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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01144338
Registration number
NCT01144338
Ethics application status
Date submitted
10/06/2010
Date registered
15/06/2010
Date last updated
8/08/2018
Titles & IDs
Public title
Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL): A Trial To Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly In Patients With Type 2 Diabetes Mellitus
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Scientific title
Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL). A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly in Patients With Type 2 Diabetes Mellitus.
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Secondary ID [1]
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MB001-002
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Secondary ID [2]
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D5551C00003
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus
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Condition category
Condition code
Metabolic and Endocrine
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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 - Exenatide Once Weekly
Treatment: Drugs - Placebo
Experimental: Exenatide Once Weekly -
Placebo comparator: Placebo -
Treatment: Drugs: Exenatide Once Weekly
Subcutaneous injection, 2 mg, administered once weekly.
Treatment: Drugs: Placebo
Subcutaneous injection, matching volume of placebo, administered once weekly.
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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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Primary Efficacy Outcome MACE Events
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Assessment method [1]
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The primary efficacy outcome variable is defined as the composite endpoint of cardiovascular death, nonfatal MI, or nonfatal stroke. The number of participants who had an event is reported in the results.
The primary efficacy endpoint is the same as the primary safety endpoint, and the statistical analysis tests the superiority of exenatide against the placebo.
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Timepoint [1]
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Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
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Primary outcome [2]
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Primary Safety Outcome MACE Events
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Assessment method [2]
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The primary safety outcome variable is defined as the composite endpoint of cardiovascular death, nonfatal MI, or nonfatal stroke. The number of participants who had an event is reported in the results.
The primary safety endpoint is the same as the primary efficacy endpoints, and the statistical analysis tests the non-inferiority of exenatide against placebo.
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Timepoint [2]
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Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
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Secondary outcome [1]
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Secondary Efficacy Outcome All-Cause Mortality
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Assessment method [1]
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The secondary efficacy outcome variable is defined as the all-cause mortality (deaths). The number of participants who had an event is reported in the results.
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Timepoint [1]
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Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
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Secondary outcome [2]
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Secondary Efficacy Outcome CV Death
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Assessment method [2]
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Component of the primary efficacy outcome: cardiovascular death. The number of participants who had an event is reported in the results.
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Timepoint [2]
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Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
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Secondary outcome [3]
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Secondary Efficacy Outcome MI
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Assessment method [3]
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Component of primary efficacy outcome: fatal or non-fatal MI. The number of participants who had an event is reported in the results.
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Timepoint [3]
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Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
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Secondary outcome [4]
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Secondary Efficacy Outcome Stroke
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Assessment method [4]
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Component of primary efficacy outcome: fatal or non-fatal stroke. The number of participants who had an event is reported in the results.
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Timepoint [4]
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Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
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Secondary outcome [5]
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Secondary Efficacy Outcome Hospitalization for ACS
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Assessment method [5]
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The secondary efficacy outcome variable is defined as hospitalization for acute coronary syndrome. The number of participants who had an event is reported in the results.
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Timepoint [5]
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Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
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Secondary outcome [6]
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Secondary Efficacy Outcome Hospitalization for HF
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Assessment method [6]
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The secondary efficacy outcome variable is defined as hospitalization for heart failure. The number of participants who had an event is reported in the results.
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Timepoint [6]
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Time to first event. Information collected during study period (anticipated to be up to 7.5 years).
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Eligibility
Key inclusion criteria
* Patient has type 2 diabetes mellitus
* Patient has an HbA1c of = 6.5 % and = 10.0% and is currently using one of the following treatment regimens: A) Treatment with 0-3 oral antihyperglycemic agents B) Insulin therapy, either alone or in combination with up to two oral agents
* Female patients must not be breast feeding and agree to use an effective method of contraception or must not otherwise be at risk of becoming pregnant.
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Minimum age
18
Years
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Maximum age
130
Years
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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
* Patient has a diagnosis of type 1 diabetes mellitus, or a history of ketoacidosis.
* Patient has ever been treated with an approved or investigational GLP-1 receptor agonist.
* Patient is enrolled in another experimental protocol which involves the use of an investigational drug or device, or an intervention that would interfere with the conduct of the trial.
* Patient has a planned or anticipated revascularization procedure.
* Pregnancy or planned pregnancy during the trial period.
* Patient has end-stage renal disease or an estimated glomerular filtration rate (eGFR) of <30 mL/min/1.73m2.
* Patient has a history of gastroparesis or pancreatitis.
* Personal or family history of medullary thyroid cancer or MEN2 (Multiple EndocrineNeoplasia Type 2) or calcitonin level of >40 ng/L at baseline.
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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 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
18/06/2010
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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
24/04/2017
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Sample size
Target
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Accrual to date
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Final
14752
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Recruitment in Australia
Recruitment state(s)
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Research Site - Adelaide
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5000 - Adelaide
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2050 - Camperdown
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3168 - Clayton
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2250 - East Gosford
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5112 - Elizabeth Vale
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3065 - Fitzroy
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2605 - Garran
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3220 - Geelong
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3081 - Heidelberg West
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4131 - Meadobank
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4064 - Milton
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3050 - Parkville
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Recruitment postcode(s) [13]
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2006 - Sydney
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Colombia
Query!
State/province [112]
0
0
Manizales
Query!
Country [113]
0
0
Colombia
Query!
State/province [113]
0
0
Medellin
Query!
Country [114]
0
0
Colombia
Query!
State/province [114]
0
0
Medellín
Query!
Country [115]
0
0
Czechia
Query!
State/province [115]
0
0
Olomouc-Lazce
Query!
Country [116]
0
0
Czechia
Query!
State/province [116]
0
0
Praha 10, Prague
Query!
Country [117]
0
0
Czechia
Query!
State/province [117]
0
0
Praha 4
Query!
Country [118]
0
0
Czechia
Query!
State/province [118]
0
0
Svitavy
Query!
Country [119]
0
0
Czechia
Query!
State/province [119]
0
0
Znojmo
Query!
Country [120]
0
0
Germany
Query!
State/province [120]
0
0
Aachen
Query!
Country [121]
0
0
Germany
Query!
State/province [121]
0
0
Aschaffenburg
Query!
Country [122]
0
0
Germany
Query!
State/province [122]
0
0
Bad Nauheim
Query!
Country [123]
0
0
Germany
Query!
State/province [123]
0
0
Bad Oeynhausen
Query!
Country [124]
0
0
Germany
Query!
State/province [124]
0
0
Berlin
Query!
Country [125]
0
0
Germany
Query!
State/province [125]
0
0
Bochum
Query!
Country [126]
0
0
Germany
Query!
State/province [126]
0
0
Burghausen
Query!
Country [127]
0
0
Germany
Query!
State/province [127]
0
0
Burg
Query!
Country [128]
0
0
Germany
Query!
State/province [128]
0
0
Chemnitz
Query!
Country [129]
0
0
Germany
Query!
State/province [129]
0
0
Dortmund
Query!
Country [130]
0
0
Germany
Query!
State/province [130]
0
0
Dresden
Query!
Country [131]
0
0
Germany
Query!
State/province [131]
0
0
Eschweiler
Query!
Country [132]
0
0
Germany
Query!
State/province [132]
0
0
Essen
Query!
Country [133]
0
0
Germany
Query!
State/province [133]
0
0
Gießen
Query!
Country [134]
0
0
Germany
Query!
State/province [134]
0
0
Herne
Query!
Country [135]
0
0
Germany
Query!
State/province [135]
0
0
Hohenmölsen
Query!
Country [136]
0
0
Germany
Query!
State/province [136]
0
0
Kassel
Query!
Country [137]
0
0
Germany
Query!
State/province [137]
0
0
Kiel-Kronshagen
Query!
Country [138]
0
0
Germany
Query!
State/province [138]
0
0
Köthen
Query!
Country [139]
0
0
Germany
Query!
State/province [139]
0
0
Lichtenfels
Query!
Country [140]
0
0
Germany
Query!
State/province [140]
0
0
Mainz
Query!
Country [141]
0
0
Germany
Query!
State/province [141]
0
0
Mayen
Query!
Country [142]
0
0
Germany
Query!
State/province [142]
0
0
München
Query!
Country [143]
0
0
Germany
Query!
State/province [143]
0
0
Münster
Query!
Country [144]
0
0
Germany
Query!
State/province [144]
0
0
Obermichelbach
Query!
Country [145]
0
0
Germany
Query!
State/province [145]
0
0
Osnabrueck
Query!
Country [146]
0
0
Germany
Query!
State/province [146]
0
0
Riesa
Query!
Country [147]
0
0
Germany
Query!
State/province [147]
0
0
Rotenburg
Query!
Country [148]
0
0
Germany
Query!
State/province [148]
0
0
Stuttgart
Query!
Country [149]
0
0
Germany
Query!
State/province [149]
0
0
Würzburg
Query!
Country [150]
0
0
Hong Kong
Query!
State/province [150]
0
0
Hong Kong
Query!
Country [151]
0
0
Hong Kong
Query!
State/province [151]
0
0
Shatin
Query!
Country [152]
0
0
Hungary
Query!
State/province [152]
0
0
Balatonfüred
Query!
Country [153]
0
0
Hungary
Query!
State/province [153]
0
0
Budapest
Query!
Country [154]
0
0
Hungary
Query!
State/province [154]
0
0
Csongrad
Query!
Country [155]
0
0
Hungary
Query!
State/province [155]
0
0
Debrecen
Query!
Country [156]
0
0
Hungary
Query!
State/province [156]
0
0
Eger
Query!
Country [157]
0
0
Hungary
Query!
State/province [157]
0
0
Gyor
Query!
Country [158]
0
0
Hungary
Query!
State/province [158]
0
0
Hodmezovasarhely
Query!
Country [159]
0
0
Hungary
Query!
State/province [159]
0
0
Jászberény
Query!
Country [160]
0
0
Hungary
Query!
State/province [160]
0
0
Kaposvár
Query!
Country [161]
0
0
Hungary
Query!
State/province [161]
0
0
Kecskemét
Query!
Country [162]
0
0
Hungary
Query!
State/province [162]
0
0
Komarom
Query!
Country [163]
0
0
Hungary
Query!
State/province [163]
0
0
Mosonmagyarovar
Query!
Country [164]
0
0
Hungary
Query!
State/province [164]
0
0
Nagykanizsa
Query!
Country [165]
0
0
Hungary
Query!
State/province [165]
0
0
Nyíregyháza
Query!
Country [166]
0
0
Hungary
Query!
State/province [166]
0
0
Pápa
Query!
Country [167]
0
0
Hungary
Query!
State/province [167]
0
0
Pécs
Query!
Country [168]
0
0
Hungary
Query!
State/province [168]
0
0
Szekszárd
Query!
Country [169]
0
0
Hungary
Query!
State/province [169]
0
0
Szentes
Query!
Country [170]
0
0
Hungary
Query!
State/province [170]
0
0
Szigetvár
Query!
Country [171]
0
0
Hungary
Query!
State/province [171]
0
0
Szikszo
Query!
Country [172]
0
0
Hungary
Query!
State/province [172]
0
0
Székesfehérvár
Query!
Country [173]
0
0
Hungary
Query!
State/province [173]
0
0
Sátoraljaújhely
Query!
Country [174]
0
0
Hungary
Query!
State/province [174]
0
0
Veszprem
Query!
Country [175]
0
0
Hungary
Query!
State/province [175]
0
0
Zalaegerszeg
Query!
Country [176]
0
0
Israel
Query!
State/province [176]
0
0
Givatayim
Query!
Country [177]
0
0
Israel
Query!
State/province [177]
0
0
Hadera
Query!
Country [178]
0
0
Israel
Query!
State/province [178]
0
0
Haifa
Query!
Country [179]
0
0
Israel
Query!
State/province [179]
0
0
Holon
Query!
Country [180]
0
0
Israel
Query!
State/province [180]
0
0
Jerusalem
Query!
Country [181]
0
0
Israel
Query!
State/province [181]
0
0
Kfar Saba
Query!
Country [182]
0
0
Israel
Query!
State/province [182]
0
0
Nahariya
Query!
Country [183]
0
0
Israel
Query!
State/province [183]
0
0
Nazareth
Query!
Country [184]
0
0
Israel
Query!
State/province [184]
0
0
Petah Tikva
Query!
Country [185]
0
0
Israel
Query!
State/province [185]
0
0
Safed
Query!
Country [186]
0
0
Israel
Query!
State/province [186]
0
0
Tel-Aviv
Query!
Country [187]
0
0
Italy
Query!
State/province [187]
0
0
Firenze
Query!
Country [188]
0
0
Italy
Query!
State/province [188]
0
0
Foggia
Query!
Country [189]
0
0
Italy
Query!
State/province [189]
0
0
Milano
Query!
Country [190]
0
0
Italy
Query!
State/province [190]
0
0
Pisa
Query!
Country [191]
0
0
Italy
Query!
State/province [191]
0
0
Roma
Query!
Country [192]
0
0
Italy
Query!
State/province [192]
0
0
Sesto San Giovanni
Query!
Country [193]
0
0
Italy
Query!
State/province [193]
0
0
Terni
Query!
Country [194]
0
0
Italy
Query!
State/province [194]
0
0
Udine
Query!
Country [195]
0
0
Korea, Republic of
Query!
State/province [195]
0
0
Busan
Query!
Country [196]
0
0
Korea, Republic of
Query!
State/province [196]
0
0
Daegu
Query!
Country [197]
0
0
Korea, Republic of
Query!
State/province [197]
0
0
Gwangjin-gu
Query!
Country [198]
0
0
Korea, Republic of
Query!
State/province [198]
0
0
Gyeonggi-do
Query!
Country [199]
0
0
Korea, Republic of
Query!
State/province [199]
0
0
Incheon
Query!
Country [200]
0
0
Korea, Republic of
Query!
State/province [200]
0
0
Seongnam
Query!
Country [201]
0
0
Korea, Republic of
Query!
State/province [201]
0
0
Seoul
Query!
Country [202]
0
0
Korea, Republic of
Query!
State/province [202]
0
0
Suwon-si
Query!
Country [203]
0
0
Korea, Republic of
Query!
State/province [203]
0
0
Suwon
Query!
Country [204]
0
0
Korea, Republic of
Query!
State/province [204]
0
0
Ulsan
Query!
Country [205]
0
0
Latvia
Query!
State/province [205]
0
0
Daugavpils
Query!
Country [206]
0
0
Latvia
Query!
State/province [206]
0
0
Jelgava
Query!
Country [207]
0
0
Latvia
Query!
State/province [207]
0
0
Kuldiga
Query!
Country [208]
0
0
Latvia
Query!
State/province [208]
0
0
Ogre
Query!
Country [209]
0
0
Latvia
Query!
State/province [209]
0
0
Riga
Query!
Country [210]
0
0
Latvia
Query!
State/province [210]
0
0
Talsi
Query!
Country [211]
0
0
Latvia
Query!
State/province [211]
0
0
Tukums
Query!
Country [212]
0
0
Lithuania
Query!
State/province [212]
0
0
Kaunas
Query!
Country [213]
0
0
Lithuania
Query!
State/province [213]
0
0
Kedainiai
Query!
Country [214]
0
0
Lithuania
Query!
State/province [214]
0
0
Klaipeda
Query!
Country [215]
0
0
Lithuania
Query!
State/province [215]
0
0
Panevezys
Query!
Country [216]
0
0
Lithuania
Query!
State/province [216]
0
0
Ukmerge
Query!
Country [217]
0
0
Lithuania
Query!
State/province [217]
0
0
Utena
Query!
Country [218]
0
0
Lithuania
Query!
State/province [218]
0
0
Vilnius
Query!
Country [219]
0
0
Malaysia
Query!
State/province [219]
0
0
Alor Setar
Query!
Country [220]
0
0
Malaysia
Query!
State/province [220]
0
0
Batu Caves
Query!
Country [221]
0
0
Malaysia
Query!
State/province [221]
0
0
Kota Samarahan
Query!
Country [222]
0
0
Malaysia
Query!
State/province [222]
0
0
Kuala Lumpur
Query!
Country [223]
0
0
Malaysia
Query!
State/province [223]
0
0
Kuching
Query!
Country [224]
0
0
Malaysia
Query!
State/province [224]
0
0
Sungai Buloh
Query!
Country [225]
0
0
Malaysia
Query!
State/province [225]
0
0
Taiping
Query!
Country [226]
0
0
Mexico
Query!
State/province [226]
0
0
Aguascalientes
Query!
Country [227]
0
0
Mexico
Query!
State/province [227]
0
0
Cuautla
Query!
Country [228]
0
0
Mexico
Query!
State/province [228]
0
0
Durango
Query!
Country [229]
0
0
Mexico
Query!
State/province [229]
0
0
Guadalajara
Query!
Country [230]
0
0
Mexico
Query!
State/province [230]
0
0
Mexico
Query!
Country [231]
0
0
Mexico
Query!
State/province [231]
0
0
Monterrey
Query!
Country [232]
0
0
Mexico
Query!
State/province [232]
0
0
Puebla
Query!
Country [233]
0
0
Mexico
Query!
State/province [233]
0
0
Queretaro
Query!
Country [234]
0
0
Mexico
Query!
State/province [234]
0
0
San Luis Potosí
Query!
Country [235]
0
0
Netherlands
Query!
State/province [235]
0
0
Amersfoort
Query!
Country [236]
0
0
Netherlands
Query!
State/province [236]
0
0
Amsterdam
Query!
Country [237]
0
0
Netherlands
Query!
State/province [237]
0
0
Eindhoven
Query!
Country [238]
0
0
Netherlands
Query!
State/province [238]
0
0
Groningen
Query!
Country [239]
0
0
Netherlands
Query!
State/province [239]
0
0
Hardenberg
Query!
Country [240]
0
0
Netherlands
Query!
State/province [240]
0
0
Hoogeveen
Query!
Country [241]
0
0
Netherlands
Query!
State/province [241]
0
0
Meppel
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
New Zealand
Query!
State/province [245]
0
0
Christchurch
Query!
Country [246]
0
0
New Zealand
Query!
State/province [246]
0
0
Hamilton
Query!
Country [247]
0
0
New Zealand
Query!
State/province [247]
0
0
Nelson
Query!
Country [248]
0
0
New Zealand
Query!
State/province [248]
0
0
Newtown
Query!
Country [249]
0
0
New Zealand
Query!
State/province [249]
0
0
Palmerston North
Query!
Country [250]
0
0
New Zealand
Query!
State/province [250]
0
0
Takapuna
Query!
Country [251]
0
0
New Zealand
Query!
State/province [251]
0
0
Tauranga
Query!
Country [252]
0
0
New Zealand
Query!
State/province [252]
0
0
Wellington
Query!
Country [253]
0
0
Philippines
Query!
State/province [253]
0
0
Cebu
Query!
Country [254]
0
0
Philippines
Query!
State/province [254]
0
0
Iloilo City
Query!
Country [255]
0
0
Philippines
Query!
State/province [255]
0
0
Manila
Query!
Country [256]
0
0
Philippines
Query!
State/province [256]
0
0
Marikina City
Query!
Country [257]
0
0
Philippines
Query!
State/province [257]
0
0
Marikina
Query!
Country [258]
0
0
Philippines
Query!
State/province [258]
0
0
Pasig
Query!
Country [259]
0
0
Philippines
Query!
State/province [259]
0
0
Quezon City
Query!
Country [260]
0
0
Philippines
Query!
State/province [260]
0
0
Quezon
Query!
Country [261]
0
0
Philippines
Query!
State/province [261]
0
0
San Juan
Query!
Country [262]
0
0
Poland
Query!
State/province [262]
0
0
Elblag
Query!
Country [263]
0
0
Poland
Query!
State/province [263]
0
0
Gdynia
Query!
Country [264]
0
0
Poland
Query!
State/province [264]
0
0
Grodzisk Mazowiecki
Query!
Country [265]
0
0
Poland
Query!
State/province [265]
0
0
Grudziadz
Query!
Country [266]
0
0
Poland
Query!
State/province [266]
0
0
Katowice
Query!
Country [267]
0
0
Poland
Query!
State/province [267]
0
0
Lublin
Query!
Country [268]
0
0
Poland
Query!
State/province [268]
0
0
Ostroleka
Query!
Country [269]
0
0
Poland
Query!
State/province [269]
0
0
Poznan
Query!
Country [270]
0
0
Poland
Query!
State/province [270]
0
0
Plock
Query!
Country [271]
0
0
Poland
Query!
State/province [271]
0
0
Slupsk
Query!
Country [272]
0
0
Poland
Query!
State/province [272]
0
0
Warszawa
Query!
Country [273]
0
0
Poland
Query!
State/province [273]
0
0
Wroclaw
Query!
Country [274]
0
0
Poland
Query!
State/province [274]
0
0
Lódz
Query!
Country [275]
0
0
Poland
Query!
State/province [275]
0
0
Leczna
Query!
Country [276]
0
0
Romania
Query!
State/province [276]
0
0
Bacau
Query!
Country [277]
0
0
Romania
Query!
State/province [277]
0
0
Bucharest
Query!
Country [278]
0
0
Romania
Query!
State/province [278]
0
0
Bucuresti
Query!
Country [279]
0
0
Romania
Query!
State/province [279]
0
0
Buzau
Query!
Country [280]
0
0
Romania
Query!
State/province [280]
0
0
Cluj Napoca
Query!
Country [281]
0
0
Romania
Query!
State/province [281]
0
0
Craiova
Query!
Country [282]
0
0
Romania
Query!
State/province [282]
0
0
Iasi
Query!
Country [283]
0
0
Romania
Query!
State/province [283]
0
0
Oradea
Query!
Country [284]
0
0
Romania
Query!
State/province [284]
0
0
Ploiesti
Query!
Country [285]
0
0
Romania
Query!
State/province [285]
0
0
Satu-Mare
Query!
Country [286]
0
0
Romania
Query!
State/province [286]
0
0
Timisoara
Query!
Country [287]
0
0
Romania
Query!
State/province [287]
0
0
Timi?oara
Query!
Country [288]
0
0
Romania
Query!
State/province [288]
0
0
Zalau
Query!
Country [289]
0
0
Russian Federation
Query!
State/province [289]
0
0
Ekaterinburg
Query!
Country [290]
0
0
Russian Federation
Query!
State/province [290]
0
0
Kemerovo
Query!
Country [291]
0
0
Russian Federation
Query!
State/province [291]
0
0
Krasnoyarsk
Query!
Country [292]
0
0
Russian Federation
Query!
State/province [292]
0
0
Moscow
Query!
Country [293]
0
0
Russian Federation
Query!
State/province [293]
0
0
Nizhnii Novgorod
Query!
Country [294]
0
0
Russian Federation
Query!
State/province [294]
0
0
Novosibirsk
Query!
Country [295]
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Funding & Sponsors
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Commercial sector/industry
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Name
AstraZeneca
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Summary
Brief summary
This study will compare the impact of including exenatide once weekly in addition to usual care vs. usual care without exenatide on major cardiovascular outcomes as measured by the primary composite endpoint of cardiovascular-related death, nonfatal myocardial infarction (MI), or nonfatal stroke.
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Trial website
https://clinicaltrials.gov/study/NCT01144338
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Trial related presentations / publications
Davis TME, Giczewska A, Lokhnygina Y, Mentz RJ, Sattar N, Holman RR; EXSCEL Study Group. Effect of race on cardiometabolic responses to once-weekly exenatide: insights from the Exenatide Study of Cardiovascular Event Lowering (EXSCEL). Cardiovasc Diabetol. 2022 Jun 27;21(1):116. doi: 10.1186/s12933-022-01555-z. Becker F, Dakin HA, Reed SD, Li Y, Leal J, Gustavson SM, Wittbrodt E, Hernandez AF, Gray AM, Holman RR. Lifetime cost-effectiveness simulation of once-weekly exenatide in type 2 diabetes: A cost-utility analysis based on the EXSCEL trial. Diabetes Res Clin Pract. 2022 Jan;183:109152. doi: 10.1016/j.diabres.2021.109152. Epub 2021 Nov 20. Bethel MA, Stevens SR, Buse JB, Choi J, Gustavson SM, Iqbal N, Lokhnygina Y, Mentz RJ, Patel RA, Ohman P, Schernthaner G, Lecube A, Hernandez AF, Holman RR. Exploring the Possible Impact of Unbalanced Open-Label Drop-In of Glucose-Lowering Medications on EXSCEL Outcomes. Circulation. 2020 Apr 28;141(17):1360-1370. doi: 10.1161/CIRCULATIONAHA.119.043353. Epub 2020 Feb 26. Standl E, Stevens SR, Lokhnygina Y, Bethel MA, Buse JB, Gustavson SM, Maggioni AP, Mentz RJ, Hernandez AF, Holman RR; EXSCEL Study Group. Confirming the Bidirectional Nature of the Association Between Severe Hypoglycemic and Cardiovascular Events in Type 2 Diabetes: Insights From EXSCEL. Diabetes Care. 2020 Mar;43(3):643-652. doi: 10.2337/dc19-1079. Epub 2019 Dec 27. Reed SD, Li Y, Dakin HA, Becker F, Leal J, Gustavson SM, Kartman B, Wittbrodt E, Mentz RJ, Pagidipati NJ, Bethel MA, Gray AM, Holman RR, Hernandez AF; EXSCEL Study Group. Within-Trial Evaluation of Medical Resources, Costs, and Quality of Life Among Patients With Type 2 Diabetes Participating in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL). Diabetes Care. 2020 Feb;43(2):374-381. doi: 10.2337/dc19-0950. Epub 2019 Dec 5. Badjatiya A, Merrill P, Buse JB, Goodman SG, Katona B, Iqbal N, Pagidipati NJ, Sattar N, Holman RR, Hernandez AF, Mentz RJ, Patel MR, Jones WS. Clinical Outcomes in Patients With Type 2 Diabetes Mellitus and Peripheral Artery Disease: Results From the EXSCEL Trial. Circ Cardiovasc Interv. 2019 Dec;12(12):e008018. doi: 10.1161/CIRCINTERVENTIONS.119.008018. Epub 2019 Nov 22. Clegg LE, Penland RC, Bachina S, Boulton DW, Thuresson M, Heerspink HJL, Gustavson S, Sjostrom CD, Ruggles JA, Hernandez AF, Buse JB, Mentz RJ, Holman RR. Effects of exenatide and open-label SGLT2 inhibitor treatment, given in parallel or sequentially, on mortality and cardiovascular and renal outcomes in type 2 diabetes: insights from the EXSCEL trial. Cardiovasc Diabetol. 2019 Oct 22;18(1):138. doi: 10.1186/s12933-019-0942-x. Fudim M, White J, Pagidipati NJ, Lokhnygina Y, Wainstein J, Murin J, Iqbal N, Ohman P, Lopes RD, Reicher B, Holman RR, Hernandez AF, Mentz RJ. Effect of Once-Weekly Exenatide in Patients With Type 2 Diabetes Mellitus With and Without Heart Failure and Heart Failure-Related Outcomes: Insights From the EXSCEL Trial. Circulation. 2019 Nov 12;140(20):1613-1622. doi: 10.1161/CIRCULATIONAHA.119.041659. Epub 2019 Sep 23. Bethel MA, Patel RA, Thompson VP, Merrill P, Reed SD, Li Y, Ahmadi S, Katona BG, Gustavson SM, Ohman P, Iqbal N, Gagel RF, Hernandez AF, Buse JB, Holman RR; EXSCEL Study Group. Changes in Serum Calcitonin Concentrations, Incidence of Medullary Thyroid Carcinoma, and Impact of Routine Calcitonin Concentration Monitoring in the EXenatide Study of Cardiovascular Event Lowering (EXSCEL). Diabetes Care. 2019 Jun;42(6):1075-1080. doi: 10.2337/dc18-2028. Epub 2019 Apr 22. Mentz RJ, Bethel MA, Merrill P, Lokhnygina Y, Buse JB, Chan JC, Felicio JS, Goodman SG, Choi J, Gustavson SM, Iqbal N, Lopes RD, Maggioni AP, Ohman P, Pagidipati NJ, Poulter NR, Ramachandran A, Reicher B, Holman RR, Hernandez AF; EXSCEL Study Group. Effect of Once-Weekly Exenatide on Clinical Outcomes According to Baseline Risk in Patients With Type 2 Diabetes Mellitus: Insights From the EXSCEL Trial. J Am Heart Assoc. 2018 Oct 2;7(19):e009304. doi: 10.1161/JAHA.118.009304. Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Am J Manag Care. 2018 Apr;24(8 Suppl):S146-S155. Holman RR, Bethel MA, Mentz RJ, Thompson VP, Lokhnygina Y, Buse JB, Chan JC, Choi J, Gustavson SM, Iqbal N, Maggioni AP, Marso SP, Ohman P, Pagidipati NJ, Poulter N, Ramachandran A, Zinman B, Hernandez AF; EXSCEL Study Group. Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2017 Sep 28;377(13):1228-1239. doi: 10.1056/NEJMoa1612917. Epub 2017 Sep 14. Mentz RJ, Bethel MA, Gustavson S, Thompson VP, Pagidipati NJ, Buse JB, Chan JC, Iqbal N, Maggioni AP, Marso SP, Ohman P, Poulter N, Ramachandran A, Zinman B, Hernandez AF, Holman RR. Baseline characteristics of patients enrolled in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL). Am Heart J. 2017 May;187:1-9. doi: 10.1016/j.ahj.2017.02.005. Epub 2017 Feb 12. Holman RR, Bethel MA, George J, Sourij H, Doran Z, Keenan J, Khurmi NS, Mentz RJ, Oulhaj A, Buse JB, Chan JC, Iqbal N, Kundu S, Maggioni AP, Marso SP, Ohman P, Pencina MJ, Poulter N, Porter LE, Ramachandran A, Zinman B, Hernandez AF. Rationale and design of the EXenatide Study of Cardiovascular Event Lowering (EXSCEL) trial. Am Heart J. 2016 Apr;174:103-10. doi: 10.1016/j.ahj.2015.12.009. Epub 2015 Dec 21. Gaebler JA, Soto-Campos G, Alperin P, Cohen M, Blickensderfer A, Wintle M, Maggs D, Hoogwerf B, Han J, Pencek R, Peskin B. Health and economic outcomes for exenatide once weekly, insulin, and pioglitazone therapies in the treatment of type 2 diabetes: a simulation analysis. Vasc Health Risk Manag. 2012;8:255-64. doi: 10.2147/VHRM.S28744. Epub 2012 Apr 23.
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Public notes
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Contacts
Principal investigator
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Stephanie Gustavson, PhD
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AstraZeneca
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Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/38/NCT01144338/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/38/NCT01144338/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01144338
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