
Parma, Italy
Research Site Active, not recruiting
Pavia, Italy
Research Site Withdrawn
Ravenna, Italy
Research Site Active, not recruiting
Rozzano, Italy
Research Site Active, not recruiting
S Maria Capua Vetere, Italy
Research Site Active, not recruiting
Sessa Aurunca, Italy
Research Site Active, not recruiting
Verona, Italy
Japan
Research Site Active, not recruiting
Bunkyo-ku, Japan
Research Site Active, not recruiting
Daito-shi, Japan
Research Site Active, not recruiting
Kasuga-shi, Japan
Research Site Active, not recruiting
Kobe-shi, Japan
Research Site Active, not recruiting
Kumamoto-shi, Japan
Research Site Active, not recruiting
Matsubara-shi, Japan
Research Site Active, not recruiting
Saga-shi, Japan
Research Site Active, not recruiting
Ube-shi, Japan
Research Site Active, not recruiting
Uji-shi, Japan
Research Site Active, not recruiting
Yao-shi, Japan
Research Site Active, not recruiting
Yokohama-shi, Japan
Korea, Republic of
Research Site Active, not recruiting
Bucheon-si, Korea, Republic of
Research Site Active, not recruiting
Busan, Korea, Republic of
Research Site Active, not recruiting
Cheongju-si, Korea, Republic of
Research Site Active, not recruiting
Daegu, Korea, Republic of
Research Site Active, not recruiting
Daejeon, Korea, Republic of
Research Site Active, not recruiting
Goyang-si, Korea, Republic of
Research Site Active, not recruiting
Guri, Gyeonggi-do, Korea, Republic of
Research Site Active, not recruiting
Jeonju-si, Jeollabuk-do, Korea, Republic of
Research Site Active, not recruiting
Seongnam-si, Korea, Republic of
Research Site Active, not recruiting
Seoul, Korea, Republic of
Research Site Active, not recruiting
Suwon, Korea, Republic of
Research Site Active, not recruiting
Uijeongbu-si, Korea, Republic of
Mexico
Research Site Active, not recruiting
Acapulco, Mexico
Research Site Active, not recruiting
Culiacan, Mexico
Research Site Active, not recruiting
Del. Cuauhtemoc, Mexico
Research Site Active, not recruiting
Distrito Federal, Mexico
Research Site Active, not recruiting
Guadalajara, Mexico
Research Site Withdrawn
Guadalajara, Mexico
Research Site Active, not recruiting
Meridas, Mexico
Research Site Active, not recruiting
Mexico, Mexico
Research Site Active, not recruiting
Monterey, Mexico
Research Site Active, not recruiting
Monterrey, Mexico
Research Site Active, not recruiting
Pachuca de Soto, Mexico
Research Site Active, not recruiting
Querétaro, Mexico
Research Site Active, not recruiting
San Luis Potosi, Mexico
Research Site Active, not recruiting
Tijuana, Mexico
Research Site Active, not recruiting
Veracruz, Mexico
Research Site Active, not recruiting
Xalapa, Mexico
Research Site Active, not recruiting
Zapopan, Mexico
Research Site Active, not recruiting
Zapopan, Jalisco, Mexico
Netherlands
Research Site Active, not recruiting
Alkmaar, Netherlands
Research Site Withdrawn
Alkmaar, Netherlands
Research Site Withdrawn
Almere, Netherlands
Research Site Active, not recruiting
Amsterdam, Netherlands
Research Site Active, not recruiting
Apeldoorn, Netherlands
Research Site Active, not recruiting
Arnhem, Netherlands
Research Site Active, not recruiting
Breda, Netherlands
Research Site Active, not recruiting
Delft, Netherlands
Research Site Active, not recruiting
Den Haag, Netherlands
Research Site Active, not recruiting
EDE, Netherlands
Research Site Active, not recruiting
Eindhoven, Netherlands
Research Site Active, not recruiting
Gouda, Netherlands
Research Site Active, not recruiting
Groningen, Netherlands
Research Site Active, not recruiting
Hardenberg, Netherlands
Research Site Active, not recruiting
Heerlen, Netherlands
Research Site Active, not recruiting
Hoofddorp, Netherlands
Research Site Active, not recruiting
Hoogeveen, Netherlands
Research Site Active, not recruiting
Nijmegen, Netherlands
Research Site Active, not recruiting
Rotterdam, Netherlands
Research Site Active, not recruiting
Sliedrecht, Netherlands
Research Site Active, not recruiting
Sneek, Netherlands
Research Site Active, not recruiting
Utrecht, Netherlands
Research Site Active, not recruiting
Velp, Netherlands
Research Site Active, not recruiting
Venlo, Netherlands
Research Site Active, not recruiting
Zutphen, Netherlands
Philippines
Research Site Active, not recruiting
Bacolod, Philippines
Research Site Withdrawn
Cebu City, Philippines
Research Site Active, not recruiting
Cebu City, Philippines
Research Site Active, not recruiting
Dasmarinas City, Philippines
Research Site Active, not recruiting
Iloilo City, Philippines
Research Site Active, not recruiting
Lipa City, Philippines
Research Site Active, not recruiting
Makati City, Philippines
Research Site Active, not recruiting
Mandaluyong City, Philippines
Research Site Withdrawn
Manila, Philippines
Research Site Active, not recruiting
Manila, Philippines
Research Site Active, not recruiting
Marikina City, Philippines
Research Site Active, not recruiting
Pasay City, Philippines
Research Site Active, not recruiting
Pasig City, Philippines
Research Site Active, not recruiting
Quezon City, Philippines
Research Site Active, not recruiting
Tanauan City, Philippines
Poland
Research Site Active, not recruiting
Biała Rawska, Poland
Research Site Active, not recruiting
Bydgoszcz, Poland
Research Site Active, not recruiting
ChrzanÓw, Poland
Research Site Active, not recruiting
Gdansk, Poland
Research Site Active, not recruiting
Gdańsk, Poland
Research Site Active, not recruiting
Gdynia, Poland
Research Site Active, not recruiting
Giżycko, Poland
Research Site Withdrawn
Inowrocław, Poland
Research Site Active, not recruiting
Katowice, Poland
Research Site Active, not recruiting
Koluszki, Poland
Research Site Active, not recruiting
Krakow, Poland
Research Site Active, not recruiting
Kraków, Poland
Research Site Withdrawn
Kraków, Poland
Research Site Active, not recruiting
Legnica, Poland
Research Site Active, not recruiting
Lublin, Poland
Research Site Active, not recruiting
Mrągowo, Poland
Research Site Active, not recruiting
Nakło nad Notecią, Poland
Research Site Active, not recruiting
Poznan, Poland
Research Site Active, not recruiting
Płock, Poland
Research Site Active, not recruiting
Ruda Śląska, Poland
Research Site Active, not recruiting
Skierniewice, Poland
Research Site Active, not recruiting
Sobótka, Poland
Research Site Active, not recruiting
Sokółka, Poland
Research Site Active, not recruiting
Torun, Poland
Research Site Active, not recruiting
Toruń, Poland
Research Site Active, not recruiting
Warszawa, Poland
Research Site Active, not recruiting
Wierzchosławice, Poland
Research Site Active, not recruiting
Wrocław, Poland
Research Site Active, not recruiting
Węgrów, Poland
Research Site Active, not recruiting
Włocławek, Poland
Research Site Active, not recruiting
Zabrze, Poland
Research Site Withdrawn
Zamość, Poland
Research Site Active, not recruiting
Łęczna, Poland
Romania
Research Site Active, not recruiting
Bacau, Romania
Research Site Withdrawn
Braila, Romania
Research Site Withdrawn
Brasov, Romania
Research Site Withdrawn
Bucharest, Romania
Research Site Active, not recruiting
Bucharest, Romania
Research Site Active, not recruiting
Bucuresti, Romania
Research Site Withdrawn
Bucuresti, Romania
Research Site Active, not recruiting
Cluj Napoca, Romania
Research Site Active, not recruiting
Constanta, Romania
Research Site Active, not recruiting
Galati, Romania
Research Site Active, not recruiting
Iasi, Romania
Research Site Withdrawn
Pitesti, Romania
Research Site Active, not recruiting
Ploiesti, Romania
Research Site Active, not recruiting
Sibiu, Romania
Research Site Active, not recruiting
Targu-Mures, Romania
Research Site Active, not recruiting
Timisoara, Romania
Research Site Withdrawn
Timisoara, Romania
Research Site Active, not recruiting
Tîrgu Mures, Romania
Research Site Active, not recruiting
Zalau, Romania
Russian Federation
Research Site Active, not recruiting
Arkhangelsk, Russian Federation
Research Site Active, not recruiting
Chelyabinsk, Russian Federation
Research Site Withdrawn
Ekaterinburg, Russian Federation
Research Site Withdrawn
Gatchina, Russian Federation
Research Site Active, not recruiting
Ivanovo, Russian Federation
Research Site Withdrawn
Izhevsk, Russian Federation
Research Site Active, not recruiting
Izhevsk, Russian Federation
Research Site Active, not recruiting
Kazan, Russian Federation
Research Site Withdrawn
Moscow, Russian Federation
Research Site Active, not recruiting
Moscow, Russian Federation
Research Site Active, not recruiting
Nizhnii Novgorod, Russian Federation
Research Site Withdrawn
Nizhniy Novgorod, Russian Federation
Research Site Active, not recruiting
Novosibirsk, Russian Federation
Research Site Active, not recruiting
Perm, Russian Federation
Research Site Active, not recruiting
Rostov-on-Don, Russian Federation
Research Site Withdrawn
Rostov-on-Don, Russian Federation
Research Site Completed
Ryazan, Russian Federation
Research Site Active, not recruiting
Saint Petersburg, Russian Federation
Research Site Withdrawn
Saint Petersburg, Russian Federation
Research Site Active, not recruiting
Saint- Petersburg, Russian Federation
Research Site Active, not recruiting
Saint-Petersburg, Russian Federation
Research Site Withdrawn
Saratov, Russian Federation
Research Site Active, not recruiting
Saratov, Russian Federation
Research Site Withdrawn
Smolensk, Russian Federation
Research Site Active, not recruiting
Tver, Russian Federation
Research Site Active, not recruiting
Ufa, Russian Federation
Research Site Active, not recruiting
Vladikavkaz, Russian Federation
Research Site Withdrawn
Vladimir, Russian Federation
Research Site Active, not recruiting
Volgograd, Russian Federation
Research Site Active, not recruiting
Yekaterinburg, Russian Federation
Slovakia
Research Site Active, not recruiting
Banská Bystrica, Slovakia
Research Site Active, not recruiting
Bratislava, Slovakia
Research Site Active, not recruiting
Dolný Kubín, Slovakia
Research Site Active, not recruiting
Kosice, Slovakia
Research Site Active, not recruiting
Košice, Slovakia
Research Site Active, not recruiting
Levice, Slovakia
Research Site Active, not recruiting
Lučenec, Slovakia
Research Site Active, not recruiting
Nové Zámky, Slovakia
Research Site Active, not recruiting
Námestovo, Slovakia
Research Site Active, not recruiting
Piešťany, Slovakia
Research Site Active, not recruiting
Poprad, Slovakia
Research Site Active, not recruiting
Povazska Bystrica, Slovakia
Research Site Active, not recruiting
Prievidza, Slovakia
Research Site Active, not recruiting
Rimavská Sobota, Slovakia
Research Site Active, not recruiting
Sabinov, Slovakia
Research Site Active, not recruiting
Trebišov, Slovakia
Research Site Active, not recruiting
Trenčín, Slovakia
Research Site Active, not recruiting
Vrútky, Slovakia
Research Site Active, not recruiting
Šaľa, Slovakia
Research Site Active, not recruiting
Žilina, Slovakia
South Africa
Research Site Active, not recruiting
Alberton, South Africa
Research Site Active, not recruiting
Benoni, South Africa
Research Site Active, not recruiting
Cape Town, South Africa
Research Site Active, not recruiting
Diepkloof, Soweto, South Africa
Research Site Active, not recruiting
Durban, South Africa
Research Site Active, not recruiting
Goodwood, South Africa
Research Site Active, not recruiting
Houghton, South Africa
Research Site Active, not recruiting
Johannesburg, South Africa
Research Site Withdrawn
Observatory, South Africa
Research Site Active, not recruiting
Parktown, South Africa
Research Site Active, not recruiting
Phoenix, South Africa
Research Site Active, not recruiting
Pretoria, South Africa
Research Site Active, not recruiting
Verulam, South Africa
Research Site Active, not recruiting
Worcester, South Africa
Spain
Research Site Active, not recruiting
Almeria, Spain
Research Site Active, not recruiting
Barcelona, Spain
Research Site Active, not recruiting
L'Hospitalet de Llobregat, Spain
Research Site Active, not recruiting
Madrid, Spain
Research Site Active, not recruiting
Oviedo, Spain
Research Site Active, not recruiting
Sant Joan Despi, Spain
Research Site Active, not recruiting
Santiago de Compostela, Spain
Research Site Withdrawn
Santiago de Compostela, Spain
Research Site Active, not recruiting
Sevilla, Spain
Sweden
Research Site Active, not recruiting
Borås, Sweden
Research Site Active, not recruiting
Eksjö, Sweden
Research Site Active, not recruiting
Finspång, Sweden
Research Site Active, not recruiting
Gothenburg, Sweden
Research Site Active, not recruiting
Jakobsberg, Sweden
Research Site Withdrawn
Jonkoping, Sweden
Research Site Active, not recruiting
Linköping, Sweden
Research Site Active, not recruiting
Lund, Sweden
Research Site Active, not recruiting
Malmo, Sweden
Research Site Active, not recruiting
Ostersund, Sweden
Research Site Active, not recruiting
Rättvik, Sweden
Research Site Active, not recruiting
Stockholm, Sweden
Research Site Withdrawn
Stockholm, Sweden
Research Site Active, not recruiting
Umeå, Sweden
Research Site Withdrawn
Vastervik, Sweden
Research Site Active, not recruiting
Vällingby, Sweden
Research Site Withdrawn
Örebro, Sweden
Taiwan
Research Site Active, not recruiting
Changhua, Taiwan
Research Site Active, not recruiting
Kaohsiung, Taiwan
Research Site Active, not recruiting
Taichung, Taiwan
Research Site Active, not recruiting
Taichung City, Taiwan
Research Site Active, not recruiting
Taipei, Taiwan
Thailand
Research Site Active, not recruiting
Bangkok, Thailand
Research Site Withdrawn
Bangkok, Thailand
Research Site Withdrawn
Bansuan, Muang, Chonburi, Thailand
Research Site Withdrawn
Chaingmai, Thailand
Research Site Active, not recruiting
Chiang Mai, Thailand
Research Site Withdrawn
Hat Yai, Songkla, Thailand
Research Site Active, not recruiting
Muang, Thailand
Research Site Withdrawn
Muang, Nan, Thailand
Research Site Active, not recruiting
Nakhon Ratchasima, Thailand
Research Site Active, not recruiting
Pathumthani, Thailand
Research Site Active, not recruiting
Phisanulok, Thailand
Research Site Active, not recruiting
Rajthevi, Thailand
Research Site Active, not recruiting
Ratchaburi, Thailand
Research Site Active, not recruiting
Ratchathewi, Thailand
Turkey
Research Site Active, not recruiting
Antalya, Turkey
Research Site Active, not recruiting
Istanbul, Turkey
Research Site Active, not recruiting
İzmir, Turkey
Ukraine
Research Site Active, not recruiting
Dnepropetrovsk, Ukraine
Research Site Active, not recruiting
Dnipropetrovsk, Ukraine
Research Site Withdrawn
Donetsk, Ukraine
Research Site Active, not recruiting
Donetsk, Ukraine
Research Site Withdrawn
Ivano-Frankivsk, Ukraine
Research Site Active, not recruiting
Kharkiv, Ukraine
Research Site Active, not recruiting
Kharkov, Ukraine
Research Site Active, not recruiting
Kiev, Ukraine
Research Site Active, not recruiting
Kyiv, Ukraine
Research Site Withdrawn
Lviv, Ukraine
Research Site Withdrawn
Lwiw, Ukraine
Research Site Withdrawn
Mykolaiv, Ukraine
Research Site Active, not recruiting
Vinnytsia, Ukraine
Research Site Active, not recruiting
Vynnitsa, Ukraine
Research Site Active, not recruiting
Zaporizhzhya, Ukraine
Research Site Active, not recruiting
Zaporozhye, Ukraine
United Kingdom
Research Site Active, not recruiting
Addlestone, United Kingdom
Research Site Active, not recruiting
Aylesbury, United Kingdom
Research Site Active, not recruiting
Bath, United Kingdom
Research Site Active, not recruiting
Belfast, United Kingdom
Research Site Active, not recruiting
Blackpool, United Kingdom
Research Site Active, not recruiting
Canterbury, United Kingdom
Research Site Active, not recruiting
Corsham, United Kingdom
Research Site Active, not recruiting
Coventry, United Kingdom
Research Site Active, not recruiting
Glasgow, United Kingdom
Research Site Active, not recruiting
Irvine, United Kingdom
Research Site Active, not recruiting
Leicester, United Kingdom
Research Site Active, not recruiting
Mortimer Reading, United Kingdom
Research Site Active, not recruiting
Sheffield, United Kingdom
Research Site Active, not recruiting
Whitstable, United Kingdom
Vietnam
Research Site Active, not recruiting
Hanoi, Vietnam
Research Site Active, not recruiting
Ho Chi Minh City, Vietnam
Research Site Withdrawn
Hochiminh, Vietnam
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
The TIMI Study Group
Hadassah Medical Organization
Investigators
Study Director: Eva Johnsson, MD AstraZeneca Sweden
Study Chair: Marc S Sabatine, MD, MPH TIMI Study Group, Boston, MA, USA
Principal Investigator: Itamar Raz, MD Hadassah Medical Organization
Principal Investigator: Stephen D Wiviott, MD TIMI Study Group, MA, USA
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01730534     History of Changes
Other Study ID Numbers: D1693C00001
Study First Received: November 15, 2012
Last Updated: April 2, 2015
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Bulgaria: Ministry of Health
Canada: Health Canada
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
India: Central Drugs Standard Control Organization
Israel: only local ERB for each site
Italy: The Italian Medicines Agency
Mexico: Federal Commission for Protection Against Health Risks
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Philippines : Food and Drug Administration
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Taiwan : Food and Drug Administration
Thailand: only local ERB for each site
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Ukraine: State Pharmacological Center - Ministry of Health
Vietnam: Ministry of Health

Keywords provided by AstraZeneca:
Phase IIIb
T2DM
cardiovascular events

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 23, 2015