Trial Review

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

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01147250




Registration number
NCT01147250
Ethics application status
Date submitted
17/06/2010
Date registered
22/06/2010
Date last updated
20/12/2016

Titles & IDs
Public title
Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide)
Scientific title
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate Cardiovascular Outcomes During Treatment With Lixisenatide in Type 2 Diabetic Patients After an Acute Coronary Syndrome
Secondary ID [1] 0 0
2009-012852-26
Secondary ID [2] 0 0
EFC11319
Universal Trial Number (UTN)
Trial acronym
ELIXA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
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 - Lixisenatide (AVE0010)
Treatment: Drugs - Placebo

Placebo Comparator: Placebo - Placebo matched to lixisenatide once daily (QD) up to end of treatment.

Experimental: Lixisenatide - Lixisenatide 10 mcg QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment.


Treatment: Drugs: Lixisenatide (AVE0010)
Pharmaceutical form: Sterile aqueous solution; Route of administration: Subcutaneous within 1-hour before breakfast using self-injector pen device (Opticlik®). If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 15 or 10 mcg.

Treatment: Drugs: Placebo
Pharmaceutical form: Sterile aqueous solution; Route of administration: Subcutaneous within 1-hour before breakfast.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to First Occurence of Primary CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke or Hospitalization for Unstable Angina
Timepoint [1] 0 0
From randomization up to the end of study (median follow-up of 25 months)
Secondary outcome [1] 0 0
Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina or Hospitalization For Heart Failure
Timepoint [1] 0 0
From randomization up to the end of study (median follow-up of 25 months)
Secondary outcome [2] 0 0
Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina, Hospitalization For Heart Failure or Coronary Revascularization Procedure
Timepoint [2] 0 0
From randomization up to the end of study (median follow-up of 25 months)
Secondary outcome [3] 0 0
Percent Change From Baseline in the Urinary Albumin/Creatinine Ratio (UACR) at Week 108
Timepoint [3] 0 0
Baseline to Week 108 (LOCF)

Eligibility
Key inclusion criteria
Inclusion criteria:

- Men and women who experienced a spontaneous ACS event (i.e., ST-segment elevation
myocardial infarction (STEMI) or non-ST-segment elevation MI (NSTEMI) or unstable
angina) with a documented elevation above the normal reference range of a cardiac
biomarker (Troponin or Creatinine Kinase (CK)-MB) and the clinical presentation
consistent with an ACS which lead to admission to an acute care facility, within 180
days following the ACS event and prior to screening.

- Participants with a history of type 2 diabetes (for participants newly diagnosed,
diagnosis was based on the World Health Organization (WHO) criteria: i.e., either a
fasting venous plasma glucose concentration = 7.0 mmol/L [126 mg/dL] or 2-hour post
glucose load venous plasma glucose = 11.1 mmol/L [200 mg/dL], confirmed on 2
occasions) prior to the screening visit.
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- Type 1 diabetes mellitus or history of ketoacidosis within 6 months prior to
screening.

- Glycosylated hemoglobin (HbA1c) <5.5 % or >11% measured at screening visit.

- Required to use incretin-based agents (e.g., Glucagon-like peptide -1 (GLP-1) agonists
or Dipeptidyl Peptidase-4 (DPP-4) inhibitors) other than the study drug during the
double-blind treatment period.

- Participants who had undergone coronary artery bypass graft (CABG) surgery following
the qualifying ACS event.

- Participants who had undergone percutaneous coronary intervention (PCI) within 15 days
prior to screening.

- Participants with planned revascularization procedure (PCI or CABG) or coronary
angiogram within 90 days after screening visit.

- History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy,
stomach/gastric surgery, inflammatory bowel disease, personal or family history of
medullary thyroid cancer (MTC), or genetic conditions that predisposes to MTC (e.g.,
multiple endocrine neoplasia syndromes).

- Any clinically significant abnormality identified at the time of screening that in the
judgment of the Investigator or any sub-Investigator would preclude safe completion of
the study or constrain endpoints assessment such as major systemic diseases.

The above information is not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial.

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 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
1/06/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2015
Sample size
Target
Accrual to date
Final
6068
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 036015 - Epping
Recruitment hospital [2] 0 0
Investigational Site Number 036001 - Fremantle
Recruitment hospital [3] 0 0
Investigational Site Number 036009 - Geelong
Recruitment hospital [4] 0 0
Investigational Site Number 036011 - Perth
Recruitment hospital [5] 0 0
Investigational Site Number 036005 - St Leonards
Recruitment hospital [6] 0 0
Investigational Site Number 036016 - Townsville
Recruitment postcode(s) [1] 0 0
3076 - Epping
Recruitment postcode(s) [2] 0 0
6160 - Fremantle
Recruitment postcode(s) [3] 0 0
3220 - Geelong
Recruitment postcode(s) [4] 0 0
6000 - Perth
Recruitment postcode(s) [5] 0 0
2065 - St Leonards
Recruitment postcode(s) [6] 0 0
4810 - Townsville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Idaho
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Indiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Kentucky
Country [14] 0 0
United States of America
State/province [14] 0 0
Louisiana
Country [15] 0 0
United States of America
State/province [15] 0 0
Maryland
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Minnesota
Country [18] 0 0
United States of America
State/province [18] 0 0
Mississippi
Country [19] 0 0
United States of America
State/province [19] 0 0
Missouri
Country [20] 0 0
United States of America
State/province [20] 0 0
Montana
Country [21] 0 0
United States of America
State/province [21] 0 0
Nebraska
Country [22] 0 0
United States of America
State/province [22] 0 0
Nevada
Country [23] 0 0
United States of America
State/province [23] 0 0
New Jersey
Country [24] 0 0
United States of America
State/province [24] 0 0
New York
Country [25] 0 0
United States of America
State/province [25] 0 0
North Carolina
Country [26] 0 0
United States of America
State/province [26] 0 0
Ohio
Country [27] 0 0
United States of America
State/province [27] 0 0
Oregon
Country [28] 0 0
United States of America
State/province [28] 0 0
Pennsylvania
Country [29] 0 0
United States of America
State/province [29] 0 0
Rhode Island
Country [30] 0 0
United States of America
State/province [30] 0 0
South Carolina
Country [31] 0 0
United States of America
State/province [31] 0 0
South Dakota
Country [32] 0 0
United States of America
State/province [32] 0 0
Tennessee
Country [33] 0 0
United States of America
State/province [33] 0 0
Texas
Country [34] 0 0
United States of America
State/province [34] 0 0
Utah
Country [35] 0 0
United States of America
State/province [35] 0 0
Virginia
Country [36] 0 0
United States of America
State/province [36] 0 0
Washington
Country [37] 0 0
United States of America
State/province [37] 0 0
Wisconsin
Country [38] 0 0
Argentina
State/province [38] 0 0
Adrogue
Country [39] 0 0
Argentina
State/province [39] 0 0
Bahia Blanca
Country [40] 0 0
Argentina
State/province [40] 0 0
Caba
Country [41] 0 0
Argentina
State/province [41] 0 0
Capital Federal
Country [42] 0 0
Argentina
State/province [42] 0 0
Cipolletti
Country [43] 0 0
Argentina
State/province [43] 0 0
Ciudad Autonoma De Bs.As
Country [44] 0 0
Argentina
State/province [44] 0 0
Cordoba
Country [45] 0 0
Argentina
State/province [45] 0 0
Coronel Suarez
Country [46] 0 0
Argentina
State/province [46] 0 0
Corrientes
Country [47] 0 0
Argentina
State/province [47] 0 0
Córdoba
Country [48] 0 0
Argentina
State/province [48] 0 0
Godoy Cruz
Country [49] 0 0
Argentina
State/province [49] 0 0
Haedo
Country [50] 0 0
Argentina
State/province [50] 0 0
Junin
Country [51] 0 0
Argentina
State/province [51] 0 0
La Plata
Country [52] 0 0
Argentina
State/province [52] 0 0
Lanus
Country [53] 0 0
Argentina
State/province [53] 0 0
Mar Del Plata
Country [54] 0 0
Argentina
State/province [54] 0 0
Mendoza
Country [55] 0 0
Argentina
State/province [55] 0 0
Moron
Country [56] 0 0
Argentina
State/province [56] 0 0
Parana
Country [57] 0 0
Argentina
State/province [57] 0 0
Qilmes
Country [58] 0 0
Argentina
State/province [58] 0 0
Rafaela
Country [59] 0 0
Argentina
State/province [59] 0 0
Ramos Mejia
Country [60] 0 0
Argentina
State/province [60] 0 0
Resistencia
Country [61] 0 0
Argentina
State/province [61] 0 0
Rosario
Country [62] 0 0
Argentina
State/province [62] 0 0
Salta
Country [63] 0 0
Argentina
State/province [63] 0 0
San Miguel De Tucuman
Country [64] 0 0
Argentina
State/province [64] 0 0
San Nicolas
Country [65] 0 0
Argentina
State/province [65] 0 0
Santa Fe
Country [66] 0 0
Argentina
State/province [66] 0 0
Santa Rosa
Country [67] 0 0
Argentina
State/province [67] 0 0
Venado Tuerto
Country [68] 0 0
Argentina
State/province [68] 0 0
Villa Maria
Country [69] 0 0
Argentina
State/province [69] 0 0
Zarate
Country [70] 0 0
Austria
State/province [70] 0 0
Graz
Country [71] 0 0
Austria
State/province [71] 0 0
Wien
Country [72] 0 0
Belarus
State/province [72] 0 0
Minsk
Country [73] 0 0
Belgium
State/province [73] 0 0
Bruxelles
Country [74] 0 0
Belgium
State/province [74] 0 0
Leuven
Country [75] 0 0
Brazil
State/province [75] 0 0
Belem
Country [76] 0 0
Brazil
State/province [76] 0 0
Belo Horizonte
Country [77] 0 0
Brazil
State/province [77] 0 0
Brasilia
Country [78] 0 0
Brazil
State/province [78] 0 0
Campinas
Country [79] 0 0
Brazil
State/province [79] 0 0
Curitiba
Country [80] 0 0
Brazil
State/province [80] 0 0
Fortaleza
Country [81] 0 0
Brazil
State/province [81] 0 0
Goiania
Country [82] 0 0
Brazil
State/province [82] 0 0
Marilia
Country [83] 0 0
Brazil
State/province [83] 0 0
Passo Fundo
Country [84] 0 0
Brazil
State/province [84] 0 0
Porto Alegre
Country [85] 0 0
Brazil
State/province [85] 0 0
Recife
Country [86] 0 0
Brazil
State/province [86] 0 0
Salvador
Country [87] 0 0
Brazil
State/province [87] 0 0
Sao Paulo
Country [88] 0 0
Brazil
State/province [88] 0 0
Uberlandia
Country [89] 0 0
Bulgaria
State/province [89] 0 0
Byala
Country [90] 0 0
Bulgaria
State/province [90] 0 0
Gabrovo
Country [91] 0 0
Bulgaria
State/province [91] 0 0
Kazanluk
Country [92] 0 0
Bulgaria
State/province [92] 0 0
Lovech
Country [93] 0 0
Bulgaria
State/province [93] 0 0
Pleven
Country [94] 0 0
Bulgaria
State/province [94] 0 0
Plovdiv
Country [95] 0 0
Bulgaria
State/province [95] 0 0
Sandanski
Country [96] 0 0
Bulgaria
State/province [96] 0 0
Sofia
Country [97] 0 0
Bulgaria
State/province [97] 0 0
Varna
Country [98] 0 0
Canada
State/province [98] 0 0
Calgary
Country [99] 0 0
Canada
State/province [99] 0 0
Cambridge
Country [100] 0 0
Canada
State/province [100] 0 0
Edmonton
Country [101] 0 0
Canada
State/province [101] 0 0
Laval
Country [102] 0 0
Canada
State/province [102] 0 0
Montreal
Country [103] 0 0
Canada
State/province [103] 0 0
Oshawa
Country [104] 0 0
Canada
State/province [104] 0 0
Quebec
Country [105] 0 0
Canada
State/province [105] 0 0
Red Deer
Country [106] 0 0
Canada
State/province [106] 0 0
Sarnia
Country [107] 0 0
Canada
State/province [107] 0 0
St-Marc-Des-Carrieres
Country [108] 0 0
Canada
State/province [108] 0 0
Sudbury
Country [109] 0 0
Canada
State/province [109] 0 0
Thetford Mines
Country [110] 0 0
Chile
State/province [110] 0 0
Antofagasta
Country [111] 0 0
Chile
State/province [111] 0 0
Concepcion
Country [112] 0 0
Chile
State/province [112] 0 0
Osorno
Country [113] 0 0
Chile
State/province [113] 0 0
Puerto Montt
Country [114] 0 0
Chile
State/province [114] 0 0
Punta Arenas
Country [115] 0 0
Chile
State/province [115] 0 0
San Felipe
Country [116] 0 0
Chile
State/province [116] 0 0
Santiago
Country [117] 0 0
Chile
State/province [117] 0 0
Talca
Country [118] 0 0
Chile
State/province [118] 0 0
Temuco
Country [119] 0 0
Chile
State/province [119] 0 0
Valdivia
Country [120] 0 0
Chile
State/province [120] 0 0
Valparaíso
Country [121] 0 0
Chile
State/province [121] 0 0
Vina Del Mar
Country [122] 0 0
Chile
State/province [122] 0 0
Viña Del Mar
Country [123] 0 0
China
State/province [123] 0 0
Beijing
Country [124] 0 0
China
State/province [124] 0 0
Dalian
Country [125] 0 0
China
State/province [125] 0 0
Guangzhou
Country [126] 0 0
China
State/province [126] 0 0
Jinan
Country [127] 0 0
China
State/province [127] 0 0
Nanjing
Country [128] 0 0
China
State/province [128] 0 0
Shanghai
Country [129] 0 0
China
State/province [129] 0 0
Shenyang
Country [130] 0 0
China
State/province [130] 0 0
Suzhou
Country [131] 0 0
China
State/province [131] 0 0
Urumchi
Country [132] 0 0
Colombia
State/province [132] 0 0
Armenia
Country [133] 0 0
Colombia
State/province [133] 0 0
Barranquilla
Country [134] 0 0
Colombia
State/province [134] 0 0
Bogota
Country [135] 0 0
Colombia
State/province [135] 0 0
Bucaramanga
Country [136] 0 0
Colombia
State/province [136] 0 0
Cali
Country [137] 0 0
Colombia
State/province [137] 0 0
Cartagena
Country [138] 0 0
Colombia
State/province [138] 0 0
Espinal - Tolima
Country [139] 0 0
Colombia
State/province [139] 0 0
Floridablanca
Country [140] 0 0
Colombia
State/province [140] 0 0
Manizales
Country [141] 0 0
Colombia
State/province [141] 0 0
Medellin
Country [142] 0 0
Colombia
State/province [142] 0 0
Pereira
Country [143] 0 0
Denmark
State/province [143] 0 0
Aarhus C
Country [144] 0 0
Denmark
State/province [144] 0 0
Aarhus
Country [145] 0 0
Denmark
State/province [145] 0 0
Esbjerg
Country [146] 0 0
Denmark
State/province [146] 0 0
Farsø
Country [147] 0 0
Denmark
State/province [147] 0 0
Hellerup
Country [148] 0 0
Denmark
State/province [148] 0 0
Herlev
Country [149] 0 0
Denmark
State/province [149] 0 0
Hillerød
Country [150] 0 0
Denmark
State/province [150] 0 0
Hvidovre
Country [151] 0 0
Denmark
State/province [151] 0 0
København Nv
Country [152] 0 0
Denmark
State/province [152] 0 0
København S
Country [153] 0 0
Denmark
State/province [153] 0 0
København Ø
Country [154] 0 0
Ecuador
State/province [154] 0 0
Guayaquil
Country [155] 0 0
Ecuador
State/province [155] 0 0
Quito
Country [156] 0 0
Egypt
State/province [156] 0 0
Alexandria
Country [157] 0 0
Egypt
State/province [157] 0 0
Cairo
Country [158] 0 0
Estonia
State/province [158] 0 0
Tallinn
Country [159] 0 0
Estonia
State/province [159] 0 0
Tartu
Country [160] 0 0
Estonia
State/province [160] 0 0
Viljandimaa
Country [161] 0 0
Finland
State/province [161] 0 0
Jyväskylä
Country [162] 0 0
Finland
State/province [162] 0 0
Rauma
Country [163] 0 0
Finland
State/province [163] 0 0
Tampere
Country [164] 0 0
Finland
State/province [164] 0 0
Turku
Country [165] 0 0
Finland
State/province [165] 0 0
Valkeakoski
Country [166] 0 0
Finland
State/province [166] 0 0
Vantaa
Country [167] 0 0
France
State/province [167] 0 0
Brest Cedex
Country [168] 0 0
France
State/province [168] 0 0
Corbeil Essonnes
Country [169] 0 0
France
State/province [169] 0 0
Nantes
Country [170] 0 0
France
State/province [170] 0 0
Nimes
Country [171] 0 0
France
State/province [171] 0 0
Paris Cedex 15
Country [172] 0 0
France
State/province [172] 0 0
Pessac
Country [173] 0 0
France
State/province [173] 0 0
Poitiers Cedex
Country [174] 0 0
France
State/province [174] 0 0
Rennes
Country [175] 0 0
France
State/province [175] 0 0
Toulouse Cedex 4
Country [176] 0 0
Georgia
State/province [176] 0 0
Batumi
Country [177] 0 0
Georgia
State/province [177] 0 0
Kutaisi
Country [178] 0 0
Georgia
State/province [178] 0 0
Tbilisi
Country [179] 0 0
Germany
State/province [179] 0 0
Berlin
Country [180] 0 0
Germany
State/province [180] 0 0
Bochum
Country [181] 0 0
Germany
State/province [181] 0 0
Chemnitz
Country [182] 0 0
Germany
State/province [182] 0 0
Dresden
Country [183] 0 0
Germany
State/province [183] 0 0
Elsterwerda
Country [184] 0 0
Germany
State/province [184] 0 0
Frankfurt A.M.
Country [185] 0 0
Germany
State/province [185] 0 0
Frankfurt Am Main
Country [186] 0 0
Germany
State/province [186] 0 0
Görlitz
Country [187] 0 0
Germany
State/province [187] 0 0
Haßloch
Country [188] 0 0
Germany
State/province [188] 0 0
Heidelberg
Country [189] 0 0
Germany
State/province [189] 0 0
Leipzig
Country [190] 0 0
Germany
State/province [190] 0 0
Magdeburg
Country [191] 0 0
Germany
State/province [191] 0 0
Mühldorf Am Inn
Country [192] 0 0
Germany
State/province [192] 0 0
Pirna
Country [193] 0 0
Germany
State/province [193] 0 0
Pohlheim
Country [194] 0 0
Germany
State/province [194] 0 0
Rotenburg An Der Fulda
Country [195] 0 0
Guatemala
State/province [195] 0 0
Guatemala
Country [196] 0 0
Guatemala
State/province [196] 0 0
Quetzaltenango
Country [197] 0 0
India
State/province [197] 0 0
Ahmedabad
Country [198] 0 0
India
State/province [198] 0 0
Bangalore
Country [199] 0 0
India
State/province [199] 0 0
Belgaum
Country [200] 0 0
India
State/province [200] 0 0
Chandigarh
Country [201] 0 0
India
State/province [201] 0 0
Cochin
Country [202] 0 0
India
State/province [202] 0 0
Gurgaon
Country [203] 0 0
India
State/province [203] 0 0
Hubli
Country [204] 0 0
India
State/province [204] 0 0
Hyderabad
Country [205] 0 0
India
State/province [205] 0 0
Jaipur
Country [206] 0 0
India
State/province [206] 0 0
Kolkata
Country [207] 0 0
India
State/province [207] 0 0
Lucknow
Country [208] 0 0
India
State/province [208] 0 0
Ludhiana
Country [209] 0 0
India
State/province [209] 0 0
Madurai
Country [210] 0 0
India
State/province [210] 0 0
Mangalore
Country [211] 0 0
India
State/province [211] 0 0
Manipal
Country [212] 0 0
India
State/province [212] 0 0
Mysore
Country [213] 0 0
India
State/province [213] 0 0
Nagpur
Country [214] 0 0
India
State/province [214] 0 0
Nashik
Country [215] 0 0
India
State/province [215] 0 0
Nasik
Country [216] 0 0
India
State/province [216] 0 0
New Delhi
Country [217] 0 0
India
State/province [217] 0 0
Pune
Country [218] 0 0
Israel
State/province [218] 0 0
Afula
Country [219] 0 0
Israel
State/province [219] 0 0
Givatayim
Country [220] 0 0
Israel
State/province [220] 0 0
Haifa
Country [221] 0 0
Israel
State/province [221] 0 0
Holon
Country [222] 0 0
Israel
State/province [222] 0 0
Jerusalem
Country [223] 0 0
Israel
State/province [223] 0 0
Nahariya
Country [224] 0 0
Israel
State/province [224] 0 0
Safed
Country [225] 0 0
Israel
State/province [225] 0 0
Tel Aviv
Country [226] 0 0
Israel
State/province [226] 0 0
Tel Hashomer
Country [227] 0 0
Israel
State/province [227] 0 0
Tzrifin
Country [228] 0 0
Italy
State/province [228] 0 0
Carpi
Country [229] 0 0
Italy
State/province [229] 0 0
Chieri
Country [230] 0 0
Italy
State/province [230] 0 0
Chieti
Country [231] 0 0
Italy
State/province [231] 0 0
Fermo
Country [232] 0 0
Italy
State/province [232] 0 0
Firenze
Country [233] 0 0
Italy
State/province [233] 0 0
Genova
Country [234] 0 0
Italy
State/province [234] 0 0
Messina
Country [235] 0 0
Italy
State/province [235] 0 0
Milano
Country [236] 0 0
Italy
State/province [236] 0 0
Napoli
Country [237] 0 0
Italy
State/province [237] 0 0
Novara
Country [238] 0 0
Italy
State/province [238] 0 0
Palermo
Country [239] 0 0
Italy
State/province [239] 0 0
Pisa
Country [240] 0 0
Italy
State/province [240] 0 0
Roma
Country [241] 0 0
Italy
State/province [241] 0 0
Rozzano
Country [242] 0 0
Japan
State/province [242] 0 0
Chuo-Ku
Country [243] 0 0
Japan
State/province [243] 0 0
Fuchu-Shi
Country [244] 0 0
Japan
State/province [244] 0 0
Fujisawa-Shi
Country [245] 0 0
Japan
State/province [245] 0 0
Hachioji-Shi
Country [246] 0 0
Japan
State/province [246] 0 0
Hakusan-Shi
Country [247] 0 0
Japan
State/province [247] 0 0
Hamamatsu-Shi
Country [248] 0 0
Japan
State/province [248] 0 0
Hitachi-Shi
Country [249] 0 0
Japan
State/province [249] 0 0
Itabashi-Ku
Country [250] 0 0
Japan
State/province [250] 0 0
Kawanishi-Shi
Country [251] 0 0
Japan
State/province [251] 0 0
Kobe-Shi
Country [252] 0 0
Japan
State/province [252] 0 0
Matsuyama-Shi
Country [253] 0 0
Japan
State/province [253] 0 0
Nagasaki-Shi
Country [254] 0 0
Japan
State/province [254] 0 0
Noda-Shi
Country [255] 0 0
Japan
State/province [255] 0 0
Osaka-Shi
Country [256] 0 0
Japan
State/province [256] 0 0
Sapporo-Shi
Country [257] 0 0
Japan
State/province [257] 0 0
Setagaya-Ku
Country [258] 0 0
Japan
State/province [258] 0 0
Shinagawa-Ku
Country [259] 0 0
Japan
State/province [259] 0 0
Shirakawa-Shi
Country [260] 0 0
Japan
State/province [260] 0 0
Suita-Shi
Country [261] 0 0
Japan
State/province [261] 0 0
Tachikawa-Shi
Country [262] 0 0
Japan
State/province [262] 0 0
Takasaki-Shi
Country [263] 0 0
Korea, Republic of
State/province [263] 0 0
Bucheon
Country [264] 0 0
Korea, Republic of
State/province [264] 0 0
Daegu
Country [265] 0 0
Korea, Republic of
State/province [265] 0 0
Gwangju
Country [266] 0 0
Korea, Republic of
State/province [266] 0 0
Incheon
Country [267] 0 0
Korea, Republic of
State/province [267] 0 0
Seongnam
Country [268] 0 0
Korea, Republic of
State/province [268] 0 0
Seoul
Country [269] 0 0
Korea, Republic of
State/province [269] 0 0
Wonju
Country [270] 0 0
Latvia
State/province [270] 0 0
Cesis
Country [271] 0 0
Latvia
State/province [271] 0 0
Daugavpils
Country [272] 0 0
Latvia
State/province [272] 0 0
Liepaja
Country [273] 0 0
Latvia
State/province [273] 0 0
Riga
Country [274] 0 0
Latvia
State/province [274] 0 0
Sigulda
Country [275] 0 0
Lithuania
State/province [275] 0 0
Kaunas
Country [276] 0 0
Lithuania
State/province [276] 0 0
Klaipeda
Country [277] 0 0
Lithuania
State/province [277] 0 0
Panevezys
Country [278] 0 0
Lithuania
State/province [278] 0 0
Vilnius
Country [279] 0 0
Mexico
State/province [279] 0 0
Acapulco
Country [280] 0 0
Mexico
State/province [280] 0 0
Aguascalientes
Country [281] 0 0
Mexico
State/province [281] 0 0
Chihuahua
Country [282] 0 0
Mexico
State/province [282] 0 0
Ciudad Madero
Country [283] 0 0
Mexico
State/province [283] 0 0
Durango
Country [284] 0 0
Mexico
State/province [284] 0 0
Guadalajara
Country [285] 0 0
Mexico
State/province [285] 0 0
Leon
Country [286] 0 0
Mexico
State/province [286] 0 0
Mexico City
Country [287] 0 0
Mexico
State/province [287] 0 0
Monterrey
Country [288] 0 0
Mexico
State/province [288] 0 0
Morelia
Country [289] 0 0
Mexico
State/province [289] 0 0
San Luis Potosi
Country [290] 0 0
Mexico
State/province [290] 0 0
Tlalnepantla
Country [291] 0 0
Mexico
State/province [291] 0 0
Xalapa
Country [292] 0 0
Netherlands
State/province [292] 0 0
Alkmaar
Country [293] 0 0
Netherlands
State/province [293] 0 0
Den Haag
Country [294] 0 0
Netherlands
State/province [294] 0 0
Deventer
Country [295] 0 0
Netherlands
State/province [295] 0 0
Hoorn
Country [296] 0 0
Netherlands
State/province [296] 0 0
Rotterdam
Country [297] 0 0
Netherlands
State/province [297] 0 0
Tilburg
Country [298] 0 0
Netherlands
State/province [298] 0 0
Venlo
Country [299] 0 0
Norway
State/province [299] 0 0
Bodø
Country [300] 0 0
Norway
State/province [300] 0 0
Haugesund
Country [301] 0 0
Norway
State/province [301] 0 0
Stavanger
Country [302] 0 0
Panama
State/province [302] 0 0
Cuidad De Panama
Country [303] 0 0
Panama
State/province [303] 0 0
La Chorrera
Country [304] 0 0
Panama
State/province [304] 0 0
Penonome
Country [305] 0 0
Peru
State/province [305] 0 0
Arequipa
Country [306] 0 0
Peru
State/province [306] 0 0
Callao
Country [307] 0 0
Peru
State/province [307] 0 0
Lima
Country [308] 0 0
Philippines
State/province [308] 0 0
Cavite
Country [309] 0 0
Philippines
State/province [309] 0 0
Iligan City, Lanao Del Norte
Country [310] 0 0
Philippines
State/province [310] 0 0
Makati City
Country [311] 0 0
Philippines
State/province [311] 0 0
Manila
Country [312] 0 0
Philippines
State/province [312] 0 0
Marikina City
Country [313] 0 0
Philippines
State/province [313] 0 0
Pasay City
Country [314] 0 0
Philippines
State/province [314] 0 0
Quezon City
Country [315] 0 0
Poland
State/province [315] 0 0
?ód?
Country [316] 0 0
Poland
State/province [316] 0 0
Bialystok
Country [317] 0 0
Poland
State/province [317] 0 0
Bydgoszcz
Country [318] 0 0
Poland
State/province [318] 0 0
Czeladz
Country [319] 0 0
Poland
State/province [319] 0 0
Czestochowa
Country [320] 0 0
Poland
State/province [320] 0 0
Gdynia
Country [321] 0 0
Poland
State/province [321] 0 0
Gliwice
Country [322] 0 0
Poland
State/province [322] 0 0
Grodzisk Mazowiecki
Country [323] 0 0
Poland
State/province [323] 0 0
Katowice
Country [324] 0 0
Poland
State/province [324] 0 0
Krakow
Country [325] 0 0
Poland
State/province [325] 0 0
Leczyca
Country [326] 0 0
Poland
State/province [326] 0 0
Poland
Country [327] 0 0
Poland
State/province [327] 0 0
Pulawy
Country [328] 0 0
Poland
State/province [328] 0 0
Ruda Slaska
Country [329] 0 0
Poland
State/province [329] 0 0
Szczecin
Country [330] 0 0
Poland
State/province [330] 0 0
Warszawa
Country [331] 0 0
Poland
State/province [331] 0 0
Wroclaw
Country [332] 0 0
Poland
State/province [332] 0 0
Zgierz
Country [333] 0 0
Portugal
State/province [333] 0 0
Amadora
Country [334] 0 0
Portugal
State/province [334] 0 0
Coimbra
Country [335] 0 0
Portugal
State/province [335] 0 0
Lisboa
Country [336] 0 0
Portugal
State/province [336] 0 0
Penafiel
Country [337] 0 0
Portugal
State/province [337] 0 0
Porto
Country [338] 0 0
Romania
State/province [338] 0 0
Arad
Country [339] 0 0
Romania
State/province [339] 0 0
Baia Mare
Country [340] 0 0
Romania
State/province [340] 0 0
Braila
Country [341] 0 0
Romania
State/province [341] 0 0
Brasov
Country [342] 0 0
Romania
State/province [342] 0 0
Bucharest
Country [343] 0 0
Romania
State/province [343] 0 0
Bucuresti
Country [344] 0 0
Romania
State/province [344] 0 0
Cluj Napoca
Country [345] 0 0
Romania
State/province [345] 0 0
Craiova
Country [346] 0 0
Romania
State/province [346] 0 0
Deva
Country [347] 0 0
Romania
State/province [347] 0 0
Iasi
Country [348] 0 0
Romania
State/province [348] 0 0
Oradea
Country [349] 0 0
Romania
State/province [349] 0 0
Pitesti
Country [350] 0 0
Romania
State/province [350] 0 0
Ploiesti
Country [351] 0 0
Romania
State/province [351] 0 0
Suceava
Country [352] 0 0
Romania
State/province [352] 0 0
Targu Mures
Country [353] 0 0
Romania
State/province [353] 0 0
Timisoara
Country [354] 0 0
Russian Federation
State/province [354] 0 0
Barnaul
Country [355] 0 0
Russian Federation
State/province [355] 0 0
Kazan
Country [356] 0 0
Russian Federation
State/province [356] 0 0
Kemerovo
Country [357] 0 0
Russian Federation
State/province [357] 0 0
Krasnodar
Country [358] 0 0
Russian Federation
State/province [358] 0 0
Moscow
Country [359] 0 0
Russian Federation
State/province [359] 0 0
Nizhny Novgorod
Country [360] 0 0
Russian Federation
State/province [360] 0 0
Novosibirsk
Country [361] 0 0
Russian Federation
State/province [361] 0 0
Omsk
Country [362] 0 0
Russian Federation
State/province [362] 0 0
Penza
Country [363] 0 0
Russian Federation
State/province [363] 0 0
Perm
Country [364] 0 0
Russian Federation
State/province [364] 0 0
Rostov-Na-Donu
Country [365] 0 0
Russian Federation
State/province [365] 0 0
Ryazan
Country [366] 0 0
Russian Federation
State/province [366] 0 0
Saint-Petersburg
Country [367] 0 0
Russian Federation
State/province [367] 0 0
Saratov
Country [368] 0 0
Russian Federation
State/province [368] 0 0
Smolensk
Country [369] 0 0
Russian Federation
State/province [369] 0 0
St-Petersburg
Country [370] 0 0
Russian Federation
State/province [370] 0 0
Tomsk
Country [371] 0 0
Russian Federation
State/province [371] 0 0
Tver
Country [372] 0 0
Russian Federation
State/province [372] 0 0
Tyumen
Country [373] 0 0
Russian Federation
State/province [373] 0 0
Vladimir
Country [374] 0 0
Russian Federation
State/province [374] 0 0
Voronezh
Country [375] 0 0
Russian Federation
State/province [375] 0 0
Yaroslavl
Country [376] 0 0
Serbia
State/province [376] 0 0
Belgrade
Country [377] 0 0
Serbia
State/province [377] 0 0
Nis
Country [378] 0 0
South Africa
State/province [378] 0 0
Alberton
Country [379] 0 0
South Africa
State/province [379] 0 0
Cape Town
Country [380] 0 0
South Africa
State/province [380] 0 0
Chatsworth
Country [381] 0 0
South Africa
State/province [381] 0 0
Durban
Country [382] 0 0
South Africa
State/province [382] 0 0
George
Country [383] 0 0
South Africa
State/province [383] 0 0
Kempton Park
Country [384] 0 0
South Africa
State/province [384] 0 0
Paarl
Country [385] 0 0
South Africa
State/province [385] 0 0
Parow
Country [386] 0 0
South Africa
State/province [386] 0 0
Pretoria
Country [387] 0 0
South Africa
State/province [387] 0 0
Richards Bay
Country [388] 0 0
South Africa
State/province [388] 0 0
Somerset West
Country [389] 0 0
South Africa
State/province [389] 0 0
Worcester
Country [390] 0 0
Spain
State/province [390] 0 0
Alcalá De Henares
Country [391] 0 0
Spain
State/province [391] 0 0
Almería
Country [392] 0 0
Spain
State/province [392] 0 0
Barakaldo
Country [393] 0 0
Spain
State/province [393] 0 0
Barcelona
Country [394] 0 0
Spain
State/province [394] 0 0
Bilbao
Country [395] 0 0
Spain
State/province [395] 0 0
Cáceres
Country [396] 0 0
Spain
State/province [396] 0 0
La Coruña
Country [397] 0 0
Spain
State/province [397] 0 0
Lérida
Country [398] 0 0
Spain
State/province [398] 0 0
Madrid
Country [399] 0 0
Spain
State/province [399] 0 0
Murcia
Country [400] 0 0
Spain
State/province [400] 0 0
Oviedo
Country [401] 0 0
Spain
State/province [401] 0 0
Pontevedra
Country [402] 0 0
Spain
State/province [402] 0 0
Sevilla
Country [403] 0 0
Spain
State/province [403] 0 0
Valencia
Country [404] 0 0
Spain
State/province [404] 0 0
Vigo
Country [405] 0 0
Sweden
State/province [405] 0 0
Karlstad
Country [406] 0 0
Sweden
State/province [406] 0 0
Kristianstad
Country [407] 0 0
Sweden
State/province [407] 0 0
Ljungby
Country [408] 0 0
Sweden
State/province [408] 0 0
Oskarshamn
Country [409] 0 0
Sweden
State/province [409] 0 0
Stockholm
Country [410] 0 0
Sweden
State/province [410] 0 0
Växjö
Country [411] 0 0
Switzerland
State/province [411] 0 0
Lugano
Country [412] 0 0
Taiwan
State/province [412] 0 0
Chia-Yi
Country [413] 0 0
Taiwan
State/province [413] 0 0
Taichung
Country [414] 0 0
Taiwan
State/province [414] 0 0
Tainan Hsien
Country [415] 0 0
Taiwan
State/province [415] 0 0
Taipei 111
Country [416] 0 0
Taiwan
State/province [416] 0 0
Taipei Hsien
Country [417] 0 0
Taiwan
State/province [417] 0 0
Taipei
Country [418] 0 0
Tunisia
State/province [418] 0 0
Sfax
Country [419] 0 0
Tunisia
State/province [419] 0 0
Tunis
Country [420] 0 0
Turkey
State/province [420] 0 0
Ankara
Country [421] 0 0
Turkey
State/province [421] 0 0
Capa / Istanbul
Country [422] 0 0
Turkey
State/province [422] 0 0
Istanbul
Country [423] 0 0
Turkey
State/province [423] 0 0
Izmir
Country [424] 0 0
Turkey
State/province [424] 0 0
Mersin
Country [425] 0 0
Turkey
State/province [425] 0 0
Samsun
Country [426] 0 0
Ukraine
State/province [426] 0 0
Chernivtsi
Country [427] 0 0
Ukraine
State/province [427] 0 0
Dnepropetrovsk
Country [428] 0 0
Ukraine
State/province [428] 0 0
Dnipropetrovsk
Country [429] 0 0
Ukraine
State/province [429] 0 0
Kharkiv
Country [430] 0 0
Ukraine
State/province [430] 0 0
Kharkov
Country [431] 0 0
Ukraine
State/province [431] 0 0
Kiev
Country [432] 0 0
Ukraine
State/province [432] 0 0
Kyiv
Country [433] 0 0
Ukraine
State/province [433] 0 0
Lviv
Country [434] 0 0
Ukraine
State/province [434] 0 0
Odessa
Country [435] 0 0
United Arab Emirates
State/province [435] 0 0
Abu Dhabi
Country [436] 0 0
United Arab Emirates
State/province [436] 0 0
Dubai
Country [437] 0 0
United Kingdom
State/province [437] 0 0
Antrim
Country [438] 0 0
United Kingdom
State/province [438] 0 0
Ashton-Under-Lyne
Country [439] 0 0
United Kingdom
State/province [439] 0 0
Barnstaple
Country [440] 0 0
United Kingdom
State/province [440] 0 0
Bath
Country [441] 0 0
United Kingdom
State/province [441] 0 0
Birmingham
Country [442] 0 0
United Kingdom
State/province [442] 0 0
Bolton
Country [443] 0 0
United Kingdom
State/province [443] 0 0
Bradford
Country [444] 0 0
United Kingdom
State/province [444] 0 0
Carmarthen
Country [445] 0 0
United Kingdom
State/province [445] 0 0
Chester
Country [446] 0 0
United Kingdom
State/province [446] 0 0
Dumfries
Country [447] 0 0
United Kingdom
State/province [447] 0 0
East Kilbride
Country [448] 0 0
United Kingdom
State/province [448] 0 0
Edinburgh
Country [449] 0 0
United Kingdom
State/province [449] 0 0
Glasgow
Country [450] 0 0
United Kingdom
State/province [450] 0 0
Harrogate
Country [451] 0 0
United Kingdom
State/province [451] 0 0
Ipswich
Country [452] 0 0
United Kingdom
State/province [452] 0 0
Larbert
Country [453] 0 0
United Kingdom
State/province [453] 0 0
Liverpool
Country [454] 0 0
United Kingdom
State/province [454] 0 0
Londonderry
Country [455] 0 0
United Kingdom
State/province [455] 0 0
Manchester
Country [456] 0 0
United Kingdom
State/province [456] 0 0
Norwich
Country [457] 0 0
United Kingdom
State/province [457] 0 0
Nuneaton
Country [458] 0 0
United Kingdom
State/province [458] 0 0
Oldham
Country [459] 0 0
United Kingdom
State/province [459] 0 0
Salford
Country [460] 0 0
United Kingdom
State/province [460] 0 0
Stoke-On-Trent
Country [461] 0 0
United Kingdom
State/province [461] 0 0
Swansea
Country [462] 0 0
United Kingdom
State/province [462] 0 0
Taunton
Country [463] 0 0
United Kingdom
State/province [463] 0 0
Truro
Country [464] 0 0
United Kingdom
State/province [464] 0 0
Wolverhampton
Country [465] 0 0
United Kingdom
State/province [465] 0 0
Yeovil

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

Ethics approval
Ethics application status

Summary
Brief summary
Primary Objective:

- To demonstrate that lixisenatide can reduce cardiovascular (CV) morbidity and mortality
(composite endpoint of CV death, non-fatal myocardial infarction (MI), non-fatal stroke,
hospitalization for unstable angina) compared to placebo in type 2 diabetic participants who
recently experienced an acute coronary syndrome (ACS) event.

Secondary Objectives:

To demonstrate that when compared to placebo, lixisenatide can reduce:

- composite endpoint of CV death, non-fatal MI, non-fatal stroke, hospitalization for
unstable angina, or hospitalization for heart failure.

- composite endpoint of CV death, non-fatal MI, non-fatal stroke, hospitalization for
unstable angina, hospitalization for heart failure, or coronary revascularization
procedure.

- urinary albumin excretion (based on the urinary albumin/creatinine ratio).

To assess the safety and tolerability of lixisenatide.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01147250
Trial related presentations / publications
Bentley-Lewis R, Aguilar D, Riddle MC, Claggett B, Diaz R, Dickstein K, Gerstein HC, Johnston P, Kober LV, Lawson F, Lewis EF, Maggioni AP, McMurray JJ, Ping L, Probstfield JL, Solomon SD, Tardif JC, Wu Y, Pfeffer MA; ELIXA Investigators. Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placebo. Am Heart J. 2015 May;169(5):631-638.e7. doi: 10.1016/j.ahj.2015.02.002. Epub 2015 Feb 12.
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
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/NCT01147250