Metabolic Diseases  >>  Adlyxin (lixisenatide)  >>  Phase 3
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20 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Adlyxin (lixisenatide) / Sanofi
GETGOAL-MONO, NCT00688701 / 2007-005887-29: GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation in Monotherapy

Checkmark P3 data
Mar 2012 - Mar 2012: P3 data
Completed
3
361
Japan, US, Europe, RoW
Lixisenatide (AVE0010), Placebo, Pen auto-injector, OptiClik®
Sanofi
Diabetes Mellitus, Type 2
12/09
12/09
GETGOAL-L-ASIA, NCT00866658: GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Basal Insulin +/- Sulfonylurea

Checkmark EASD 2013
Jul 2013 - Jul 2013: EASD 2013
Checkmark ADA 2013
Jun 2013 - Jun 2013: ADA 2013
Checkmark Data
More
Completed
3
311
Japan, RoW
Lixisenatide (AVE0010), Placebo, Pen auto-injector, OptiClik®, Sulfonylurea, Basal Insulin
Sanofi
Diabetes Mellitus, Type 2
06/10
06/10
GETGOAL-X, NCT00707031 / 2007-005883-28: GLP-1 Receptor Agonist Lixisenatide Versus Exenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin

Checkmark
May 2013 - May 2013: 
Checkmark Data
Jul 2011 - Jul 2011: Data
Checkmark Data
More
Completed
3
639
US, Europe, RoW
Lixisenatide (AVE0010), Pen auto-injector, OptiClik®, Exenatide, Byetta®, Prefilled pen injector, Metformin
Sanofi
Diabetes Mellitus, Type 2
11/10
11/10
GETGOAL-S, NCT00713830 / 2007-005881-11: GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Sulfonylurea

Checkmark
Mar 2014 - Mar 2014: 
Checkmark EASD 2013
Jul 2013 - Jul 2013: EASD 2013
Checkmark ADA 2013
More
Completed
3
859
Japan, US, Europe, RoW
Lixisenatide (AVE0010), Placebo, Pen auto-injector, OptiClik®, Sulfonylurea, Metformin
Sanofi
Diabetes Mellitus, Type 2
01/11
01/11
GETGOAL-F1, NCT00763451 / 2008-001002-16: GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin

Checkmark
Oct 2013 - Oct 2013: 
Checkmark Data
Nov 2011 - Nov 2011: Data
Checkmark Data
More
Completed
3
484
US, Europe, RoW
Lixisenatide (AVE0010), Placebo, Pen auto-injector, OptiClik®, Metformin
Sanofi
Diabetes Mellitus, Type 2
01/11
01/11
GETGOAL-MONO, NCT00905255: GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation in Monotherapy ( Japan LTS)

Completed
3
69
Japan
Lixisenatide (AVE0010), Pen auto-injector, OptiClik®
Sanofi
Diabetes Mellitus, Type 2
01/11
01/11
GETGOAL-L, NCT00715624 / 2007-005886-36: GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Basal Insulin

Checkmark EASD 2013
Jul 2013 - Jul 2013: EASD 2013
Checkmark EASD 2013
Jul 2013 - Jul 2013: EASD 2013
Checkmark
More
Completed
3
496
US, Canada, Europe, RoW
Lixisenatide (AVE0010), Placebo, Basal Insulin, Metformin, Pen auto-injector, OptiClik®
Sanofi
Diabetes Mellitus, Type 2
02/11
02/11
GETGOAL-M, NCT00712673 / 2007-005880-80: GLP-1 Receptor Agonist Lixisenatide (Morning or Evening) in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Metformin

Checkmark EASD 2013
Jul 2013 - Jul 2013: EASD 2013
Checkmark
Mar 2013 - Mar 2013: 
Checkmark Data
More
Completed
3
680
US, Canada, Europe, RoW
Lixisenatide (AVE0010), Placebo, Pen auto-injector, OptiClik®, Metformin
Sanofi
Diabetes Mellitus, Type 2
03/11
03/11
NCT00976937 / 2008-007334-22: 24-week Study Comparing Lixisenatide to Sitagliptin as add-on to Metformin in Obese Type 2 Diabetic Patients Younger Than 50 Years

Completed
3
319
US, Canada, Europe, RoW
Lixisenatide (AVE0010), Lixisenatide Placebo, Pen auto-injector, OptiClik®, Sitagliptin, Januvia®, Sitagliptin Placebo, Metformin
Sanofi
Type 2 Diabetes Mellitus
03/11
03/11
GETGOAL-P, NCT00763815 / 2007-005884-92: GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Pioglitazone

Checkmark
May 2013 - May 2013: 
Checkmark P3 data - ADA
May 2012 - May 2012: P3 data - ADA
Completed
3
484
US, Canada, Europe, RoW
Lixisenatide (AVE0010), Placebo, Pen auto-injector, OptiClik®, Pioglitazone, Metformin
Sanofi
Diabetes Mellitus Type 2
06/11
06/11
GetGoal Duo1, NCT00975286 / 2008-007335-40: 24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine

Checkmark EASD 2013
Jul 2013 - Jul 2013: EASD 2013
Checkmark
Apr 2013 - Apr 2013: 
Checkmark P3 data - EASD
More
Completed
3
446
US, Canada, Europe, RoW
Lixisenatide (AVE0010), Placebo, Insulin glargine, Lantus®, Pen auto-injector, Metformin, Thiazolidinedione (TZD)
Sanofi
Type 2 Diabetes Mellitus
08/11
08/11
GetGoal-M-Asia, NCT01169779: Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled by Metformin

Checkmark
Mar 2014 - Mar 2014: 
Completed
3
391
RoW
Lixisenatide (AVE0010), Placebo, Pen auto-injector, OptiClik®, Metformin, Sulfonylurea
Sanofi
Type 2 Diabetes Mellitus
12/11
12/11
NCT01517412 / 2011-002416-85: Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin

Checkmark
Dec 2013 - Dec 2013: 
Checkmark IDF 2013
Oct 2013 - Oct 2013: IDF 2013
Completed
3
451
US, Canada, Europe, RoW
Lixisenatide (AVE0010), Self-injector pen device (OptiClik®), Metformin, Route of administration: Oral
Sanofi
Type 2 Diabetes Mellitus
05/13
05/13
GetGoal Duo-2, NCT01768559 / 2012-004096-38: Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients

Completed
3
894
US, Canada, Europe, RoW
Lixisenatide (AVE0010), Lyxumia®, Device: Disposable self-injector prefilled pen (Delta 14®), Insulin glulisine QD, HMR1964, Device: Disposable self-injector prefilled pen (Apidra® Solostar®), Insulin glulisine TID, Insulin Glargine (Mandatory background drug), Device: Disposable self-injector prefilled pen (Lantus® Solostar®), Metformin (Background drug)
Sanofi
Type 2 Diabetes
12/14
12/14
GetGoal-O, NCT01798706 / 2012-003292-19: Efficacy and Safety of Lixisenatide Versus Placebo on Top of Basal Insulin and/or Oral Antidiabetic Treatment in Older Type 2 Diabetic Patients

Checkmark ADA 2013
Jun 2013 - Jun 2013: ADA 2013
Completed
3
350
US, Canada, Europe, RoW
Lixisenatide (AVE0010), Lyxumia, Placebo, Antidiabetic background therapy
Sanofi
Type 2 Diabetes
02/15
02/15
NCT01960179: Safety And Tolerability Of Lixisenatide In Monotherapy In Patients With Type 2 Diabetes

Completed
3
361
Japan
lixisenatide AVE0010
Sanofi
Type 2 Diabetes Mellitus
03/15
03/15
NCT01632163: Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin

Completed
3
447
RoW
Lixisenatide (AVE0010), Placebo
Sanofi
Type 2 Diabetes Mellitus
05/15
05/15
LixiLan-O, NCT02058147 / 2013-003131-30: 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

Completed
3
1170
US, Canada, Europe, RoW
Insulin glargine/lixisenatide Fixed Ratio Combination, (HOE901/AVE0010), Insulin glargine (HOE901), Lantus, Lixisenatide (AVE0010), Lyxumia, Metformin
Sanofi
Type 2 Diabetes
06/15
06/15
NCT01940965: Safety and Tolerability of Lixisenatide in Combination With Oral Anti-Diabetic Treatment in Patients With Type 2 Diabetes

Completed
3
294
Japan
lixisenatide AVE0010, biguanide, TZD, alpha-GI, glinide
Sanofi
Type 2 Diabetes Mellitus
07/15
07/15
LixiBIT, NCT02168491 / 2013-005334-37: Feasibility of Once/Daily Administered GLP/1 Receptoragonist (Lixisenatide) in Combination With Basal Insulin

Completed
3
10
Europe
Lixisenatide, Lyxumia, Insulin glargine, Lantus
Medical University of Vienna
Type 2 Diabetes Mellitus
07/15
08/15

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