Liraglutide for treating type 1 diabetes

References

• Gepts W. Pathologic anatomy of the pancreas in juvenile diabetes mellitus. Diabetes. 1965 Oct;14(10):619–633.
   PubMed Web of Science ®Google Scholar
• Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977–986. doi:10.1056/NEJM199309303291401.
   PubMed Web of Science ®Google Scholar
• American Diabetes Association. Standards of medical care in diabetes–2014. Diabetes Care. 2014 Jan;37(Suppl 1):S14–S80. doi:10.2337/dc14-S014.
   PubMed Web of Science ®Google Scholar
• Conway B, Miller RG, Costacou T, et al. Temporal patterns in overweight and obesity in Type 1 diabetes. Diabet Med. 2010 Apr;27(4):398–404. doi:10.1111/j.1464-5491.2010.02956.x.
   PubMed Web of Science ®Google Scholar
• Chillaron JJ, Flores Le-Roux JA, Benaiges D, et al. Type 1 diabetes, metabolic syndrome and cardiovascular risk. Metabolism. 2014 Feb;63(2):181–187. doi:10.1016/j.metabol.2013.10.002.
   PubMed Web of Science ®Google Scholar
• Metascreen Writing C, Bonadonna R, Cucinotta D, et al. The metabolic syndrome is a risk indicator of microvascular and macrovascular complications in diabetes: results from Metascreen, a multicenter diabetes clinic-based survey. Diabetes Care. 2006 Dec;29(12):2701–2707. doi:10.2337/dc06-0942.
   PubMed Web of Science ®Google Scholar
• Thorn LM, Forsblom C, Fagerudd J, et al. Metabolic syndrome in type 1 diabetes: association with diabetic nephropathy and glycemic control (the FinnDiane study). Diabetes Care. 2005 Aug;28(8):2019–2024.
   PubMed Web of Science ®Google Scholar
• Lee Y, Wang M-Y, Du XQ, et al. Glucagon receptor knockout prevents insulin-deficient type 1 diabetes in mice. Diabetes. 2011 Feb;60(2):391–397. doi:10.2337/db10-0426.
   PubMed Web of Science ®Google Scholar
• Holst JJ. Incretin hormones and the satiation signal. Int J Obes. 2013 Sep;37(9):1161–1168. doi:10.1038/ijo.2012.208.
   PubMed Web of Science ®Google Scholar
• Jendle J, Nauck MA, Matthews DR, et al. Weight loss with liraglutide, a once-daily human glucagon-like peptide-1 analogue for type 2 diabetes treatment as monotherapy or added to metformin, is primarily as a result of a reduction in fat tissue. Diabetes Obes Metab. 2009 Dec;11(12):1163–1172. doi:10.1111/j.1463-1326.2009.01158.x.
   PubMed Web of Science ®Google Scholar
• Kjems LL, Holst JJ, Volund A, et al. The influence of GLP-1 on glucose-stimulated insulin secretion: effects on beta-cell sensitivity in type 2 and nondiabetic subjects. Diabetes. 2003 Feb;52(2):380–386.
   PubMed Web of Science ®Google Scholar
• Lind M, Hirsch IB, Tuomilehto J, et al. Liraglutide in people treated for type 2 diabetes with multiple daily insulin injections: randomised clinical trial (MDI Liraglutide trial). BMJ. 2015;351:h5364.
   PubMed Web of Science ®Google Scholar
• Harrison LB, Mora PF, Clark GO, et al. Type 1 diabetes treatment beyond insulin: role of GLP-1 analogs. J Invest Med. 2013 Jan;61(1):40–44. doi:10.231/JIM.0b013e318279b7d6.
   PubMed Web of Science ®Google Scholar
• Kielgast U, Krarup T, Holst JJ, et al. Four weeks of treatment with liraglutide reduces insulin dose without loss of glycemic control in type 1 diabetic patients with and without residual beta-cell function. Diabetes Care. 2011 Jul;34(7):1463–1468.
   PubMed Web of Science ®Google Scholar
• Kuhadiya ND, Malik R, Bellini NJ, et al. Liraglutide as additional treatment to insulin in obese patients with type 1 diabetes mellitus. Endocr Pract. 2013 Nov;19(6):963–967. doi:10.4158/EP13065.OR.
   PubMed Web of Science ®Google Scholar
• Varanasi A, Bellini N, Rawal D, et al. Liraglutide as additional treatment for type 1 diabetes. Eur J Endocrinol. 2011 Jul;165(1):77–84. doi:10.1530/EJE-11-0330.
   PubMed Web of Science ®Google Scholar
• Crisci I, Aragona M, Politi KS, et al. GLP-1 receptor agonists in type 1 diabetes: a proof-of-concept approach. Acta Diabetol. 2015 Dec;52(6):1129–1133. doi:10.1007/s00592-015-0800-6.
   PubMed Web of Science ®Google Scholar
• Dejgaard TF, Frandsen CS, Hansen TS, et al. Efficacy and safety of liraglutide for overweight adult patients with type 1 diabetes and insufficient glycaemic control (Lira-1): a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2016 Mar;4(3):221–232.
   PubMedGoogle Scholar
• Frandsen CS, Dejgaard TF, Holst JJ, et al. Twelve-week treatment with liraglutide as add-on to insulin in normal-weight patients with poorly controlled type 1 diabetes: a randomized, placebo-controlled, double-blind parallel study. Diabetes Care. 2015 Dec;38(12):2250–2257.
   PubMed Web of Science ®Google Scholar
• Holst JJ. The physiology of glucagon-like peptide 1. Physiol Rev. 2007 Oct;87(4):1409–1439. doi:10.1152/physrev.00034.2006.
   PubMed Web of Science ®Google Scholar
• Theodorakis MJ, Carlson O, Michopoulos S, et al. Human duodenal enteroendocrine cells: source of both incretin peptides, GLP-1 and GIP. Am J Physiol Endocrinol Metab. 2006 Mar;290(3):E550–E559. doi:10.1152/ajpendo.00484.2005.
   PubMed Web of Science ®Google Scholar
• Vollmer K, Holst JJ, Baller B, et al. Predictors of incretin concentrations in subjects with normal, impaired, and diabetic glucose tolerance. Diabetes. 2008 Mar;57(3):678–687. doi:10.2337/db07-1124.
   PubMed Web of Science ®Google Scholar
• Vilsboll T, Agerso H, Krarup T, et al. Similar elimination rates of glucagon-like peptide-1 in obese type 2 diabetic patients and healthy subjects. J Clin Endocrinol Metab. 2003 Jan;88(1):220–224. doi:10.1210/jc.2002-021053.
   PubMed Web of Science ®Google Scholar
• Gutniak M, Orskov C, Holst JJ, et al. Antidiabetogenic effect of glucagon-like peptide-1 (7-36)amide in normal subjects and patients with diabetes mellitus. N Engl J Med. 1992 May 14;326(20):1316–1322.
   PubMed Web of Science ®Google Scholar
• Holst JJ. Glucagon-like peptide-1: from extract to agent. The Claude Bernard Lecture, 2005. Diabetologia. 2006 Feb;49(2):253–260.
   PubMed Web of Science ®Google Scholar
• Thorens B, Porret A, Buhler L, et al. Cloning and functional expression of the human islet GLP-1 receptor. Demonstration that exendin-4 is an agonist and exendin-(9-39) an antagonist of the receptor. Diabetes. 1993 Nov;42(11):1678–1682.
   PubMed Web of Science ®Google Scholar
• Meier JJ. GLP-1 receptor agonists for individualized treatment of type 2 diabetes mellitus. Nat Rev Endocrinol. 2012 Dec;8(12):728–742.
   PubMed Web of Science ®Google Scholar
• Buse JB, Rosenstock J, Sesti G, et al. Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6). Lancet. 2009 Jul 4;374(9683):39–47.
   PubMed Web of Science ®Google Scholar
• Garber A, Henry R, Ratner R, et al. Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, parallel-treatment trial. Lancet. 2009 Feb 7;373(9662):473–481.
   PubMed Web of Science ®Google Scholar
• Russell-Jones D, Vaag A, Schmitz O, et al. Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+SU): a randomised controlled trial. Diabetologia. 2009 Oct;52(10):2046–2055. doi:10.1007/s00125-009-1472-y.
   PubMed Web of Science ®Google Scholar
• Knudsen LB, Nielsen PF, Huusfeldt PO, et al. Potent derivatives of glucagon-like peptide-1 with pharmacokinetic properties suitable for once daily administration. J Med Chem. 2000 May 4;43(9):1664–1669.
   PubMed Web of Science ®Google Scholar
• Neumiller JJ, Sonnett TE, Wood LD, et al. Pharmacology, efficacy and safety of liraglutide in the management of type 2 diabetes. Diabetes Metab Syndr Obes. 2010;3:215–226.
   PubMedGoogle Scholar
• Jacobsen LV, Flint A, Olsen AK, et al. Liraglutide in Type 2 diabetes mellitus: clinical pharmacokinetics and pharmacodynamics. Clin Pharmacokinet. 2015 Nov 23. [Epub ahead of print]
   PubMed Web of Science ®Google Scholar
• Nauck MA, El-Ouaghlidi A, Hompesch M, et al. No impairment of hypoglycemia counterregulation via glucagon with the long-acting GLP-1 derivative, NN2211, in subjects with Type 2-diabetes. Diabetologia. 2003 Aug;46:A285–A85.
   Web of Science ®Google Scholar
• Marre M, Shaw J, Brandle M, et al. Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemic and weight control compared with adding rosiglitazone or placebo in subjects with Type 2 diabetes (LEAD-1 SU). Diabet Med. 2009 Mar;26(3):268–278. doi:10.1111/j.1464-5491.2009.02666.x.
   PubMed Web of Science ®Google Scholar
• Nauck M, Frid A, Hermansen K, et al. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study. Diabetes Care. 2009 Jan;32(1):84–90. doi:10.2337/dc08-1355.
   PubMed Web of Science ®Google Scholar
• Zinman B, Gerich J, Buse JB, et al. Efficacy and safety of the human glucagon-like peptide-1 analog liraglutide in combination with metformin and thiazolidinedione in patients with type 2 diabetes (LEAD-4 Met+TZD). Diabetes Care. 2009 Jul;32(7):1224–1230. doi:10.2337/dc08-2124.
   PubMed Web of Science ®Google Scholar
• Pratley RE, Nauck M, Bailey T, et al. Liraglutide versus sitagliptin for patients with type 2 diabetes who did not have adequate glycaemic control with metformin: a 26-week, randomised, parallel-group, open-label trial. Lancet. 2010 Apr 24;375(9724):1447–1456.
   PubMed Web of Science ®Google Scholar
• Seino Y, Rasmussen MF, Nishida T, et al. Efficacy and safety of the once-daily human GLP-1 analogue, liraglutide, vs glibenclamide monotherapy in Japanese patients with type 2 diabetes. Curr Med Res Opin. 2010 May;26(5):1013–1022. doi:10.1185/03007991003672551.
   PubMed Web of Science ®Google Scholar
• Kaku K, Rasmussen MF, Clauson P, et al. Improved glycaemic control with minimal hypoglycaemia and no weight change with the once-daily human glucagon-like peptide-1 analogue liraglutide as add-on to sulphonylurea in Japanese patients with type 2 diabetes. Diabetes Obes Metab. 2010 Apr;12(4):341–347. doi:10.1111/j.1463-1326.2009.01194.x.
   PubMed Web of Science ®Google Scholar
• Astrup A, Rossner S, Van Gaal L, et al. Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study. Lancet. 2009 Nov 7;374(9701):1606–1616.
   PubMed Web of Science ®Google Scholar
• Davies MJ, Bergenstal R, Bode B, et al. Efficacy of liraglutide for weight loss among patients with Type 2 diabetes: the SCALE diabetes randomized clinical trial. JAMA. 2015 Aug 18;314(7):687–699.
   PubMed Web of Science ®Google Scholar
• NovoNordisk AS. Company announcement: Saxenda® approved in Europe for the treatment of obesity; 2015 Mar 23 [cited 2015 Dec 20]. Available from: https://www.novonordisk.com/bin/getPDF.1905678.pdf
   Google Scholar
• FDA. FDA approves weight-management drug Saxenda; 2014 Dec [cited 2015 Dec 20]. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427913.htm
   Google Scholar
• Marso SP, Poulter NR, Nissen SE, et al. Design of the liraglutide effect and action in diabetes: evaluation of cardiovascular outcome results (LEADER) trial. Am Heart J. 2013 Nov;166(5):823–830.e5. doi:10.1016/j.ahj.2013.07.012.
   PubMed Web of Science ®Google Scholar
• Davies M, Speight J. Patient-reported outcomes in trials of incretin-based therapies in patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2012 Oct;14(10):882–892. doi:10.1111/j.1463-1326.2012.01595.x.
   PubMed Web of Science ®Google Scholar
• Buse JB, Garber A, Rosenstock J, et al. Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials. J Clin Endocrinol Metab. 2011 Jun;96(6):1695–1702.
   PubMed Web of Science ®Google Scholar
• Madsbad S. A review of head-to-head comparisons of GLP-1 receptor agonists. Diabetes Obes Metab. 2015 Oct 29. doi:10.1111/dom.12596.
   Google Scholar
• Butler PC, Elashoff M, Elashoff R, et al. A critical analysis of the clinical use of incretin-based therapies: are the GLP-1 therapies safe? Diabetes Care. 2013 Jul;36(7):2118–2125. doi:10.2337/dc12-2713.
   PubMed Web of Science ®Google Scholar
• Egan AG, Blind E, Dunder K, et al. Pancreatic safety of incretin-based drugs–FDA and EMA assessment. N Engl J Med. 2014 Feb 27;370(9):794–797.
   PubMed Web of Science ®Google Scholar
• Bjerre Knudsen L, Madsen LW, Andersen S, et al. Glucagon-like peptide-1 receptor agonists activate rodent thyroid C-cells causing calcitonin release and C-cell proliferation. Endocrinology. 2010 Apr;151(4):1473–1486. doi:10.1210/en.2009-1272.
   PubMed Web of Science ®Google Scholar
• Parks M, Rosebraugh C. Weighing risks and benefits of liraglutide–the FDA’s review of a new antidiabetic therapy. N Engl J Med. 2010 Mar 4;362(9):774–777.
   PubMed Web of Science ®Google Scholar
• EMA. Victoza: EPAR - product information; 2015 [cited 2016 Feb 16]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001026/WC500050017.pdf
   Google Scholar
• Creutzfeldt WO, Kleine N, Willms B, et al. Glucagonostatic actions and reduction of fasting hyperglycemia by exogenous glucagon-like peptide I(7-36) amide in type I diabetic patients. Diabetes Care. 1996 Jun;19(6):580–586.
   PubMed Web of Science ®Google Scholar
• Dupre J, Behme MT, Hramiak IM, et al. Glucagon-like peptide I reduces postprandial glycemic excursions in IDDM. Diabetes. 1995 Jun;44(6):626–630.
   PubMed Web of Science ®Google Scholar
• Dupre J, Behme MT, Hramiak IM, et al. Subcutaneous glucagon-like peptide I combined with insulin normalizes postcibal glycemic excursions in IDDM. Diabetes Care. 1997 Mar;20(3):381–384.
   PubMed Web of Science ®Google Scholar
• Orskov L, Holst JJ, Moller J, et al. GLP-1 does not acutely affect insulin sensitivity in healthy man. Diabetologia. 1996 Oct;39(10):1227–1232.
   PubMed Web of Science ®Google Scholar
• Toft-Nielson M, Madsbad S, Holst JJ. The effect of glucagon-like peptide I (GLP-I) on glucose elimination in healthy subjects depends on the pancreatic glucoregulatory hormones. Diabetes. 1996 May;45(5):552–556.
   PubMed Web of Science ®Google Scholar
• Zander M, Madsbad S, Madsen JL, et al. Effect of 6-week course of glucagon-like peptide 1 on glycaemic control, insulin sensitivity, and beta-cell function in type 2 diabetes: a parallel-group study. Lancet. 2002 Mar 9;359(9309):824–830.
   PubMed Web of Science ®Google Scholar
• Dupre J, Behme MT, McDonald TJ. Exendin-4 normalized postcibal glycemic excursions in type 1 diabetes. J Clin Endocrinol Metab. 2004 Jul;89(7):3469–3473. doi:10.1210/jc.2003-032001.
   PubMed Web of Science ®Google Scholar
• Behme MT, Dupre J, McDonald TJ. Glucagon-like peptide 1 improved glycemic control in type 1 diabetes. BMC Endocr Disord. 2003 Apr 10;3(1):3.
   PubMedGoogle Scholar
• Kielgast U, Holst JJ, Madsbad S. Antidiabetic actions of endogenous and exogenous GLP-1 in type 1 diabetic patients with and without residual beta-cell function. Diabetes. 2011 May;60(5):1599–1607.
   PubMed Web of Science ®Google Scholar
• Kuhadiya N, Dhindsa S, Mehta A, et al. Abstract: liraglutide as additional treatment to insulin in patients with type 1 diabetes mellitus: a randomized clinical trial. 23rd Annual Meeting and Clinical Congress of the American Association of Clinical Endocrinologists (AACE); 2014; Las Vegas, NV.
   Google Scholar
• NovoNordisk AS Novo Nordisk completes second and final phase 3a trial with liraglutide as adjunct therapy to insulin for people with type 1 diabetes (NN9211); 2015 [cited 2016 Feb 16]. Available from: http://www.novonordisk.com/bin/getPDF.1947182.pdf
   Google Scholar
• NovoNordisk AS. First phase 3a trial with liraglutide as adjunct therapy to insulin for people with type 1 diabetes (NN9211) succesfully completed; 2015 [cited 2016 Feb 16]. Available from: https://www.novonordisk.com/bin/getPDF.1943925.pdf
   Google Scholar
• Nathan DM, Cleary PA, Backlund JY, et al. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005 Dec 22;353(25):2643–2653.
   PubMed Web of Science ®Google Scholar
• Purnell JQ, Hokanson JE, Marcovina SM, et al. Effect of excessive weight gain with intensive therapy of type 1 diabetes on lipid levels and blood pressure: results from the DCCT. Diabetes Control and Complications Trial. JAMA. 1998 Jul 8;280(2):140–146.
   PubMed Web of Science ®Google Scholar
• Eng C, Kramer CK, Zinman B, et al. Glucagon-like peptide-1 receptor agonist and basal insulin combination treatment for the management of type 2 diabetes: a systematic review and meta-analysis. Lancet. 2014 Nov 9;384:2228–2234. doi:10.1016/S0140-6736(14)61335-0.
   PubMed Web of Science ®Google Scholar
• Wajchenberg BL, Feitosa AC, Rassi N, et al. Glycemia and cardiovascular disease in type 1 diabetes mellitus. Endocr Pract. 2008 Oct;14(7):912–923. doi:10.4158/EP.14.7.912.
   PubMedGoogle Scholar
• Cleland SJ. Cardiovascular risk in double diabetes mellitus–when two worlds collide. Nat Rev Endocrinol. 2012 Aug;8(8):476–485. doi:10.1038/nrendo.2012.47.
   PubMed Web of Science ®Google Scholar
• Bradley C. Diabetes treatment satisfaction questionnaire. Change version for use alongside status version provides appropriate solution where ceiling effects occur. Diabetes Care. 1999 Mar;22(3):530–532.
   PubMedGoogle 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 Dec 3;373(23):2247–2257.
   PubMed Web of Science ®Google Scholar
• Miller KM, Foster NC, Beck RW, et al. Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D exchange clinic registry. Diabetes Care. 2015 Jun;38(6):971–978. doi:10.2337/dc15-0078.
   PubMed Web of Science ®Google Scholar
• Aschner P, Horton E, Leiter LA, et al. Practical steps to improving the management of type 1 diabetes: recommendations from the global partnership for effective diabetes management. Int J Clin Pract. 2010 Feb;64(3):305–315. doi:10.1111/j.1742-1241.2009.02296.x.
   PubMed Web of Science ®Google Scholar
• Østergaard L, Frandsen CS, Dejgaard TF, et al. Effects of liraglutide as add-on to insulin on counter-regulatory hormone responses, gastric emptying and glycaemic recovery during hypoglycaemia. EASD Annual Meeting 2015; 2015 Sep 15; Stockholm, Sweden.
   Google Scholar
• Pieber TR, Deller S, Korsatko S, et al. Counter-regulatory hormone responses to hypoglycaemia in people with type 1 diabetes after 4 weeks of treatment with liraglutide adjunct to insulin: a randomized, placebo-controlled, double-blind, crossover trial. Diabetes Obes Metab. 2015 Aug;17(8):742–750.
   PubMed Web of Science ®Google Scholar
• Buteau J, El-Assaad W, Rhodes CJ, et al. Glucagon-like peptide-1 prevents beta cell glucolipotoxicity. Diabetologia. 2004 May;47(5):806–815. doi:10.1007/s00125-004-1379-6.
   PubMed Web of Science ®Google Scholar
• Farilla L, Bulotta A, Hirshberg B, et al. Glucagon-like peptide 1 inhibits cell apoptosis and improves glucose responsiveness of freshly isolated human islets. Endocrinology. 2003 Dec;144(12):5149–5158. doi:10.1210/en.2003-0323.
   PubMed Web of Science ®Google Scholar
• Li Y, Hansotia T, Yusta B, et al. Glucagon-like peptide-1 receptor signaling modulates beta cell apoptosis. J Biol Chem. 2003 Jan 3;278(1):471–478.
   PubMed Web of Science ®Google Scholar
• Pettus J, Hirsch I, Edelman S. GLP-1 agonists in type 1 diabetes. Clin Immunol. 2013 Dec;149(3):317–323. doi:10.1016/j.clim.2013.04.006.
   PubMed Web of Science ®Google Scholar
• Madsbad S. Prevalence of residual B cell function and its metabolic consequences in type 1 (insulin-dependent) diabetes. Diabetologia. 1983 Mar;24(3):141–147.
   PubMed Web of Science ®Google Scholar
• Gough SCL, Bode B, Woo V, et al. Efficacy and safety of a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with its components given alone: results of a phase 3, open-label, randomised, 26-week, treat-to-target trial in insulin-naive patients with type 2 diabetes. Lancet Diabetes Endocrinol. 2014 Nov;2(11):885–893. doi:10.1016/S2213-8587(14)70174-3.
   PubMed Web of Science ®Google Scholar
• Rosenstock J, Diamant M, Silvestre L, et al. Benefits of a fixed-ratio formulation of once-daily insulin glargine/lixisenatide (LixiLan) vs glargine in type 2 diabetes inadequately controlled on metformin. EASD Annual Meeting 2014; 2014; Vienna, Austria.
   Google Scholar