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Review

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

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Pages 217-231 | Published online: 17 Jun 2013

References

  • 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 15111519
  • 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 12610053
  • Göke B Islet cell function: alpha and beta cells – partners towards normoglycaemia Int J Clin Pract Suppl 2008 159 2 7 18269435
  • 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 20427697
  • Nathan DM Buse JB Davidson MB 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 18941734
  • 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 18036163
  • 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
  • Inzucchi SE Bergenstal RM Buse JB 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 22526604
  • Vilsbøll T Holst JJ Incretins, insulin secretion and Type 2 diabetes mellitus Diabetologia 2004 47 3 357 366 14968296
  • 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 6074000
  • Nauck MA Homberger E Siegel EG 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 3522621
  • 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 15271645
  • 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 7671853
  • 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 12832099
  • 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 8473405
  • Holst JJ The physiology of glucagon-like peptide 1 Physiol Rev 2007 87 4 1409 1439 17928588
  • 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 7657039
  • Nauck MA Heimesaat MM Behle K 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 11889194
  • 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 12673779
  • 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 15095038
  • 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 9338524
  • Hare KJ Knop FK Incretin-based therapy and type 2 diabetes Vitam Horm 2010 84 389 413 21094909
  • 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 9449682
  • 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 21430088
  • Nikolaidis LA Mankad S Sokos GG Effects of glucagon-like peptide-1 in patients with acute myocardial infarction and left ventricular dysfunction after successful reperfusion Circulation 2004 109 8 962 965 14981009
  • Nikolaidis LA Elahi D Hentosz T Recombinant glucagon-like peptide-1 increases myocardial glucose uptake and improves left ventricular performance in conscious dogs with pacing-induced dilated cardiomyopathy Circulation 2004 110 8 955 961 15313949
  • Nyström T Gutniak MK Zhang Q 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 15353407
  • Lønborg J Vejlstrup N Kelbæk H Exenatide reduces reperfusion injury in patients with ST-segment elevation myocardial infarction Eur Heart J 2012 33 12 1491 1499 21920963
  • Meier JJ Gethmann A Götze O Glucagon-like peptide 1 abolishes the postprandial rise in triglyceride concentrations and lowers levels of nonesterified fatty acids in humans Diabetologia 2006 49 3 452 458 16447057
  • Yerram P Whaley-Connell A Novel role for the incretins in blood pressure regulation Curr Opin Nephrol Hypertens 2012 21 5 463 468 22871675
  • 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 15582729
  • Carraro-Lacroix LR Malnic G Girardi AC Regulation of Na+/H+ exchanger NHE3 by glucagon-like peptide 1 receptor agonist exendin-4 in renal proximal tubule cells Am J Physiol Renal Physiol 2009 297 6 F1647 F1655 19776173
  • 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
  • Distiller L Ruus P Pharmacokinetics and pharmacodynamics of GLP-1 agonist AVE0010 in type 2 diabetes patients [Abstract] Diabetes 2008 57 Suppl 1 520-P
  • Meier JJ Nauck MA Kranz D 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 14988249
  • 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
  • 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
  • Liu YH Ruus P Pharmacokinetics and safety of the GLP-1 Agonist AVE0010 in patients with renal impairment [Abstract] Diabetes 2009 58 Suppl 1 557-P
  • Liu YH Ruus P Effect of the GLP-1 Agonist AVE0010 on absorption of concomitant oral drugs [Abstract] Diabetes 2009 58 Suppl 1 495-P
  • 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
  • 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 12975499
  • 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 20570597
  • 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 20722676
  • Meier JJ GLP-1 receptor agonists for individualized treatment of type 2 diabetes mellitus Nat Rev Endocrinol 2012 8 12 728 742 22945360
  • Makris K Spanou L Is there a relationship between mean blood glucose and glycated hemoglobin? J Diabetes Sci Technol 2011 5 6 1572 1583 22226280
  • Rosenstock J Forst T Aronson R 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
  • Aronson R Riddle M Home P 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
  • 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 22564709
  • Rosenstock J Raccah D Korányi L 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
  • 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 1 31 2013
  • 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 3 27 2013
  • Raccah D Miossec P Esposito V Niemoeller E Cho M Gerich J 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 program [Poster] 48th EASD Annual Meeting 1–5 October 2012 P815
  • 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 22432104
  • 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]
  • 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
  • Ratner RE Hanefeld M Shamanna P 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
  • 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 23423907
  • Bolli G Munteanu M Dotsenko S Niemoeller E Wardęcki 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
  • 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
  • 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 17259389
  • 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/medi-cines/000698/human_med_000682.jsp&mid=WC0b01ac058001d124 Accessed April 20, 2013
  • De La Loge C Trudeau E Marquis P Responsiveness and interpretation of a quality of life questionnaire specific to upper gastrointestinal disorders Clin Gastroenterol Hepatol 2004 2 9 778 786 15354278
  • 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 23263796
  • 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 19748064
  • Aroda VR Henry RR Han J Efficacy of GLP-1 receptor agonists and DPP-4 inhibitors: meta-analysis and systematic review Clin Ther 2012 34 6 1247 1258 22608780
  • 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 19149642