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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00968708
Registration number
NCT00968708
Ethics application status
Date submitted
28/08/2009
Date registered
31/08/2009
Date last updated
2/05/2014
Titles & IDs
Public title
Cardiovascular Outcomes Study of Alogliptin in Patients With Type 2 Diabetes and Acute Coronary Syndrome
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Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment With Alogliptin in Addition to Standard of Care in Subjects With Type 2 Diabetes and Acute Coronary Syndrome
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Secondary ID [1]
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0
U1111-1111-6825
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Secondary ID [2]
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SYR-322_402
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Universal Trial Number (UTN)
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Trial acronym
EXAMINE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2
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0
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Acute Coronary Syndrome
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Condition category
Condition code
Cardiovascular
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0
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Coronary heart disease
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Metabolic and Endocrine
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0
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0
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Diabetes
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Other
0
0
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0
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Alogliptin
Treatment: Drugs - Placebo
Experimental: Placebo - Alogliptin placebo matching tablets, orally, once daily. Participants continued to receive standard of care for cardiovascular disease and diabetes according to regional guidelines.
Experimental: Alogliptin - Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) = 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR =30 and \<60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR \<30 mL/min). Participants continued to receive standard of care for cardiovascular disease and diabetes according to regional guidelines.
Treatment: Drugs: Alogliptin
Alogliptin tablets
Treatment: Drugs: Placebo
Alogliptin placebo matching tablets
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Intervention code [1]
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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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Percentage of Participants With Primary Major Adverse Cardiac Events (MACE)
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Assessment method [1]
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Primary Major Adverse Cardiac Events were defined as a composite of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke; these events were adjudicated by an independent cardiovascular endpoints committee.
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Timepoint [1]
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From randomization until the adjudication cut-off date of May 31 2013 (maximum time on study was 41 months).
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Secondary outcome [1]
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Percentage of Participants With Secondary Major Adverse Cardiac Events (MACE)
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Assessment method [1]
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Secondary MACE composite consisted of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or urgent revascularization due to unstable angina; these events were adjudicated by an independent cardiovascular endpoint committee.
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Timepoint [1]
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From randomization until the adjudication cut-of date of May 31 2013 (maximum time on study was 41 months).
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Eligibility
Key inclusion criteria
* Diagnosis of type 2 diabetes mellitus
* Is receiving monotherapy or combination antidiabetic therapy with a glycosylated hemoglobin level between 6.5% and 11.0%, inclusive, at Screening (between 7.0 and 11.0%, inclusive, if the participant's antidiabetic regimen includes insulin)
* Diagnosis of acute coronary syndrome within 15 to 90 days prior to randomization.
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Minimum age
18
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
* Signs of type 1 diabetes mellitus
* Currently receiving a glucagon-like peptide-1 analogue for glycemic control of type 2 diabetes mellitus at Screening
* Received a dipeptidyl peptidase-4 inhibitor for either more than 14 days total or within the 3 months prior to Screening.
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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 3
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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
1/09/2009
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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
1/06/2013
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Sample size
Target
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Accrual to date
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Final
5380
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
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Recruitment hospital [1]
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- Broken Hill
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- Kogarah
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- Milton
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- Nambour
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- Hobart
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- Fitzroy
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- Frankston
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- Heidelberg
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- Prahran
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- Adelaide, SA
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- Bruce
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- Broken Hill
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- Kogarah
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- Milton
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- Heidelberg
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- Adelaide, SA
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- Bruce
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Country [127]
0
0
Brazil
Query!
State/province [127]
0
0
Rio de Janeiro - RJ
Query!
Country [128]
0
0
Brazil
Query!
State/province [128]
0
0
Rio de Janeiro
Query!
Country [129]
0
0
Brazil
Query!
State/province [129]
0
0
Salvador - BA
Query!
Country [130]
0
0
Brazil
Query!
State/province [130]
0
0
Salvador, Bahia
Query!
Country [131]
0
0
Brazil
Query!
State/province [131]
0
0
Santo Andre
Query!
Country [132]
0
0
Brazil
Query!
State/province [132]
0
0
Sao Jose do Rio Preto, Sao Paulo
Query!
Country [133]
0
0
Brazil
Query!
State/province [133]
0
0
Sao Jose do Rio Preto- SP
Query!
Country [134]
0
0
Brazil
Query!
State/province [134]
0
0
Sao Jose do Rio Preto
Query!
Country [135]
0
0
Brazil
Query!
State/province [135]
0
0
Sao Jose, Santa Catarina
Query!
Country [136]
0
0
Brazil
Query!
State/province [136]
0
0
Sao Paulo, Sao Paulo
Query!
Country [137]
0
0
Brazil
Query!
State/province [137]
0
0
Sao Paulo, SP
Query!
Country [138]
0
0
Brazil
Query!
State/province [138]
0
0
Sao Paulo
Query!
Country [139]
0
0
Brazil
Query!
State/province [139]
0
0
Sobral, CE
Query!
Country [140]
0
0
Brazil
Query!
State/province [140]
0
0
Taguatinga
Query!
Country [141]
0
0
Brazil
Query!
State/province [141]
0
0
Uberlandia, Minas Gerais
Query!
Country [142]
0
0
Brazil
Query!
State/province [142]
0
0
Votuporanga
Query!
Country [143]
0
0
Bulgaria
Query!
State/province [143]
0
0
Blagoevgrad
Query!
Country [144]
0
0
Bulgaria
Query!
State/province [144]
0
0
Dimitrovgrad
Query!
Country [145]
0
0
Bulgaria
Query!
State/province [145]
0
0
Kazanlak
Query!
Country [146]
0
0
Bulgaria
Query!
State/province [146]
0
0
Lovech
Query!
Country [147]
0
0
Bulgaria
Query!
State/province [147]
0
0
Pleven
Query!
Country [148]
0
0
Bulgaria
Query!
State/province [148]
0
0
Plovdiv
Query!
Country [149]
0
0
Bulgaria
Query!
State/province [149]
0
0
Sevlievo
Query!
Country [150]
0
0
Bulgaria
Query!
State/province [150]
0
0
Smolian
Query!
Country [151]
0
0
Bulgaria
Query!
State/province [151]
0
0
Sofia
Query!
Country [152]
0
0
Bulgaria
Query!
State/province [152]
0
0
Stara Zagora
Query!
Country [153]
0
0
Bulgaria
Query!
State/province [153]
0
0
Varna
Query!
Country [154]
0
0
Canada
Query!
State/province [154]
0
0
Alberta
Query!
Country [155]
0
0
Canada
Query!
State/province [155]
0
0
British Columbia
Query!
Country [156]
0
0
Canada
Query!
State/province [156]
0
0
Newfoundland and Labrador
Query!
Country [157]
0
0
Canada
Query!
State/province [157]
0
0
Nova Scotia
Query!
Country [158]
0
0
Canada
Query!
State/province [158]
0
0
Ontario
Query!
Country [159]
0
0
Canada
Query!
State/province [159]
0
0
Quebec
Query!
Country [160]
0
0
Chile
Query!
State/province [160]
0
0
Antofagasta, Region II
Query!
Country [161]
0
0
Chile
Query!
State/province [161]
0
0
Antofagasta
Query!
Country [162]
0
0
Chile
Query!
State/province [162]
0
0
Iquique, Region I
Query!
Country [163]
0
0
Chile
Query!
State/province [163]
0
0
Osorno
Query!
Country [164]
0
0
Chile
Query!
State/province [164]
0
0
Rancagua
Query!
Country [165]
0
0
Chile
Query!
State/province [165]
0
0
Santiago
Query!
Country [166]
0
0
Chile
Query!
State/province [166]
0
0
Talcahuano
Query!
Country [167]
0
0
Chile
Query!
State/province [167]
0
0
Temuco, Region de la Araucania
Query!
Country [168]
0
0
Chile
Query!
State/province [168]
0
0
Temuco
Query!
Country [169]
0
0
Chile
Query!
State/province [169]
0
0
Vina del Mar
Query!
Country [170]
0
0
Colombia
Query!
State/province [170]
0
0
Barranquilla
Query!
Country [171]
0
0
Colombia
Query!
State/province [171]
0
0
Bogota
Query!
Country [172]
0
0
Colombia
Query!
State/province [172]
0
0
Bucaramanga
Query!
Country [173]
0
0
Colombia
Query!
State/province [173]
0
0
Medellin
Query!
Country [174]
0
0
Croatia
Query!
State/province [174]
0
0
Cakovec
Query!
Country [175]
0
0
Croatia
Query!
State/province [175]
0
0
Krapinske Toplice
Query!
Country [176]
0
0
Croatia
Query!
State/province [176]
0
0
Osijek
Query!
Country [177]
0
0
Croatia
Query!
State/province [177]
0
0
Rijeka
Query!
Country [178]
0
0
Croatia
Query!
State/province [178]
0
0
Sisak
Query!
Country [179]
0
0
Croatia
Query!
State/province [179]
0
0
Split
Query!
Country [180]
0
0
Croatia
Query!
State/province [180]
0
0
Virovitica
Query!
Country [181]
0
0
Croatia
Query!
State/province [181]
0
0
Zadar
Query!
Country [182]
0
0
Croatia
Query!
State/province [182]
0
0
Zagreb
Query!
Country [183]
0
0
Czech Republic
Query!
State/province [183]
0
0
Caslav
Query!
Country [184]
0
0
Czech Republic
Query!
State/province [184]
0
0
Hradec Kralove
Query!
Country [185]
0
0
Czech Republic
Query!
State/province [185]
0
0
Olomouc
Query!
Country [186]
0
0
Czech Republic
Query!
State/province [186]
0
0
Ostrava - Vitkovice
Query!
Country [187]
0
0
Czech Republic
Query!
State/province [187]
0
0
Zlin
Query!
Country [188]
0
0
Czech Republic
Query!
State/province [188]
0
0
Znojmo
Query!
Country [189]
0
0
Denmark
Query!
State/province [189]
0
0
Herlev
Query!
Country [190]
0
0
Denmark
Query!
State/province [190]
0
0
Herning
Query!
Country [191]
0
0
Denmark
Query!
State/province [191]
0
0
Kobenhavn NV
Query!
Country [192]
0
0
Egypt
Query!
State/province [192]
0
0
Alexandria
Query!
Country [193]
0
0
Egypt
Query!
State/province [193]
0
0
Giza
Query!
Country [194]
0
0
Egypt
Query!
State/province [194]
0
0
Monofia
Query!
Country [195]
0
0
Finland
Query!
State/province [195]
0
0
Helsinki
Query!
Country [196]
0
0
Finland
Query!
State/province [196]
0
0
Jyvaskyla
Query!
Country [197]
0
0
Finland
Query!
State/province [197]
0
0
Kokkola
Query!
Country [198]
0
0
Finland
Query!
State/province [198]
0
0
Kuopio
Query!
Country [199]
0
0
Finland
Query!
State/province [199]
0
0
Tampere
Query!
Country [200]
0
0
Finland
Query!
State/province [200]
0
0
Turku
Query!
Country [201]
0
0
France
Query!
State/province [201]
0
0
Bordeaux
Query!
Country [202]
0
0
France
Query!
State/province [202]
0
0
Corbeil Essonnes
Query!
Country [203]
0
0
France
Query!
State/province [203]
0
0
Corbeil-Essonnes
Query!
Country [204]
0
0
France
Query!
State/province [204]
0
0
Creteil
Query!
Country [205]
0
0
France
Query!
State/province [205]
0
0
Dijon
Query!
Country [206]
0
0
France
Query!
State/province [206]
0
0
La Rochelle
Query!
Country [207]
0
0
France
Query!
State/province [207]
0
0
Lille
Query!
Country [208]
0
0
France
Query!
State/province [208]
0
0
Montpellier
Query!
Country [209]
0
0
France
Query!
State/province [209]
0
0
Narbonne
Query!
Country [210]
0
0
France
Query!
State/province [210]
0
0
Paris
Query!
Country [211]
0
0
France
Query!
State/province [211]
0
0
Pau
Query!
Country [212]
0
0
France
Query!
State/province [212]
0
0
Pessac
Query!
Country [213]
0
0
France
Query!
State/province [213]
0
0
Rennes
Query!
Country [214]
0
0
France
Query!
State/province [214]
0
0
Toulouse
Query!
Country [215]
0
0
Germany
Query!
State/province [215]
0
0
Bad Nauheim
Query!
Country [216]
0
0
Germany
Query!
State/province [216]
0
0
Bensheim
Query!
Country [217]
0
0
Germany
Query!
State/province [217]
0
0
Berlin
Query!
Country [218]
0
0
Germany
Query!
State/province [218]
0
0
Dortmund
Query!
Country [219]
0
0
Germany
Query!
State/province [219]
0
0
Dresden
Query!
Country [220]
0
0
Germany
Query!
State/province [220]
0
0
Essen
Query!
Country [221]
0
0
Germany
Query!
State/province [221]
0
0
Halle (Saale)
Query!
Country [222]
0
0
Germany
Query!
State/province [222]
0
0
Jena
Query!
Country [223]
0
0
Germany
Query!
State/province [223]
0
0
Kassel
Query!
Country [224]
0
0
Germany
Query!
State/province [224]
0
0
Koln
Query!
Country [225]
0
0
Germany
Query!
State/province [225]
0
0
Leipzig
Query!
Country [226]
0
0
Germany
Query!
State/province [226]
0
0
Mainz
Query!
Country [227]
0
0
Germany
Query!
State/province [227]
0
0
Mannheim
Query!
Country [228]
0
0
Germany
Query!
State/province [228]
0
0
Muenchen
Query!
Country [229]
0
0
Germany
Query!
State/province [229]
0
0
Munster
Query!
Country [230]
0
0
Germany
Query!
State/province [230]
0
0
Neumuenster
Query!
Country [231]
0
0
Germany
Query!
State/province [231]
0
0
Neuwied
Query!
Country [232]
0
0
Germany
Query!
State/province [232]
0
0
Sankt Ingbert
Query!
Country [233]
0
0
Germany
Query!
State/province [233]
0
0
Siegen
Query!
Country [234]
0
0
Germany
Query!
State/province [234]
0
0
Wangen
Query!
Country [235]
0
0
Greece
Query!
State/province [235]
0
0
Marousi
Query!
Country [236]
0
0
Guatemala
Query!
State/province [236]
0
0
Guatemala City
Query!
Country [237]
0
0
Guatemala
Query!
State/province [237]
0
0
Guatemala
Query!
Country [238]
0
0
Guatemala
Query!
State/province [238]
0
0
Quetzaltenango
Query!
Country [239]
0
0
Hong Kong
Query!
State/province [239]
0
0
Hong Kong
Query!
Country [240]
0
0
Hong Kong
Query!
State/province [240]
0
0
Kowloon
Query!
Country [241]
0
0
Hong Kong
Query!
State/province [241]
0
0
Shatin
Query!
Country [242]
0
0
Hong Kong
Query!
State/province [242]
0
0
Tsuen Wan
Query!
Country [243]
0
0
Hungary
Query!
State/province [243]
0
0
Budaors
Query!
Country [244]
0
0
Hungary
Query!
State/province [244]
0
0
Budapest
Query!
Country [245]
0
0
Hungary
Query!
State/province [245]
0
0
Debrecen
Query!
Country [246]
0
0
Hungary
Query!
State/province [246]
0
0
Dunaujvaros
Query!
Country [247]
0
0
Hungary
Query!
State/province [247]
0
0
Gyula
Query!
Country [248]
0
0
Hungary
Query!
State/province [248]
0
0
H0dmezovasarhely
Query!
Country [249]
0
0
Hungary
Query!
State/province [249]
0
0
Kaposvar
Query!
Country [250]
0
0
Hungary
Query!
State/province [250]
0
0
Kecskemet
Query!
Country [251]
0
0
Hungary
Query!
State/province [251]
0
0
Nagykanizsa
Query!
Country [252]
0
0
Hungary
Query!
State/province [252]
0
0
Pecs
Query!
Country [253]
0
0
Hungary
Query!
State/province [253]
0
0
Sopron
Query!
Country [254]
0
0
Hungary
Query!
State/province [254]
0
0
Szekesfehervar
Query!
Country [255]
0
0
Hungary
Query!
State/province [255]
0
0
Szentes
Query!
Country [256]
0
0
Hungary
Query!
State/province [256]
0
0
Szombathely
Query!
Country [257]
0
0
Hungary
Query!
State/province [257]
0
0
Zalaegerszeg
Query!
Country [258]
0
0
India
Query!
State/province [258]
0
0
Andhra Pradesh
Query!
Country [259]
0
0
India
Query!
State/province [259]
0
0
Chennai
Query!
Country [260]
0
0
India
Query!
State/province [260]
0
0
Delhi
Query!
Country [261]
0
0
India
Query!
State/province [261]
0
0
Gujarat
Query!
Country [262]
0
0
India
Query!
State/province [262]
0
0
Karnataka
Query!
Country [263]
0
0
India
Query!
State/province [263]
0
0
Kerala
Query!
Country [264]
0
0
India
Query!
State/province [264]
0
0
Maharashtra
Query!
Country [265]
0
0
India
Query!
State/province [265]
0
0
Punjab
Query!
Country [266]
0
0
India
Query!
State/province [266]
0
0
Rajasthan
Query!
Country [267]
0
0
India
Query!
State/province [267]
0
0
Tamil Nadu
Query!
Country [268]
0
0
India
Query!
State/province [268]
0
0
West Bengal
Query!
Country [269]
0
0
Israel
Query!
State/province [269]
0
0
Ashkelon
Query!
Country [270]
0
0
Israel
Query!
State/province [270]
0
0
Beer Sheva
Query!
Country [271]
0
0
Israel
Query!
State/province [271]
0
0
Haifa
Query!
Country [272]
0
0
Israel
Query!
State/province [272]
0
0
Holon
Query!
Country [273]
0
0
Israel
Query!
State/province [273]
0
0
Jerusalem
Query!
Country [274]
0
0
Israel
Query!
State/province [274]
0
0
Kfar-Saba
Query!
Country [275]
0
0
Israel
Query!
State/province [275]
0
0
Nahariya
Query!
Country [276]
0
0
Israel
Query!
State/province [276]
0
0
Nazareth
Query!
Country [277]
0
0
Israel
Query!
State/province [277]
0
0
Petach Tikva
Query!
Country [278]
0
0
Israel
Query!
State/province [278]
0
0
Rehovot
Query!
Country [279]
0
0
Israel
Query!
State/province [279]
0
0
Rishon Lezion
Query!
Country [280]
0
0
Israel
Query!
State/province [280]
0
0
Safed
Query!
Country [281]
0
0
Israel
Query!
State/province [281]
0
0
Tel Aviv
Query!
Country [282]
0
0
Israel
Query!
State/province [282]
0
0
Tiberias
Query!
Country [283]
0
0
Italy
Query!
State/province [283]
0
0
Cosenza
Query!
Country [284]
0
0
Italy
Query!
State/province [284]
0
0
Isernia
Query!
Country [285]
0
0
Italy
Query!
State/province [285]
0
0
Milano
Query!
Country [286]
0
0
Italy
Query!
State/province [286]
0
0
Napoli
Query!
Country [287]
0
0
Italy
Query!
State/province [287]
0
0
Palermo
Query!
Country [288]
0
0
Italy
Query!
State/province [288]
0
0
Pavia
Query!
Country [289]
0
0
Italy
Query!
State/province [289]
0
0
Ravenna
Query!
Country [290]
0
0
Italy
Query!
State/province [290]
0
0
Roma
Query!
Country [291]
0
0
Italy
Query!
State/province [291]
0
0
Sesto San Giovanni
Query!
Country [292]
0
0
Japan
Query!
State/province [292]
0
0
Aichi
Query!
Country [293]
0
0
Japan
Query!
State/province [293]
0
0
Chiba
Query!
Country [294]
0
0
Japan
Query!
State/province [294]
0
0
Ehime
Query!
Country [295]
0
0
Japan
Query!
State/province [295]
0
0
Fukuoka
Query!
Country [296]
0
0
Japan
Query!
State/province [296]
0
0
Fukushima
Query!
Country [297]
0
0
Japan
Query!
State/province [297]
0
0
Gifu
Query!
Country [298]
0
0
Japan
Query!
State/province [298]
0
0
Gunma
Query!
Country [299]
0
0
Japan
Query!
State/province [299]
0
0
Hiroshima
Query!
Country [300]
0
0
Japan
Query!
State/province [300]
0
0
Hokkaido
Query!
Country [301]
0
0
Japan
Query!
State/province [301]
0
0
Hyogo
Query!
Country [302]
0
0
Japan
Query!
State/province [302]
0
0
Ishikawa
Query!
Country [303]
0
0
Japan
Query!
State/province [303]
0
0
Kagawa
Query!
Country [304]
0
0
Japan
Query!
State/province [304]
0
0
Kanagawa
Query!
Country [305]
0
0
Japan
Query!
State/province [305]
0
0
Kochi
Query!
Country [306]
0
0
Japan
Query!
State/province [306]
0
0
Kumamoto
Query!
Country [307]
0
0
Japan
Query!
State/province [307]
0
0
Kyoto
Query!
Country [308]
0
0
Japan
Query!
State/province [308]
0
0
Mie
Query!
Country [309]
0
0
Japan
Query!
State/province [309]
0
0
Nagasaki
Query!
Country [310]
0
0
Japan
Query!
State/province [310]
0
0
Oita
Query!
Country [311]
0
0
Japan
Query!
State/province [311]
0
0
Okayama
Query!
Country [312]
0
0
Japan
Query!
State/province [312]
0
0
Okinawa
Query!
Country [313]
0
0
Japan
Query!
State/province [313]
0
0
Osaka
Query!
Country [314]
0
0
Japan
Query!
State/province [314]
0
0
Saitama
Query!
Country [315]
0
0
Japan
Query!
State/province [315]
0
0
Shimane
Query!
Country [316]
0
0
Japan
Query!
State/province [316]
0
0
Shizuoka
Query!
Country [317]
0
0
Japan
Query!
State/province [317]
0
0
Tokushima
Query!
Country [318]
0
0
Japan
Query!
State/province [318]
0
0
Tokyo
Query!
Country [319]
0
0
Japan
Query!
State/province [319]
0
0
Yamaguchi
Query!
Country [320]
0
0
Japan
Query!
State/province [320]
0
0
Niigata
Query!
Country [321]
0
0
Japan
Query!
State/province [321]
0
0
Saga
Query!
Country [322]
0
0
Korea, Republic of
Query!
State/province [322]
0
0
Anyang
Query!
Country [323]
0
0
Korea, Republic of
Query!
State/province [323]
0
0
Busan
Query!
Country [324]
0
0
Korea, Republic of
Query!
State/province [324]
0
0
Daegu
Query!
Country [325]
0
0
Korea, Republic of
Query!
State/province [325]
0
0
Goyang-Si
Query!
Country [326]
0
0
Korea, Republic of
Query!
State/province [326]
0
0
Guri
Query!
Country [327]
0
0
Korea, Republic of
Query!
State/province [327]
0
0
Gyeonggi-do
Query!
Country [328]
0
0
Korea, Republic of
Query!
State/province [328]
0
0
Jeonju-si
Query!
Country [329]
0
0
Korea, Republic of
Query!
State/province [329]
0
0
Kangwon-do
Query!
Country [330]
0
0
Korea, Republic of
Query!
State/province [330]
0
0
Pusan
Query!
Country [331]
0
0
Korea, Republic of
Query!
State/province [331]
0
0
Seoul
Query!
Country [332]
0
0
Korea, Republic of
Query!
State/province [332]
0
0
Suwon
Query!
Country [333]
0
0
Korea, Republic of
Query!
State/province [333]
0
0
Yangsan
Query!
Country [334]
0
0
Kuwait
Query!
State/province [334]
0
0
Dasman
Query!
Country [335]
0
0
Latvia
Query!
State/province [335]
0
0
Daugavpils
Query!
Country [336]
0
0
Latvia
Query!
State/province [336]
0
0
Ogre
Query!
Country [337]
0
0
Latvia
Query!
State/province [337]
0
0
Riga
Query!
Country [338]
0
0
Latvia
Query!
State/province [338]
0
0
Tukums
Query!
Country [339]
0
0
Latvia
Query!
State/province [339]
0
0
Valmiera
Query!
Country [340]
0
0
Lithuania
Query!
State/province [340]
0
0
Kaunas
Query!
Country [341]
0
0
Lithuania
Query!
State/province [341]
0
0
Kedainiai
Query!
Country [342]
0
0
Lithuania
Query!
State/province [342]
0
0
Klaipeda
Query!
Country [343]
0
0
Lithuania
Query!
State/province [343]
0
0
Palanga
Query!
Country [344]
0
0
Lithuania
Query!
State/province [344]
0
0
Panevezys
Query!
Country [345]
0
0
Lithuania
Query!
State/province [345]
0
0
Vilnius
Query!
Country [346]
0
0
Malaysia
Query!
State/province [346]
0
0
Alor Setar
Query!
Country [347]
0
0
Malaysia
Query!
State/province [347]
0
0
Batu Caves
Query!
Country [348]
0
0
Malaysia
Query!
State/province [348]
0
0
Georgetown
Query!
Country [349]
0
0
Malaysia
Query!
State/province [349]
0
0
Kuala Lumpur
Query!
Country [350]
0
0
Malaysia
Query!
State/province [350]
0
0
Kuantan
Query!
Country [351]
0
0
Malaysia
Query!
State/province [351]
0
0
Kubang Kerian
Query!
Country [352]
0
0
Malaysia
Query!
State/province [352]
0
0
Pulau Pinang
Query!
Country [353]
0
0
Malaysia
Query!
State/province [353]
0
0
Selangor
Query!
Country [354]
0
0
Mexico
Query!
State/province [354]
0
0
Acapulco, Guerrero
Query!
Country [355]
0
0
Mexico
Query!
State/province [355]
0
0
Aguascalientes
Query!
Country [356]
0
0
Mexico
Query!
State/province [356]
0
0
Chihuahua
Query!
Country [357]
0
0
Mexico
Query!
State/province [357]
0
0
Chihuhua, Chihuhua
Query!
Country [358]
0
0
Mexico
Query!
State/province [358]
0
0
Ciudad Obregon, Sonora
Query!
Country [359]
0
0
Mexico
Query!
State/province [359]
0
0
Cuernavaca, Morelos
Query!
Country [360]
0
0
Mexico
Query!
State/province [360]
0
0
Cuernavaca
Query!
Country [361]
0
0
Mexico
Query!
State/province [361]
0
0
Culiacan
Query!
Country [362]
0
0
Mexico
Query!
State/province [362]
0
0
Durango
Query!
Country [363]
0
0
Mexico
Query!
State/province [363]
0
0
Guadalajara, Jalisco
Query!
Country [364]
0
0
Mexico
Query!
State/province [364]
0
0
Guadalajara
Query!
Country [365]
0
0
Mexico
Query!
State/province [365]
0
0
Merida, Yucatan
Query!
Country [366]
0
0
Mexico
Query!
State/province [366]
0
0
Metepec
Query!
Country [367]
0
0
Mexico
Query!
State/province [367]
0
0
Mexicali, Baja California
Query!
Country [368]
0
0
Mexico
Query!
State/province [368]
0
0
Mexico City, Mexico
Query!
Country [369]
0
0
Mexico
Query!
State/province [369]
0
0
Mexico City
Query!
Country [370]
0
0
Mexico
Query!
State/province [370]
0
0
Mexico
Query!
Country [371]
0
0
Mexico
Query!
State/province [371]
0
0
Monclova, Coahuila
Query!
Country [372]
0
0
Mexico
Query!
State/province [372]
0
0
Monterrey, NL
Query!
Country [373]
0
0
Mexico
Query!
State/province [373]
0
0
Monterrey, Nuevo Le0n
Query!
Country [374]
0
0
Mexico
Query!
State/province [374]
0
0
Monterrey, Nuevo Leon
Query!
Country [375]
0
0
Mexico
Query!
State/province [375]
0
0
Monterrey
Query!
Country [376]
0
0
Mexico
Query!
State/province [376]
0
0
Morelia, Michoacan
Query!
Country [377]
0
0
Mexico
Query!
State/province [377]
0
0
Pachuca
Query!
Country [378]
0
0
Mexico
Query!
State/province [378]
0
0
Saltillo, Coahuila
Query!
Country [379]
0
0
Mexico
Query!
State/province [379]
0
0
Saltillo
Query!
Country [380]
0
0
Mexico
Query!
State/province [380]
0
0
San Luis Potosi.SLP
Query!
Country [381]
0
0
Mexico
Query!
State/province [381]
0
0
San Luis Potosi
Query!
Country [382]
0
0
Mexico
Query!
State/province [382]
0
0
Tijuana, Baja California Norte
Query!
Country [383]
0
0
Mexico
Query!
State/province [383]
0
0
Tlalnepantla, Edo de Mexico
Query!
Country [384]
0
0
Mexico
Query!
State/province [384]
0
0
Tlalnepantla
Query!
Country [385]
0
0
Mexico
Query!
State/province [385]
0
0
Xalapa, Veracruz
Query!
Country [386]
0
0
Mexico
Query!
State/province [386]
0
0
Zapopan
Query!
Country [387]
0
0
New Zealand
Query!
State/province [387]
0
0
Auckland
Query!
Country [388]
0
0
New Zealand
Query!
State/province [388]
0
0
Christchurch
Query!
Country [389]
0
0
New Zealand
Query!
State/province [389]
0
0
Otahuhu
Query!
Country [390]
0
0
New Zealand
Query!
State/province [390]
0
0
Palmerston North
Query!
Country [391]
0
0
New Zealand
Query!
State/province [391]
0
0
Takapuna
Query!
Country [392]
0
0
New Zealand
Query!
State/province [392]
0
0
Tauranga
Query!
Country [393]
0
0
Peru
Query!
State/province [393]
0
0
Arequipa
Query!
Country [394]
0
0
Peru
Query!
State/province [394]
0
0
Bellavista
Query!
Country [395]
0
0
Peru
Query!
State/province [395]
0
0
Callao
Query!
Country [396]
0
0
Peru
Query!
State/province [396]
0
0
Cusco
Query!
Country [397]
0
0
Peru
Query!
State/province [397]
0
0
Huacho
Query!
Country [398]
0
0
Peru
Query!
State/province [398]
0
0
Ica
Query!
Country [399]
0
0
Peru
Query!
State/province [399]
0
0
La Victoria, Lima
Query!
Country [400]
0
0
Peru
Query!
State/province [400]
0
0
Lima San Isidro
Query!
Country [401]
0
0
Peru
Query!
State/province [401]
0
0
Lima
Query!
Country [402]
0
0
Peru
Query!
State/province [402]
0
0
Los Olivos
Query!
Country [403]
0
0
Peru
Query!
State/province [403]
0
0
Miraflores, Lima
Query!
Country [404]
0
0
Peru
Query!
State/province [404]
0
0
Piura
Query!
Country [405]
0
0
Peru
Query!
State/province [405]
0
0
San Isidro, Lima
Query!
Country [406]
0
0
Peru
Query!
State/province [406]
0
0
San Miguel, Lima
Query!
Country [407]
0
0
Peru
Query!
State/province [407]
0
0
Trujillo, La Libertad
Query!
Country [408]
0
0
Peru
Query!
State/province [408]
0
0
Trujillo
Query!
Country [409]
0
0
Philippines
Query!
State/province [409]
0
0
Baguio
Query!
Country [410]
0
0
Philippines
Query!
State/province [410]
0
0
Dasmarinas
Query!
Country [411]
0
0
Philippines
Query!
State/province [411]
0
0
Davao City
Query!
Country [412]
0
0
Philippines
Query!
State/province [412]
0
0
Iloilo City
Query!
Country [413]
0
0
Philippines
Query!
State/province [413]
0
0
Laoag City
Query!
Country [414]
0
0
Philippines
Query!
State/province [414]
0
0
Makati City
Query!
Country [415]
0
0
Philippines
Query!
State/province [415]
0
0
Manila
Query!
Country [416]
0
0
Philippines
Query!
State/province [416]
0
0
Marikina City
Query!
Country [417]
0
0
Philippines
Query!
State/province [417]
0
0
Pasig City
Query!
Country [418]
0
0
Philippines
Query!
State/province [418]
0
0
Quezon City
Query!
Country [419]
0
0
Poland
Query!
State/province [419]
0
0
Bialystok
Query!
Country [420]
0
0
Poland
Query!
State/province [420]
0
0
Bydgoszcz
Query!
Country [421]
0
0
Poland
Query!
State/province [421]
0
0
Czestochowa
Query!
Country [422]
0
0
Poland
Query!
State/province [422]
0
0
Dabrowa Gornicza
Query!
Country [423]
0
0
Poland
Query!
State/province [423]
0
0
Elblag
Query!
Country [424]
0
0
Poland
Query!
State/province [424]
0
0
Gdansk
Query!
Country [425]
0
0
Poland
Query!
State/province [425]
0
0
Gdynia
Query!
Country [426]
0
0
Poland
Query!
State/province [426]
0
0
Grodzisk Mazowiecki
Query!
Country [427]
0
0
Poland
Query!
State/province [427]
0
0
Inowroclaw
Query!
Country [428]
0
0
Poland
Query!
State/province [428]
0
0
Katowice
Query!
Country [429]
0
0
Poland
Query!
State/province [429]
0
0
Kielce
Query!
Country [430]
0
0
Poland
Query!
State/province [430]
0
0
Krakow
Query!
Country [431]
0
0
Poland
Query!
State/province [431]
0
0
Legnica
Query!
Country [432]
0
0
Poland
Query!
State/province [432]
0
0
Lodz
Query!
Country [433]
0
0
Poland
Query!
State/province [433]
0
0
Lubartow
Query!
Country [434]
0
0
Poland
Query!
State/province [434]
0
0
Lublin
Query!
Country [435]
0
0
Poland
Query!
State/province [435]
0
0
Plock
Query!
Country [436]
0
0
Poland
Query!
State/province [436]
0
0
Pulawy
Query!
Country [437]
0
0
Poland
Query!
State/province [437]
0
0
Radom
Query!
Country [438]
0
0
Poland
Query!
State/province [438]
0
0
Ruda Slaska
Query!
Country [439]
0
0
Poland
Query!
State/province [439]
0
0
Skierniewice
Query!
Country [440]
0
0
Poland
Query!
State/province [440]
0
0
Slupsk
Query!
Country [441]
0
0
Poland
Query!
State/province [441]
0
0
Szczecin
Query!
Country [442]
0
0
Poland
Query!
State/province [442]
0
0
Torun
Query!
Country [443]
0
0
Poland
Query!
State/province [443]
0
0
Warsaw
Query!
Country [444]
0
0
Poland
Query!
State/province [444]
0
0
Warszawa
Query!
Country [445]
0
0
Poland
Query!
State/province [445]
0
0
Wroclaw
Query!
Country [446]
0
0
Poland
Query!
State/province [446]
0
0
Zabrze
Query!
Country [447]
0
0
Poland
Query!
State/province [447]
0
0
Zgierz
Query!
Country [448]
0
0
Portugal
Query!
State/province [448]
0
0
Coimbra
Query!
Country [449]
0
0
Portugal
Query!
State/province [449]
0
0
Faro
Query!
Country [450]
0
0
Portugal
Query!
State/province [450]
0
0
Lisboa
Query!
Country [451]
0
0
Portugal
Query!
State/province [451]
0
0
Vila Real
Query!
Country [452]
0
0
Puerto Rico
Query!
State/province [452]
0
0
Aibonito
Query!
Country [453]
0
0
Puerto Rico
Query!
State/province [453]
0
0
Carolina
Query!
Country [454]
0
0
Puerto Rico
Query!
State/province [454]
0
0
Cidra
Query!
Country [455]
0
0
Puerto Rico
Query!
State/province [455]
0
0
Halo Rey
Query!
Country [456]
0
0
Puerto Rico
Query!
State/province [456]
0
0
Levittown
Query!
Country [457]
0
0
Puerto Rico
Query!
State/province [457]
0
0
Manati
Query!
Country [458]
0
0
Puerto Rico
Query!
State/province [458]
0
0
Mayaguez
Query!
Country [459]
0
0
Puerto Rico
Query!
State/province [459]
0
0
Ponce
Query!
Country [460]
0
0
Puerto Rico
Query!
State/province [460]
0
0
Salinas
Query!
Country [461]
0
0
Puerto Rico
Query!
State/province [461]
0
0
San Juan
Query!
Country [462]
0
0
Puerto Rico
Query!
State/province [462]
0
0
Santurce
Query!
Country [463]
0
0
Romania
Query!
State/province [463]
0
0
Bacau
Query!
Country [464]
0
0
Romania
Query!
State/province [464]
0
0
Baia Mare
Query!
Country [465]
0
0
Romania
Query!
State/province [465]
0
0
Braila
Query!
Country [466]
0
0
Romania
Query!
State/province [466]
0
0
Brasov
Query!
Country [467]
0
0
Romania
Query!
State/province [467]
0
0
Bucharest
Query!
Country [468]
0
0
Romania
Query!
State/province [468]
0
0
Bucuresti
Query!
Country [469]
0
0
Romania
Query!
State/province [469]
0
0
Buzau
Query!
Country [470]
0
0
Romania
Query!
State/province [470]
0
0
Galati
Query!
Country [471]
0
0
Romania
Query!
State/province [471]
0
0
Iasi
Query!
Country [472]
0
0
Romania
Query!
State/province [472]
0
0
Oradea
Query!
Country [473]
0
0
Romania
Query!
State/province [473]
0
0
Ploiesti
Query!
Country [474]
0
0
Romania
Query!
State/province [474]
0
0
Satu Mare
Query!
Country [475]
0
0
Romania
Query!
State/province [475]
0
0
Targu Mures
Query!
Country [476]
0
0
Romania
Query!
State/province [476]
0
0
Timisoara
Query!
Country [477]
0
0
Russian Federation
Query!
State/province [477]
0
0
Arkhangelsk
Query!
Country [478]
0
0
Russian Federation
Query!
State/province [478]
0
0
Barnaul
Query!
Country [479]
0
0
Russian Federation
Query!
State/province [479]
0
0
Ivanovo
Query!
Country [480]
0
0
Russian Federation
Query!
State/province [480]
0
0
Kazan
Query!
Country [481]
0
0
Russian Federation
Query!
State/province [481]
0
0
Kemerovo
Query!
Country [482]
0
0
Russian Federation
Query!
State/province [482]
0
0
Krasnodar
Query!
Country [483]
0
0
Russian Federation
Query!
State/province [483]
0
0
Krasnoyarsk
Query!
Country [484]
0
0
Russian Federation
Query!
State/province [484]
0
0
Kursk
Query!
Country [485]
0
0
Russian Federation
Query!
State/province [485]
0
0
Moscow
Query!
Country [486]
0
0
Russian Federation
Query!
State/province [486]
0
0
Nizhniy Novgorod
Query!
Country [487]
0
0
Russian Federation
Query!
State/province [487]
0
0
Novosibirsk
Query!
Country [488]
0
0
Russian Federation
Query!
State/province [488]
0
0
Rostov-on-Don
Query!
Country [489]
0
0
Russian Federation
Query!
State/province [489]
0
0
Saratov
Query!
Country [490]
0
0
Russian Federation
Query!
State/province [490]
0
0
St. Petersburg
Query!
Country [491]
0
0
Russian Federation
Query!
State/province [491]
0
0
Ufa
Query!
Country [492]
0
0
Russian Federation
Query!
State/province [492]
0
0
Volgograd
Query!
Country [493]
0
0
Russian Federation
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Funding & Sponsors
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Commercial sector/industry
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Name
Takeda
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Summary
Brief summary
The purpose of this study is to evaluate the cardiovascular outcomes of alogliptin, once daily (QD), compared with placebo, in addition to standard of care, in patients with type 2 diabetes mellitus and acute coronary syndrome.
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Trial website
https://clinicaltrials.gov/study/NCT00968708
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Trial related presentations / publications
Ferreira JP, Rossignol P, Bakris G, Mehta C, White WB, Zannad F. Blood and Urine Biomarkers Predicting Worsening Kidney Function in Patients with Type 2 Diabetes Post-Acute Coronary Syndrome: An Analysis from the EXAMINE Trial. Am J Nephrol. 2021;52(12):969-976. doi: 10.1159/000519436. Epub 2021 Dec 6. Ferreira JP, Mehta C, Sharma A, Nissen SE, Rossignol P, Zannad F. Alogliptin after acute coronary syndrome in patients with type 2 diabetes: a renal function stratified analysis of the EXAMINE trial. BMC Med. 2020 Jun 4;18(1):165. doi: 10.1186/s12916-020-01616-8. Sharma A, Vaduganathan M, Ferreira JP, Liu Y, Bakris GL, Cannon CP, White WB, Zannad F. Clinical and Biomarker Predictors of Expanded Heart Failure Outcomes in Patients With Type 2 Diabetes Mellitus After a Recent Acute Coronary Syndrome: Insights From the EXAMINE Trial. J Am Heart Assoc. 2020 Jan 7;9(1):e012797. doi: 10.1161/JAHA.119.012797. Epub 2020 Jan 4. White WB, Jalil F, Cushman WC, Bakris GL, Bergenstal R, Heller SR, Liu Y, Mehta C, Zannad F, Cannon CP. Average Clinician-Measured Blood Pressures and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus and Ischemic Heart Disease in the EXAMINE Trial. J Am Heart Assoc. 2018 Oct 16;7(20):e009114. doi: 10.1161/JAHA.118.009114. Jarolim P, White WB, Cannon CP, Gao Q, Morrow DA. Serial Measurement of Natriuretic Peptides and Cardiovascular Outcomes in Patients With Type 2 Diabetes in the EXAMINE Trial. Diabetes Care. 2018 Jul;41(7):1510-1515. doi: 10.2337/dc18-0109. Epub 2018 May 30. Sharma A, Cannon CP, White WB, Liu Y, Bakris GL, Cushman WC, Zannad F. Early and Chronic Dipeptidyl-Peptidase-IV Inhibition and Cardiovascular Events in Patients With Type 2 Diabetes Mellitus After an Acute Coronary Syndrome: A Landmark Analysis of the EXAMINE Trial. J Am Heart Assoc. 2018 May 16;7(11):e007649. doi: 10.1161/JAHA.117.007649. White WB, Heller SR, Cannon CP, Howitt H, Khunti K, Bergenstal RM; EXAMINE Investigators. Alogliptin in Patients with Type 2 Diabetes Receiving Metformin and Sulfonylurea Therapies in the EXAMINE Trial. Am J Med. 2018 Jul;131(7):813-819.e5. doi: 10.1016/j.amjmed.2018.02.023. Epub 2018 Mar 23. Hwang YC, Morrow DA, Cannon CP, Liu Y, Bergenstal R, Heller S, Mehta C, Cushman W, Bakris GL, Zannad F, White WB. High-sensitivity C-reactive protein, low-density lipoprotein cholesterol and cardiovascular outcomes in patients with type 2 diabetes in the EXAMINE (Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care) trial. Diabetes Obes Metab. 2018 Mar;20(3):654-659. doi: 10.1111/dom.13136. Epub 2017 Nov 21. Kay S, Strickson A, Puelles J, Selby R, Benson E, Tolley K. Comparative Effectiveness of Adding Alogliptin to Metformin Plus Sulfonylurea with Other DPP-4 Inhibitors in Type 2 Diabetes: A Systematic Review and Network Meta-Analysis. Diabetes Ther. 2017 Apr;8(2):251-273. doi: 10.1007/s13300-017-0245-8. Epub 2017 Mar 8. Cavender MA, White WB, Jarolim P, Bakris GL, Cushman WC, Kupfer S, Gao Q, Mehta CR, Zannad F, Cannon CP, Morrow DA. Serial Measurement of High-Sensitivity Troponin I and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus in the EXAMINE Trial (Examination of Cardiovascular Outcomes With Alogliptin Versus Standard of Care). Circulation. 2017 May 16;135(20):1911-1921. doi: 10.1161/CIRCULATIONAHA.116.024632. Epub 2017 Feb 28. White WB, Kupfer S, Zannad F, Mehta CR, Wilson CA, Lei L, Bakris GL, Nissen SE, Cushman WC, Heller SR, Bergenstal RM, Fleck PR, Cannon CP; EXAMINE Investigators. Cardiovascular Mortality in Patients With Type 2 Diabetes and Recent Acute Coronary Syndromes From the EXAMINE Trial. Diabetes Care. 2016 Jul;39(7):1267-73. doi: 10.2337/dc16-0303. Epub 2016 Jun 11. Zannad F, Cannon CP, Cushman WC, Bakris GL, Menon V, Perez AT, Fleck PR, Mehta CR, Kupfer S, Wilson C, Lam H, White WB; EXAMINE Investigators. Heart failure and mortality outcomes in patients with type 2 diabetes taking alogliptin versus placebo in EXAMINE: a multicentre, randomised, double-blind trial. Lancet. 2015 May 23;385(9982):2067-76. doi: 10.1016/S0140-6736(14)62225-X. Epub 2015 Mar 10. White WB, Cannon CP, Heller SR, Nissen SE, Bergenstal RM, Bakris GL, Perez AT, Fleck PR, Mehta CR, Kupfer S, Wilson C, Cushman WC, Zannad F; EXAMINE Investigators. Alogliptin after acute coronary syndrome in patients with type 2 diabetes. N Engl J Med. 2013 Oct 3;369(14):1327-35. doi: 10.1056/NEJMoa1305889. Epub 2013 Sep 2. White WB, Bakris GL, Bergenstal RM, Cannon CP, Cushman WC, Fleck P, Heller S, Mehta C, Nissen SE, Perez A, Wilson C, Zannad F. EXamination of cArdiovascular outcoMes with alogliptIN versus standard of carE in patients with type 2 diabetes mellitus and acute coronary syndrome (EXAMINE): a cardiovascular safety study of the dipeptidyl peptidase 4 inhibitor alogliptin in patients with type 2 diabetes with acute coronary syndrome. Am Heart J. 2011 Oct;162(4):620-626.e1. doi: 10.1016/j.ahj.2011.08.004. Epub 2011 Sep 14.
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Results are available at
https://clinicaltrials.gov/study/NCT00968708
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