iGlarLixi, a titratable once-daily fixed-ratio combination of basal insulin and lixisenatide for intensifying type 2 diabetes management for patients inadequately controlled on basal insulin with or without oral agents

References

• World Health Organization. Global Report on Diabetes: Executive Summary; 2016. http://apps.who.int/iris/bitstream/10665/204874/1/WHO_NMH_NVI_16.3_eng.pdf. [Last accessed 20 February 2017]
   Google Scholar
• Centers for Disease Control and Prevention. National Diabetes Statistics Report 2017: estimates of diabetes and its burden in the United States. Atlanta (GA): US Department of Health and Human Services; 2017. available from: https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf
   Google Scholar
• Narayan KMV, Boyle JP, Geiss LS, et al. Impact of recent increase in incidence on future diabetes burden, U.S., 2005–2050. Diabetes Care 2006;29:2114-16
   PubMed Web of Science ®Google Scholar
• Dall TM, Yang W, Halder P, et al. The economic burden of elevated blood glucose levels in 2012: diagnosed and undiagnosed diabetes, gestational diabetes mellitus, and prediabetes. Diabetes Care 2014;37:3172-9
   PubMed Web of Science ®Google Scholar
• American Diabetes Association. Standards of medical care in diabetes—2017. Diabetes Care 2017;40(Suppl 1):S1-S135
   PubMedGoogle Scholar
• Stratton IM, Adler AI, Neil AW, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ 2000;321:405-12
   PubMed Web of Science ®Google Scholar
• UK Prospective Diabetes Study (UKPDS) Study Group. Intensive blood-glucose control with sulfonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998;352:837-53
   PubMed Web of Science ®Google Scholar
• 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;359:1577-89
   PubMed Web of Science ®Google Scholar
• Writing Group for the DCCT/EDIC Research Group. Coprogression of cardiovascular risk factors in type 1 diabetes during 30 years of follow-up in the DCCT/EDIC study. Research group. Diabetes Care 2016;39:1621-30
   PubMed Web of Science ®Google Scholar
• DeFronzo RA. Banting Lecture: From the triumvirate to the ominous octet: a new paradigm for the treatment of type 2 diabetes. Diabetes 2009;58:773-95
   PubMed Web of Science ®Google Scholar
• Phillips LS, Ratner RE, Buse JB, et al. We can change the natural history of type 2 diabetes. Diabetes Care 2014;37:2668-76
   PubMed Web of Science ®Google Scholar
• Weng J, Li Y, Xu W, et al. Effect of intensive insulin therapy on beta-cell function and glycaemic control in patients with newly diagnosed type 2 diabetes: a multicentre randomised parallel-group trial. Lancet 2008;371:1753-60
   PubMed Web of Science ®Google Scholar
• Harrison LB, Adams-Huet B, Li X, et al. Intensive therapy in newly diagnosed type 2 diabetes—results of a 6-year randomized trial: beta-cell preservation in type 2 diabetes. J Investig Med 2014;62:676-86
   PubMed Web of Science ®Google Scholar
• Nathan DM, Bayless M, Cleary P, et al. Diabetes control and complications trial/epidemiology of diabetes interventions and complications study at 30 years: advances and contributions. Diabetes 2013;62:3976-86
   PubMed Web of Science ®Google Scholar
• Abdul-Ghani MA, Puckett C, Triplitt C, et al. Initial combination therapy with metformin, pioglitazone and exenatide is more effective than sequential add-on therapy in subjects with new-onset diabetes. Results from the Efficacy and Durability of Initial Combination Therapy for Type 2 Diabetes (EDICT): a randomized trial. Diabetes Obes Metab 2015;17:268-75
   PubMed Web of Science ®Google Scholar
• The Action to Control Cardiovascular Risk in Diabetes Follow-On (ACCORDION) Eye Study Group and the Action to Control Cardiovascular Risk in Diabetes Follow-On (ACCORDION) Study Group. Persistent effects of intensive glycemic control on retinopathy in type 2 diabetes in the Action to Control Cardiovascular Risk (ACCORD) Follow On Study. Diabetes Care 2016;39:1089-100
   PubMed Web of Science ®Google Scholar
• Nichols GA, Alexander CM, Girman CJ, et al. Treatment escalation and risk in HbA1c following successful initial metformin therapy. Diabetes Care 2006;29:504-9
   PubMed Web of Science ®Google Scholar
• The ORIGIN Trial Investigators. Basal insulin glargine and microvascular outcomes in dysglycaemic individuals: results of the Outcome Reduction with an Initial Glargine Intervention (ORIGIN) trial. Diabetologia 2014;57:1325-31
   PubMed Web of Science ®Google Scholar
• Garber AJ, Chair. AACE/ACE comprehensive diabetes management algorithm 2015. Endocr Pract 2015;21:438-47
   PubMed Web of Science ®Google Scholar
• Stark Casagrande S, Fradkin JE, Saydah SH, et al. The prevalence of meeting A1C, blood pressure, and LDL goals among people with diabetes, 1988–2010. Diabetes Care 2013;36:2271-9
   PubMed Web of Science ®Google Scholar
• Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach. Update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2015;38:140-9
   PubMed Web of Science ®Google Scholar
• Cavalot F, Pagliarino A, Valle M, et al. Postprandial blood glucose predicts cardiovascular events and all-cause mortality in type 2 diabetes in a 14-year follow-up. Lessons from the San Luigi Gonzaga Diabetes Study. Diabetes Care 2011;34:2237-43
   PubMed Web of Science ®Google Scholar
• Strojek K, Raz I, Jermendy G, et al. Factors associated with cardiovascular events in patients with type 2 diabetes and acute myocardial infarction. J Clin Endocrinol Metab 2016;101:243-53
   PubMed Web of Science ®Google Scholar
• Khunti K, Wolden ML, Thorsted BL, et al. Clinical inertia in people with type 2 diabetes. Diabetes Care 2013;36:3411-7
   PubMed Web of Science ®Google Scholar
• Kostev K, Dippel FW, Rathmann W. Glycemic control after initiating basal insulin therapy in patients with type 2 diabetes: a primary care database analysis. Diabetes Metab Syndr Obes 2015;8:45-8
   PubMed Web of Science ®Google Scholar
• Khunti K, Nikolajsen A, Thorsted BL, et al. Clinical inertia with regard to intensifying therapy in people with type 2 diabetes treated with basal insulin. Diabetes Obes Metab 2016;18:401-9
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Davidson JA. Differential effects of prandial and non-prandial GLP-1 receptor agonists in type 2 diabetes. Postgrad Med 2015;127:827-41
   PubMed Web of Science ®Google Scholar
• Pfeffer MA, Claggett B, Diaz R, et al. Lixisenatide in patients with type 2 diabetes and acute coronary syndrome. N Engl J Med 2015;373:2247-57
   PubMed Web of Science ®Google Scholar
• Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med 2016;375:311-22
   PubMed Web of Science ®Google Scholar
• Ahrén B. Insulin plus incretin: a glucose-lowering strategy for type 2 diabetes. World J Diabetes 2014;5:40-51
   PubMedGoogle Scholar
• Prasad-Reddy L, Isaacs D. A clinical review of GLP-1 receptor agonists: efficacy and safety in diabetes and beyond. Drugs Context 2015;4:212283
   PubMedGoogle Scholar
• Trulicity prescribing information. http://pi.lilly.com/us/trulicity-uspi.pdf. [Last accessed 12 January 2017]
   Google Scholar
• Victoza prescribing information. http://www.novo-pi.com/victoza.pdf. [Last accessed 20 February 2017]
   Google Scholar
• Xultophy prescribing information. http://www.novo-pi.com/xultophy10036.pdf. [Last accessed 20 February 2017]
   Google Scholar
• FDA announcement; 2016. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208673Orig1s000ltr.pdf. [Last accessed 30 December 2016]
   Google Scholar
• Lantus (insulin glargine [rDNA origin]). Full prescribing information. http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021081s034lbl.pdf. [Last accessed 20 February 2017]
   Google Scholar
• FDA announcement; 2016. http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm513602.htm. [Last accessed 31 August 2016]
   Google Scholar
• Anderson SL, Trujillo JM. Lixisenatide in type 2 diabetes: latest evidence and clinical usefulness. Ther Adv Chronic Dis 2016;7:4-17
   PubMed Web of Science ®Google Scholar
• Fonseca VA, Alvarado-Ruiz R, Raccah D, et al. Efficacy and safety of the once-daily GLP-1 receptor agonist lixisenatide in monotherapy. Diabetes Care 2012;35:1225-31
   PubMed Web of Science ®Google Scholar
• Seino Y, Terauchi Y, Wang X, et al. Safety, tolerability and efficacy of lixisenatide as monotherapy in Japanese patients with type 2 diabetes mellitus: An open-label, multicenter study. J Diabetes Investig 2017. doi: 10.1111/jdi.12646. [Epub ahead of print]
   Google Scholar
• Vora J. Combining incretin-based therapies with insulin. Diabetes Care 2013;36(Suppl 2):S226-S32
   PubMed Web of Science ®Google Scholar
• Rosenstock J, Raccah D, Korány 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;36:2945-51
   PubMed Web of Science ®Google Scholar
• 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;36:2489-96
   PubMed Web of Science ®Google Scholar
• 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;14:910-17
   PubMed Web of Science ®Google Scholar
• Rosenstock J, Guerci B, Hanefeld M, et al. Prandial options to advance basal insulin glargine therapy: testing lixisenatide plus basal insulin versus insulin glulisine either as basal-plus or basal-bolus in type 2 diabetes: The GetGoal Duo-2 trial. Diabetes Care 2016;39:1318-28
   PubMed Web of Science ®Google Scholar
• Rosenstock J, Aronson R, Grunberger G, et al. Benefits of LixiLan, a titratable fixed-ratio combination of insulin glargine plus lixisenatide, versus insulin glargine and lixisenatide monocomponents in type 2 diabetes inadequately controlled with oral agents: the LixiLan-O randomized trial. Diabetes Care 2016;39:2026-35
   PubMed Web of Science ®Google Scholar
• Aroda VR, Rosenstock J, Wysham C, et al. Efficacy and safety of LixiLan, a titratable fixed-ratio combination of insulin glargine plus lixisenatide in type 2 diabetes inadequately controlled on basal insulin and metformin: the LixiLan-L randomized trial. Diabetes Care 2016;39:1972-80
   PubMed Web of Science ®Google Scholar
• Henry RR, Ahrén B, Davies M, et al. Consistent outcomes across dose ranges with titratable LixiLan, insulin glargine/lixisenatide fixed-ratio combination, in the LixiLan-O trial [abstract 1017-P]. Proceedings of the 76th Scientific Sessions of the American Diabetes Association; June 12, 2016; New Orleans, LA
   Google Scholar
• Soliqua 100/33 prescribing information. http://products.sanofi.us/Soliqua100-33/Soliqua100-33.pdf. [Last accessed 28 November 2016]
   Google Scholar
• Davies M, Leiter LA, Grunberger G, et al. Impact of baseline HbA1c, BMI, and diabetes duration on the efficacy and safety of LixiLan (insulin glargine/lixisenatide titratable fixed-ratio combination) versus insulin glargine and lixisenatide in the LixiLan-O trial [Abstract 1028-P]. Proceedings of the 76th Scientific Sessions of the American Diabetes Association; June 12, 2016; New Orleans, LA
   Google Scholar
• Handelsman Y, Chovanes C, Dex T, et al. Efficacy and safety of insulin glargine/lixisenatide fixed-ratio combination in older people with T2D. Diabetes 2016;65:A246
   Web of Science ®Google Scholar
• Wysham C, Bonadonna RC, Aroda V, et al. Efficacy and safety of LixiLan vs insulin glargine according to baseline characteristics in patients with type 2 diabetes from the LixiLan-L trial [Abstract 1010-P]. Proceedings of the 76th Scientific Sessions of the American Diabetes Association; June 12, 2016; New Orleans, LA
   Google Scholar
• Ritzel R, Vidal J, Aroda V, et al. Efficacy and safety across the dose ranges in patients with T2DM receiving insulin glargine/lixisenatide fixed-ratio combination in the LixiLan-L trial. Diabetes 2016;65:A266-7
   Web of Science ®Google Scholar
• 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;27:1024-32
   PubMed Web of Science ®Google Scholar
• de Vries ST, Keers JC, Visser R, et al. Medication beliefs, treatment complexity, and non-adherence to different drug classes in patients with type 2 diabetes. J Psychosomat Res 2014;76:134-8
   PubMed Web of Science ®Google Scholar
• Miya A, Nakamura A, Miyoshi H, et al. Satisfaction of switching to combination therapy with lixisenatide and basal insulin in patients with type 2 diabetes receiving multiple daily insulin injection therapy: a randomized controlled trial. J Diabetes Investig 2017. doi: 10.1111/jdi.12654. [Epub ahead of print]
   PubMedGoogle Scholar
• Rosenstock J, Diamant M, Aroda VR, et al. Efficacy and safety of LixiLan, a titratable fixed-ratio combination of lixisenatide and insulin glargine, versus insulin glargine in type 2 diabetes inadequately controlled on metformin monotherapy: the LixiLan proof-of-concept randomized trial. Diabetes Care 2016;9:1579-86
   Web of Science ®Google Scholar
• American Diabetes Association. Economic costs of diabetes in the U.S. in 2012. Diabetes Care 2013;36:1033-46
   PubMed Web of Science ®Google Scholar