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Published in: BioDrugs 5/2013

01-10-2013 | Adis Drug Evaluation

Lixisenatide: A Review of Its Use in Patients with Type 2 Diabetes Mellitus

Author: Lesley J. Scott

Published in: BioDrugs | Issue 5/2013

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Abstract

Lixisenatide (Lyxumia®) is a glucagon-like peptide-1 receptor agonist that acts in a glucose-dependent manner to improve glycemic control in adult patients with type 2 diabetes mellitus. Subcutaneous once-daily prandial lixisenatide is indicated for the treatment of adult patients with type 2 diabetes to achieve glycemic control in combination with oral antihyperglycemic drugs (OADs) and/or basal insulin when these antihyperglycemic drugs do not provide adequate glycemic control. In an extensive phase III clinical trial program, lixisenatide once daily in combination with OADs and/or basal insulin for 24 weeks improved glycemic control, had beneficial effects on bodyweight, and was generally well tolerated in adult patients with inadequately controlled type 2 diabetes despite treatment with OADs and/or basal insulin. At 24 weeks, in terms of the primary efficacy endpoint of each trial, combination therapy with lixisenatide was associated with better efficacy than placebo in patients inadequately controlled on OADs and/or basal insulin, was shown to be noninferior to exenatide in patients inadequately controlled on background metformin therapy, and showed similar efficacy to sitagliptin in patients inadequately controlled on background metformin therapy. Further clinical experience/post-marketing surveillance studies and long-term safety data, along with pharmacoeconomic analyses, are required to fully define the position of lixisenatide in relation to other antihyperglycemics. In the meantime, once-daily prandial lixisenatide in combination with OADs and/or basal insulin (plus diet and exercise) is an effective option for improving glycemic control in adult patients with type 2 diabetes, including in patients where bodyweight loss is an essential component in their management.
Literature
2.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
3.
go back to reference Sherwin R, Jastreboff AM. Year in diabetes 2012: the diabetes tsunami. J Clin Endocrinol Metab. 2012;97(12):4293–301.PubMedCrossRef Sherwin R, Jastreboff AM. Year in diabetes 2012: the diabetes tsunami. J Clin Endocrinol Metab. 2012;97(12):4293–301.PubMedCrossRef
4.
go back to reference Nauck MA. Incretin-based therapies for type 2 diabetes mellitus: properties, functions, and clinical implications. Am J Med. 2011;124 Suppl.:S3–18. Nauck MA. Incretin-based therapies for type 2 diabetes mellitus: properties, functions, and clinical implications. Am J Med. 2011;124 Suppl.:S3–18.
5.
go back to reference Nauck MA. Unraveling the science of incretin biology. Am J Med. 2009;122 Suppl.:S3–10. Nauck MA. Unraveling the science of incretin biology. Am J Med. 2009;122 Suppl.:S3–10.
6.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
7.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
8.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
9.
go back to reference 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.CrossRef 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.CrossRef
10.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
11.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
12.
go back to reference 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. 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.
14.
go back to reference 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.CrossRef 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.CrossRef
15.
go back to reference 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. 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.
go back to reference 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. 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.
go back to reference 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. 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.
go back to reference 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. 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.
go back to reference 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.CrossRef 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.CrossRef
20.
go back to reference 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. 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.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
22.
go back to reference 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. 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.
go back to reference 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. 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.
go back to reference 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. 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.
go back to reference 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. 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.
go back to reference 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.PubMed 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.PubMed
27.
go back to reference 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. 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.
go back to reference 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. 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.
go back to reference 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. 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.
go back to reference 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. 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.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
32.
go back to reference 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. 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.
go back to reference 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. 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.
35.
go back to reference 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). 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.
go back to reference 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). 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.
go back to reference 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). 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.
go back to reference 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). 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.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
40.
go back to reference 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. 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.
go back to reference 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. 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.
44.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
45.
go back to reference Node K, Inoue T. Postprandial hyperglycaemia as an etiological factor in vascular failure. Cardiovasc Diabetol. 2009;8:23.PubMedCrossRef Node K, Inoue T. Postprandial hyperglycaemia as an etiological factor in vascular failure. Cardiovasc Diabetol. 2009;8:23.PubMedCrossRef
46.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
47.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
48.
go back to reference 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.CrossRef 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.CrossRef
49.
go back to reference Turnbull FM, Abraira C, Anderson RJ, et al. Intensive glucose control and macrovascular outcomes in type 2 diabetes. Diabetologia. 2009;52(11):2288–98.PubMedCrossRef Turnbull FM, Abraira C, Anderson RJ, et al. Intensive glucose control and macrovascular outcomes in type 2 diabetes. Diabetologia. 2009;52(11):2288–98.PubMedCrossRef
50.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
51.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
52.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
53.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
54.
go back to reference Stolar M. Glycemic control and complications in type 2 diabetes mellitus. Am J Med. 2010;123:S3–11.PubMedCrossRef Stolar M. Glycemic control and complications in type 2 diabetes mellitus. Am J Med. 2010;123:S3–11.PubMedCrossRef
55.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
56.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
57.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
59.
go back to reference Bailey CJ, Kodack M. Patient adherence to medication requirements for therapy of type 2 diabetes. Int J Clin Pract. 2011;65(3):314–22.PubMedCrossRef Bailey CJ, Kodack M. Patient adherence to medication requirements for therapy of type 2 diabetes. Int J Clin Pract. 2011;65(3):314–22.PubMedCrossRef
62.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
63.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
64.
go back to reference 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.CrossRef 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.CrossRef
65.
go back to reference 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. 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.
go back to reference 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). 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.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
68.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
69.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
70.
go back to reference 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. 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.
Metadata
Title
Lixisenatide: A Review of Its Use in Patients with Type 2 Diabetes Mellitus
Author
Lesley J. Scott
Publication date
01-10-2013
Publisher
Springer International Publishing
Published in
BioDrugs / Issue 5/2013
Print ISSN: 1173-8804
Electronic ISSN: 1179-190X
DOI
https://doi.org/10.1007/s40259-013-0057-y

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