Lixisenatide: A review of its use in patients with type 2 diabetes mellitus

BioDrugs

Volumn 27, Issue 5, 2013, Pages 509-523

  Scott, Lesley J ^a  

^a NONE   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

2,4 THIAZOLIDINEDIONE; COUMARIN DERIVATIVE; DIGOXIN; EXENDIN 4; GLUCAGON LIKE PEPTIDE 1 RECEPTOR AGONIST; HEMOGLOBIN A1C; INSULIN; INSULIN GLARGINE; LIRAGLUTIDE; LIXISENATIDE; METFORMIN; ORAL ANTIDIABETIC AGENT; PARACETAMOL; PIOGLITAZONE; PLACEBO; RAMIPRIL; SITAGLIPTIN; SULFONYLUREA DERIVATIVE; WARFARIN;

ACUTE PANCREATITIS; ANAPHYLAXIS; ANGIONEUROTIC EDEMA; ARTICLE; BACKACHE; BODY WEIGHT; CARDIOVASCULAR RISK; CYSTITIS; DIARRHEA; DIET THERAPY; DIZZINESS; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG INDICATION; DRUG MECHANISM; DRUG METABOLISM; DRUG SAFETY; DRUG SELECTIVITY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; FOOD INTAKE; GASTROINTESTINAL SYMPTOM; GLYCEMIC CONTROL; HEADACHE; HUMAN; HYPOGLYCEMIA; INFLUENZA; INJECTION SITE PRURITUS; INJECTION SITE REACTION; KINESIOTHERAPY; MONOTHERAPY; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; NONHUMAN; PANCREAS CANCER; PANCREATITIS; PHASE 3 CLINICAL TRIAL (TOPIC); PRACTICE GUIDELINE; PRIORITY JOURNAL; RECOMMENDED DRUG DOSE; SOMNOLENCE; THYROID CANCER; TREATMENT DURATION; UPPER RESPIRATORY TRACT INFECTION; URTICARIA; VIRUS INFECTION; VOMITING; WEIGHT REDUCTION;

DIABETES MELLITUS, TYPE 2; DRUG THERAPY, COMBINATION; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN; PEPTIDES;

EID: 84885131556     PISSN: 11738804     EISSN: 1179190X     Source Type: Journal    
DOI: 10.1007/s40259-013-0057-y     Document Type: Article

References (72)

1. International Diabetes Federation. Global diabetes plan 2011-2021; 2012. http://www.idf.org/sites/default/files/Global-Diabetes-Plan-Final.pdf (Accessed 6 May 2013).
2. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycaemia in type 2 diabetes: a patient-centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes. Diabetes Care. 2012;35:1364-79.
3. Sherwin R, Jastreboff AM. Year in diabetes 2012: the diabetes tsunami. J Clin Endocrinol Metab. 2012;97(12):4293-301.
4. Nauck MA. Incretin-based therapies for type 2 diabetes mellitus: properties, functions, and clinical implications. Am J Med. 2011;124 Suppl.:S3-18.
5. Nauck MA. Unraveling the science of incretin biology. Am J Med. 2009;122 Suppl.:S3-10.
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. Malm-Erjefalt M, Bjornsdottir I, Vanggaard J, et al. Metabolism and excretion of the once-daily human glucagon-like peptide-1 analog liraglutide in healthy male subjects and its in vitro degradation by dipeptidyl peptidase IV and neutral endopeptidase. Drug Metab Dispos. 2010;38(11):1944-53.
8. Fonseca VA, Alvarado-Ruiz R, Raccah D, et al. Efficacy and safety of the once-daily GLP-1 receptor agonist lixisenatide in monotherapy: a randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes (GetGoal-Mono). Diabetes Care. 2012;35(6):1225-31.
9. 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;302(2):490-6.
10. Werner U, Haschke G, Herling AW, et al. Pharmacological profile of lixisenatide: a new GLP-1 receptor agonist for the treatment of type 2 diabetes. Regul Pept. 2010;164(2-3):58-64.
11. Horowitz M, Rayner CK, Jones KL. Mechanisms and clinical efficacy of lixisenatide for the management of type 2 diabetes. Adv Ther. 2013;30(2):81-101.
12. Werner U, Gerlach M, Hofmann M, et al. Combination of lixisenatide and insulin glargine demonstrates complementary pharmacological activity on glycemic control in animal models of diabetes [abstract no.1051-p]. Diabetes. 2012;61 Suppl.1:A270.
13. European Medicines Agency. Lixisenatide: summary of product characteristics; 2013. http://www.ema.europa.eu/docs/en-GB/document-library/ EPAR-Product-Information/human/002445/WC500140401.pdf (Accessed 8 Apr 2013).
14. Kapitza C, Forst T, Coester H-V, et al. Pharmacodynamic characteristics of lixisenatide once daily versus liraglutide once daily in patients with type 2 diabetes inadequately controlled on metformin. Diabetes Obes Metabol. 2013;15(7):642-9.
15. Becker RH, Kapitza C, Stechl J, et al. Restitution of glucose disposition with lixisenatide in subjects with type 2 diabetes [abstract no.813]. Diabetologia. 2012;55 Suppl.1:S335-S6.
16. Becker RHA, Ruus P, Li YH, et al. Restoration of insulin release with lixisenatide in patients with type 2 diabetes [abstract no. 850]. Diabetologia. 2010;53 Suppl.1:S339.
17. Stechl J, Becker RH, Kapitza C, et al. Augmentation of first-phase insulin release with lixisenatide in nondiabetic subjects [abstract no. 814]. Diabetologia. 2012;55:S336.
18. Ratner RE, Hanefeld M, Shamanna P, et al. Post-meal pharmacodynamic profile of lixisenatide once daily vs placebo in T2DM insufficiently controlled on SU ± metformin (GetGoal-S) [abstract no. D-0743]. 21st World Congress of the International Diabetes Federation, Dubai; 4-8 Dec 2011.
19. Lorenz M, Pfeiffer C, Steinstraser A, et al. Effects of lixisenatide once daily on gastric emptying in type 2 diabetes: relationship to postprandial glycemia. Regul Peptides. 2013;185C:1-8.
20. Hubschle T, Schafer HL, Juretschke HP, et al. Anti-atherosclerotic activity of lixisenatide in ApoE knockout mice [abstract no. 809]. Diabetologia. 2012;55 Suppl.1:S334.
21. Wohlfart P, Linz W, Hubschle T, et al. Cardioprotective effects of lixisenatide in rat myocardial ischaemia-reperfusion injury studies. J Transl Med. 2013;11:84.
22. Liu Y-H, Ruus P. Effect of GLP-1 receptor agonist AVE0010 on the absorption of concomitant oral drugs: acetaminophen and ethinylestradiol/ levonorgestrel [abstract no. 776]. 45th Annual Meeting of the European Association for the Study of Diabetes, Vienna; 29 Sep-2 Oct 2009.
23. Liu YH, Ruus P, Steinstraesser A, et al. Effect of the GLP-1 agonist lixisenatide on the pharmacokinetics of warfarin [abstract no. 2128-PO]. 70th Annual Scientific Sessions of the American Diabetes Association, Orlando; 25-29 Jun 2010.
24. Dahmen R, Steinstraesser A, Poitiers F, et al. Interaction of subcutaneous lixisenatide 20 μg QD on pharmacokinetic and pharmacodynamic properties of oral ramipril 5 mg QD [abstract]. Basic Clin Pharmacol Toxicol. 2011;109 Suppl.:89.
25. Bolli G, Munteanu M, Dotsenko S, et al. Efficacy and safety of lixisenatide once-daily versus placebo in patients with type 2 diabetes mellitus insufficiently controlled on metformin (GetGoal-F1) [abstract no. 784]. Diabetologia. 2011;54(Suppl. 1):S316-7.
26. Ahren B, Leguizamo A, Miossec P, et al. Efficacy and safety of lixisenatide once-daily morning or evening injections in type 2 diabetes inadequately controlled on metformin (GetGoal-M). Diabetes Care. 2013. doi: 10.2337/dc12-2006.
27. Pan CY, Zhao Q, Niemoeller E. Lixisenatide in Asian patients with type 2 diabetes (T2DM) uncontrolled on metformin ± sulfonylurea (SU): GetGoal-M Asia [abstract no. PCS-20-3]. J Diabetes Invest. 2012;3 Suppl.1:204.
28. Ratner RE, Hanefeld M, Shamanna P, 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) [abstract no. 785]. Diabetologia. 2011;54 Suppl.1:S317.
29. Pinget M, Goldenberg R, Niemoeller E, et al. Efficacy and safety of lixisenatide once daily versus placebo in patients with type 2 diabetes insufficiently controlled on pioglitazone (GetGoal-P). Diabetes Obes Metab. 2013. doi: 10.1111/dom.12121.
30. Riddle MC, Aronson R, Home P, et al. Adding once-daily lixisenatide for type 2 diabetes inadequately controlled by established basal insulin: a 24-week, randomized, placebo-controlled comparison (GetGoal-L). Diabetes Care. 2013. doi: 10.2337/dc12-2454.
31. Seino Y, Min KW, Niemoeller E, et al. Randomized, double-blind, placebo-controlled trial of the once-daily GLP-1 receptor agonist lixisenatide in Asian patients with type 2 diabetes insufficiently controlled on basal insulin with or without a sulfonylurea (GetGoal-L-Asia). Diabetes Obes Metab. 2012;14(10):910-7.
32. Riddle MC, Forst T, Aronson R, et al. Adding once-daily lixisenatide in type 2 diabetes inadequately controlled with newly initiated insulin and continuously titrated basal insulin glargine: a 24-week, randomized, placebo-controlled study (GetGoal-DUO-l). Diabetes Care. 2013. doi: 10.2337/dc12-2462.
33. Rosenstock J, Raccah D, Koranyi L, et al. Efficacy and safety of lixisenatide once daily versus exenatide twice daily in type 2 diabetes inadequately controlled on metformin: a 24-week, randomized, open-label, active-controlled study (GetGoal-X). Diabetes Care. 2013. doi: 10.2337/dc12-2709.
34. European Medicines Agency. Assessment report Lyxumia. 2012. http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Public-assessment- report/human/002445/WC500140449.pdf (Accessed 8 Apr 2013).
35. Sanofi. 24-week study comparing lixisenatide (AVE0010) to sitagliptin as add-on to metformin in obese type 2 diabetic patients younger than 50 [ClinicalTrials.gov identifier NCT00976937]. US National Institutes of Health, ClinicalTrials.gov; 2012. http://www.clinicaltrials.gov (Accessed 9 April 2013).
36. Sanofi. GLP-1 agonist AVE0010 in patients with type 2 diabetes for gylcemic control and safety evaluation, on top of sulfonylurea (GetGoal-S) [ClinicalTrials.gov identifier NCT00713830]. US National Institutes of Health, ClinicalTrials.gov; 2012. http://www.clinicaltrials.gov (Accessed 12 Apr 2013).
37. Sanofi. Efficacy and safety of lixisenatide in patients with type 2 diabetes mellitus insufficiently controlled by metformin (GetGoal-M-Asia) [ClinicalTrials.gov identifier NCT01169779]. US National Institutes of Health, ClinicalTrials.gov; 2012. http://www.clinicaltrials.gov (Accessed 12 Apr 2013).
38. Sanofi. GLP-1 agonist AVE0010 in patients with type 2 diabetes for gylcemic control and safety evaluation, on top of metformin (GetGoal-F1) [ClinicalTrials.gov identifier NCT00763451]. US National Institutes of Health, ClinicalTrials.gov; 2012. http://www.clinicaltrials.gov (Accessed 12 Apr 2013).
39. Ratner RE, Rosenstock J, Boka G, et al. 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(9):1024-32.
40. Raccah D, Miossec P, Esposito V, et al. Efficacy and safety of lixisenatide in elderly (≥65 years) and very elderly (≥75 years) patients with type 2 diabetes: an analysis from the GetGoal Phase 3 programme [abstract no. 815]. Diabetologia. 2012;55 Suppl.1:S336.
41. Bolli G, Munteanu M, Dotsenko S, et al. Long-term (up to 2 years) safety of lixisenatide once daily vs placebo in T2DM insufficiently controlled on metformin (GetGoal-F1) [abstract no. O-0595]. 21st World Congress of the International Diabetes Federation, Dubai; 4-8 Dec 2011.
42. ® is first diabetes therapy of its class approved for use combination with basal insulin; 2013. http://en.sanofi.com/ Images/33261-20130628-LYXUMIA-en.pdf (Accessed 2 Jul 2013).
43. Sanofi. Sanofi New Drug Application for lixisenatide accepted for review by FDA; 2013. http://en.sanofi.com/Images/31904-20130219-LIXISENATIDE-en.pdf (Accessed 30 Apr 2013).
44. Zhang Y, Hu G, Yuan Z, et al. Glycosylated hemoglobin in relationship to cardiovascular outcomes and death in patients with type 2 diabetes: a systematic review and meta-analysis. PLoS ONE. 2012;7(8):e42551.
45. Node K, Inoue T. Postprandial hyperglycaemia as an etiological factor in vascular failure. Cardiovasc Diabetol. 2009;8:23.
46. Monnier L, Lapinski H, Colette C. Contributions of fasting and postprandial plasma glucose increments to the overall diurnal hyperglycaemia of type 2 diabetic patients: variations with increasing levels of HbA(1c). Diabetes Care. 2003;26(3):881-5.
47. Bonora E, Muggeo M. Postprandial blood glucose as a risk factor for cardiovascular disease in type II diabetes: the epidemiological evidence. Diabetologia. 2001;44(12):2107-14.
48. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood glucose control with sulphonylureas or insulin compared with conventional treatments and risk of complications in patients with type 2 diabetes. Lancet. 1998;352:837-53.
49. Turnbull FM, Abraira C, Anderson RJ, et al. Intensive glucose control and macrovascular outcomes in type 2 diabetes. Diabetologia. 2009;52(11):2288-98.
50. Ray KK, Seshasai SR, Wijesuriya S, et al. Effect of intensive control of glucose on cardiovascular outcomes and death in patients with diabetes mellitus: a meta-analysis of randomised controlled trials. Lancet. 2009;373(9677):1765- 72.
51. Kelly TN, Bazzano LA, Fonseca VA, et al. Systematic review: glucose control and cardiovascular disease in type 2 diabetes. Ann Intern Med. 2009;151(6):394-403.
52. Holman RR, Paul SK, Bethel MA, et al. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med. 2008;359(15):1577-89.
53. Selvin E, Marinopoulos S, Berkenblit G, et al. Meta-analysis: glycosylated hemoglobin and cardiovascular disease in diabetes mellitus. Ann Intern Med. 2004;141(6):421-31.
54. Stolar M. Glycemic control and complications in type 2 diabetes mellitus. Am J Med. 2010;123:S3-11.
55. Del Prato S, LaSalle J, Matthaei S, et al. Tailoring treatment to the individual in type 2 diabetes practical guidance from the Global Partnership for Effective Diabetes Management. Int J Clin Pract. 2010;64(3):295-304.
56. Monnier L, Colette C, Dunseath GJ, et al. The loss of prandial glycemic control precedes stepwise deterioration of fasting with worsening diabetes. Diabetes Care. 2007;30(2):263-9.
57. Riddle M, Umpierrez G, DiGenio A, et al. Contributions of basal and postprandial hyperglycemia over a wide range of A1C levels before and after treatment intensification in type 2 diabetes. Diabetes Care. 2011;34(12):2508-14.
58. International Diabetes Foundation Clinical Guidelines Task Force. Global Guideline for type 2 diabetes; 2012. http://www.idf.org/sites/default/files/IDF- Guideline-for-Type-2-Diabetes.pdf (Accessed 8 May 2013).
59. Bailey CJ, Kodack M. Patient adherence to medication requirements for therapy of type 2 diabetes. Int J Clin Pract. 2011;65(3):314-22.
60. European Medicines Agency. Forxiga: summary of product characteristics; 2013. http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product- Information/human/002322/WC500136026.pdf (Accessed 10 May 2013).
61. Janssen Pharmaceuticals Inc. Invokana™: US prescribing information. 2013. http://www.invokanahcp.com/prescribing-information.pdf (Accessed 10 May 2013).
62. Tahrani AA, Bailey CJ, Del Prato S, et al. Management of type 2 diabetes: new and future developments in the treatment. Lancet. 2011;378:182-97.
63. Ghosh RK, Ghosh SM, Chawla S, et al. SGLT2 inhibitors: a new emerging class in the treatment of type 2 diabetes mellitus. J Clin Pharmacol. 2012;52:457-63.
64. DeFronzo RA, Davidson JA, Del Prato S. The role of the kidneys in glucose homeostasis: a new path towards normalizing glycaemia. Diabetes Obes Metabol. 2012;14:5-14.
65. Hirshberg B, Raz I. Impact of the US Food and Drug Administration cardiovascular assessment requirements on the drug development of novel antidiabetes drugs. Diabetes Care. 2011;34 Suppl.2:S101-6.
66. Sanofi. Evaluation of cardiovascular outcomes in patients with type 2 diabetes after acute coronary syndrome during treatment with AVE0010 (lixisenatide) (ELIXA) [ClinicalTrials.gov identifier NCT01147250]. US National Institutes of Health, ClinicalTrials.gov; 2013. http://www.clinicaltrials.gov (Accessed 9 May 2013).
67. Singh S, Chang H-Y, Richards TM, et al. Glucagon like peptide 1-based therapies and risk of hospitalization for acute pancreatitis in type 2 diabetes mellitus. JAMA Intern Med. 2013;173(7):534-9.
68. Butler AE, Campbell-Thompson M, Gurlo T, et al. Marked expansion of exocrine and endocrine pancreas with incretin therapy in humans with increased exocrine pancreas dysplasia and the potential for glucagon-producing neuroendocrine tumors. Diabetes. 2013;62:2595-604.
69. Elashoff M, Matveyenko AV, Gier B, et al. Pancreatitis, pancreatic, and thyroid cancer with glucagon-like peptide-1-based therapies. Gastroenterology. 2011;141:150-6.
70. Nauck MA. A critical analysis of the clinical use of incretin-based therapies: the benefits by far outweigh the potential risks. Diabetes Care. 2013. doi: 10.2337/dc12-2504.
71. European Medicines Agency. European Medcines Agency investigates findings on pancreatic risks with GLP-1-based therapies for type 2 diabetes; 2013. http://www.ema.europa.eu/docs/en-GB/document-library/Press-release/2013/03/ WC500140866.pdf (Accessed 19 Jun 2013).
72. US Food and Drug Administration. FDA drug safety communication: FDA investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes; 2013. http://www.fda.gov/Drugs/DrugSafety/ucm343187.htm (Accessed 19 Jun 2013).