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Lixisenatide – Once-daily Glucagon-like Peptide-1 Receptor Agonist in the Management of Type 2 Diabetes


receptor agonist AVE0010 preserves beta cell function and insulin secretion after a 6 week treatment in male obese Zucker diabetic fatty rats – an isolated perfused pancreas study, Diabetologia, 2006;49(Suppl. 1):S400.


18. Werner U, Vandewalle B, Kerr Conte J, et al., The GLP-1 receptor agonist AVE0010 improves GSIS, prevents lipotoxicity-induced insulin depletion and preserves β-cell function in human pancreatic islets, Diabetes, 2008;57(Suppl. 1). Available at:


http://professional.diabetes.org/Abstracts_Display.aspx? TYP=1&CID=68468 (accessed 19 December 2011).


19. Werner U, Gerlach M, Hofmann M, Herling A, Treatment of obese Zucker diabetic fatty rats with novel GLP-1 receptor agonist AVE0010 improves oral glucose tolerance and glycaemic control without risk of hypoglycaemia, Diabetologia, 2006;49(Suppl. 1):398.


20. Werner U, Gerlach M, Hofmann M, Herling AW, The GLP-1 receptor agonist AVE0010 abolishes OGTT-induced blood glucose excursion in healthy, normoglycemic dog without risk of hypoglycemia, Diabetes, 2007;56(Suppl. 1). Available at:


http://professional.diabetes.org/Abstracts_Display.aspx?TYP =1&CID=53630 (accessed 19 December 2011).


21. Moore M, Werner U, Smith M, Rodewald T, Effect of the glucagon-like peptide-1 receptor agonist AVE0010 on postprandial hepatic glucose metabolism in the conscious dog, Diabetologia, 2007;50(Suppl. 1):S242.


22. Werner U, Kuhlmann-Gottke J, Schafer H, Herling A, Effect of once-daily GLP1R agonist lixisenatide on gastric emptying and prandial carbohydrate utilization in animal models: a comparison with liraglutide, Diabetes, 2011;60(Suppl. 1).


23. Huber J, Janecek E, Meister S, et al., Cardiogenic effect of GLP-1 receptor agonist lixisenatide on ischemia-reperfusion- induced injury in the isolated rat heart, Diabetes, 2011;60(Suppl. 1).


24. Ratner RE, Rosenstock J, Boka G, Dose-dependent effects of the once-daily GLP-1 receptor agonist lixisenatide in patients with Type 2 diabetes inadequately controlled with metformin: a randomized, double-blind, placebo-controlled trial, Diabet Med, 2010;27:1024–32.


25. Distiller L, Ruus PE, Pharmacokinetics and pharmacodynamics of GLP-1 agonist AVE0010 in type 2 diabetes patients, Diabetes, 2008;57(Suppl. 1). Available at: http://professional.diabetes.org/Abstracts_Display.aspx?TYP =1&CID=69828 (accessed 19 December 2011).


26. Sanofi press release, Sanofi Getgoal programme on Lyxumia (lixisenatide), as an add-on to basal insulin, shows significant positive phase III results, June 3, 2011. Available at:


www.pharmiweb.com/PressReleases/pressrel.asp?ROW_ID= 41979 (accessed 19 December 2011).


27. Gerich J, Fonseca V, Alvarado-Ruiz R, et al., Monotherapy with GLP-1 receptor agonist, lixisenatide, significantly improves glycaemic control in type 2 diabetic patients, Diabetologia, 2010;53(Suppl. 1):S330.


28. Seino Y, Min K, Niemoeller E, Takami A, Lixisenatide significantly improves glycemic control in Asian patients with T2DM insufficiently controlled on basal insulin +/- SU, Diabetes, 2011;60(Suppl. 1).


29. Rosenstock J, Raccah D, Koranyi L, et al., Efficacy and safety of lixisenatide once-daily vs exenatide twice-daily in type 2 DM inadequately controlled on metformin, Diabetes,


2011;60(Suppl. 1).


30. Ratner R, et al., Efficacy and safety of lixisenatide once-daily versus placebo in patients with type 2 diabetes mellitus insufficiently controlled on sulfonylurea ± metformin (GetGoal-S), Presented at: 47th annual meeting of the European Association for the Study of Diabetes, Lisbon, Portugal, 14 September 2011.


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33. Byetta package insert, San Diego, CA: Amylin Pharmaceuticals, Inc; 2010.


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35. Victoza package insert, Copenhagen, Denmark: Novo Nordisk A/S; 2011.


36. Kim D, MacConell L, Zhuang D, et al., Effects of once-weekly dosing of a long-acting release formulation of exenatide on glucose control and body weight in subjects with type 2 diabetes, Diabetes Care, 2007;30:1487–93.


37. Liu Y-H, Ruus P, Pharmacokinetics and safety of the GLP-1 agonist AAVE0010 in patients with renal impairment, Diabetes 2009;58(Suppl. 1). Available at:


http://professional.diabetes.org/Abstracts_Display.aspx?TYP =1&CID=73287 (accessed 19 December 2011).


38. ClinicalTrials.gov, Identifier NCT00688701, GLP-1 agonist AVE0010 in patients with type 2 diabetes for glycemic control and safety evaluation in monotherapy (GETGOAL- MONO). Available at:


http://clinicaltrials.gov/ct2/show/NCT00688701?term=lixisen atide&rank=8 (accessed 19 December 2011).


39. ClinicalTrials.gov, Identifier NCT00866658, GLP-1 agonist AVE0010 in patients with type 2 diabetes for glycemic control and safety evaluation, on top of basal insulin +/- sulfonylurea (GETGOAL-L-ASIA). Available at: http://clinicaltrials.gov/ct2/show/NCT00866658?term=lixisen atide&rank=15 (accessed 19 December 2011).


40. ClinicalTrials.gov, Identifier NCT00707031, GLP-1 agonist AVE0010 versus exenatide in patients with type 2 diabetes for glycemic control and safety evaluation, on top of metformin (GETGOAL-X). Available at:


http://clinicaltrials.gov/ct2/show/NCT00707031?term=lixisen atide&rank=12 (accessed 19 December 2011).


41. ClinicalTrials.gov, Identifier NCT00713830, GLP-1 agonist AVE0010 in patients with type 2 diabetes for glycemic control and safety evaluation, on top of sulfonylurea (GETGOAL-S). Available at:


http://clinicaltrials.gov/ct2/show/NCT00713830? term=lixisenatide&rank=11 (accessed 19 December 2011).


42. ClinicalTrials.gov, Identifier NCT00715624, GLP-1 agonist AVE0010 in patients with type 2 diabetes for glycemic control and safety evaluation, on top of basal insulin (GETGOAL-L). Available at:


http://clinicaltrials.gov/ct2/show/NCT00715624?term=lixisen atide&rank=10 (accessed 19 December 2011).


43. ClinicalTrials.gov, Identifier NCT00712673, GLP-1 agonist AVE0010 (morning or evening) in patients with type 2 diabetes for glycemic control and safety evaluation, on top


of metformin (GETGOAL-M). Available at:


http://clinicaltrials.gov/ct2/show/NCT00712673?term=lixisen atide&rank=17 (accessed 19 December 2011).


44. ClinicalTrials.gov, Identifier NCT01169779, Efficacy and safety of lixisenatide in patients with type 2 diabetes mellitus insufficiently controlled by metformin (GETGOAL-M- As). Available at:


http://clinicaltrials.gov/ct2/show/NCT01169779?term=lixisen atide&rank=2 (accessed 19 December 2011).


45. ClinicalTrials.gov, Identifier NCT00763451, GLP-1 agonist AVE0010 in patients with type 2 diabetes for glycemic control and safety evaluation, on top of metformin (GETGOAL-F1). Available at:


http://clinicaltrials.gov/ct2/show/NCT00763451?term=lixisen atide&rank=13 (accessed 19 December 2011).


46. ClinicalTrials.gov, Identifier NCT00763815, GLP-1 agonist AVE0010 in patients with type 2 diabetes for glycemic control and safety evaluation, on top of pioglitazone (GETGOAL-P). Available from:


http://clinicaltrials.gov/ct2/show/NCT00763815?term=lixisen atide&rank=9 (accessed 19 December 2011).


47. ClinicalTrials.gov, Identifier NCT00905255, GLP-1 agonist AVE0010 in patients with type 2 diabetes for glycemic control and safety evaluation in monotherapy (GETGOAL- MONO Japan LTS). Available at:


http://clinicaltrials.gov/ct2/show/NCT00905255?term=lixisen atide&rank=14 (accessed 19 December 2011).


48. ClinicalTrials.gov, Identifier NCT00976937, 24-week study comparing lixisenatide (AVE0010) to sitagliptin as add-on to metformin in obese type 2 diabetic patients younger than 50. Available at:


http://clinicaltrials.gov/ct2/show/NCT00976937?term=lixisen atide&rank=6 (accessed 19 December 2011).


49. ClinicalTrials.gov, Identifier NCT00975286, 24-week treatment with lixisenatide in type 2 diabetes insufficiently controlled with metformin and insulin glargine (GetGoal Duo1). Available at:


http://clinicaltrials.gov/ct2/show/NCT00975286?term=lixisen atide&rank=4 (accessed 19 December 2011).


50. ClinicalTrials.gov, Identifier NCT01147250, Evaluation of cardiovascular outcomes in patients with type 2 diabetes after acute coronary syndrome during treatment with AVE0010 (lixisenatide) (ELIXA). Available at: http://clinicaltrials.gov/ct2/show/NCT01147250?term=lixisen atide&rank=3 (accessed 19 December 2011).


51. Aronson R, et al., Efficacy and safety of lixisenatide QD morning and evening injections vs placebo in T2DM inadequately controlled on metformin (GetGoal-M), Presented at: 21st World Diabetes Congress, Dubai, UAE, 8 December 2011.


52. Bolli GB, et al., Efficacy and safety of lixisenatide once-daily versus placebo in patients with type 2 diabetes mellitus insufficiently controlled on metformin (GetGoal-F1), Presented at: 47th annual meeting of the European Association for the Study of Diabetes, Lisbon, Portugal, 14 September 2011.


53. Sanofi press release, Sanofi Reports Positive Results for Once-daily Lyxumia® (lixisenatide) in Combination with Lantus® (insulin glargine) in Type 2 Diabetes, 6 December 2011. Available at:


http://en.sanofi.com/Images/29252_20111206_GETGOAL- DUO_en.pdf (accessed 25 December 2011).


EUROPEAN ENDOCRINOLOGY


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