Clinical potential of lixisenatide once daily treatment for type 2 diabetes mellitus

Diabetes, Metabolic Syndrome and Obesity

Volumn 6, Issue , 2013, Pages 217-231

  Petersen, Andreas B ^a   Christensen, Mikkel ^a,b  

^a BISPEBJERG HOSPITAL   (Denmark)

^b GENTOFTE UNIVERSITY HOSPITAL   (Denmark)

Author keywords

GetGoal; GLP 1; Incretin; Pharmacology; T2DM

Indexed keywords

ETHINYLESTRADIOL; EXENDIN 4; GLITAZONE DERIVATIVE; GLUCAGON LIKE PEPTIDE 1; HEMOGLOBIN A1C; INCRETIN; INSULIN; INSULIN GLARGINE; LIRAGLUTIDE; LIXISENATIDE; METFORMIN; PARACETAMOL; PIOGLITAZONE; PLACEBO; SULFONYLUREA; WARFARIN;

ALLERGIC REACTION; ANGIONEUROTIC EDEMA; ANTIBODY PRODUCTION; ANTIDIABETIC ACTIVITY; ARTICLE; CREATININE CLEARANCE; DIARRHEA; DIZZINESS; DRUG ABSORPTION; DRUG ANTAGONISM; DRUG CLEARANCE; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG POTENTIATION; DRUG SAFETY; DRUG STRUCTURE; DRUG TOLERABILITY; DRUG WITHDRAWAL; EVENING DOSAGE; GASTROINTESTINAL SYMPTOM; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HEART RATE; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPERGLYCEMIA; HYPOGLYCEMIA; INSULIN RELEASE; INSULIN RESPONSE; LIFE EXPECTANCY; MAXIMUM PLASMA CONCENTRATION; MORNING DOSAGE; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; OUTCOME ASSESSMENT; PANCREATITIS; PATHOPHYSIOLOGY; PATIENT SATISFACTION; SIDE EFFECT; STOMACH EMPTYING; TIME TO MAXIMUM PLASMA CONCENTRATION; URTICARIA; VOMITING;

EID: 84879166768     PISSN: 11787007     EISSN: None     Source Type: Journal    
DOI: 10.2147/DMSO.S45379     Document Type: Article

References (66)

1. Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004;27(5):1047-1053.
2. Monnier L, Lapinski H, Colette C. Contributions of fasting and postprandial plasma glucose increments to the overall diurnal hyperglycemia of type 2 diabetic patients: variations with increasing levels of HbA(1c). Diabetes Care. 2003;26(3):881-885.
3. Göke B. Islet cell function: alpha and beta cells-partners towards normoglycaemia. Int J Clin Pract Suppl. 2008;159:2-7.
4. Meier JJ, Nauck MA. Is the diminished incretin effect in type 2 diabetes just an epi-phenomenon of impaired beta-cell function? Diabetes. 2010;59(5):1117-1125.
5. Nathan DM, Buse JB, Davidson MB, etal; American Diabetes Association; European Association for the Study of Diabetes. Medical management of hyperglycaemia in type 2 diabetes mellitus: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetologia. 2009;52(1):17-30.
6. Cubbon R, Kahn M, Kearney MT. Secondary prevention of cardiovascular disease in type 2 diabetes and prediabetes: a cardiologist's perspective. Int J Clin Pract. 2008;62(2):287-299.
7. Gaede P, Lund-Andersen H, Parving H-H, Pedersen O. Effect of a multifactorial intervention on mortality in type 2 diabetes. N Eng J Med. 2008;358(6):580-591.
8. Inzucchi SE, Bergenstal RM, Buse JB, etal. 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 (EASD). Diabetologia. 2012;55(6):1577-1596.
9. Vilsbøll T, Holst JJ. Incretins, insulin secretion and Type 2 diabetes mellitus. Diabetologia. 2004;47(3):357-366.
10. Perley MJ, Kipnis DM. Plasma insulin responses to oral and intravenous glucose: studies in normal and diabetic subjects. J Clin Invest. 1967;46(12):1954-1962.
11. Nauck MA, Homberger E, Siegel EG, etal. Incretin effects of increasing glucose loads in man calculated from venous insulin and C-peptide responses. J Clin Endocrinol Metab. 1986;63(2):492-498.
12. Holst JJ, Gromada J. Role of incretin hormones in the regulation of insulin secretion in diabetic and nondiabetic humans. Am J Physiol Endocrinol Metab. 2004;287(2):E199-E206.
13. Fehmann HC, Göke R, Göke B. Cell and molecular biology of the incretin hormones glucagon-like peptide-I and glucose-dependent insulin releasing polypeptide. Endocr Rev. 1995;16(3):390-410.
14. Vilsbøll T, Krarup T, Madsbad S, Holst JJ. Both GLP-1 and GIP are insulinotropic at basal and postprandial glucose levels and contribute nearly equally to the incretin effect of a meal in healthy subjects. Regul Pept. 2003;114(2-3):115-121.
15. Nauck MA, Bartels E, Orskov C, Ebert R, Creutzfeldt W. Additive insulinotropic effects of exogenous synthetic human gastric inhibitory polypeptide and glucagon-like peptide-1-(7-36) amide infused at near-physiological insulinotropic hormone and glucose concentrations. J Clin Endocrinol Metab. 1993;76(4):912-917.
16. Holst JJ. The physiology of glucagon-like peptide 1. Physiol Rev. 2007;87(4):1409-1439.
17. Deacon CF, Nauck MA, Toft-Nielsen M, Pridal L, Willms B, Holst JJ. Both subcutaneously and intravenously administered glucagon-like peptide I are rapidly degraded from the NH2-terminus in type II diabetic patients and in healthy subjects. Diabetes. 1995;44(9):1126-1131.
18. Nauck MA, Heimesaat MM, Behle K, etal. Effects of glucagon-like peptide 1 on counterregulatory hormone responses, cognitive functions, and insulin secretion during hyperinsulinemic, stepped hypoglycemic clamp experiments in healthy volunteers. J Clin Endocrinol Metab. 2002;87(3):1239-1246.
19. Egan JM, Bulotta A, Hui H, Perfetti R. GLP-1 receptor agonists are growth and differentiation factors for pancreatic islet beta cells. Diabetes Metab Res Rev. 2003;19(2):115-123.
20. Buteau J, El-Assaad W, Rhodes CJ, Rosenberg L, Joly E, Prentki M. Glucagon-like peptide-1 prevents beta cell glucolipotoxicity. Diabetologia. 2004;47(5):806-815.
21. Larsson H, Holst JJ, Ahrén B. Glucagon-like peptide-1 reduces hepatic glucose production indirectly through insulin and glucagon in humans. Acta Physiol Scand. 1997;160(4):413-422.
22. Hare KJ, Knop FK. Incretin-based therapy and type 2 diabetes. Vitam Horm. 2010;84:389-413.
23. Flint A, Raben A, Astrup A, Holst JJ. Glucagon-like peptide 1 promotes satiety and suppresses energy intake in humans. J Clin Invest. 1998;101(3):515-520.
24. Nauck MA, Kemmeries G, Holst JJ, Meier JJ. Rapid tachyphylaxis of the glucagon-like peptide 1-induced deceleration of gastric emptying in humans. Diabetes. 2011;60(5):1561-1565.
25. Nikolaidis LA, Mankad S, Sokos GG, etal. Effects of glucagon-like peptide-1in patients with acute myocardial infarction and left ventricular dysfunction after successful reperfusion. Circulation. 2004;109(8):962-965.
26. Nikolaidis LA, Elahi D, Hentosz T, etal. Recombinant glucagon-like peptide-1increases myocardial glucose uptake and improves left ventricular performance in conscious dogs with pacing-induced dilated cardiomyopathy. Circulation. 2004;110(8):955-961.
27. Nyström T, Gutniak MK, Zhang Q, etal. Effects of glucagon-like peptide-1 on endothelial function in type 2 diabetes patients with stable coronary artery disease. Am J Physiol Endocrinol Metab. 2004; 287(6):E1209-E1215.
28. Lønborg J, Vejlstrup N, Kelbæk H, etal. Exenatide reduces reperfusion injury in patients with ST-segment elevation myocardial infarction. Eur Heart J. 2012;33(12):1491-1499.
29. Meier JJ, Gethmann A, Götze O, etal. Glucagon-like peptide 1 abolishes the postprandial rise in triglyceride concentrations and lowers levels of non-esterified fatty acids in humans. Diabetologia. 2006;49(3):452-458.
30. Yerram P, Whaley-Connell A. Novel role for the incretins in blood pressure regulation. Curr Opin Nephrol Hypertens. 2012;21(5):463-468.
31. Nyström T, Gonon AT, Sjöholm A, Pernow J. Glucagon-like peptide-1 relaxes rat conduit arteries via an endothelium-independent mechanism. Regul Pept. 2005;125(1-3):173-177.
32. Carraro-Lacroix LR, Malnic G, Girardi AC. Regulation of Na+/H+ exchanger NHE3 by glucagon-like peptide 1 receptor agonist exendin-4in renal proximal tubule cells. Am J Physiol Renal Physiol. 2009;297(6):F1647-F1655.
33. Becker R, Kapitza C, Stechl J, Ruus P, Msihid J. Restitution of glucose disposition with lixisenatide in subjects with type 2 diabetes [Abstract]. Diabetologia. 2012;55 Suppl 1:S335-S336.
34. Distiller L, Ruus P. Pharmacokinetics and pharmacodynamics of GLP-1 agonist AVE0010in type 2 diabetes patients [Abstract]. Diabetes. 2008;57 Suppl 1:520-P.
35. Meier JJ, Nauck MA, Kranz D, etal. Secretion, degradation, and elimination of glucagon-like peptide 1 and gastric inhibitory polypeptide in patients with chronic renal insufficiency and healthy control subjects. Diabetes. 2004;53(3):654-662.
36. Stechl J, Becker R, Kapitza C, Msihid J. Augmentation of 1st-phase insulin release with lixisenatide in non-diabetic subjects [Abstract]. Diabetologia. 2012;55 Suppl 1:S336.
37. European Medicines Agency. Byetta: EPAR-Product Information. London: European Medicines Agency; 2009 [updated March 25, 2013; cited January 10, 2013]. Available from: http://www.emea.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000698/human_med_000682.jsp&mid=WC0b01ac058001d124#product-info. Accessed April 20, 2013.
38. Liu YH, Ruus P. Pharmacokinetics and safety of the GLP-1 Agonist AVE0010in patients with renal impairment [Abstract]. Diabetes. 2009;58 Suppl 1:557-P.
39. Liu YH, Ruus P. Effect of the GLP-1Agonist AVE0010 on absorption of concomitant oral drugs [Abstract]. Diabetes. 2009;58 Suppl 1:495-P.
40. Liu YH, Ruus P, Steinstraesser A, Teichert L. Effect of the GLP-1 agonist lixisenatide on the pharmacokinetics of warfarin [Abstract]. Diabetes. 2010;59 Suppl 1:2128-PO.
41. Thorkildsen C, Neve S, Larsen BD, Meier E, Petersen JS. 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(2):490-496.
42. 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(2-3):58-64.
43. Ratner RE, Rosenstock J, Boka G; DR16012 Study Investigators. 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):1024-1032.
44. Meier JJ. GLP-1 receptor agonists for individualized treatment of type 2 diabetes mellitus. Nat Rev Endocrinol. 2012;8(12):728-742.
45. Makris K, Spanou L. Is there a relationship between mean blood glucose and glycated hemoglobin? J Diabetes Sci Technol. 2011;5(6):1572-1583.
46. Rosenstock J, Forst T, Aronson R, etal. Once-daily lixisenatide added on to consistently titrated insulin glargine plus oral agents in type 2 diabetes: the getgoal-duo 1 study [Abstract]. Diabetologia. 2012;55 Suppl 1:S333.
47. Aronson R, Riddle M, Home P, etal. Efficacy and safety of once-daily lixisenatide in type 2 diabetes insufficiently controlled with basal insulin ± metformin: GetGoal-L study [Abstract]. Diabetologia. 2012; 55 Suppl 1:S8.
48. Seino Y, Min KW, Niemoeller E, Takami A; EFC10887 GETGOAL-L Asia Study Investigators. 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):910-917.
49. Rosenstock J, Raccah D, Korányi L, etal. Efficacy and safety of lixisenatide once-daily versus exenatide twice-daily in patients with type 2 diabetes insufficiently controlled on metformin (GetGoal-X) [Abstract]. Diabetologia. 2011;54 Suppl 1:S317-S318.
50. Kapitza C, Forst T, Coester HV, Poitiers F, Ruus P, Hincelin-Méry A. Pharmacodynamic characteristics of lixisenatide once daily versus liraglutide once daily in patients with type 2 diabetes insufficiently controlled on metformin. Diabetes Obes Metab. 2013. Epub January 31, 2013.
51. Ahrén B, Leguizamo Dimas A, Miossec P, Saubadu S, Aronson R. Efficacy and safety of lixisenatide once-daily morning or evening injections in type 2 diabetes inadequately controlled on metformin (GetGoal-M). Diabetes Care. Epub March 27, 2013.
52. Raccah D, Miossec P, Esposito V, Niemoeller E, Cho M, Gerich J. 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 program [Poster]. 48th EASD Annual Meeting 1-5 October 2012. P815.
53. Fonseca VA, Alvarado-Ruiz R, Raccah D, Boka G, Miossec P, Gerich JE; EFC6018 GetGoal-Mono Study Investigators. 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):1225-1231.
54. Lorenz M, Pfeiffer C, Steinstraesser A, Ruus P, Becker R. Effects of lixisenatide once daily on gastric emptying and its relationship to postprandial glycemia in type 2 diabetes mellitus. Diabetes. 2012, 61:A212-A344. [Abstract 1085-P].
55. Bolli G, Munteanu M, Dotsenko S, Niemoeller E, Boka G, Hanefeld M. Efficacy and safety of lixisenatide once-daily versus placebo in patients with type 2 diabetes mellitus insufficiently controlled on metformin (GetGoal-F1) [Abstract]. Diabetologia. 2011;54 Suppl 1: S316-S317.
56. Ratner RE, Hanefeld M, Shamanna P, etal. Post-meal pharmacodynamic profile of lixisenatide once daily vs placebo in T2DM insufficiently controlled on SU ± metformin (GetGoal-S) [Abstract D-0743]. Proceedings of the World Diabetes Congress 2011; December 4-8, 2011; Dubai, United Arab Emirates.
57. 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.
58. Bolli G, Munteanu M, Dotsenko S, Niemoeller E, Warde{ogonek}cki M, Hanefeld M. Long-term (up to 2 Years) safety of lixisenatide once daily vs placebo in t2dm insufficiently controlled on metformin (GetGoal-F1) [Abstract O-0595]. Proceedings of the World Diabetes Congress 2011; December 4-8, 2011; Dubai, United Arab Emirates.
59. Pinget M, Goldenberg R, Niemoeller E, Muehlen-Bartmer I, Aronson R. Efficacy and safety of lixisenatide once daily versus placebo in patients with type 2 diabetes insufficiently controlled on pioglitazone (GetGoal-P) [Abstract]. Diabetologia. 2012;55 Suppl 1:S334.
60. De Heer J, Holst JJ. Sulfonylurea compounds uncouple the glucose dependence of the insulinotropic effect of glucagon-like peptide 1. Diabetes. 2007;56(2):438-443.
61. European Medicines Agency. Byetta: EPAR-Scientific Discussion. London: European Medicines Agency; 2006. Available from: http://www.emea.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000698/human_med_000682.jsp&mid=WC0b01ac058001d124. Accessed April 20, 2013.
62. De La Loge C, Trudeau E, Marquis P, etal. Responsiveness and interpretation of a quality of life questionnaire specific to upper gastrointestinal disorders. Clin Gastroenterol Hepatol. 2004;2(9):778-786.
63. Russell S. Incretin-based therapies for type 2 diabetes mellitus: a review of direct comparisons of efficacy, safety and patient satisfaction. Int J Clin Pharm. 2013;35(2):159-172.
64. Madsbad S. Exenatide and liraglutide: different approaches to develop GLP-1 receptor agonists (incretin mimetics)-preclinical and clinical results. Best Pract Res Clin Endocrinol Metab. 2009;23(4):463-477.
65. Aroda VR, Henry RR, Han J, etal. Efficacy of GLP-1 receptor agonists and DPP-4inhibitors: meta-analysis and systematic review. Clin Ther. 2012;34(6):1247-1258.
66. Peter R, Okoseime OE, Rees A, Owens DR. Postprandial glucose-a potential therapeutic target to reduce cardiovascular mortality. Curr Vasc Pharmacol. 2009;7(1):68-74.