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Completed Phase 3 Interventional Results available

Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide)

ClinicalTrials.gov ID: NCT01147250

Public ClinicalTrials.gov record NCT01147250. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 12:08 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official 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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01147250
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Sanofi
Industry
Enrollment
6,068 participants

Conditions and interventions

Eligibility (public fields only)

Age range
30 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 2010 (Type not available)
Primary completion
Feb 2015 (Actual)
Completion
Feb 2015 (Actual)
Last update posted
Dec 20, 2016

2010 – 2015

United States locations

U.S. sites
200
U.S. states
37
U.S. cities
163
Facility City State ZIP Site status
Investigational Site Number 840415 Birmingham Alabama 35203 —
Investigational Site Number 840307 Foley Alabama 36535 —
Investigational Site Number 840692 Mobile Alabama 36604 —
Investigational Site Number 840037 Mobile Alabama 36608 —
Investigational Site Number 840210 Mobile Alabama 36609 —
Investigational Site Number 840326 Muscle Shoals Alabama 35661 —
Investigational Site Number 840393 Toney Alabama 35773 —
Investigational Site Number 840656 Mesa Arizona 85206 —
Investigational Site Number 840506 Phoenix Arizona 85012 —
Investigational Site Number 840520 Phoenix Arizona 85020 —
Investigational Site Number 840322 Phoenix Arizona 85032 —
Investigational Site Number 840250 Tempe Arizona 85284 —
Investigational Site Number 840042 Tucson Arizona 85723 —
Investigational Site Number 840303 Hot Springs Arkansas 71913 —
Investigational Site Number 840184 Jonesboro Arkansas 72401 —
Investigational Site Number 840361 Little Rock Arkansas 72204 —
Investigational Site Number 840023 Little Rock Arkansas 72205 —
Investigational Site Number 840706 Anaheim California 92801 —
Investigational Site Number 840497 Anaheim California 92804 —
Investigational Site Number 840667 Downey California 90242 —
Investigational Site Number 840150 Fresno California 93722 —
Investigational Site Number 840624 Hawthorne California 90250 —
Investigational Site Number 840623 Inglewood California 90301 —
Investigational Site Number 840636 Inglewood California 90301 —
Investigational Site Number 840455 La Mesa California 91942 —
Investigational Site Number 840240 Loma Linda California 92354 —
Investigational Site Number 840262 Long Beach California 90806 —
Investigational Site Number 840606 Long Beach California 90813 —
Investigational Site Number 840694 Los Angeles California 90024 —
Investigational Site Number 840431 Los Angeles California 90033 —
Investigational Site Number 840135 Los Angeles California 90073 —
Investigational Site Number 840314 Merced California 95348 —
Investigational Site Number 840290 Mission Viejo California 92691 —
Investigational Site Number 840592 National City California 91950 —
Investigational Site Number 840275 Northridge California 91328 —
Investigational Site Number 840654 Oakland California 94609 —
Investigational Site Number 840351 Orange California 92868 —
Investigational Site Number 840689 Orange California 92868 —
Investigational Site Number 840582 Pomona California 91767 —
Investigational Site Number 840346 Port Hueneme California 93041 —
Investigational Site Number 840466 Roseville California 95661 —
Investigational Site Number 840575 San Marino California 91108 —
Investigational Site Number 840131 Santa Ana California 82705 —
Investigational Site Number 840335 Santa Ana California 92704 —
Investigational Site Number 840576 Simi Valley California 93065 —
Investigational Site Number 840414 Sylmar California 91342 —
Investigational Site Number 840395 Ventura California 93003 —
Investigational Site Number 840206 Vista California 92081-7832 —
Investigational Site Number 840480 Westlake Village California 91361 —
Investigational Site Number 840350 Whittier California 90602 —
Investigational Site Number 840093 Colorado Springs Colorado 80910 —
Investigational Site Number 840631 Washington D.C. District of Columbia 20060 —
Investigational Site Number 840044 Washington D.C. District of Columbia 20422 —
Investigational Site Number 840281 Clearwater Florida 33755 —
Investigational Site Number 840477 Homosassa Florida 34448 —
Investigational Site Number 840261 Miami Florida 33135 —
Investigational Site Number 840459 Miami Florida 33155 —
Investigational Site Number 840432 Oviedo Florida 32765 —
Investigational Site Number 840318 Panama City Florida 32401 —
Investigational Site Number 840056 St. Petersburg Florida 33707 —
Investigational Site Number 840295 Wellington Florida 33449 —
Investigational Site Number 840066 Atlanta Georgia 30322 —
Investigational Site Number 840446 Atlanta Georgia 30322 —
Investigational Site Number 840487 Atlanta Georgia 30322 —
Investigational Site Number 840578 Blue Ridge Georgia 30513 —
Investigational Site Number 840534 Columbus Georgia 31904-5245 —
Investigational Site Number 840447 Duluth Georgia 30096 —
Investigational Site Number 840499 Duluth Georgia 30096 —
Investigational Site Number 840536 Idaho Falls Idaho 83404 —
Investigational Site Number 840413 Pocatello Idaho 83201 —
Investigational Site Number 840519 Arlington Heights Illinois 60005 —
Investigational Site Number 840589 Belleville Illinois 62220 —
Investigational Site Number 840107 Chicago Illinois 60415 —
Investigational Site Number 840633 Chicago Illinois 60611 —
Investigational Site Number 840663 Chicago Illinois 60612 —
Investigational Site Number 840212 Hines Illinois 60141 —
Investigational Site Number 840345 Joliet Illinois 60435 —
Investigational Site Number 840681 Peoria Illinois 61602 —
Investigational Site Number 840360 Elwood Indiana 46036 —
Investigational Site Number 840676 Gary Indiana 46409 —
Investigational Site Number 840657 Hammond Indiana 46320 —
Investigational Site Number 840621 Huntington Indiana 46750 —
Investigational Site Number 840702 Indianapolis Indiana 46202 —
Investigational Site Number 840009 Topeka Kansas 66606 —
Investigational Site Number 840533 Covington Kentucky 41011 —
Investigational Site Number 840251 Madisonville Kentucky 42431 —
Investigational Site Number 840168 Owensboro Kentucky 42303 —
Investigational Site Number 840449 Pikeville Kentucky 41501 —
Investigational Site Number 840299 Baton Rouge Louisiana 70808 —
Investigational Site Number 840671 Hammond Louisiana 70403 —
Investigational Site Number 840470 Metairie Louisiana 70006 —
Investigational Site Number 840178 Shreveport Louisiana 71130 —
Investigational Site Number 840043 Annapolis Maryland 21401 —
Investigational Site Number 840639 Catonsville Maryland 21228 —
Investigational Site Number 840430 Rockville Maryland 20852 —
Investigational Site Number 840640 Takoma Park Maryland 20912 —
Investigational Site Number 840293 Towson Maryland 21204 —
Investigational Site Number 840019 Alpena Michigan 49707 —
Investigational Site Number 840352 Buckley Michigan 49620 —
Investigational Site Number 840555 Chesterfield Michigan 48047 —
Investigational Site Number 840411 Dearborn Michigan 48124 —
Investigational Site Number 840205 Detroit Michigan 48235 —
Investigational Site Number 840581 Flint Michigan 48503 —
Investigational Site Number 840404 Kalamazoo Michigan 49048 —
Investigational Site Number 840312 Southfield Michigan 48075 —
Investigational Site Number 840484 Sterling Heights Michigan 48310 —
Investigational Site Number 840219 Duluth Minnesota 55805 —
Investigational Site Number 840199 Eagan Minnesota 55122 —
Investigational Site Number 840196 Biloxi Mississippi 39531 —
Investigational Site Number 840445 Kansas City Missouri 64111 —
Investigational Site Number 840008 Kansas City Missouri 64128 —
Investigational Site Number 840091 St Louis Missouri 63122 —
Investigational Site Number 840046 St Louis Missouri 63128 —
Investigational Site Number 840678 St Louis Missouri 63131 —
Investigational Site Number 840400 St Louis Missouri 63141 —
Investigational Site Number 840337 Kalispell Montana 59901 —
Investigational Site Number 840509 Lincoln Nebraska 68521 —
Investigational Site Number 840007 Omaha Nebraska 68131 —
Investigational Site Number 840382 Las Vegas Nevada 89102 —
Investigational Site Number 840680 Las Vegas Nevada 89102 —
Investigational Site Number 840217 Las Vegas Nevada 89148 —
Investigational Site Number 840072 Linden New Jersey — —
Investigational Site Number 840628 Ridgewood New Jersey 07450 —
Investigational Site Number 840162 Somerset New Jersey 08873 —
Investigational Site Number 840285 Albany New York 12206 —
Investigational Site Number 840585 Jamaica New York 11432 —
Investigational Site Number 840348 Mineola New York 11501 —
Investigational Site Number 840119 Northport New York 11768 —
Investigational Site Number 840696 Rosedale New York 14221 —
Investigational Site Number 840310 Asheville North Carolina 28805 —
Investigational Site Number 840454 Calabash North Carolina 28467 —
Investigational Site Number 840672 Charlotte North Carolina 28203 —
Investigational Site Number 840152 Charlotte North Carolina 28205 —
Investigational Site Number 840344 Elizabeth City North Carolina 27909 —
Investigational Site Number 840328 Greensboro North Carolina 27401 —
Investigational Site Number 840513 Greensboro North Carolina 27405 —
Investigational Site Number 840504 Greenville North Carolina 27858 —
Investigational Site Number 840642 Monroe North Carolina 28110 —
Investigational Site Number 840481 Raleigh North Carolina 27609 —
Investigational Site Number 840381 Wilmington North Carolina 28401 —
Investigational Site Number 840532 Winston-Salem North Carolina 27157-1071 —
Investigational Site Number 840028 Cincinnati Ohio 45219 —
Investigational Site Number 840198 Cincinnati Ohio 45220 —
Investigational Site Number 840543 Columbus Ohio 43201 —
Investigational Site Number 840456 Dayton Ohio 45439 —
Investigational Site Number 840368 Marion Ohio 43302 —
Investigational Site Number 840427 Bend Oregon 97701 —
Investigational Site Number 840422 Portland Oregon 97201-3098 —
Investigational Site Number 840511 Portland Oregon 97227-1191 —
Investigational Site Number 840560 Butler Pennsylvania 16001 —
Investigational Site Number 840464 Clark Summit Pennsylvania 18411 —
Investigational Site Number 840401 Pittsburgh Pennsylvania 15220 —
Investigational Site Number 840266 Providence Rhode Island 02908 —
Investigational Site Number 840223 Anderson South Carolina 29621 —
Investigational Site Number 840353 Columbia South Carolina 29201 —
Investigational Site Number 840529 Greenville South Carolina 29605 —
Investigational Site Number 840550 Greer South Carolina 29651 —
Investigational Site Number 840258 Myrtle Beach South Carolina 29572 —
Investigational Site Number 840309 Taylors South Carolina 29687-4105 —
Investigational Site Number 840551 Rapid City South Dakota 57701 —
Investigational Site Number 840524 Bartlett Tennessee 38133 —
Investigational Site Number 840308 Chattanooga Tennessee 37404 —
Investigational Site Number 840047 Germantown Tennessee 38138 —
Investigational Site Number 840313 Jackson Tennessee 38305 —
Investigational Site Number 840625 Memphis Tennessee 38114 —
Investigational Site Number 840637 Memphis Tennessee 38163 —
Investigational Site Number 840096 Nashville Tennessee 37208 —
Investigational Site Number 840388 Nashville Tennessee 37232 —
Investigational Site Number 840473 Dallas Texas 75246 —
Investigational Site Number 840677 Edinburg Texas 78539 —
Investigational Site Number 840698 El Paso Texas 79925 —
Investigational Site Number 840439 Fair Oaks Ranch Texas 78015 —
Investigational Site Number 840164 Houston Texas 77081 —
Investigational Site Number 840545 Longview Texas 75605 —
Investigational Site Number 840385 Lubbock Texas 79409 —
Investigational Site Number 840530 Lubbock Texas 79409 —
Investigational Site Number 840174 Marshall Texas 75670 —
Investigational Site Number 840565 Plano Texas 75024 —
Investigational Site Number 840608 Richmond Texas 77469 —
Investigational Site Number 840573 San Antonio Texas 78258 —
Investigational Site Number 840564 Sugarland Texas 77479 —
Investigational Site Number 840241 Waco Texas 76708 —
Investigational Site Number 840232 American Fork Utah 84003 —
Investigational Site Number 840471 Draper Utah 84020 —
Investigational Site Number 840503 Charlottesville Virginia 22908-0679 —
Investigational Site Number 840180 Chesapeake Virginia 23320 —
Investigational Site Number 840465 Chesapeake Virginia 23321 —
Investigational Site Number 840128 Chesapeake Virginia 23323 —
Investigational Site Number 840045 Norfolk Virginia 23502 —
Investigational Site Number 840213 Norfolk Virginia 23510 —
Investigational Site Number 840001 Richmond Virginia 23219 —
Investigational Site Number 840286 Roanoke Virginia 24014 —
Investigational Site Number 840170 Olympia Washington 98506 —
Investigational Site Number 840094 Spokane Washington 99207 —
Investigational Site Number 840343 Spokane Washington 99207 —
Investigational Site Number 840268 Spokane Washington 99220 —
Investigational Site Number 840061 Tacoma Washington 98405 —
Investigational Site Number 840613 Fairmount Wisconsin 26554 —
Investigational Site Number 840121 La Crosse Wisconsin 54601 —
Investigational Site Number 840493 Milwaukee Wisconsin 53211 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 629 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01147250, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 20, 2016 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01147250 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →