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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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
Secondary ID [1] 0 0
U1111-1111-6825
Secondary ID [2] 0 0
SYR-322_402
Universal Trial Number (UTN)
Trial acronym
EXAMINE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Acute Coronary Syndrome 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Metabolic and Endocrine 0 0 0 0
Diabetes
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Primary Major Adverse Cardiac Events (MACE)
Timepoint [1] 0 0
From randomization until the adjudication cut-off date of May 31 2013 (maximum time on study was 41 months).
Secondary outcome [1] 0 0
Percentage of Participants With Secondary Major Adverse Cardiac Events (MACE)
Timepoint [1] 0 0
From randomization until the adjudication cut-of date of May 31 2013 (maximum time on study was 41 months).

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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 3
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
1/09/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2013
Sample size
Target
Accrual to date
Final
5380
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Recruitment hospital [1] 0 0
- Broken Hill
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- Kogarah
Recruitment hospital [3] 0 0
- Milton
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- Nambour
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- Hobart
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- Fitzroy
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- Frankston
Recruitment hospital [8] 0 0
- Heidelberg
Recruitment hospital [9] 0 0
- Prahran
Recruitment hospital [10] 0 0
- Adelaide, SA
Recruitment hospital [11] 0 0
- Bruce
Recruitment postcode(s) [1] 0 0
- 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
Recruitment postcode(s) [11] 0 0
- Bruce
Recruitment outside Australia
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Mar del Plata
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Mendoza
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Moron, Buenos Aires
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Argentina
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Olivos
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Quilmes
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Ramos Mejia, Buenos Aries
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Santa Fe
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Trelew, Chubut
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Villa Maria
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Feldkirch
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Graz
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Belem - PA
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Marilia
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Mogi das Cruzes
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Brazil
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Natal, RN
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Brazil
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Natal
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Brazil
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Passo Fundo, Rio Grande do Sul
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Porto Alegre - RS
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Brazil
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Porto Alegre, Rio Grande do Sul
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Brazil
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Recife, Pernambuco
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Recife, PE
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Recife
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Brazil
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Rio de Janeiro - RJ
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Brazil
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Rio de Janeiro
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Brazil
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Salvador - BA
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Brazil
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Salvador, Bahia
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Santo Andre
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Brazil
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Sao Jose do Rio Preto, Sao Paulo
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Brazil
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Sao Jose do Rio Preto- SP
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Brazil
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Sao Jose do Rio Preto
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Brazil
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Sao Jose, Santa Catarina
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Brazil
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Sao Paulo, Sao Paulo
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Sao Paulo, SP
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Brazil
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Sao Paulo
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Sobral, CE
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Taguatinga
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Uberlandia, Minas Gerais
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Blagoevgrad
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Lovech
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Zagreb
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Caslav
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Zlin
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Znojmo
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Herlev
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Herning
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Egypt
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Alexandria
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Egypt
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Giza
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Egypt
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Monofia
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Finland
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Helsinki
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Finland
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Jyvaskyla
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Finland
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Kokkola
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Finland
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Kuopio
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Finland
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Tampere
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Finland
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Turku
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Bordeaux
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Corbeil Essonnes
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Corbeil-Essonnes
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Creteil
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France
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Dijon
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La Rochelle
Country [207] 0 0
France
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Lille
Country [208] 0 0
France
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Montpellier
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France
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Narbonne
Country [210] 0 0
France
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Paris
Country [211] 0 0
France
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Pau
Country [212] 0 0
France
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Pessac
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France
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Rennes
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France
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Toulouse
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Bad Nauheim
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Bensheim
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Dortmund
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Dresden
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Essen
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Halle (Saale)
Country [222] 0 0
Germany
State/province [222] 0 0
Jena
Country [223] 0 0
Germany
State/province [223] 0 0
Kassel
Country [224] 0 0
Germany
State/province [224] 0 0
Koln
Country [225] 0 0
Germany
State/province [225] 0 0
Leipzig
Country [226] 0 0
Germany
State/province [226] 0 0
Mainz
Country [227] 0 0
Germany
State/province [227] 0 0
Mannheim
Country [228] 0 0
Germany
State/province [228] 0 0
Muenchen
Country [229] 0 0
Germany
State/province [229] 0 0
Munster
Country [230] 0 0
Germany
State/province [230] 0 0
Neumuenster
Country [231] 0 0
Germany
State/province [231] 0 0
Neuwied
Country [232] 0 0
Germany
State/province [232] 0 0
Sankt Ingbert
Country [233] 0 0
Germany
State/province [233] 0 0
Siegen
Country [234] 0 0
Germany
State/province [234] 0 0
Wangen
Country [235] 0 0
Greece
State/province [235] 0 0
Marousi
Country [236] 0 0
Guatemala
State/province [236] 0 0
Guatemala City
Country [237] 0 0
Guatemala
State/province [237] 0 0
Guatemala
Country [238] 0 0
Guatemala
State/province [238] 0 0
Quetzaltenango
Country [239] 0 0
Hong Kong
State/province [239] 0 0
Hong Kong
Country [240] 0 0
Hong Kong
State/province [240] 0 0
Kowloon
Country [241] 0 0
Hong Kong
State/province [241] 0 0
Shatin
Country [242] 0 0
Hong Kong
State/province [242] 0 0
Tsuen Wan
Country [243] 0 0
Hungary
State/province [243] 0 0
Budaors
Country [244] 0 0
Hungary
State/province [244] 0 0
Budapest
Country [245] 0 0
Hungary
State/province [245] 0 0
Debrecen
Country [246] 0 0
Hungary
State/province [246] 0 0
Dunaujvaros
Country [247] 0 0
Hungary
State/province [247] 0 0
Gyula
Country [248] 0 0
Hungary
State/province [248] 0 0
H0dmezovasarhely
Country [249] 0 0
Hungary
State/province [249] 0 0
Kaposvar
Country [250] 0 0
Hungary
State/province [250] 0 0
Kecskemet
Country [251] 0 0
Hungary
State/province [251] 0 0
Nagykanizsa
Country [252] 0 0
Hungary
State/province [252] 0 0
Pecs
Country [253] 0 0
Hungary
State/province [253] 0 0
Sopron
Country [254] 0 0
Hungary
State/province [254] 0 0
Szekesfehervar
Country [255] 0 0
Hungary
State/province [255] 0 0
Szentes
Country [256] 0 0
Hungary
State/province [256] 0 0
Szombathely
Country [257] 0 0
Hungary
State/province [257] 0 0
Zalaegerszeg
Country [258] 0 0
India
State/province [258] 0 0
Andhra Pradesh
Country [259] 0 0
India
State/province [259] 0 0
Chennai
Country [260] 0 0
India
State/province [260] 0 0
Delhi
Country [261] 0 0
India
State/province [261] 0 0
Gujarat
Country [262] 0 0
India
State/province [262] 0 0
Karnataka
Country [263] 0 0
India
State/province [263] 0 0
Kerala
Country [264] 0 0
India
State/province [264] 0 0
Maharashtra
Country [265] 0 0
India
State/province [265] 0 0
Punjab
Country [266] 0 0
India
State/province [266] 0 0
Rajasthan
Country [267] 0 0
India
State/province [267] 0 0
Tamil Nadu
Country [268] 0 0
India
State/province [268] 0 0
West Bengal
Country [269] 0 0
Israel
State/province [269] 0 0
Ashkelon
Country [270] 0 0
Israel
State/province [270] 0 0
Beer Sheva
Country [271] 0 0
Israel
State/province [271] 0 0
Haifa
Country [272] 0 0
Israel
State/province [272] 0 0
Holon
Country [273] 0 0
Israel
State/province [273] 0 0
Jerusalem
Country [274] 0 0
Israel
State/province [274] 0 0
Kfar-Saba
Country [275] 0 0
Israel
State/province [275] 0 0
Nahariya
Country [276] 0 0
Israel
State/province [276] 0 0
Nazareth
Country [277] 0 0
Israel
State/province [277] 0 0
Petach Tikva
Country [278] 0 0
Israel
State/province [278] 0 0
Rehovot
Country [279] 0 0
Israel
State/province [279] 0 0
Rishon Lezion
Country [280] 0 0
Israel
State/province [280] 0 0
Safed
Country [281] 0 0
Israel
State/province [281] 0 0
Tel Aviv
Country [282] 0 0
Israel
State/province [282] 0 0
Tiberias
Country [283] 0 0
Italy
State/province [283] 0 0
Cosenza
Country [284] 0 0
Italy
State/province [284] 0 0
Isernia
Country [285] 0 0
Italy
State/province [285] 0 0
Milano
Country [286] 0 0
Italy
State/province [286] 0 0
Napoli
Country [287] 0 0
Italy
State/province [287] 0 0
Palermo
Country [288] 0 0
Italy
State/province [288] 0 0
Pavia
Country [289] 0 0
Italy
State/province [289] 0 0
Ravenna
Country [290] 0 0
Italy
State/province [290] 0 0
Roma
Country [291] 0 0
Italy
State/province [291] 0 0
Sesto San Giovanni
Country [292] 0 0
Japan
State/province [292] 0 0
Aichi
Country [293] 0 0
Japan
State/province [293] 0 0
Chiba
Country [294] 0 0
Japan
State/province [294] 0 0
Ehime
Country [295] 0 0
Japan
State/province [295] 0 0
Fukuoka
Country [296] 0 0
Japan
State/province [296] 0 0
Fukushima
Country [297] 0 0
Japan
State/province [297] 0 0
Gifu
Country [298] 0 0
Japan
State/province [298] 0 0
Gunma
Country [299] 0 0
Japan
State/province [299] 0 0
Hiroshima
Country [300] 0 0
Japan
State/province [300] 0 0
Hokkaido
Country [301] 0 0
Japan
State/province [301] 0 0
Hyogo
Country [302] 0 0
Japan
State/province [302] 0 0
Ishikawa
Country [303] 0 0
Japan
State/province [303] 0 0
Kagawa
Country [304] 0 0
Japan
State/province [304] 0 0
Kanagawa
Country [305] 0 0
Japan
State/province [305] 0 0
Kochi
Country [306] 0 0
Japan
State/province [306] 0 0
Kumamoto
Country [307] 0 0
Japan
State/province [307] 0 0
Kyoto
Country [308] 0 0
Japan
State/province [308] 0 0
Mie
Country [309] 0 0
Japan
State/province [309] 0 0
Nagasaki
Country [310] 0 0
Japan
State/province [310] 0 0
Oita
Country [311] 0 0
Japan
State/province [311] 0 0
Okayama
Country [312] 0 0
Japan
State/province [312] 0 0
Okinawa
Country [313] 0 0
Japan
State/province [313] 0 0
Osaka
Country [314] 0 0
Japan
State/province [314] 0 0
Saitama
Country [315] 0 0
Japan
State/province [315] 0 0
Shimane
Country [316] 0 0
Japan
State/province [316] 0 0
Shizuoka
Country [317] 0 0
Japan
State/province [317] 0 0
Tokushima
Country [318] 0 0
Japan
State/province [318] 0 0
Tokyo
Country [319] 0 0
Japan
State/province [319] 0 0
Yamaguchi
Country [320] 0 0
Japan
State/province [320] 0 0
Niigata
Country [321] 0 0
Japan
State/province [321] 0 0
Saga
Country [322] 0 0
Korea, Republic of
State/province [322] 0 0
Anyang
Country [323] 0 0
Korea, Republic of
State/province [323] 0 0
Busan
Country [324] 0 0
Korea, Republic of
State/province [324] 0 0
Daegu
Country [325] 0 0
Korea, Republic of
State/province [325] 0 0
Goyang-Si
Country [326] 0 0
Korea, Republic of
State/province [326] 0 0
Guri
Country [327] 0 0
Korea, Republic of
State/province [327] 0 0
Gyeonggi-do
Country [328] 0 0
Korea, Republic of
State/province [328] 0 0
Jeonju-si
Country [329] 0 0
Korea, Republic of
State/province [329] 0 0
Kangwon-do
Country [330] 0 0
Korea, Republic of
State/province [330] 0 0
Pusan
Country [331] 0 0
Korea, Republic of
State/province [331] 0 0
Seoul
Country [332] 0 0
Korea, Republic of
State/province [332] 0 0
Suwon
Country [333] 0 0
Korea, Republic of
State/province [333] 0 0
Yangsan
Country [334] 0 0
Kuwait
State/province [334] 0 0
Dasman
Country [335] 0 0
Latvia
State/province [335] 0 0
Daugavpils
Country [336] 0 0
Latvia
State/province [336] 0 0
Ogre
Country [337] 0 0
Latvia
State/province [337] 0 0
Riga
Country [338] 0 0
Latvia
State/province [338] 0 0
Tukums
Country [339] 0 0
Latvia
State/province [339] 0 0
Valmiera
Country [340] 0 0
Lithuania
State/province [340] 0 0
Kaunas
Country [341] 0 0
Lithuania
State/province [341] 0 0
Kedainiai
Country [342] 0 0
Lithuania
State/province [342] 0 0
Klaipeda
Country [343] 0 0
Lithuania
State/province [343] 0 0
Palanga
Country [344] 0 0
Lithuania
State/province [344] 0 0
Panevezys
Country [345] 0 0
Lithuania
State/province [345] 0 0
Vilnius
Country [346] 0 0
Malaysia
State/province [346] 0 0
Alor Setar
Country [347] 0 0
Malaysia
State/province [347] 0 0
Batu Caves
Country [348] 0 0
Malaysia
State/province [348] 0 0
Georgetown
Country [349] 0 0
Malaysia
State/province [349] 0 0
Kuala Lumpur
Country [350] 0 0
Malaysia
State/province [350] 0 0
Kuantan
Country [351] 0 0
Malaysia
State/province [351] 0 0
Kubang Kerian
Country [352] 0 0
Malaysia
State/province [352] 0 0
Pulau Pinang
Country [353] 0 0
Malaysia
State/province [353] 0 0
Selangor
Country [354] 0 0
Mexico
State/province [354] 0 0
Acapulco, Guerrero
Country [355] 0 0
Mexico
State/province [355] 0 0
Aguascalientes
Country [356] 0 0
Mexico
State/province [356] 0 0
Chihuahua
Country [357] 0 0
Mexico
State/province [357] 0 0
Chihuhua, Chihuhua
Country [358] 0 0
Mexico
State/province [358] 0 0
Ciudad Obregon, Sonora
Country [359] 0 0
Mexico
State/province [359] 0 0
Cuernavaca, Morelos
Country [360] 0 0
Mexico
State/province [360] 0 0
Cuernavaca
Country [361] 0 0
Mexico
State/province [361] 0 0
Culiacan
Country [362] 0 0
Mexico
State/province [362] 0 0
Durango
Country [363] 0 0
Mexico
State/province [363] 0 0
Guadalajara, Jalisco
Country [364] 0 0
Mexico
State/province [364] 0 0
Guadalajara
Country [365] 0 0
Mexico
State/province [365] 0 0
Merida, Yucatan
Country [366] 0 0
Mexico
State/province [366] 0 0
Metepec
Country [367] 0 0
Mexico
State/province [367] 0 0
Mexicali, Baja California
Country [368] 0 0
Mexico
State/province [368] 0 0
Mexico City, Mexico
Country [369] 0 0
Mexico
State/province [369] 0 0
Mexico City
Country [370] 0 0
Mexico
State/province [370] 0 0
Mexico
Country [371] 0 0
Mexico
State/province [371] 0 0
Monclova, Coahuila
Country [372] 0 0
Mexico
State/province [372] 0 0
Monterrey, NL
Country [373] 0 0
Mexico
State/province [373] 0 0
Monterrey, Nuevo Le0n
Country [374] 0 0
Mexico
State/province [374] 0 0
Monterrey, Nuevo Leon
Country [375] 0 0
Mexico
State/province [375] 0 0
Monterrey
Country [376] 0 0
Mexico
State/province [376] 0 0
Morelia, Michoacan
Country [377] 0 0
Mexico
State/province [377] 0 0
Pachuca
Country [378] 0 0
Mexico
State/province [378] 0 0
Saltillo, Coahuila
Country [379] 0 0
Mexico
State/province [379] 0 0
Saltillo
Country [380] 0 0
Mexico
State/province [380] 0 0
San Luis Potosi.SLP
Country [381] 0 0
Mexico
State/province [381] 0 0
San Luis Potosi
Country [382] 0 0
Mexico
State/province [382] 0 0
Tijuana, Baja California Norte
Country [383] 0 0
Mexico
State/province [383] 0 0
Tlalnepantla, Edo de Mexico
Country [384] 0 0
Mexico
State/province [384] 0 0
Tlalnepantla
Country [385] 0 0
Mexico
State/province [385] 0 0
Xalapa, Veracruz
Country [386] 0 0
Mexico
State/province [386] 0 0
Zapopan
Country [387] 0 0
New Zealand
State/province [387] 0 0
Auckland
Country [388] 0 0
New Zealand
State/province [388] 0 0
Christchurch
Country [389] 0 0
New Zealand
State/province [389] 0 0
Otahuhu
Country [390] 0 0
New Zealand
State/province [390] 0 0
Palmerston North
Country [391] 0 0
New Zealand
State/province [391] 0 0
Takapuna
Country [392] 0 0
New Zealand
State/province [392] 0 0
Tauranga
Country [393] 0 0
Peru
State/province [393] 0 0
Arequipa
Country [394] 0 0
Peru
State/province [394] 0 0
Bellavista
Country [395] 0 0
Peru
State/province [395] 0 0
Callao
Country [396] 0 0
Peru
State/province [396] 0 0
Cusco
Country [397] 0 0
Peru
State/province [397] 0 0
Huacho
Country [398] 0 0
Peru
State/province [398] 0 0
Ica
Country [399] 0 0
Peru
State/province [399] 0 0
La Victoria, Lima
Country [400] 0 0
Peru
State/province [400] 0 0
Lima San Isidro
Country [401] 0 0
Peru
State/province [401] 0 0
Lima
Country [402] 0 0
Peru
State/province [402] 0 0
Los Olivos
Country [403] 0 0
Peru
State/province [403] 0 0
Miraflores, Lima
Country [404] 0 0
Peru
State/province [404] 0 0
Piura
Country [405] 0 0
Peru
State/province [405] 0 0
San Isidro, Lima
Country [406] 0 0
Peru
State/province [406] 0 0
San Miguel, Lima
Country [407] 0 0
Peru
State/province [407] 0 0
Trujillo, La Libertad
Country [408] 0 0
Peru
State/province [408] 0 0
Trujillo
Country [409] 0 0
Philippines
State/province [409] 0 0
Baguio
Country [410] 0 0
Philippines
State/province [410] 0 0
Dasmarinas
Country [411] 0 0
Philippines
State/province [411] 0 0
Davao City
Country [412] 0 0
Philippines
State/province [412] 0 0
Iloilo City
Country [413] 0 0
Philippines
State/province [413] 0 0
Laoag City
Country [414] 0 0
Philippines
State/province [414] 0 0
Makati City
Country [415] 0 0
Philippines
State/province [415] 0 0
Manila
Country [416] 0 0
Philippines
State/province [416] 0 0
Marikina City
Country [417] 0 0
Philippines
State/province [417] 0 0
Pasig City
Country [418] 0 0
Philippines
State/province [418] 0 0
Quezon City
Country [419] 0 0
Poland
State/province [419] 0 0
Bialystok
Country [420] 0 0
Poland
State/province [420] 0 0
Bydgoszcz
Country [421] 0 0
Poland
State/province [421] 0 0
Czestochowa
Country [422] 0 0
Poland
State/province [422] 0 0
Dabrowa Gornicza
Country [423] 0 0
Poland
State/province [423] 0 0
Elblag
Country [424] 0 0
Poland
State/province [424] 0 0
Gdansk
Country [425] 0 0
Poland
State/province [425] 0 0
Gdynia
Country [426] 0 0
Poland
State/province [426] 0 0
Grodzisk Mazowiecki
Country [427] 0 0
Poland
State/province [427] 0 0
Inowroclaw
Country [428] 0 0
Poland
State/province [428] 0 0
Katowice
Country [429] 0 0
Poland
State/province [429] 0 0
Kielce
Country [430] 0 0
Poland
State/province [430] 0 0
Krakow
Country [431] 0 0
Poland
State/province [431] 0 0
Legnica
Country [432] 0 0
Poland
State/province [432] 0 0
Lodz
Country [433] 0 0
Poland
State/province [433] 0 0
Lubartow
Country [434] 0 0
Poland
State/province [434] 0 0
Lublin
Country [435] 0 0
Poland
State/province [435] 0 0
Plock
Country [436] 0 0
Poland
State/province [436] 0 0
Pulawy
Country [437] 0 0
Poland
State/province [437] 0 0
Radom
Country [438] 0 0
Poland
State/province [438] 0 0
Ruda Slaska
Country [439] 0 0
Poland
State/province [439] 0 0
Skierniewice
Country [440] 0 0
Poland
State/province [440] 0 0
Slupsk
Country [441] 0 0
Poland
State/province [441] 0 0
Szczecin
Country [442] 0 0
Poland
State/province [442] 0 0
Torun
Country [443] 0 0
Poland
State/province [443] 0 0
Warsaw
Country [444] 0 0
Poland
State/province [444] 0 0
Warszawa
Country [445] 0 0
Poland
State/province [445] 0 0
Wroclaw
Country [446] 0 0
Poland
State/province [446] 0 0
Zabrze
Country [447] 0 0
Poland
State/province [447] 0 0
Zgierz
Country [448] 0 0
Portugal
State/province [448] 0 0
Coimbra
Country [449] 0 0
Portugal
State/province [449] 0 0
Faro
Country [450] 0 0
Portugal
State/province [450] 0 0
Lisboa
Country [451] 0 0
Portugal
State/province [451] 0 0
Vila Real
Country [452] 0 0
Puerto Rico
State/province [452] 0 0
Aibonito
Country [453] 0 0
Puerto Rico
State/province [453] 0 0
Carolina
Country [454] 0 0
Puerto Rico
State/province [454] 0 0
Cidra
Country [455] 0 0
Puerto Rico
State/province [455] 0 0
Halo Rey
Country [456] 0 0
Puerto Rico
State/province [456] 0 0
Levittown
Country [457] 0 0
Puerto Rico
State/province [457] 0 0
Manati
Country [458] 0 0
Puerto Rico
State/province [458] 0 0
Mayaguez
Country [459] 0 0
Puerto Rico
State/province [459] 0 0
Ponce
Country [460] 0 0
Puerto Rico
State/province [460] 0 0
Salinas
Country [461] 0 0
Puerto Rico
State/province [461] 0 0
San Juan
Country [462] 0 0
Puerto Rico
State/province [462] 0 0
Santurce
Country [463] 0 0
Romania
State/province [463] 0 0
Bacau
Country [464] 0 0
Romania
State/province [464] 0 0
Baia Mare
Country [465] 0 0
Romania
State/province [465] 0 0
Braila
Country [466] 0 0
Romania
State/province [466] 0 0
Brasov
Country [467] 0 0
Romania
State/province [467] 0 0
Bucharest
Country [468] 0 0
Romania
State/province [468] 0 0
Bucuresti
Country [469] 0 0
Romania
State/province [469] 0 0
Buzau
Country [470] 0 0
Romania
State/province [470] 0 0
Galati
Country [471] 0 0
Romania
State/province [471] 0 0
Iasi
Country [472] 0 0
Romania
State/province [472] 0 0
Oradea
Country [473] 0 0
Romania
State/province [473] 0 0
Ploiesti
Country [474] 0 0
Romania
State/province [474] 0 0
Satu Mare
Country [475] 0 0
Romania
State/province [475] 0 0
Targu Mures
Country [476] 0 0
Romania
State/province [476] 0 0
Timisoara
Country [477] 0 0
Russian Federation
State/province [477] 0 0
Arkhangelsk
Country [478] 0 0
Russian Federation
State/province [478] 0 0
Barnaul
Country [479] 0 0
Russian Federation
State/province [479] 0 0
Ivanovo
Country [480] 0 0
Russian Federation
State/province [480] 0 0
Kazan
Country [481] 0 0
Russian Federation
State/province [481] 0 0
Kemerovo
Country [482] 0 0
Russian Federation
State/province [482] 0 0
Krasnodar
Country [483] 0 0
Russian Federation
State/province [483] 0 0
Krasnoyarsk
Country [484] 0 0
Russian Federation
State/province [484] 0 0
Kursk
Country [485] 0 0
Russian Federation
State/province [485] 0 0
Moscow
Country [486] 0 0
Russian Federation
State/province [486] 0 0
Nizhniy Novgorod
Country [487] 0 0
Russian Federation
State/province [487] 0 0
Novosibirsk
Country [488] 0 0
Russian Federation
State/province [488] 0 0
Rostov-on-Don
Country [489] 0 0
Russian Federation
State/province [489] 0 0
Saratov
Country [490] 0 0
Russian Federation
State/province [490] 0 0
St. Petersburg
Country [491] 0 0
Russian Federation
State/province [491] 0 0
Ufa
Country [492] 0 0
Russian Federation
State/province [492] 0 0
Volgograd
Country [493] 0 0
Russian Federation
State/province [493] 0 0
Vsevolozhsk
Country [494] 0 0
Serbia
State/province [494] 0 0
Belgrade
Country [495] 0 0
Serbia
State/province [495] 0 0
Beograd
Country [496] 0 0
Serbia
State/province [496] 0 0
Nis
Country [497] 0 0
Slovakia
State/province [497] 0 0
Bardejov
Country [498] 0 0
Slovakia
State/province [498] 0 0
Bratislava
Country [499] 0 0
Slovakia
State/province [499] 0 0
Dolny Kubin
Country [500] 0 0
Slovakia
State/province [500] 0 0
Komarno
Country [501] 0 0
Slovakia
State/province [501] 0 0
Kosice - Saca
Country [502] 0 0
Slovakia
State/province [502] 0 0
Kosice
Country [503] 0 0
Slovakia
State/province [503] 0 0
Levice
Country [504] 0 0
Slovakia
State/province [504] 0 0
Liptovsky Hradok
Country [505] 0 0
Slovakia
State/province [505] 0 0
Nove Mesto nad Vahom
Country [506] 0 0
Slovakia
State/province [506] 0 0
Nove Zamky
Country [507] 0 0
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West Midlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Takeda
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00968708
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director Clinical Science
Address 0 0
Takeda
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/ct2/show/NCT00968708