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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
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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
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Secondary ID [1]
0
0
EudraCT No 2009-017358-10
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Secondary ID [2]
0
0
D1680C00003
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Universal Trial Number (UTN)
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Trial acronym
SAVOR- TIMI 53
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus
0
0
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Condition category
Condition code
Metabolic and Endocrine
0
0
0
0
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Diabetes
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
0
0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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0
Participants With Any Event From the Composite of Cardiovascular Death (CV Death), Non-fatal Myocardial Infarction (MI), or Non-fatal Ischaemic Stroke
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Assessment method [1]
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0
Participants with CV death, non-fatal MI or non-fatal ischaemic stroke. If no event, censoring occurs at the patient withdrawal of consent, last contact, or death (when applicable)-whichever was later.
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Timepoint [1]
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0
Randomization (day 0) up to 2.9 years
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Secondary outcome [1]
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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
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Assessment method [1]
0
0
Participants with CV death, non-fatal MI, non-fatal ischaemic stroke, hospitalisation for heart failure, hospitalisation for unstable angina pectoris, or hospitalisation for coronary revascularisation. If no event, censoring occurs at the patient withdrawal of consent, last contact, or death (when applicable)-whichever was later.
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Timepoint [1]
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0
Randomization (day 0) up to 2.9 years
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Secondary outcome [2]
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0
Participants With Event of Death
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Assessment method [2]
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0
Participants with event of death. If no event, censoring occurs at the patient withdrawal of consent, or last contact -whichever was later.
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Timepoint [2]
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0
Randomization (day 0) up to 2.9 years
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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
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2013
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Sample size
Target
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Accrual to date
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Final
18206
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Ashford
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Research Site - Fitzroy
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Research Site - Windsor
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Recruitment postcode(s) [1]
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- Ashford
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- Fitzroy
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- Frankston
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- Garran
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- Geelong
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- Launceston
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- Maroubra
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Recruitment postcode(s) [8]
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- Milton
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Recruitment postcode(s) [9]
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- Sherwood
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Recruitment postcode(s) [10]
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- Southport
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Recruitment postcode(s) [11]
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- Windsor
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Recruitment outside Australia
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0
0
Deggingen
Query!
Country [132]
0
0
Germany
Query!
State/province [132]
0
0
Dippoldiswalde
Query!
Country [133]
0
0
Germany
Query!
State/province [133]
0
0
Dortmund
Query!
Country [134]
0
0
Germany
Query!
State/province [134]
0
0
Dresden
Query!
Country [135]
0
0
Germany
Query!
State/province [135]
0
0
Eschweiler
Query!
Country [136]
0
0
Germany
Query!
State/province [136]
0
0
Gießen
Query!
Country [137]
0
0
Germany
Query!
State/province [137]
0
0
Goch
Query!
Country [138]
0
0
Germany
Query!
State/province [138]
0
0
Gueglingen
Query!
Country [139]
0
0
Germany
Query!
State/province [139]
0
0
Hamburg
Query!
Country [140]
0
0
Germany
Query!
State/province [140]
0
0
Hohenmölsen
Query!
Country [141]
0
0
Germany
Query!
State/province [141]
0
0
Kassel
Query!
Country [142]
0
0
Germany
Query!
State/province [142]
0
0
Leipzig
Query!
Country [143]
0
0
Germany
Query!
State/province [143]
0
0
Mayen
Query!
Country [144]
0
0
Germany
Query!
State/province [144]
0
0
Rehlingen Siersburg
Query!
Country [145]
0
0
Germany
Query!
State/province [145]
0
0
Rotenburg
Query!
Country [146]
0
0
Hong Kong
Query!
State/province [146]
0
0
Shatin
Query!
Country [147]
0
0
Hong Kong
Query!
State/province [147]
0
0
Hong Kong
Query!
Country [148]
0
0
Hungary
Query!
State/province [148]
0
0
Balatonfüred
Query!
Country [149]
0
0
Hungary
Query!
State/province [149]
0
0
Budapest
Query!
Country [150]
0
0
Hungary
Query!
State/province [150]
0
0
Békéscsaba
Query!
Country [151]
0
0
Hungary
Query!
State/province [151]
0
0
Cegled
Query!
Country [152]
0
0
Hungary
Query!
State/province [152]
0
0
Csongrad
Query!
Country [153]
0
0
Hungary
Query!
State/province [153]
0
0
Eger
Query!
Country [154]
0
0
Hungary
Query!
State/province [154]
0
0
Gyor
Query!
Country [155]
0
0
Hungary
Query!
State/province [155]
0
0
Gyula
Query!
Country [156]
0
0
Hungary
Query!
State/province [156]
0
0
Gyöngyös
Query!
Country [157]
0
0
Hungary
Query!
State/province [157]
0
0
Miskolc
Query!
Country [158]
0
0
Hungary
Query!
State/province [158]
0
0
Nagykanizsa
Query!
Country [159]
0
0
Hungary
Query!
State/province [159]
0
0
Pecs
Query!
Country [160]
0
0
Hungary
Query!
State/province [160]
0
0
Siofok
Query!
Country [161]
0
0
Hungary
Query!
State/province [161]
0
0
Szolnok
Query!
Country [162]
0
0
Hungary
Query!
State/province [162]
0
0
Veszprém
Query!
Country [163]
0
0
India
Query!
State/province [163]
0
0
Ahmedabad
Query!
Country [164]
0
0
India
Query!
State/province [164]
0
0
Bangalore
Query!
Country [165]
0
0
India
Query!
State/province [165]
0
0
Bengaluru
Query!
Country [166]
0
0
India
Query!
State/province [166]
0
0
Ernakulam District
Query!
Country [167]
0
0
India
Query!
State/province [167]
0
0
Hyderabad
Query!
Country [168]
0
0
India
Query!
State/province [168]
0
0
Indore
Query!
Country [169]
0
0
India
Query!
State/province [169]
0
0
Jaipur
Query!
Country [170]
0
0
India
Query!
State/province [170]
0
0
Mumbai
Query!
Country [171]
0
0
India
Query!
State/province [171]
0
0
Mysore
Query!
Country [172]
0
0
India
Query!
State/province [172]
0
0
Nagpur
Query!
Country [173]
0
0
India
Query!
State/province [173]
0
0
New Delhi
Query!
Country [174]
0
0
India
Query!
State/province [174]
0
0
Pune
Query!
Country [175]
0
0
India
Query!
State/province [175]
0
0
Vadodara
Query!
Country [176]
0
0
Israel
Query!
State/province [176]
0
0
Ashkelon
Query!
Country [177]
0
0
Israel
Query!
State/province [177]
0
0
Beer Sheva
Query!
Country [178]
0
0
Israel
Query!
State/province [178]
0
0
Dimona
Query!
Country [179]
0
0
Israel
Query!
State/province [179]
0
0
Givatayim
Query!
Country [180]
0
0
Israel
Query!
State/province [180]
0
0
Haifa
Query!
Country [181]
0
0
Israel
Query!
State/province [181]
0
0
Holon
Query!
Country [182]
0
0
Israel
Query!
State/province [182]
0
0
Jerusalem
Query!
Country [183]
0
0
Israel
Query!
State/province [183]
0
0
Kfar-Saba
Query!
Country [184]
0
0
Israel
Query!
State/province [184]
0
0
Nahariya
Query!
Country [185]
0
0
Israel
Query!
State/province [185]
0
0
Petach Tikva
Query!
Country [186]
0
0
Israel
Query!
State/province [186]
0
0
Rehovot
Query!
Country [187]
0
0
Israel
Query!
State/province [187]
0
0
Tel Aviv
Query!
Country [188]
0
0
Israel
Query!
State/province [188]
0
0
Tel-Aviv
Query!
Country [189]
0
0
Israel
Query!
State/province [189]
0
0
Zefat
Query!
Country [190]
0
0
Israel
Query!
State/province [190]
0
0
Zerifin
Query!
Country [191]
0
0
Italy
Query!
State/province [191]
0
0
Bergamo
Query!
Country [192]
0
0
Italy
Query!
State/province [192]
0
0
Catania
Query!
Country [193]
0
0
Italy
Query!
State/province [193]
0
0
Firenze
Query!
Country [194]
0
0
Italy
Query!
State/province [194]
0
0
Mercato San Severino
Query!
Country [195]
0
0
Italy
Query!
State/province [195]
0
0
Milano
Query!
Country [196]
0
0
Italy
Query!
State/province [196]
0
0
Napoli
Query!
Country [197]
0
0
Italy
Query!
State/province [197]
0
0
Negrar - VR
Query!
Country [198]
0
0
Italy
Query!
State/province [198]
0
0
Padova
Query!
Country [199]
0
0
Italy
Query!
State/province [199]
0
0
Parma
Query!
Country [200]
0
0
Italy
Query!
State/province [200]
0
0
Pavia
Query!
Country [201]
0
0
Italy
Query!
State/province [201]
0
0
Pozzuoli
Query!
Country [202]
0
0
Italy
Query!
State/province [202]
0
0
Prato
Query!
Country [203]
0
0
Italy
Query!
State/province [203]
0
0
Ravenna
Query!
Country [204]
0
0
Italy
Query!
State/province [204]
0
0
Roma
Query!
Country [205]
0
0
Italy
Query!
State/province [205]
0
0
Rozzano
Query!
Country [206]
0
0
Italy
Query!
State/province [206]
0
0
S Maria Capua Vetere
Query!
Country [207]
0
0
Italy
Query!
State/province [207]
0
0
San Giovanni Rotondo
Query!
Country [208]
0
0
Italy
Query!
State/province [208]
0
0
Sessa Aurunca
Query!
Country [209]
0
0
Italy
Query!
State/province [209]
0
0
Taormina
Query!
Country [210]
0
0
Italy
Query!
State/province [210]
0
0
Terni
Query!
Country [211]
0
0
Mexico
Query!
State/province [211]
0
0
Aguascalientes
Query!
Country [212]
0
0
Mexico
Query!
State/province [212]
0
0
Culiacan
Query!
Country [213]
0
0
Mexico
Query!
State/province [213]
0
0
Durango
Query!
Country [214]
0
0
Mexico
Query!
State/province [214]
0
0
Guadalajara
Query!
Country [215]
0
0
Mexico
Query!
State/province [215]
0
0
Mexico
Query!
Country [216]
0
0
Mexico
Query!
State/province [216]
0
0
Monclova
Query!
Country [217]
0
0
Mexico
Query!
State/province [217]
0
0
Monterrey
Query!
Country [218]
0
0
Mexico
Query!
State/province [218]
0
0
México
Query!
Country [219]
0
0
Mexico
Query!
State/province [219]
0
0
Nuevo Leon
Query!
Country [220]
0
0
Mexico
Query!
State/province [220]
0
0
Oaxaca
Query!
Country [221]
0
0
Mexico
Query!
State/province [221]
0
0
Queretaro
Query!
Country [222]
0
0
Mexico
Query!
State/province [222]
0
0
San Luis Potosi
Query!
Country [223]
0
0
Mexico
Query!
State/province [223]
0
0
San Luis Potosí
Query!
Country [224]
0
0
Mexico
Query!
State/province [224]
0
0
Tijuana
Query!
Country [225]
0
0
Mexico
Query!
State/province [225]
0
0
Xalapa
Query!
Country [226]
0
0
Netherlands
Query!
State/province [226]
0
0
Almelo
Query!
Country [227]
0
0
Netherlands
Query!
State/province [227]
0
0
Amersfoort
Query!
Country [228]
0
0
Netherlands
Query!
State/province [228]
0
0
Amsterdam
Query!
Country [229]
0
0
Netherlands
Query!
State/province [229]
0
0
Apeldoorn
Query!
Country [230]
0
0
Netherlands
Query!
State/province [230]
0
0
Arnhem
Query!
Country [231]
0
0
Netherlands
Query!
State/province [231]
0
0
Breda
Query!
Country [232]
0
0
Netherlands
Query!
State/province [232]
0
0
Delft
Query!
Country [233]
0
0
Netherlands
Query!
State/province [233]
0
0
Eindhoven
Query!
Country [234]
0
0
Netherlands
Query!
State/province [234]
0
0
Goes
Query!
Country [235]
0
0
Netherlands
Query!
State/province [235]
0
0
Gouda
Query!
Country [236]
0
0
Netherlands
Query!
State/province [236]
0
0
Groningen
Query!
Country [237]
0
0
Netherlands
Query!
State/province [237]
0
0
Hardenberg
Query!
Country [238]
0
0
Netherlands
Query!
State/province [238]
0
0
Hoogeveen
Query!
Country [239]
0
0
Netherlands
Query!
State/province [239]
0
0
Hoorn
Query!
Country [240]
0
0
Netherlands
Query!
State/province [240]
0
0
Leiderdorp
Query!
Country [241]
0
0
Netherlands
Query!
State/province [241]
0
0
Nijmegen
Query!
Country [242]
0
0
Netherlands
Query!
State/province [242]
0
0
Rotterdam
Query!
Country [243]
0
0
Netherlands
Query!
State/province [243]
0
0
Sneek
Query!
Country [244]
0
0
Netherlands
Query!
State/province [244]
0
0
Utrecht
Query!
Country [245]
0
0
Netherlands
Query!
State/province [245]
0
0
Velp
Query!
Country [246]
0
0
Netherlands
Query!
State/province [246]
0
0
Waalwijk
Query!
Country [247]
0
0
Netherlands
Query!
State/province [247]
0
0
Zoetermeer
Query!
Country [248]
0
0
Peru
Query!
State/province [248]
0
0
Callao
Query!
Country [249]
0
0
Peru
Query!
State/province [249]
0
0
Lima
Query!
Country [250]
0
0
Peru
Query!
State/province [250]
0
0
San Isidro
Query!
Country [251]
0
0
Poland
Query!
State/province [251]
0
0
Bydgoszcz
Query!
Country [252]
0
0
Poland
Query!
State/province [252]
0
0
Gdansk
Query!
Country [253]
0
0
Poland
Query!
State/province [253]
0
0
Kamieniec Zabkowicki
Query!
Country [254]
0
0
Poland
Query!
State/province [254]
0
0
Koluszki
Query!
Country [255]
0
0
Poland
Query!
State/province [255]
0
0
Krakow
Query!
Country [256]
0
0
Poland
Query!
State/province [256]
0
0
Lodz
Query!
Country [257]
0
0
Poland
Query!
State/province [257]
0
0
Mrgowo
Query!
Country [258]
0
0
Poland
Query!
State/province [258]
0
0
Nakso nad Noteci
Query!
Country [259]
0
0
Poland
Query!
State/province [259]
0
0
Opole
Query!
Country [260]
0
0
Poland
Query!
State/province [260]
0
0
Olawa
Query!
Country [261]
0
0
Poland
Query!
State/province [261]
0
0
Poznan
Query!
Country [262]
0
0
Poland
Query!
State/province [262]
0
0
Przemysl
Query!
Country [263]
0
0
Poland
Query!
State/province [263]
0
0
Sieradz
Query!
Country [264]
0
0
Poland
Query!
State/province [264]
0
0
Skierniewice
Query!
Country [265]
0
0
Poland
Query!
State/province [265]
0
0
Torun
Query!
Country [266]
0
0
Poland
Query!
State/province [266]
0
0
Warszawa
Query!
Country [267]
0
0
Poland
Query!
State/province [267]
0
0
Wroclaw
Query!
Country [268]
0
0
Poland
Query!
State/province [268]
0
0
Wabrzezno
Query!
Country [269]
0
0
Poland
Query!
State/province [269]
0
0
Zabrze
Query!
Country [270]
0
0
Poland
Query!
State/province [270]
0
0
Leczna
Query!
Country [271]
0
0
Puerto Rico
Query!
State/province [271]
0
0
Aguas Buneas
Query!
Country [272]
0
0
Puerto Rico
Query!
State/province [272]
0
0
Bayamon
Query!
Country [273]
0
0
Puerto Rico
Query!
State/province [273]
0
0
Cidra
Query!
Country [274]
0
0
Puerto Rico
Query!
State/province [274]
0
0
Hato Rey
Query!
Country [275]
0
0
Puerto Rico
Query!
State/province [275]
0
0
Jardines de Loiza, Loiza
Query!
Country [276]
0
0
Puerto Rico
Query!
State/province [276]
0
0
Juncos
Query!
Country [277]
0
0
Puerto Rico
Query!
State/province [277]
0
0
Ponce
Query!
Country [278]
0
0
Puerto Rico
Query!
State/province [278]
0
0
Rio Piedras
Query!
Country [279]
0
0
Puerto Rico
Query!
State/province [279]
0
0
San Juan
Query!
Country [280]
0
0
Puerto Rico
Query!
State/province [280]
0
0
Toa Baja
Query!
Country [281]
0
0
Russian Federation
Query!
State/province [281]
0
0
Ekaterinburg
Query!
Country [282]
0
0
Russian Federation
Query!
State/province [282]
0
0
Kazan
Query!
Country [283]
0
0
Russian Federation
Query!
State/province [283]
0
0
Moscow
Query!
Country [284]
0
0
Russian Federation
Query!
State/province [284]
0
0
Novosibirsk
Query!
Country [285]
0
0
Russian Federation
Query!
State/province [285]
0
0
Saint Petersburg
Query!
Country [286]
0
0
Russian Federation
Query!
State/province [286]
0
0
Saint-Petersburg
Query!
Country [287]
0
0
Russian Federation
Query!
State/province [287]
0
0
Saratov
Query!
Country [288]
0
0
Russian Federation
Query!
State/province [288]
0
0
St. Petersburg
Query!
Country [289]
0
0
Russian Federation
Query!
State/province [289]
0
0
St.-Petersburg
Query!
Country [290]
0
0
Russian Federation
Query!
State/province [290]
0
0
St.Petersburg
Query!
Country [291]
0
0
Russian Federation
Query!
State/province [291]
0
0
StPetersburg
Query!
Country [292]
0
0
South Africa
Query!
State/province [292]
0
0
Benoni
Query!
Country [293]
0
0
South Africa
Query!
State/province [293]
0
0
Cape Town
Query!
Country [294]
0
0
South Africa
Query!
State/province [294]
0
0
Durban
Query!
Country [295]
0
0
South Africa
Query!
State/province [295]
0
0
Johannesburg
Query!
Country [296]
0
0
South Africa
Query!
State/province [296]
0
0
Parow
Query!
Country [297]
0
0
South Africa
Query!
State/province [297]
0
0
Pretoria
Query!
Country [298]
0
0
South Africa
Query!
State/province [298]
0
0
Umkomaas
Query!
Country [299]
0
0
South Africa
Query!
State/province [299]
0
0
Verulam
Query!
Country [300]
0
0
Spain
Query!
State/province [300]
0
0
Alicante
Query!
Country [301]
0
0
Spain
Query!
State/province [301]
0
0
Barcelona
Query!
Country [302]
0
0
Spain
Query!
State/province [302]
0
0
Granada
Query!
Country [303]
0
0
Spain
Query!
State/province [303]
0
0
Jerez de la Frontera Cadiz
Query!
Country [304]
0
0
Spain
Query!
State/province [304]
0
0
Lérida
Query!
Country [305]
0
0
Spain
Query!
State/province [305]
0
0
Madrid
Query!
Country [306]
0
0
Spain
Query!
State/province [306]
0
0
Majadahonda
Query!
Country [307]
0
0
Spain
Query!
State/province [307]
0
0
Oviedo
Query!
Country [308]
0
0
Spain
Query!
State/province [308]
0
0
Palma de Mallorca
Query!
Country [309]
0
0
Spain
Query!
State/province [309]
0
0
Santiago de Compostela
Query!
Country [310]
0
0
Spain
Query!
State/province [310]
0
0
Sevilla
Query!
Country [311]
0
0
Spain
Query!
State/province [311]
0
0
Valencia
Query!
Country [312]
0
0
Sweden
Query!
State/province [312]
0
0
Brämhult
Query!
Country [313]
0
0
Sweden
Query!
State/province [313]
0
0
Eksjö
Query!
Country [314]
0
0
Sweden
Query!
State/province [314]
0
0
Goteborg
Query!
Country [315]
0
0
Sweden
Query!
State/province [315]
0
0
Göteborg
Query!
Country [316]
0
0
Sweden
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Helsingborg
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Sweden
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Jönköping
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Sweden
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Malmo
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Sweden
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Rättvik
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Sweden
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Stockholm
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Sweden
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Söråker
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Sweden
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Umeå
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Östersund
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Taiwan
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Kaohsiung Hsien
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Taiwan
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Kaohsiung
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Taichung
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Taipei
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Yong-Kang City
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Thailand
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Thailand
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Chiang Mai
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Thailand
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Khon Kaen
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Thailand
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Ratchaburi
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United Kingdom
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Aylesbury
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Bath
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Belfast
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Blackpool
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Coventry
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Fowey
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Kenton
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Leicester
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Mortimer Reading
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Sheffield
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Sunbury on Thames
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Warminster
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Whitstable
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Bristol-Myers Squibb
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Ethics approval
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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
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Trial website
https://clinicaltrials.gov/study/NCT01107886
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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.
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Public notes
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Contacts
Principal investigator
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Eugene Braunwald
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TIMI
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
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Results are available at
https://clinicaltrials.gov/study/NCT01107886
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