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Showing 1–21 of 21 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Lixisenatide (AVE0010) Clear all
Completed Phase 3 Interventional Results available

Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin

NCT01517412
View directory record Official record
Conditions
Type 2 Diabetes Mellitus
Interventions
Lixisenatide (AVE0010), Self-injector pen device (OptiClik®), Metformin
Drug · Device
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
451 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2013
U.S. locations
17
States / cities
Glendale, Arizona • Mesa, Arizona • Phoenix, Arizona + 12 more
Source: ClinicalTrials.gov public record
Updated Oct 13, 2016 · Synced Sep 9, 2026, 11:24 AM EDT
Completed Phase 1 Interventional

A Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients With Type 2 Diabetes Mellitus (T2DM)

NCT02803918
View directory record Official record
Conditions
Type 2 Diabetes Mellitus
Interventions
Lixisenatide (AVE0010), Placebo, Basal Insulin, Metformin
Drug
Lead sponsor
Sanofi
Industry
Eligibility
10 Years to 17 Years
Enrollment
23 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2020
U.S. locations
4
States / cities
Baton Rouge, Louisiana • New Orleans, Louisiana • Philadelphia, Pennsylvania + 1 more
Source: ClinicalTrials.gov public record
Updated Apr 24, 2022 · Synced Sep 9, 2026, 11:24 AM EDT
Completed Phase 3 Interventional Results available

GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Pioglitazone

NCT00763815
View directory record Official record
Conditions
Diabetes Mellitus Type 2
Interventions
Lixisenatide (AVE0010), Placebo, Pen auto-injector, Pioglitazone, Metformin
Drug · Device
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
484 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2011
U.S. locations
85
States / cities
Birmingham, Alabama • Mobile, Alabama • Chandler, Arizona + 72 more
Source: ClinicalTrials.gov public record
Updated Nov 27, 2016 · Synced Sep 9, 2026, 11:24 AM EDT
Completed Phase 3 Interventional Results available

Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination Compared to Insulin Glargine Alone and Lixisenatide Alone on Top of Metformin in Patients With T2DM

NCT02058147
View directory record Official record
Conditions
Type 2 Diabetes
Interventions
Insulin glargine/lixisenatide Fixed Ratio Combination, Insulin glargine (HOE901), Lixisenatide (AVE0010), Metformin
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
1,170 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
118
States / cities
Phoenix, Arizona • Tempe, Arizona • Little Rock, Arkansas + 98 more
Source: ClinicalTrials.gov public record
Updated May 8, 2017 · Synced Sep 9, 2026, 11:24 AM EDT
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)

NCT01147250
View directory record Official record
Conditions
Acute Coronary Syndrome
Interventions
Lixisenatide (AVE0010), Placebo
Drug
Lead sponsor
Sanofi
Industry
Eligibility
30 Years and older
Enrollment
6,068 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2015
U.S. locations
200
States / cities
Birmingham, Alabama • Foley, Alabama • Mobile, Alabama + 160 more
Source: ClinicalTrials.gov public record
Updated Dec 19, 2016 · Synced Sep 9, 2026, 11:24 AM EDT
Completed Phase 3 Interventional Results available

GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin

NCT00763451
View directory record Official record
Conditions
Diabetes Mellitus, Type 2
Interventions
Lixisenatide (AVE0010), Placebo, Pen auto-injector, Metformin
Drug · Device
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
484 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2011
U.S. locations
1
States / cities
Bridgewater, New Jersey
Source: ClinicalTrials.gov public record
Updated Dec 13, 2016 · Synced Sep 9, 2026, 11:24 AM EDT
Completed Phase 3 Interventional Results available

Efficacy and Safety of Lixisenatide Versus Placebo on Top of Basal Insulin and/or Oral Antidiabetic Treatment in Older Type 2 Diabetic Patients

NCT01798706
View directory record Official record
Conditions
Type 2 Diabetes
Interventions
Lixisenatide (AVE0010), Placebo, Antidiabetic background therapy
Drug
Lead sponsor
Sanofi
Industry
Eligibility
70 Years and older
Enrollment
350 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
14
States / cities
La Jolla, California • Norwalk, California • Miami, Florida + 10 more
Source: ClinicalTrials.gov public record
Updated Apr 17, 2017 · Synced Sep 9, 2026, 11:24 AM EDT
Completed Phase 3 Interventional Results available

Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients

NCT01768559
View directory record Official record
Conditions
Type 2 Diabetes
Interventions
Lixisenatide (AVE0010), Insulin glulisine QD, Insulin glulisine TID, Insulin Glargine (Mandatory background drug), Metformin (Background drug)
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
894 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
46
States / cities
Sun City, Arizona • Tempe, Arizona • Little Rock, Arkansas + 41 more
Source: ClinicalTrials.gov public record
Updated Jan 3, 2017 · Synced Sep 9, 2026, 11:24 AM EDT
Completed Phase 2 Interventional Results available

Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic Patients

NCT01476475
View directory record Official record
Conditions
Type 2 Diabetes Mellitus
Interventions
Insulin glargine /lixisenatide Fixed Ratio Combination, Insulin glargine, Metformin (Background drug)
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
323 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2012
U.S. locations
14
States / cities
Little Rock, Arkansas • Paramount, California • Larenceville, Georgia + 11 more
Source: ClinicalTrials.gov public record
Updated Feb 9, 2017 · Synced Sep 9, 2026, 11:24 AM EDT
Completed Phase 3 Interventional Results available

GLP-1 Receptor Agonist Lixisenatide (Morning or Evening) in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin

NCT00712673
View directory record Official record
Conditions
Diabetes Mellitus, Type 2
Interventions
Lixisenatide (AVE0010), Placebo, Pen auto-injector, Metformin
Drug · Device
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
680 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2011
U.S. locations
1
States / cities
Bridgewater, New Jersey
Source: ClinicalTrials.gov public record
Updated Dec 14, 2016 · Synced Sep 9, 2026, 11:24 AM EDT
Completed Phase 3 Interventional Results available

GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Basal Insulin

NCT00715624
View directory record Official record
Conditions
Diabetes Mellitus, Type 2
Interventions
Lixisenatide (AVE0010), Placebo, Basal Insulin, Metformin, Pen auto-injector
Drug · Device
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
496 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2011
U.S. locations
1
States / cities
Bridgewater, New Jersey
Source: ClinicalTrials.gov public record
Updated Nov 27, 2016 · Synced Sep 9, 2026, 11:24 AM EDT
Completed Phase 3 Interventional Results available

Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes

NCT02058160
View directory record Official record
Conditions
Type 2 Diabetes
Interventions
Insulin glargine/lixisenatide (HOE901/AVE0010), Insulin glargine (HOE901), Metformin (Background Drug)
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
736 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
108
States / cities
Birmingham, Alabama • Sun City, Arizona • Tempe, Arizona + 91 more
Source: ClinicalTrials.gov public record
Updated May 8, 2017 · Synced Sep 9, 2026, 11:24 AM EDT
Completed Phase 2 Interventional

Dose Ranging Study of the GLP-1 Agonist AVE0010 in Metformin-Treated Subjects With Type 2 Diabetes Mellitus

NCT00299871
View directory record Official record
Conditions
Type 2 Diabetes
Interventions
LIXISENATIDE (AVE0010)
Drug
Lead sponsor
Sanofi
Industry
Eligibility
30 Years to 75 Years
Enrollment
542 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2007
U.S. locations
1
States / cities
Bridgewater, New Jersey
Source: ClinicalTrials.gov public record
Updated Jan 27, 2014 · Synced Sep 9, 2026, 11:24 AM EDT
Completed Phase 1 Interventional

Evaluation of the Blood Levels of the Drug (Lixisenatide), the Plasma Glucose Levels and Safety in Paediatric and Adult Patients With Type 2 Diabetes

NCT01572649
View directory record Official record
Conditions
Type 2 Diabetes Mellitus
Interventions
Lixisenatide (AVE0010), Placebo
Drug
Lead sponsor
Sanofi
Industry
Eligibility
10 Years to 65 Years
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2014
U.S. locations
3
States / cities
Chula Vista, California • Overland Park, Kansas • Louisville, Kentucky
Source: ClinicalTrials.gov public record
Updated May 22, 2014 · Synced Sep 9, 2026, 11:24 AM EDT
Completed Phase 3 Interventional Results available

GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation in Monotherapy

NCT00688701
View directory record Official record
Conditions
Diabetes Mellitus, Type 2
Interventions
Lixisenatide (AVE0010), Placebo, Pen auto-injector
Drug · Device
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
361 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2009
U.S. locations
1
States / cities
Bridgewater, New Jersey
Source: ClinicalTrials.gov public record
Updated Dec 11, 2016 · Synced Sep 9, 2026, 11:24 AM EDT
Completed Phase 3 Interventional Results available

24-week Study Comparing Lixisenatide to Sitagliptin as add-on to Metformin in Obese Type 2 Diabetic Patients Younger Than 50 Years

NCT00976937
View directory record Official record
Conditions
Type 2 Diabetes Mellitus
Interventions
Lixisenatide (AVE0010), Lixisenatide Placebo, Pen auto-injector, Sitagliptin, Sitagliptin Placebo, Metformin
Drug · Device
Lead sponsor
Sanofi
Industry
Eligibility
18 Years to 49 Years
Enrollment
319 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2011
U.S. locations
21
States / cities
Montgomery, Alabama • Muscle Shoals, Alabama • Mesa, Arizona + 17 more
Source: ClinicalTrials.gov public record
Updated Oct 10, 2016 · Synced Sep 9, 2026, 11:24 AM EDT
Completed Phase 3 Interventional Results available

24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine

NCT00975286
View directory record Official record
Conditions
Type 2 Diabetes Mellitus
Interventions
Lixisenatide (AVE0010), Placebo, Insulin glargine, Pen auto-injector, Metformin, Thiazolidinedione (TZD)
Drug · Device
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
446 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2011
U.S. locations
23
States / cities
Mesa, Arizona • Hot Springs, Arkansas • Little Rock, Arkansas + 19 more
Source: ClinicalTrials.gov public record
Updated Oct 10, 2016 · Synced Sep 9, 2026, 11:24 AM EDT
Completed Phase 3 Interventional Results available

Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) Versus GLP-1 Receptor Agonist in Patients With Type 2 Diabetes, With a FRC Extension Period

NCT02787551
View directory record Official record
Conditions
Type 2 Diabetes Mellitus
Interventions
Insulin glargine/lixisenatide fixed ratio combination, liraglutide, exenatide, exenatide extended-release, albiglutide, dulaglutide, Background therapy: Oral Anti-diabetic Drug (Metformin, Pioglitazone, SGLT2 inhibitor)
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
514 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2018
U.S. locations
74
States / cities
Birmingham, Alabama • Fountain Hills, Arizona • Phoenix, Arizona + 62 more
Source: ClinicalTrials.gov public record
Updated Mar 24, 2022 · Synced Sep 9, 2026, 11:24 AM EDT
Completed Phase 3 Interventional Results available

GLP-1 Receptor Agonist Lixisenatide Versus Exenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin

NCT00707031
View directory record Official record
Conditions
Diabetes Mellitus, Type 2
Interventions
Lixisenatide (AVE0010), Pen auto-injector, Exenatide, Prefilled pen injector, Metformin
Drug · Device
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
639 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2010
U.S. locations
1
States / cities
Bridgewater, New Jersey
Source: ClinicalTrials.gov public record
Updated Dec 1, 2016 · Synced Sep 9, 2026, 11:24 AM EDT
Completed Phase 3 Interventional Results available

GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Sulfonylurea

NCT00713830
View directory record Official record
Conditions
Diabetes Mellitus, Type 2
Interventions
Lixisenatide (AVE0010), Placebo, Pen auto-injector, Sulfonylurea, Metformin
Drug · Device
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
859 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2011
U.S. locations
1
States / cities
Bridgewater, New Jersey
Source: ClinicalTrials.gov public record
Updated Dec 13, 2016 · Synced Sep 9, 2026, 11:24 AM EDT
Terminated Phase 3 Interventional Results available

Efficacy and Safety of Soliqua Versus Lantus in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents

NCT03434119
View directory record Official record
Conditions
Type 2 Diabetes Mellitus
Interventions
Insulin glargine/Lixisenatide, Insulin glargine (HOE901), Background therapy
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
241 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2019
U.S. locations
85
States / cities
Montgomery, Alabama • Little Rock, Arkansas • Anaheim, California + 63 more
Source: ClinicalTrials.gov public record
Updated Mar 27, 2022 · Synced Sep 9, 2026, 11:24 AM EDT