Albiglutide for treating type 2 diabetes: an evaluation of pharmacokinetics/pharmacodynamics and clinical efficacy

Bibliography

• 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(1):140-9
   PubMed Web of Science ®Google Scholar
• Boussageon R, Bejan-Angoulvant T, Saadatian-Elahi M, et al. Effect of intensive glucose lowering treatment on all cause mortality, cardiovascular death, and microvascular events in type 2 diabetes: meta-analysis of randomised controlled trials. BMJ 2011;343:d4169
   PubMed Web of Science ®Google Scholar
• Kahn SE, Cooper ME, Del Prato S. Pathophysiology and treatment of type 2 diabetes: perspectives on the past, present, and future. Lancet 2014;383(9922):1068-83
   PubMed Web of Science ®Google Scholar
• Holst JJ. The physiology of glucagon-like peptide 1. Physiol Rev 2007;87(4):1409-39
   PubMed Web of Science ®Google Scholar
• EPERZAN (Product Information). Eur Med Agency. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002735/WC500165117.pdf [Last Accessed 2 May 2015]
   Google Scholar
• Research C for DE and. Press Announcements - FDA approves Tanzeum to treat type 2 diabetes. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm393289.htm [Last Accessed 2 May 2015]
   Google Scholar
• EPERZAN (European Public Assesment Report). Eur Med Agency. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002735/WC500165119.pdf [Last Accessed 2 May 2015]
   Google Scholar
• Blair HA, Keating GM. Albiglutide: a review of its use in patients with type 2 diabetes mellitus. Drugs 2015;75(6):651-63
   PubMed Web of Science ®Google Scholar
• Trujillo JM, Nuffer W. Albiglutide: a new GLP-1 receptor agonist for the treatment of type 2 diabetes. Ann Pharmacother 2014;48(11):1494-501
   PubMed Web of Science ®Google Scholar
• TANZEUM (albiglutide) prescribing information. US Food Drug Adm. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125431s000lbl.pdf [Last Accessed 1 May 2015]
   Google Scholar
• Young MA, Wald JA, Matthews JE, et al. Effect of renal impairment on the pharmacokinetics, efficacy, and safety of albiglutide. Postgrad Med 2014;126(3):35-46
   PubMed Web of Science ®Google Scholar
• Bush M, Scott R, Watanalumlerd P, et al. Effects of multiple doses of albiglutide on the pharmacokinetics, pharmacodynamics, and safety of digoxin, warfarin, or a low-dose oral contraceptive. Postgrad Med 2012;124(6):55-72
   PubMed Web of Science ®Google Scholar
• Hompesch M, Jones-Leone A, Carr MC, et al. Albiglutide does not impair the counter-regulatory hormone response to hypoglycaemia: a randomized, double-blind, placebo-controlled, stepped glucose clamp study in subjects with type 2 diabetes mellitus. Diabetes Obes Metab 2015;17(1):82-90
   PubMed Web of Science ®Google Scholar
• Young MA, Wald JA, Matthews JE, et al. Clinical pharmacology of Albiglutide, a GLP-1 receptor agonist. Postgrad Med 2014;126(7):84-97
   PubMed Web of Science ®Google Scholar
• Darpo B, Zhou M, Matthews J, et al. Albiglutide does not prolong QTc interval in healthy subjects: A thorough ECG study. Diabetes Ther 2014;5(1):141-53
   PubMed Web of Science ®Google Scholar
• Seino Y, Nakajima H, Miyahara H, et al. Safety, tolerability, pharmacokinetics and pharmacodynamics of albiglutide, a long-acting GLP-1-receptor agonist, in Japanese subjects with type 2 diabetes mellitus. Curr Med Res Opin 2009;25(12):3049-57
   PubMed Web of Science ®Google Scholar
• Seino Y, Inagaki N, Miyahara H, et al. A randomized dose-finding study demonstrating the efficacy and tolerability of albiglutide in Japanese patients with type 2 diabetes mellitus. Curr Med Res Opin 2014;30(6):1095-106
   PubMed Web of Science ®Google Scholar
• Rosenstock J, Reusch J, Bush M, et al. Potential of albiglutide, a long-acting GLP-1 receptor agonist, in type 2 diabetes: a randomized controlled trial exploring weekly, biweekly, and monthly dosing. Diabetes Care 2009;32(10):1880-6
   PubMed Web of Science ®Google Scholar
• Reusch J, Stewart MW, Perkins CM, et al. Efficacy and safety of once-weekly glucagon-like peptide 1 receptor agonist albiglutide (HARMONY 1 trial): 52-week primary endpoint results from a randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes mellitus not controlled on pioglitazone, with or without metformin. Diabetes Obes Metab 2014;16(12):1257-64
   PubMed Web of Science ®Google Scholar
• Reinhardt R, Nauck MA, Stewart MW, et al. HARMONY 2 results at week 52 primary endpoint: once-weekly albiglutide mono- therapy for patients with type 2 diabetes mellitus inadequately controlled with diet and exercise [abstract no. 903]. Proceedings of 49th Annual Meeting of the European Association for the Study of Diabetes; 2013
   Google Scholar
• Ahrén B, Johnson SL, Stewart M, et al. HARMONY 3: 104-week randomized, double-blind, placebo- and active-controlled trial assessing the efficacy and safety of albiglutide compared with placebo, sitagliptin, and glimepiride in patients with type 2 diabetes taking metformin. Diabetes Care 2014;37(8):2141-8
   PubMed Web of Science ®Google Scholar
• Home PD, Shamanna P, Stewart M, et al. Efficacy and tolerability of albiglutide versus placebo or pioglitazone over 1er 1biglutidele with type 2 diabetes currently taking metformin and glimepiride: HARMONY 5. Diabetes Obes Metab 2015;17(2):179-87
   PubMed Web of Science ®Google Scholar
• Weissman PN, Carr MC, Ye J, et al. HARMONY 4: randomised clinical trial comparing once-weekly albiglutide and insulin glargine in patients with type 2 diabetes inadequately controlled with metformin with or without sulfonylurea. Diabetologia 2014;57(12):2475-84
   PubMed Web of Science ®Google Scholar
• Rosenstock J, Fonseca VA, Gross JL, et al. Advancing basal insulin replacement in type 2 diabetes inadequately controlled with insulin glargine plus oral agents: a comparison of adding albiglutide, a weekly GLP-1 receptor agonist, versus thrice-daily prandial insulin lispro. Diabetes Care 2014;37(8):2317-25
   PubMed Web of Science ®Google Scholar
• Pratley RE, Nauck MA, Barnett AH, et al. Once-weekly albiglutide versus once-daily liraglutide in patients with type 2 diabetes inadequately controlled on oral drugs (HARMONY 7): a randomised, open-label, multicentre, non-inferiority phase 3 study. Lancet Diabetes Endocrinol 2014;2(4):289-97
   PubMed Web of Science ®Google Scholar
• Leiter LA, Carr MC, Stewart M, et al. Efficacy and safety of the once-weekly GLP-1 receptor agonist albiglutide versus sitagliptin in patients with type 2 diabetes and renal impairment: a randomized phase III study. Diabetes Care 2014;37(10):2723-30
   PubMed Web of Science ®Google Scholar
• Umapathysivam MM, Lee MY, Jones KL, et al. Comparative effects of prolonged and intermittent stimulation of the glucagon-like peptide 1 receptor on gastric emptying and glycemia. Diabetes 2014;63(2):785-90
   PubMed Web of Science ®Google Scholar
• Phillips LK, Rayner CK, Jones KL, et al. Measurement of gastric emptying in diabetes. J Diabetes Complications 2014;28(6):894-903
   PubMed Web of Science ®Google Scholar
• Petersen AB, Christensen M. Clinical potential of lixisenatide once daily treatment for type 2 diabetes mellitus. Diabetes Metab Syndr Obes 2013;17(6):217-31
   Google Scholar
• Hermansen K, Mortensen LS. Bodyweight changes associated with antihyperglycaemic agents in type 2 diabetes mellitus. Drug Saf 2007;30(12):1127-42
   PubMed Web of Science ®Google Scholar
• Sun F, Chai S, Yu K, et al. Gastrointestinal adverse events of glucagon-like peptide-1 receptor agonists in patients with type 2 diabetes: a systematic review and network meta-analysis. Diabetes Technol Ther 2015;17(1):35-42
   PubMed Web of Science ®Google Scholar
• Orskov C, Poulsen SS, MSller M, et al. Glucagon-like peptide I receptors in the subfornical organ and the area postrema are accessible to circulating glucagon-like peptide I. Diabetes 1996;45(6):832-5
   PubMed Web of Science ®Google Scholar
• Secher A, Jelsing J, Baquero AF, et al. The arcuate nucleus mediates GLP-1 receptor agonist liraglutide-dependent weight loss. J Clin Invest 2014;124(10):4473-88
   PubMed Web of Science ®Google Scholar