Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01107886




Registration number
NCT01107886
Ethics application status
Date submitted
25/03/2010
Date registered
21/04/2010
Date last updated
17/07/2014

Titles & IDs
Public title
Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications
Scientific title
A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IV Trial to Evaluate the Effect of Saxagliptin on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischaemic Stroke in Patients With Type 2 Diabetes
Secondary ID [1] 0 0
EudraCT No 2009-017358-10
Secondary ID [2] 0 0
D1680C00003
Universal Trial Number (UTN)
Trial acronym
SAVOR- TIMI 53
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Saxagliptin

Experimental: Saxagliptin -

Placebo comparator: Placebo - Placebo


Treatment: Drugs: Saxagliptin
5 mg or 2.5 mg once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Participants With Any Event From the Composite of Cardiovascular Death (CV Death), Non-fatal Myocardial Infarction (MI), or Non-fatal Ischaemic Stroke
Timepoint [1] 0 0
Randomization (day 0) up to 2.9 years
Secondary outcome [1] 0 0
Participants With Any Event From the Composite of CV Death, Non-fatal MI, Non-fatal Ischaemic Stroke, Hospitalisation for Heart Failure, Hospitalisation for Unstable Angina Pectoris, or Hospitalisation for Coronary Revascularisation
Timepoint [1] 0 0
Randomization (day 0) up to 2.9 years
Secondary outcome [2] 0 0
Participants With Event of Death
Timepoint [2] 0 0
Randomization (day 0) up to 2.9 years

Eligibility
Key inclusion criteria
* Patients with type 2 diabetes mellitus
* HbA1c =6.5%. (based on the last measured and documented laboratory measurement within 6 months)
* High risk for CV events -Established cardiovascular disease and/or multiple risk factors
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Current or previous (within 6 months) treatment with DPP4 inhibitors and/or GLP-1 mimetics
* Acute vascular event <2months prior to randomisation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2013
Sample size
Target
Accrual to date
Final
18206
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Ashford
Recruitment hospital [2] 0 0
Research Site - Fitzroy
Recruitment hospital [3] 0 0
Research Site - Frankston
Recruitment hospital [4] 0 0
Research Site - Garran
Recruitment hospital [5] 0 0
Research Site - Geelong
Recruitment hospital [6] 0 0
Research Site - Launceston
Recruitment hospital [7] 0 0
Research Site - Maroubra
Recruitment hospital [8] 0 0
Research Site - Milton
Recruitment hospital [9] 0 0
Research Site - Sherwood
Recruitment hospital [10] 0 0
Research Site - Southport
Recruitment hospital [11] 0 0
Research Site - Windsor
Recruitment postcode(s) [1] 0 0
- Ashford
Recruitment postcode(s) [2] 0 0
- Fitzroy
Recruitment postcode(s) [3] 0 0
- Frankston
Recruitment postcode(s) [4] 0 0
- Garran
Recruitment postcode(s) [5] 0 0
- Geelong
Recruitment postcode(s) [6] 0 0
- Launceston
Recruitment postcode(s) [7] 0 0
- Maroubra
Recruitment postcode(s) [8] 0 0
- Milton
Recruitment postcode(s) [9] 0 0
- Sherwood
Recruitment postcode(s) [10] 0 0
- Southport
Recruitment postcode(s) [11] 0 0
- Windsor
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
District of Columbia
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Georgia
Country [10] 0 0
United States of America
State/province [10] 0 0
Hawaii
Country [11] 0 0
United States of America
State/province [11] 0 0
Idaho
Country [12] 0 0
United States of America
State/province [12] 0 0
Illinois
Country [13] 0 0
United States of America
State/province [13] 0 0
Indiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Iowa
Country [15] 0 0
United States of America
State/province [15] 0 0
Kansas
Country [16] 0 0
United States of America
State/province [16] 0 0
Kentucky
Country [17] 0 0
United States of America
State/province [17] 0 0
Louisiana
Country [18] 0 0
United States of America
State/province [18] 0 0
Maine
Country [19] 0 0
United States of America
State/province [19] 0 0
Maryland
Country [20] 0 0
United States of America
State/province [20] 0 0
Massachusetts
Country [21] 0 0
United States of America
State/province [21] 0 0
Michigan
Country [22] 0 0
United States of America
State/province [22] 0 0
Minnesota
Country [23] 0 0
United States of America
State/province [23] 0 0
Missouri
Country [24] 0 0
United States of America
State/province [24] 0 0
Montana
Country [25] 0 0
United States of America
State/province [25] 0 0
Nebraska
Country [26] 0 0
United States of America
State/province [26] 0 0
Nevada
Country [27] 0 0
United States of America
State/province [27] 0 0
New Jersey
Country [28] 0 0
United States of America
State/province [28] 0 0
New Mexico
Country [29] 0 0
United States of America
State/province [29] 0 0
New York
Country [30] 0 0
United States of America
State/province [30] 0 0
North Carolina
Country [31] 0 0
United States of America
State/province [31] 0 0
North Dakota
Country [32] 0 0
United States of America
State/province [32] 0 0
Ohio
Country [33] 0 0
United States of America
State/province [33] 0 0
Oklahoma
Country [34] 0 0
United States of America
State/province [34] 0 0
Oregon
Country [35] 0 0
United States of America
State/province [35] 0 0
Pennsylvania
Country [36] 0 0
United States of America
State/province [36] 0 0
Rhode Island
Country [37] 0 0
United States of America
State/province [37] 0 0
South Carolina
Country [38] 0 0
United States of America
State/province [38] 0 0
South Dakota
Country [39] 0 0
United States of America
State/province [39] 0 0
Tennessee
Country [40] 0 0
United States of America
State/province [40] 0 0
Texas
Country [41] 0 0
United States of America
State/province [41] 0 0
Virginia
Country [42] 0 0
United States of America
State/province [42] 0 0
Washington
Country [43] 0 0
United States of America
State/province [43] 0 0
Wisconsin
Country [44] 0 0
Argentina
State/province [44] 0 0
Buenos Aires
Country [45] 0 0
Argentina
State/province [45] 0 0
Ciudad Autonom de Buenos Aires
Country [46] 0 0
Argentina
State/province [46] 0 0
CiudadAutonoma de Buenos Aires
Country [47] 0 0
Argentina
State/province [47] 0 0
Cordoba
Country [48] 0 0
Argentina
State/province [48] 0 0
Corrientes
Country [49] 0 0
Argentina
State/province [49] 0 0
La Plata
Country [50] 0 0
Argentina
State/province [50] 0 0
Lanus Buenos Aires
Country [51] 0 0
Argentina
State/province [51] 0 0
Mar del Plata
Country [52] 0 0
Argentina
State/province [52] 0 0
Mendoza
Country [53] 0 0
Argentina
State/province [53] 0 0
Morón
Country [54] 0 0
Argentina
State/province [54] 0 0
Ramos Mejía
Country [55] 0 0
Argentina
State/province [55] 0 0
Rosario Santa Fe
Country [56] 0 0
Argentina
State/province [56] 0 0
Rosario
Country [57] 0 0
Argentina
State/province [57] 0 0
Santa Fe
Country [58] 0 0
Argentina
State/province [58] 0 0
Sarandi Buenos Aires
Country [59] 0 0
Argentina
State/province [59] 0 0
Villa Ballester
Country [60] 0 0
Brazil
State/province [60] 0 0
Belem
Country [61] 0 0
Brazil
State/province [61] 0 0
Brasilia
Country [62] 0 0
Brazil
State/province [62] 0 0
Campinas
Country [63] 0 0
Brazil
State/province [63] 0 0
Curitiba
Country [64] 0 0
Brazil
State/province [64] 0 0
Goiânia
Country [65] 0 0
Brazil
State/province [65] 0 0
Marilia
Country [66] 0 0
Brazil
State/province [66] 0 0
Porto Alegre
Country [67] 0 0
Brazil
State/province [67] 0 0
Recife
Country [68] 0 0
Brazil
State/province [68] 0 0
Rio de Janeiro
Country [69] 0 0
Brazil
State/province [69] 0 0
Sao Paulo
Country [70] 0 0
Brazil
State/province [70] 0 0
São Paulo
Country [71] 0 0
Canada
State/province [71] 0 0
Alberta
Country [72] 0 0
Canada
State/province [72] 0 0
British Columbia
Country [73] 0 0
Canada
State/province [73] 0 0
Manitoba
Country [74] 0 0
Canada
State/province [74] 0 0
Newfoundland and Labrador
Country [75] 0 0
Canada
State/province [75] 0 0
Nova Scotia
Country [76] 0 0
Canada
State/province [76] 0 0
Ontario
Country [77] 0 0
Canada
State/province [77] 0 0
Quebec
Country [78] 0 0
Canada
State/province [78] 0 0
Saskatchewan
Country [79] 0 0
Chile
State/province [79] 0 0
Santiago
Country [80] 0 0
Chile
State/province [80] 0 0
Temuco
Country [81] 0 0
China
State/province [81] 0 0
Beijing
Country [82] 0 0
China
State/province [82] 0 0
Changsha
Country [83] 0 0
China
State/province [83] 0 0
Guangzhou
Country [84] 0 0
China
State/province [84] 0 0
Hong Kong
Country [85] 0 0
China
State/province [85] 0 0
Nanjing
Country [86] 0 0
China
State/province [86] 0 0
Shanghai
Country [87] 0 0
China
State/province [87] 0 0
Suzhou
Country [88] 0 0
China
State/province [88] 0 0
Tianjin
Country [89] 0 0
Czech Republic
State/province [89] 0 0
Beroun
Country [90] 0 0
Czech Republic
State/province [90] 0 0
Blansko
Country [91] 0 0
Czech Republic
State/province [91] 0 0
Breclav
Country [92] 0 0
Czech Republic
State/province [92] 0 0
Brno
Country [93] 0 0
Czech Republic
State/province [93] 0 0
Caslav
Country [94] 0 0
Czech Republic
State/province [94] 0 0
Cheb
Country [95] 0 0
Czech Republic
State/province [95] 0 0
Chrudim III
Country [96] 0 0
Czech Republic
State/province [96] 0 0
Havirov
Country [97] 0 0
Czech Republic
State/province [97] 0 0
Hodonin
Country [98] 0 0
Czech Republic
State/province [98] 0 0
Horovice
Country [99] 0 0
Czech Republic
State/province [99] 0 0
Hradec Kralove
Country [100] 0 0
Czech Republic
State/province [100] 0 0
Jablonec nad Nisou
Country [101] 0 0
Czech Republic
State/province [101] 0 0
Kromeriz
Country [102] 0 0
Czech Republic
State/province [102] 0 0
Olomouc-Lazce
Country [103] 0 0
Czech Republic
State/province [103] 0 0
Ostrava - Belsky les
Country [104] 0 0
Czech Republic
State/province [104] 0 0
Ostrava - Kuncice
Country [105] 0 0
Czech Republic
State/province [105] 0 0
Ostrava-Vitkovice
Country [106] 0 0
Czech Republic
State/province [106] 0 0
Ostrava
Country [107] 0 0
Czech Republic
State/province [107] 0 0
Pardubice
Country [108] 0 0
Czech Republic
State/province [108] 0 0
Plzen
Country [109] 0 0
Czech Republic
State/province [109] 0 0
Praha 2
Country [110] 0 0
Czech Republic
State/province [110] 0 0
Praha 6
Country [111] 0 0
Czech Republic
State/province [111] 0 0
Praha
Country [112] 0 0
Czech Republic
State/province [112] 0 0
Prelouc
Country [113] 0 0
Czech Republic
State/province [113] 0 0
Slany
Country [114] 0 0
Czech Republic
State/province [114] 0 0
Uherske Hradiste
Country [115] 0 0
Czech Republic
State/province [115] 0 0
Valaske Klobouky
Country [116] 0 0
Czech Republic
State/province [116] 0 0
Zlin
Country [117] 0 0
France
State/province [117] 0 0
Amiens
Country [118] 0 0
France
State/province [118] 0 0
Bron
Country [119] 0 0
France
State/province [119] 0 0
Colmar Cedex
Country [120] 0 0
France
State/province [120] 0 0
Corbeil Essonnes
Country [121] 0 0
France
State/province [121] 0 0
Nantes cedex 1
Country [122] 0 0
France
State/province [122] 0 0
Paris Cedex 10
Country [123] 0 0
France
State/province [123] 0 0
Pessac
Country [124] 0 0
France
State/province [124] 0 0
Poitiers Cedex
Country [125] 0 0
France
State/province [125] 0 0
Reims Cedex
Country [126] 0 0
France
State/province [126] 0 0
Toulouse Cedex
Country [127] 0 0
Germany
State/province [127] 0 0
Aschaffenburg
Country [128] 0 0
Germany
State/province [128] 0 0
Bad Nauheim
Country [129] 0 0
Germany
State/province [129] 0 0
Bad Oeynhausen
Country [130] 0 0
Germany
State/province [130] 0 0
Berlin
Country [131] 0 0
Germany
State/province [131] 0 0
Deggingen
Country [132] 0 0
Germany
State/province [132] 0 0
Dippoldiswalde
Country [133] 0 0
Germany
State/province [133] 0 0
Dortmund
Country [134] 0 0
Germany
State/province [134] 0 0
Dresden
Country [135] 0 0
Germany
State/province [135] 0 0
Eschweiler
Country [136] 0 0
Germany
State/province [136] 0 0
Gießen
Country [137] 0 0
Germany
State/province [137] 0 0
Goch
Country [138] 0 0
Germany
State/province [138] 0 0
Gueglingen
Country [139] 0 0
Germany
State/province [139] 0 0
Hamburg
Country [140] 0 0
Germany
State/province [140] 0 0
Hohenmölsen
Country [141] 0 0
Germany
State/province [141] 0 0
Kassel
Country [142] 0 0
Germany
State/province [142] 0 0
Leipzig
Country [143] 0 0
Germany
State/province [143] 0 0
Mayen
Country [144] 0 0
Germany
State/province [144] 0 0
Rehlingen Siersburg
Country [145] 0 0
Germany
State/province [145] 0 0
Rotenburg
Country [146] 0 0
Hong Kong
State/province [146] 0 0
Shatin
Country [147] 0 0
Hong Kong
State/province [147] 0 0
Hong Kong
Country [148] 0 0
Hungary
State/province [148] 0 0
Balatonfüred
Country [149] 0 0
Hungary
State/province [149] 0 0
Budapest
Country [150] 0 0
Hungary
State/province [150] 0 0
Békéscsaba
Country [151] 0 0
Hungary
State/province [151] 0 0
Cegled
Country [152] 0 0
Hungary
State/province [152] 0 0
Csongrad
Country [153] 0 0
Hungary
State/province [153] 0 0
Eger
Country [154] 0 0
Hungary
State/province [154] 0 0
Gyor
Country [155] 0 0
Hungary
State/province [155] 0 0
Gyula
Country [156] 0 0
Hungary
State/province [156] 0 0
Gyöngyös
Country [157] 0 0
Hungary
State/province [157] 0 0
Miskolc
Country [158] 0 0
Hungary
State/province [158] 0 0
Nagykanizsa
Country [159] 0 0
Hungary
State/province [159] 0 0
Pecs
Country [160] 0 0
Hungary
State/province [160] 0 0
Siofok
Country [161] 0 0
Hungary
State/province [161] 0 0
Szolnok
Country [162] 0 0
Hungary
State/province [162] 0 0
Veszprém
Country [163] 0 0
India
State/province [163] 0 0
Ahmedabad
Country [164] 0 0
India
State/province [164] 0 0
Bangalore
Country [165] 0 0
India
State/province [165] 0 0
Bengaluru
Country [166] 0 0
India
State/province [166] 0 0
Ernakulam District
Country [167] 0 0
India
State/province [167] 0 0
Hyderabad
Country [168] 0 0
India
State/province [168] 0 0
Indore
Country [169] 0 0
India
State/province [169] 0 0
Jaipur
Country [170] 0 0
India
State/province [170] 0 0
Mumbai
Country [171] 0 0
India
State/province [171] 0 0
Mysore
Country [172] 0 0
India
State/province [172] 0 0
Nagpur
Country [173] 0 0
India
State/province [173] 0 0
New Delhi
Country [174] 0 0
India
State/province [174] 0 0
Pune
Country [175] 0 0
India
State/province [175] 0 0
Vadodara
Country [176] 0 0
Israel
State/province [176] 0 0
Ashkelon
Country [177] 0 0
Israel
State/province [177] 0 0
Beer Sheva
Country [178] 0 0
Israel
State/province [178] 0 0
Dimona
Country [179] 0 0
Israel
State/province [179] 0 0
Givatayim
Country [180] 0 0
Israel
State/province [180] 0 0
Haifa
Country [181] 0 0
Israel
State/province [181] 0 0
Holon
Country [182] 0 0
Israel
State/province [182] 0 0
Jerusalem
Country [183] 0 0
Israel
State/province [183] 0 0
Kfar-Saba
Country [184] 0 0
Israel
State/province [184] 0 0
Nahariya
Country [185] 0 0
Israel
State/province [185] 0 0
Petach Tikva
Country [186] 0 0
Israel
State/province [186] 0 0
Rehovot
Country [187] 0 0
Israel
State/province [187] 0 0
Tel Aviv
Country [188] 0 0
Israel
State/province [188] 0 0
Tel-Aviv
Country [189] 0 0
Israel
State/province [189] 0 0
Zefat
Country [190] 0 0
Israel
State/province [190] 0 0
Zerifin
Country [191] 0 0
Italy
State/province [191] 0 0
Bergamo
Country [192] 0 0
Italy
State/province [192] 0 0
Catania
Country [193] 0 0
Italy
State/province [193] 0 0
Firenze
Country [194] 0 0
Italy
State/province [194] 0 0
Mercato San Severino
Country [195] 0 0
Italy
State/province [195] 0 0
Milano
Country [196] 0 0
Italy
State/province [196] 0 0
Napoli
Country [197] 0 0
Italy
State/province [197] 0 0
Negrar - VR
Country [198] 0 0
Italy
State/province [198] 0 0
Padova
Country [199] 0 0
Italy
State/province [199] 0 0
Parma
Country [200] 0 0
Italy
State/province [200] 0 0
Pavia
Country [201] 0 0
Italy
State/province [201] 0 0
Pozzuoli
Country [202] 0 0
Italy
State/province [202] 0 0
Prato
Country [203] 0 0
Italy
State/province [203] 0 0
Ravenna
Country [204] 0 0
Italy
State/province [204] 0 0
Roma
Country [205] 0 0
Italy
State/province [205] 0 0
Rozzano
Country [206] 0 0
Italy
State/province [206] 0 0
S Maria Capua Vetere
Country [207] 0 0
Italy
State/province [207] 0 0
San Giovanni Rotondo
Country [208] 0 0
Italy
State/province [208] 0 0
Sessa Aurunca
Country [209] 0 0
Italy
State/province [209] 0 0
Taormina
Country [210] 0 0
Italy
State/province [210] 0 0
Terni
Country [211] 0 0
Mexico
State/province [211] 0 0
Aguascalientes
Country [212] 0 0
Mexico
State/province [212] 0 0
Culiacan
Country [213] 0 0
Mexico
State/province [213] 0 0
Durango
Country [214] 0 0
Mexico
State/province [214] 0 0
Guadalajara
Country [215] 0 0
Mexico
State/province [215] 0 0
Mexico
Country [216] 0 0
Mexico
State/province [216] 0 0
Monclova
Country [217] 0 0
Mexico
State/province [217] 0 0
Monterrey
Country [218] 0 0
Mexico
State/province [218] 0 0
México
Country [219] 0 0
Mexico
State/province [219] 0 0
Nuevo Leon
Country [220] 0 0
Mexico
State/province [220] 0 0
Oaxaca
Country [221] 0 0
Mexico
State/province [221] 0 0
Queretaro
Country [222] 0 0
Mexico
State/province [222] 0 0
San Luis Potosi
Country [223] 0 0
Mexico
State/province [223] 0 0
San Luis Potosí
Country [224] 0 0
Mexico
State/province [224] 0 0
Tijuana
Country [225] 0 0
Mexico
State/province [225] 0 0
Xalapa
Country [226] 0 0
Netherlands
State/province [226] 0 0
Almelo
Country [227] 0 0
Netherlands
State/province [227] 0 0
Amersfoort
Country [228] 0 0
Netherlands
State/province [228] 0 0
Amsterdam
Country [229] 0 0
Netherlands
State/province [229] 0 0
Apeldoorn
Country [230] 0 0
Netherlands
State/province [230] 0 0
Arnhem
Country [231] 0 0
Netherlands
State/province [231] 0 0
Breda
Country [232] 0 0
Netherlands
State/province [232] 0 0
Delft
Country [233] 0 0
Netherlands
State/province [233] 0 0
Eindhoven
Country [234] 0 0
Netherlands
State/province [234] 0 0
Goes
Country [235] 0 0
Netherlands
State/province [235] 0 0
Gouda
Country [236] 0 0
Netherlands
State/province [236] 0 0
Groningen
Country [237] 0 0
Netherlands
State/province [237] 0 0
Hardenberg
Country [238] 0 0
Netherlands
State/province [238] 0 0
Hoogeveen
Country [239] 0 0
Netherlands
State/province [239] 0 0
Hoorn
Country [240] 0 0
Netherlands
State/province [240] 0 0
Leiderdorp
Country [241] 0 0
Netherlands
State/province [241] 0 0
Nijmegen
Country [242] 0 0
Netherlands
State/province [242] 0 0
Rotterdam
Country [243] 0 0
Netherlands
State/province [243] 0 0
Sneek
Country [244] 0 0
Netherlands
State/province [244] 0 0
Utrecht
Country [245] 0 0
Netherlands
State/province [245] 0 0
Velp
Country [246] 0 0
Netherlands
State/province [246] 0 0
Waalwijk
Country [247] 0 0
Netherlands
State/province [247] 0 0
Zoetermeer
Country [248] 0 0
Peru
State/province [248] 0 0
Callao
Country [249] 0 0
Peru
State/province [249] 0 0
Lima
Country [250] 0 0
Peru
State/province [250] 0 0
San Isidro
Country [251] 0 0
Poland
State/province [251] 0 0
Bydgoszcz
Country [252] 0 0
Poland
State/province [252] 0 0
Gdansk
Country [253] 0 0
Poland
State/province [253] 0 0
Kamieniec Zabkowicki
Country [254] 0 0
Poland
State/province [254] 0 0
Koluszki
Country [255] 0 0
Poland
State/province [255] 0 0
Krakow
Country [256] 0 0
Poland
State/province [256] 0 0
Lodz
Country [257] 0 0
Poland
State/province [257] 0 0
Mrgowo
Country [258] 0 0
Poland
State/province [258] 0 0
Nakso nad Noteci
Country [259] 0 0
Poland
State/province [259] 0 0
Opole
Country [260] 0 0
Poland
State/province [260] 0 0
Olawa
Country [261] 0 0
Poland
State/province [261] 0 0
Poznan
Country [262] 0 0
Poland
State/province [262] 0 0
Przemysl
Country [263] 0 0
Poland
State/province [263] 0 0
Sieradz
Country [264] 0 0
Poland
State/province [264] 0 0
Skierniewice
Country [265] 0 0
Poland
State/province [265] 0 0
Torun
Country [266] 0 0
Poland
State/province [266] 0 0
Warszawa
Country [267] 0 0
Poland
State/province [267] 0 0
Wroclaw
Country [268] 0 0
Poland
State/province [268] 0 0
Wabrzezno
Country [269] 0 0
Poland
State/province [269] 0 0
Zabrze
Country [270] 0 0
Poland
State/province [270] 0 0
Leczna
Country [271] 0 0
Puerto Rico
State/province [271] 0 0
Aguas Buneas
Country [272] 0 0
Puerto Rico
State/province [272] 0 0
Bayamon
Country [273] 0 0
Puerto Rico
State/province [273] 0 0
Cidra
Country [274] 0 0
Puerto Rico
State/province [274] 0 0
Hato Rey
Country [275] 0 0
Puerto Rico
State/province [275] 0 0
Jardines de Loiza, Loiza
Country [276] 0 0
Puerto Rico
State/province [276] 0 0
Juncos
Country [277] 0 0
Puerto Rico
State/province [277] 0 0
Ponce
Country [278] 0 0
Puerto Rico
State/province [278] 0 0
Rio Piedras
Country [279] 0 0
Puerto Rico
State/province [279] 0 0
San Juan
Country [280] 0 0
Puerto Rico
State/province [280] 0 0
Toa Baja
Country [281] 0 0
Russian Federation
State/province [281] 0 0
Ekaterinburg
Country [282] 0 0
Russian Federation
State/province [282] 0 0
Kazan
Country [283] 0 0
Russian Federation
State/province [283] 0 0
Moscow
Country [284] 0 0
Russian Federation
State/province [284] 0 0
Novosibirsk
Country [285] 0 0
Russian Federation
State/province [285] 0 0
Saint Petersburg
Country [286] 0 0
Russian Federation
State/province [286] 0 0
Saint-Petersburg
Country [287] 0 0
Russian Federation
State/province [287] 0 0
Saratov
Country [288] 0 0
Russian Federation
State/province [288] 0 0
St. Petersburg
Country [289] 0 0
Russian Federation
State/province [289] 0 0
St.-Petersburg
Country [290] 0 0
Russian Federation
State/province [290] 0 0
St.Petersburg
Country [291] 0 0
Russian Federation
State/province [291] 0 0
StPetersburg
Country [292] 0 0
South Africa
State/province [292] 0 0
Benoni
Country [293] 0 0
South Africa
State/province [293] 0 0
Cape Town
Country [294] 0 0
South Africa
State/province [294] 0 0
Durban
Country [295] 0 0
South Africa
State/province [295] 0 0
Johannesburg
Country [296] 0 0
South Africa
State/province [296] 0 0
Parow
Country [297] 0 0
South Africa
State/province [297] 0 0
Pretoria
Country [298] 0 0
South Africa
State/province [298] 0 0
Umkomaas
Country [299] 0 0
South Africa
State/province [299] 0 0
Verulam
Country [300] 0 0
Spain
State/province [300] 0 0
Alicante
Country [301] 0 0
Spain
State/province [301] 0 0
Barcelona
Country [302] 0 0
Spain
State/province [302] 0 0
Granada
Country [303] 0 0
Spain
State/province [303] 0 0
Jerez de la Frontera Cadiz
Country [304] 0 0
Spain
State/province [304] 0 0
Lérida
Country [305] 0 0
Spain
State/province [305] 0 0
Madrid
Country [306] 0 0
Spain
State/province [306] 0 0
Majadahonda
Country [307] 0 0
Spain
State/province [307] 0 0
Oviedo
Country [308] 0 0
Spain
State/province [308] 0 0
Palma de Mallorca
Country [309] 0 0
Spain
State/province [309] 0 0
Santiago de Compostela
Country [310] 0 0
Spain
State/province [310] 0 0
Sevilla
Country [311] 0 0
Spain
State/province [311] 0 0
Valencia
Country [312] 0 0
Sweden
State/province [312] 0 0
Brämhult
Country [313] 0 0
Sweden
State/province [313] 0 0
Eksjö
Country [314] 0 0
Sweden
State/province [314] 0 0
Goteborg
Country [315] 0 0
Sweden
State/province [315] 0 0
Göteborg
Country [316] 0 0
Sweden
State/province [316] 0 0
Helsingborg
Country [317] 0 0
Sweden
State/province [317] 0 0
Jönköping
Country [318] 0 0
Sweden
State/province [318] 0 0
Malmo
Country [319] 0 0
Sweden
State/province [319] 0 0
Rättvik
Country [320] 0 0
Sweden
State/province [320] 0 0
Stockholm
Country [321] 0 0
Sweden
State/province [321] 0 0
Söråker
Country [322] 0 0
Sweden
State/province [322] 0 0
Umeå
Country [323] 0 0
Sweden
State/province [323] 0 0
Örebro
Country [324] 0 0
Sweden
State/province [324] 0 0
Östersund
Country [325] 0 0
Taiwan
State/province [325] 0 0
Kaohsiung Hsien
Country [326] 0 0
Taiwan
State/province [326] 0 0
Kaohsiung
Country [327] 0 0
Taiwan
State/province [327] 0 0
Taichung
Country [328] 0 0
Taiwan
State/province [328] 0 0
Taipei
Country [329] 0 0
Taiwan
State/province [329] 0 0
Yong-Kang City
Country [330] 0 0
Thailand
State/province [330] 0 0
Bangkoknoi
Country [331] 0 0
Thailand
State/province [331] 0 0
Bangkok
Country [332] 0 0
Thailand
State/province [332] 0 0
Chiang Mai
Country [333] 0 0
Thailand
State/province [333] 0 0
Khon Kaen
Country [334] 0 0
Thailand
State/province [334] 0 0
Ratchaburi
Country [335] 0 0
United Kingdom
State/province [335] 0 0
Aylesbury
Country [336] 0 0
United Kingdom
State/province [336] 0 0
Bath
Country [337] 0 0
United Kingdom
State/province [337] 0 0
Belfast
Country [338] 0 0
United Kingdom
State/province [338] 0 0
Blackpool
Country [339] 0 0
United Kingdom
State/province [339] 0 0
Corsham
Country [340] 0 0
United Kingdom
State/province [340] 0 0
Coventry
Country [341] 0 0
United Kingdom
State/province [341] 0 0
Fowey
Country [342] 0 0
United Kingdom
State/province [342] 0 0
Kenton
Country [343] 0 0
United Kingdom
State/province [343] 0 0
Leicester
Country [344] 0 0
United Kingdom
State/province [344] 0 0
Mortimer Reading
Country [345] 0 0
United Kingdom
State/province [345] 0 0
Plymouth
Country [346] 0 0
United Kingdom
State/province [346] 0 0
Sheffield
Country [347] 0 0
United Kingdom
State/province [347] 0 0
Sunbury on Thames
Country [348] 0 0
United Kingdom
State/province [348] 0 0
Swindon
Country [349] 0 0
United Kingdom
State/province [349] 0 0
Wansford
Country [350] 0 0
United Kingdom
State/province [350] 0 0
Warminster
Country [351] 0 0
United Kingdom
State/province [351] 0 0
Whitstable

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Bristol-Myers Squibb
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether saxagliptin can reduce the risk of cardiovascular events when used alone or added to other diabetes medications
Trial website
https://clinicaltrials.gov/study/NCT01107886
Trial related presentations / publications
Cavallari I, Bhatt DL, Steg PG, Leiter LA, McGuire DK, Mosenzon O, Im K, Raz I, Braunwald E, Scirica BM. Causes and Risk Factors for Death in Diabetes: A Competing-Risk Analysis From the SAVOR-TIMI 53 Trial. J Am Coll Cardiol. 2021 Apr 13;77(14):1837-1840. doi: 10.1016/j.jacc.2021.02.030. No abstract available.
Berg DD, Wiviott SD, Scirica BM, Gurmu Y, Mosenzon O, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Johanson P, Johansson PA, Langkilde AM, Raz I, Braunwald E, Sabatine MS. Heart Failure Risk Stratification and Efficacy of Sodium-Glucose Cotransporter-2 Inhibitors in Patients With Type 2 Diabetes Mellitus. Circulation. 2019 Nov 5;140(19):1569-1577. doi: 10.1161/CIRCULATIONAHA.119.042685. Epub 2019 Aug 31.
Bergmark BA, Bhatt DL, McGuire DK, Cahn A, Mosenzon O, Steg PG, Im K, Kanevsky E, Gurmu Y, Raz I, Braunwald E, Scirica BM; SAVOR-TIMI 53 Steering Committee and Investigators. Metformin Use and Clinical Outcomes Among Patients With Diabetes Mellitus With or Without Heart Failure or Kidney Dysfunction: Observations From the SAVOR-TIMI 53 Trial. Circulation. 2019 Sep 17;140(12):1004-1014. doi: 10.1161/CIRCULATIONAHA.119.040144. Epub 2019 Jul 31.
Scirica BM, Mosenzon O, Bhatt DL, Udell JA, Steg PG, McGuire DK, Im K, Kanevsky E, Stahre C, Sjostrand M, Raz I, Braunwald E. Cardiovascular Outcomes According to Urinary Albumin and Kidney Disease in Patients With Type 2 Diabetes at High Cardiovascular Risk: Observations From the SAVOR-TIMI 53 Trial. JAMA Cardiol. 2018 Feb 1;3(2):155-163. doi: 10.1001/jamacardio.2017.4228.
Xia C, Goud A, D'Souza J, Dahagam C, Rao X, Rajagopalan S, Zhong J. DPP4 inhibitors and cardiovascular outcomes: safety on heart failure. Heart Fail Rev. 2017 May;22(3):299-304. doi: 10.1007/s10741-017-9617-4.
Mosenzon O, Leibowitz G, Bhatt DL, Cahn A, Hirshberg B, Wei C, Im K, Rozenberg A, Yanuv I, Stahre C, Ray KK, Iqbal N, Braunwald E, Scirica BM, Raz I. Effect of Saxagliptin on Renal Outcomes in the SAVOR-TIMI 53 Trial. Diabetes Care. 2017 Jan;40(1):69-76. doi: 10.2337/dc16-0621. Epub 2016 Oct 17.
Scirica BM, Bhatt DL, Braunwald E, Raz I, Cavender MA, Im K, Mosenzon O, Udell JA, Hirshberg B, Pollack PS, Steg PG, Jarolim P, Morrow DA. Prognostic Implications of Biomarker Assessments in Patients With Type 2 Diabetes at High Cardiovascular Risk: A Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2016 Dec 1;1(9):989-998. doi: 10.1001/jamacardio.2016.3030.
Cavender MA, Scirica BM, Raz I, Steg PG, McGuire DK, Leiter LA, Hirshberg B, Davidson J, Cahn A, Mosenzon O, Im K, Braunwald E, Bhatt DL. Cardiovascular Outcomes of Patients in SAVOR-TIMI 53 by Baseline Hemoglobin A1c. Am J Med. 2016 Mar;129(3):340.e1-8. doi: 10.1016/j.amjmed.2015.09.022. Epub 2015 Oct 31.
Mosenzon O, Wei C, Davidson J, Scirica BM, Yanuv I, Rozenberg A, Hirshberg B, Cahn A, Stahre C, Strojek K, Bhatt DL, Raz I. Incidence of Fractures in Patients With Type 2 Diabetes in the SAVOR-TIMI 53 Trial. Diabetes Care. 2015 Nov;38(11):2142-50. doi: 10.2337/dc15-1068. Epub 2015 Sep 10.
Leiter LA, Teoh H, Braunwald E, Mosenzon O, Cahn A, Kumar KM, Smahelova A, Hirshberg B, Stahre C, Frederich R, Bonnici F, Scirica BM, Bhatt DL, Raz I; SAVOR-TIMI 53 Steering Committee and Investigators. Efficacy and safety of saxagliptin in older participants in the SAVOR-TIMI 53 trial. Diabetes Care. 2015 Jun;38(6):1145-53. doi: 10.2337/dc14-2868. Epub 2015 Mar 10.
Udell JA, Bhatt DL, Braunwald E, Cavender MA, Mosenzon O, Steg PG, Davidson JA, Nicolau JC, Corbalan R, Hirshberg B, Frederich R, Im K, Umez-Eronini AA, He P, McGuire DK, Leiter LA, Raz I, Scirica BM; SAVOR-TIMI 53 Steering Committee and Investigators. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes and moderate or severe renal impairment: observations from the SAVOR-TIMI 53 Trial. Diabetes Care. 2015 Apr;38(4):696-705. doi: 10.2337/dc14-1850. Epub 2014 Dec 31.
Scirica BM, Braunwald E, Raz I, Cavender MA, Morrow DA, Jarolim P, Udell JA, Mosenzon O, Im K, Umez-Eronini AA, Pollack PS, Hirshberg B, Frederich R, Lewis BS, McGuire DK, Davidson J, Steg PG, Bhatt DL; SAVOR-TIMI 53 Steering Committee and Investigators*. Heart failure, saxagliptin, and diabetes mellitus: observations from the SAVOR-TIMI 53 randomized trial. Circulation. 2014 Oct 28;130(18):1579-88. doi: 10.1161/CIRCULATIONAHA.114.010389. Epub 2014 Sep 4. Erratum In: Circulation. 2015 Oct 13;132(15):e198. doi: 10.1161/CIR.0000000000000330.
Scirica BM, Bhatt DL, Braunwald E, Steg PG, Davidson J, Hirshberg B, Ohman P, Frederich R, Wiviott SD, Hoffman EB, Cavender MA, Udell JA, Desai NR, Mosenzon O, McGuire DK, Ray KK, Leiter LA, Raz I; SAVOR-TIMI 53 Steering Committee and Investigators. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med. 2013 Oct 3;369(14):1317-26. doi: 10.1056/NEJMoa1307684. Epub 2013 Sep 2.
Mosenzon O, Raz I, Scirica BM, Hirshberg B, Stahre CI, Steg PG, Davidson J, Ohman P, Price DL, Frederich B, Udell JA, Braunwald E, Bhatt DL. Baseline characteristics of the patient population in the Saxagliptin Assessment of Vascular Outcomes Recorded in patients with diabetes mellitus (SAVOR)-TIMI 53 trial. Diabetes Metab Res Rev. 2013 Jul;29(5):417-26. doi: 10.1002/dmrr.2413. Epub 2013 May 21.
Scirica BM, Bhatt DL, Braunwald E, Steg PG, Davidson J, Hirshberg B, Ohman P, Price DL, Chen R, Udell J, Raz I. The design and rationale of the saxagliptin assessment of vascular outcomes recorded in patients with diabetes mellitus-thrombolysis in myocardial infarction (SAVOR-TIMI) 53 study. Am Heart J. 2011 Nov;162(5):818-825.e6. doi: 10.1016/j.ahj.2011.08.006.
Public notes

Contacts
Principal investigator
Name 0 0
Eugene Braunwald
Address 0 0
TIMI
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01107886