Lixisenatide - once-daily glucagon-like peptide-1 receptor agonist in the management of type 2 diabetes

European Endocrinology

Volumn 8, Issue 1, 2012, Pages 12-17

  Quianzon, Celeste C L ^a   Shomali, Mansur E ^a  

^a UNION MEMORIAL HOSPITAL   (United States)

Author keywords

Glucagon like peptide 1 receptor agonist; Lixisenatide; Type 2 diabetes

Indexed keywords

ANTIHISTAMINIC AGENT; DRUG ANTIBODY; EXENDIN 4; GLUCAGON; GLUCAGON LIKE PEPTIDE 1 RECEPTOR AGONIST; GLUCOSE; HEMOGLOBIN A1C; INSULIN; INSULIN GLARGINE; LIRAGLUTIDE; LIXISENATIDE; METFORMIN; ORAL ANTIDIABETIC AGENT; PLACEBO; SULFONYLUREA;

ABDOMINAL DISTENSION; ABDOMINAL PAIN; ADD ON THERAPY; ARTICLE; CONSTIPATION; DIABETES CONTROL; DIARRHEA; DOSAGE SCHEDULE COMPARISON; DRUG BLOOD LEVEL; DRUG DEGRADATION; DRUG DOSE TITRATION; DRUG EFFECT; DRUG HALF LIFE; DRUG MECHANISM; DRUG POTENCY; DRUG TOLERABILITY; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; DYSPEPSIA; DYSPNEA; HUMAN; HYPOGLYCEMIA; INSULIN RELEASE; LIP DISEASE; MAXIMUM PLASMA CONCENTRATION; MONOTHERAPY; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; NONHUMAN; PRURITUS; TIME TO MAXIMUM PLASMA CONCENTRATION; TONGUE SWELLING; URTICARIA; VOMITING; WEIGHT REDUCTION;

EID: 84872831889     PISSN: 17583772     EISSN: 17583780     Source Type: Journal    
DOI: 10.17925/ee.2012.08.01.12     Document Type: Article

References (53)

1. Centers for Disease Control and Prevention, National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011; Atlanta, GA, Department of Health and Human Services.
2. Shaw J, Sicree R, Zimmet P, Global estimates of the prevalence of diabetes for 2010 and 2030, Diabetes Res Clin Pract, 2010;87:4-14.
3. Nathan DM, Buse JB, Davidson MB, et al., Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes, Diabetes Care, 2009;32:193-203.
4. Rodbard HW, Blonde L, Braithwaite SS, et al., American Association of Clinical Endocrinologists medical guidelines for clinical practice for the management of diabetes mellitus, Endocr Pract, 2007;13(Suppl. 1):1-68.
5. Garber AJ, Long-acting glucagon-like peptide 1 receptor agonists: a review of their efficacy and tolerability, Diabetes Care, 2011;34(Suppl. 2):S279-84.
6. Drucker DJ, Nauck MA, The incretin system: glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors in type 2 diabetes, Lancet, 2006;368:1696-705.
7. Pratley RE, Overview of glucagon-like peptide-1 analogs and dipeptidyl peptidase-4 inhibitors for type 2 diabetes, Medscape J Med, 2008;10:171.
8. Zealand Pharma A/S, Lixisenatide (Lyxumia®). Available at: www.zealandpharma.com/Pipeline/Lixisenatide_(Lyxumia) (accessed 25 December 2011).
9. Werner U, Haschke G, Herling AW, Kramer W, Pharmacological profile of lixisenatide: a new GLP-1 receptor agonist for the treatment of type 2 diabetes, Regul Pept, 2010;164:58-64.
10. Christensen M, Knop FK, Vilsboll T, Holst JJ, Lixisenatide for type 2 diabetes mellitus, Expert Opin Investig Drugs, 2011; 20:549-57.
11. Christensen M, Knop FK, Holst JJ, Vilsboll T, Lixisenatide, a novel GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus, IDrugs, 2009;12:503-13.
12. Thorkildsen C, Neve S, Larsen BD, et al., Glucagon-like peptide 1 receptor agonist ZP10A increases insulin mRNA expression and prevents diabetic progression in db/db mice, J Pharmacol Exp Ther, 2003;307:490-6.
13. Werner U, Preclinical pharmacology of the new GLP-1 receptor agonist AVE0010, Ann Endocrinol (Paris), 2008;69:164-5.
14. Becker R, Ruus P, Liu Y, Kapitza C, Restoration of insulin release with lixisenatide in patients with type 2 diabetes [abstract], Diabetologia, 2010;53(Suppl. 1):S339.
15. Liu Y-H, Ruus P, Effect of the GLP-1 agonist AVE0010 on absorption of concomitant oral drugs, Diabetes, 2009; 58(Suppl. 1). Available at: http://professional.diabetes.org/Abstracts_Display.aspx?TYP =1&CID=73257 (accessed 19 December 2011).
16. Tews D, Werner U, Eckel J, Enhanced protection against cytokine- and fatty acid-induced apoptosis in pancreatic beta cells by combined treatment with glucagon-like peptide-1 receptor agonists and insulin analogues, Horm Metab Res, 2008;40:172-80.
17. Haschke G, Haag-Diegarten S, Werner U, et al., The GLP-1 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=53 630 (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-reperfusioninduced 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=69 828 (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.
31. Drucker D, Minireview: the glucagon-like peptides, Endocrinology, 2001;142:521-7.
32. Nauck MA, Incretin-based therapies for type 2 diabetes mellitus: properties, functions, and clinical implications, Am J Med, 2011;124:S3-18.
33. Byetta package insert, San Diego, CA: Amylin Pharmaceuticals, Inc; 2010.
34. Knudsen LB, Nielsen PF, Huusfeldt PO et al., Potent derivatives of glucagon-like peptide-1 with pharmacokinetic properties suitable for once daily administration, J Med Chem, 2000;43:1664-9.
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 (GETGOALMONO). Available at: http://clinicaltrials.gov/ct2/show/NCT00688701?term=lixisenatide&ran k=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=lixisenatide&ran k=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&ran k=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=lixisenatide&ran k=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=lixisenatide&ran k=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-MAs). Available at: http://clinicaltrials.gov/ct2/show/NCT01169779?term=lixisenatide&ran k=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=lixisenatide&ran k=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=lixisenatide&ran k=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 (GETGOALMONO Japan LTS). Available at: http://clinicaltrials.gov/ct2/show/NCT00905255?term=lixisenatide&ran k=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=lixisenatide&ran k=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=lixisenatide&ran k=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=lixisenatide&ran k=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_GETGOALDUO_en.pdf (accessed 25 December 2011).