The GetGoal clinical trial program of lixisenatide, a once-daily GLP-1 receptor agonist

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 Care27(5), 1047–1053 (2004).
   PubMed Web of Science ®Google Scholar
• Göke B. Islet cell function: α and β cells – partners towards normoglycaemia. Int. J. Clin. Pract. Suppl.62(159), 2–7 (2008).
   Google Scholar
• 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.62(2), 287–299 (2008).
   PubMed Web of Science ®Google Scholar
• Stratton IM, Adler AI, Neil HA et al. Association of glycaemia with macrovascular and microvascular complications of Type 2 diabetes (UKPDS 35): prospective observational study. BMJ321(7258), 405–412 (2000).
   PubMed Web of Science ®Google Scholar
• Del Prato S. Megatrials in Type 2 diabetes. From excitement to frustration? Diabetologia52(7), 1219–1226 (2009).
   PubMed Web of Science ®Google Scholar
• Rosenzweig JL, Ferrannini E, Grundy SM et al. Primary prevention of cardiovascular disease and Type 2 diabetes in patients at metabolic risk: an endocrine society clinical practice guideline. J. Clin. Endocrinol. Metab.93(10), 3671–3689 (2008).
   PubMed Web of Science ®Google Scholar
• Gaede P, Lund-Andersen H, Parving H, Pedersen O. Effect of a multifactorial intervention on mortality in Type 2 diabetes. N. Engl. J. Med.358(6), 580–591 (2008).
   PubMed Web of Science ®Google Scholar
• Nathan DM, Buse JB, Davidson MB et al. Medical management of hyperglycemia in Type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care32(1), 193–203 (2009).
   PubMed Web of Science ®Google Scholar
• Holst JJ. The physiology of glucagon-like peptide 1. Physiol. Rev.87(4), 1409–1439 (2007).
   PubMed Web of Science ®Google Scholar
• Deacon CF, Johnsen AH, Holst JJ. Degradation of glucagon-like peptide-1 by human plasma in vitro yields an N-terminally truncated peptide that is a major endogenous metabolite in vivo. J. Clin. Endocrinol. Metab.80(3), 952–957 (1995).
   PubMed Web of Science ®Google Scholar
• Mentlein R. Dipeptidyl-peptidase IV (CD26) – role in the inactivation of regulatory peptides. Regul. Pept.85(1), 9–24 (1999).
   PubMed Web of Science ®Google Scholar
• 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. Diabetes44(9), 1126–1131 (1995).
   PubMed Web of Science ®Google Scholar
• 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.16(3), 390–410 (1995).
   PubMed Web of Science ®Google Scholar
• Egan JM, Bulotta A, Hui H, Perfetti R. GLP-1 receptor agonists are growth and differentiation factors for pancreatic islet β cells. Diabetes Metab. Res. Rev.19(2), 115–123 (2003).
   PubMed Web of Science ®Google Scholar
• Zhou J, Wang X, Pineyro MA, Egan JM. Glucagon-like peptide 1 and exendin-4 convert pancreatic AR42J cells into glucagon- and insulin-producing cells. Diabetes48(12), 2358–2366 (1999).
   PubMed Web of Science ®Google Scholar
• Buteau J, El-Assaad W, Rhodes CJ, Rosenberg L, Joly E, Prentki M. Glucagon-like peptide-1 prevents β cell glucolipotoxicity. Diabetologia47(5), 806–815 (2004).
   PubMed Web of Science ®Google Scholar
• Larsson H, Holst JJ, Ahrén B. Glucagon-like peptide-1 reduces hepatic glucose production indirectly through insulin and glucagon in humans. Acta Physiol. Scand.160(4), 413–422 (1997).
   PubMedGoogle Scholar
• Flint A, Raben A, Astrup A, Holst JJ. Glucagon-like peptide 1 promotes satiety and suppresses energy intake in humans. J. Clin. Invest.101(3), 515–520 (1998).
   PubMed Web of Science ®Google Scholar
• Nikolaidis LA, Mankad S, Sokos GG et al. Effects of glucagon-like peptide-1 in patients with acute myocardial infarction and left ventricular dysfunction after successful reperfusion. Circulation109(8), 962–965 (2004).
   PubMed Web of Science ®Google Scholar
• Nikolaidis LA, Elahi D, Hentosz T et al. Recombinant glucagon-like peptide-1 increases myocardial glucose uptake and improves left ventricular performance in conscious dogs with pacing-induced dilated cardiomyopathy. Circulation110(8), 955–961 (2004).
   PubMed Web of Science ®Google Scholar
• Meier JJ, Gethmann A, Götze O et al. Glucagon-like peptide 1 abolishes the postprandial rise in triglyceride concentrations and lowers levels of non-esterified fatty acids in humans. Diabetologia49(3), 452–458 (2006).
   PubMed Web of Science ®Google Scholar
• Nyström T, Gutniak MK, Zhang Q et al. Effects of glucagon-like peptide-1 on endothelial function in Type 2 diabetes patients with stable coronary artery disease. Am. J. Physiol. Endocrinol. Metab.287(6), E1209–E1215 (2004).
   PubMed Web of Science ®Google Scholar
• 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.297(6), F1647–F1655 (2009).
   Web of Science ®Google Scholar
• Li Y, Perry T, Kindy MS et al. GLP-1 receptor stimulation preserves primary cortical and dopaminergic neurons in cellular and rodent models of stroke and Parkinsonism. Proc. Natl Acad. Sci. USA106(4), 1285–1290 (2009).
   PubMed Web of Science ®Google Scholar
• During MJ, Cao L, Zuzga DS et al. Glucagon-like peptide-1 receptor is involved in learning and neuroprotection. Nat. Med.9(9), 1173–1179 (2003).
   PubMed Web of Science ®Google Scholar
• Christensen M, Knop FK, Holst JJ, Vilsboll T. Lixisenatide, a novel GLP-1 receptor agonist for the treatment of Type 2 diabetes mellitus. Drugs12(8), 503–513 (2009).
   PubMed Web of Science ®Google Scholar
• 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.307(2), 490–496 (2003).
   PubMed Web of Science ®Google Scholar
• 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.164(2–3), 58–64 (2010).
   PubMed Web of Science ®Google Scholar
• Göke R, Fehmann HC, Linn T et al. Exendin-4 is a high potency agonist and truncated exendin-(9–39)-amide an antagonist at the glucagon-like peptide 1-(7–36)-amide receptor of insulin-secreting β-cells. J. Biol. Chem.268(26), 19650–19655 (1993).
   PubMed Web of Science ®Google Scholar
• van Eyll B, Lankat-Buttgereit B, Bode HP, Göke R, Göke B. Signal transduction of the GLP-1-receptor cloned from a human insulinoma. FEBS Lett.348(1), 7–13 (1994).
   PubMed Web of Science ®Google Scholar
• Liu Y, Ruus P. Pharmacokinetics and safety of the GLP-1 agonist AVE0010 in patient with renal impairment. Presented at: 69th Annual Meeting of the American Diabetes Association. New Orleans, LA, USA, 5–9 June 2009 (Abstract 557-P).
   Google Scholar
• Distiller L, Ruus PE. Pharmacokinetics and pharmacodynamics of GLP-1 agonist AVE0010 in Type 2 diabetes patients. Presented at: 68th Annual Meeting of the American Diabetes Association. San Francisco, CA, USA, 6–8 June 2008 (Abstract 520-P).
   Google Scholar
• Becker RHA, Ruus P. Restoration of insulin release with lixisenatide in patients with Type 2 diabetes. Presented at: EASD 46th Annual Meeting, Stockholm, Sweden, 20–24 September 2010.
   Google Scholar
• Liu Y, Ruus P. Effect of the GLP-1 agonist AVE0010 on absorption of concomitant oral drugs. Presented at: 69th Annual Meeting of the American Diabetes Association, 5–9 June 2009, New Orleans, LA, USA, (Abstract 495-P).
   Google Scholar
• Ratner R, Rosenstock J, Boka G. A dose-finding study of the new GLP-1 agonist AVE0010 in Type 2 diabetes insufficiently controlled with metformin. Presented at: 68th Annual Meeting of the American Diabetes Association. San Francisco, CA, USA, 8 June 2008 (Abstract 433-P).
   Google Scholar
• Rosenstock J, Ratner R. Post-meal effects of AVE0010, a once-daily GLP-1 receptor agonist, in Type 2 diabetes inadequately controlled on metformin. Presented at: 69th Annual Meeting of the American Diabetes Association. New Orleans, LA, USA, 5–9 June 2009 (Abstract 564-P).
   Google Scholar
• 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 Care26(3), 881–885 (2003).
   PubMed Web of Science ®Google Scholar
• Gerich JE, Fonseca VA. Monotherapy with GLP-1 receptor agonist, lixisenatide, significantly improves glycaemic control in Type 2 diabetic patients. Presented at: EASD 46th Annual Meeting. Stockholm, Sweden, 20–24 September 2010 (Poster 830).
   Google Scholar
• Feinglos M, Dailey G, Cefalu W et al. Effect on glycemic control of the addition of 2.5 mg glipizide GITS to metformin in patients with T2DM. Diabetes Res. Clin. Pract.68(2), 167–175 (2005).
   PubMed Web of Science ®Google Scholar
• Ratner RE, Rosenstock J, Boka G. 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.27(9), 1024–1032 (2010).
   PubMed Web of Science ®Google Scholar
• Drucker DJ, Buse JB, Taylor K et al. Exenatide once weekly versus twice daily for the treatment of Type 2 diabetes: a randomised, open-label, non-inferiority study. Lancet372(9645), 1240–1250 (2008).
   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). Lancet374(9683), 39–47 (2009).
   PubMed Web of Science ®Google Scholar
• Vilsbøll T, Toft-Nielsen MB, Krarup T, Madsbad S, Dinesen B, Holst JJ. Evaluation of β-cell secretory capacity using glucagon-like peptide 1. Diabetes Care23(6), 807–812 (2000).
   PubMed Web of Science ®Google Scholar
• Christensen M, Knop FK. Once-weekly GLP-1 agonists: how do they differ from exenatide and liraglutide? Curr. Diab. Rep.10(2), 124–132 (2010).
   PubMed Web of Science ®Google Scholar
• Heine RJ, Van Gaal LF, Johns D, Mihm MJ, Widel MH, Brodows RG. Exenatide versus insulin glargine in patients with suboptimally controlled Type 2 diabetes: a randomized trial. Ann. Intern. Med.143(8), 559–569 (2005).
   PubMed Web of Science ®Google Scholar
• [No authors listed]. Effect of intensive blood-glucose control with metformin on complications in overweight patients with Type 2 diabetes (UKPDS 34). UK Prospective Diabetes Study (UKPDS) Group. Lancet352(9131), 854–865 (1998).
   PubMed Web of Science ®Google Scholar
• Schernthaner G, Barnett AH, Betteridge DJ et al. Is the ADA/EASD algorithm for the management of Type 2 diabetes (January 2009) based on evidence or opinion? A critical analysis. Diabetologia53(7), 1258–1269 (2010).
   PubMed Web of Science ®Google Scholar
• Wright EE, Stonehouse AH, Cuddihy RM. In support of an early polypharmacy approach to the treatment of Type 2 diabetes. Diabetes Obes. Metab.12(11), 929–940 (2010).
   PubMed Web of Science ®Google Scholar
• Gill A, Hoogwerf BJ, Burger J et al. Effect of exenatide on heart rate and blood pressure in subjects with Type 2 diabetes mellitus: a double-blind, placebo-controlled, randomized pilot study. Cardiovasc. Diabetol.9, 6 (2010).
   PubMed Web of Science ®Google Scholar
• Astrup A, Rössner S, Van Gaal L et al. Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study. Lancet374(9701), 1606–1616 (2009).
   PubMed Web of Science ®Google Scholar
• Rosenstock J, Klaff LJ, Schwartz S et al. Effects of exenatide and lifestyle modification on body weight and glucose tolerance in obese subjects with and without pre-diabetes. Diabetes Care33(6), 1173–1175 (2010).
   PubMed Web of Science ®Google Scholar
• Kielgast U, Holst JJ, Madsbad S. Treatment of Type 1 diabetic patients with residual β cell function with the once-daily glucagon-like peptide-1 analogue liraglutide. Presented at: 46th EASD Annual Meeting. Stockholm, Sweden, 21 September 2010.
   Google Scholar