284
Views
0
CrossRef citations to date
0
Altmetric
Drug Profile

Albiglutide for the management of type 2 diabetes

Pages 1-8 | Received 31 Aug 2017, Accepted 15 Dec 2017, Published online: 20 Dec 2017

References

  • Holst JJ. The physiology of glucagon-like peptide 1. Physiol Rev. 2007;87:1409–1439.
  • Drucker DJ. The biology of incretin hormones. Cell Metab. 2006;3:153–165.
  • Larsen PJ, Tang-Christensen M, Holst JJ, et al. Distribution of glucagon-like peptide-1 and other preproglucagon-derived peptides in the rat hypothalamus and brainstem. Neuroscience. 1997;77:257–270.
  • Larsen PJ, Holst JJ. Glucagon-related peptide 1 (GLP-1): hormone and neurotransmitter. Regul Pept. 2005;128:97–107.
  • Gautier J, Fetita S, Sobngwi E, et al. Biological actions of the incretins GIP and GLP-1 and therapeutic perspectives in patients with type 2 diabetes. Diabetes Metab. 2005;31:233–242.
  • 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. 1995;80:952–957.
  • Deacon CF, Pridal L, Klarskov L, et al. Glucagon-like peptide 1 undergoes differential tissue-specific metabolism in the anesthetized pig. Am J Physiol Endocrinol Metab. 1996;271:E458–E464.
  • Nauck M, Stöckmann F, Ebert R, et al. Reduced incretin effect in type 2 (non-insulin-dependent) diabetes. Diabetologia. 1986;29:46–52.
  • Mari A, Bagger JI, Ferrannini E, et al. Mechanisms of the incretin effect in subjects with normal glucose tolerance and patients with type 2 diabetes. PLoS One. 2013 Sep 3;8(9):e73154.
  • Harris KB, Boland CL. Adjunctive role of glucagon-like peptide-1 receptor agonists in the management of type 1 diabetes mellitus. Pharmacotherapy. 2016 Sep;36(9):1011–1020.
  • Tella SH, Rendell MS. Glucagon-like polypeptide agonists in type 2 diabetes mellitus: efficacy and tolerability, a balance. Ther Adv Endocrinol Metab. 2015;6:109–134.
  • Neumiller J, Campbell R. Liraglutide: a once-daily incretin mimetic for the treatment of type 2 di-abetes mellitus. Ann Pharmacother. 2009;43:1433–1444.
  • Norris S, Lee N, Thakurta S, et al. Exenatide efficacy and safety: a systematic review. Diabet Med. 2009;26:837–846.
  • Petersen A, Christensen M. Clinical potential of lixisenatide once daily treatment for type 2 diabetes mellitus. Diabetes Metab Syndr Obes. 2013;6:217–231.
  • Trujillo J, Nuffer W. Albiglutide: a new GLP-1 receptor agonist for the treatment of type 2 diabetes. Ann Pharmacother. 2014;48:1494–1501.
  • Gurung T, Shyangdan DS, O’Hare JP, et al. A novel, long-acting glucagon-like peptide receptor-agonist: dulaglutide. Diabetes Metab Syndr Obes. 2015;8:363–386.
  • 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;63:785–790.
  • Lorenz M, Pfeiffer C, Steinsträsser A, et al. Effects of lixisenatide once daily on gastric emptying in type 2 diabetes–relationship to postprandial glycemia. Regul Pept. 2013;185:1–8.
  • Turton MD, O’Shea D, Gunn I, et al. A role for glucagon-like peptide-1 in the central regulation of feeding. Nature. 1996;379:69–72.
  • Steinert RE, Schirra J, Meyer-Gerspach AC, et al. Effect of glucagon-like peptide-1 receptor antagonism on appetite and food intake in healthy men. Am J Clin Nutr. 2014;100:514–523.
  • Baggio LL, Drucker DJ. Glucagon-like peptide-1 receptors in the brain: controlling food intake and body weight. J Clin Invest. 2014;124:4223–4226.
  • Astrup A, Carraro R, Finer N, et al.; NN8022–1807 Investigators. Safety, tolerability and sustained weight loss over 2 years with the once-daily human GLP-1 analog, liraglutide. Int J Obes. 2012;36:843–854.
  • Lean M, Carraro R, Finer N, et al. Tolerability of nausea and vomiting and associations with weight loss in a randomized trial of liraglutide in obese, non-diabetic adults. Int J Obes. 2014;38:689–697.
  • Bush MA, Matthews JE, De Boever EH, et al. Safety, tolerability, pharmacodynamics and pharmacokinetics of albiglutide, a long-acting glucagon-like peptide-1 mimetic, in healthy subjects. Diabetes Obes Metab. 2009;11:498–505.
  • Matthews JE, Stewart MW, De Boever EH, et al. Pharmacodynamics, pharmacokinetics, safety, and tolerability of albiglutide, a long-acting Glucagon-Like Peptide-1 mimetic, in patients with Type 2 diabetes. J Clin Endocrin & Metab. 2008;93:4810–4817.
  • Young MA, Wald JA, Matthews JE, et al. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014;126:84–97.
  • Cho YM. Incretin physiology and pathophysiology from an Asian perspective. J Diabetes Investig. 2015;6:495–507.
  • Oh TJ, Kim MY, Shin JY, et al. The incretin effect in Korean subjects with normal glucose tolerance or type 2 diabetes. Clin Endocrinol (Oxf). 2014;80:221–227.
  • European Medicines Agency. Assessment report, Eperzan, International non-proprietary name: albiglutide, Procedure No. EMEA/H/C/002735/0000 23 January 2014 EMA/CHMP/705417/2013 Committee for Medicinal Products for Human Use (CHMP).
  • Drug Approval Package. FDA Tanzeum (Albiglutide) Injection Company: GlaxoSmithKline LLC Application No.: 125431 Approval Date: 4/15/2014.
  • 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;17:82–90.
  • Nauck MA, Stewart MW, Perkins C, et al. Efficacy and safety of once-weekly GLP-1 receptor agonist albiglutide (HARMONY 2): 52 week primary endpoint results from a randomised, placebo-controlled trial in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. Diabetologia. 2016;59:266–274.
  • Reusch J, Stewart M, Perkins C, et al. Efficacy and safety of once weekly GLP-1 receptor agonist albiglutide (HARMONY 1): 52 week primary endpoint results from a randomized, double-blind, placebo controlled trial in patients with type 2 diabetes mellitus not controlled on pioglitazone ± metformin. Diabetes Obes Metab. 2014;16:1257–1264.
  • Ahrén B, Johnson SL, Stewart M, et al.; HARMONY 3 Study Group. 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;37:2141–2148.
  • 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;57:2475–2484.
  • Home PD, Shamanna P, Stewart M, et al. Efficacy and tolerability of albiglutide versus placebo or pioglitazone over 1 year in people with type 2 diabetes currently taking metformin and glimepiride: HARMONY 5. Diabetes Obes Metab. 2015;17:179–187.
  • Rosenstock J, Fonseca VA, Gross JL, et al., Harmony 6 Study Group. 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;37:2317–2325.
  • Pratley RE, Nauck MA, Barnett AH, et al.; HARMONY 7 Study Group. 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;2:289–297.
  • 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;37:2723–2730.
  • Rosol TJ. On-target effects of GLP-1 receptor agonists on thyroid C-cells in rats and mice. Toxicol Pathol. 2013;41:303–309.
  • Ahrén B, Carr MC, Murphy K, et al. Albiglutide for the treatment of type 2 diabetes mellitus: an integrated safety analysis of the HARMONY phase 3 trials. Diabetes Res Clin Pract. 2017;126:230–239.
  • Egan AG, Blind E, Dunder K, et al. Pancreatic safety of incretin-based drugs — FDA and EMA assessment. N Engl J Med. 2014;370:794–797.
  • Fisher M, Petrie MC, Ambery PD, et al. Cardiovascular safety of albiglutide in the Harmony programme: a meta-analysis. Lancet Diabetes Endocrinol. 2015;3:697–703.
  • Knudsen LB, Secher A, Hecksher-Sørensen J, et al. Long-acting glucagon-like peptide-1 receptor agonists have direct access to and effects on pro-opiomelanocortin/cocaine- and amphetamine-stimulated transcript neurons in the mouse hypothalamus. J Diabetes Investig. 2016 Apr;7 Suppl 1:56–63.
  • Hottenstein CS, Szapacs ME, Maier CC Investigation of blood-brain barrier penetration of albiglutide in mice. Abstract 1044P presented at American Diabetes Association Annual Meeting; 2016 Jun 11; New Orleans, LA.
  • Vahle JL, Byrd RA, Blackbourne JL, et al. Effects of Dulaglutide on thyroid C cells and serum calcitonin in male monkeys. Endocrinology. 2015;156:2409–2416.
  • Yabe D, Seino Y, Fukushima M, et al. β cell dysfunction versus insulin resistance in the pathogenesis of type 2 diabetes in East Asians. Curr Diab Rep. 2015;15:602.
  • Seino Y, Kuwata H, Yabe D. Incretin-based drugs for type 2 diabetes: focus on East Asian perspectives. J Diabetes Investig. 2016;7 Suppl 1:102–109.
  • Okuda I, Wilson TH, Yue L, et al. Albiglutide, a weekly GLP-1 receptor agonist, improves glycemic parameters in Japanese patients with type 2 diabetes over 1 year when added to single oral antidiabetic drugs. Curr Med Res Opin. 2017;33:431–438.
  • Seino Y, Inagaki N, Miyahara H, et al. Randomized dose-finding study demonstrating the efficacy and tolerability of albiglutide in Japanese patients with type 2 diabetes mellitus. Curr Med Res Opin. 2014;30:1095–1106.
  • Marso SP, Daniels GH, Brown-Frandsen K, et al.; LEADER Steering Committee; LEADER Trial Investigators. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2016 28;375:311–322.
  • Bentley-Lewis R, Aguilar D, Riddle MC, et al.; ELIXA Investigators. Rationale, design, and Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placebo. Am Heart J. 2015;169:631–638.
  • Davies MJ, Bain SC, Atkin SL, et al. Efficacy and safety of liraglutide versus placebo as add-on to glucose-lowering therapy in patients with type 2 diabetes and moderate renal impairment (LIRA-RENAL): a randomized clinical trial. Diabetes Care. 2016;39:222–230.
  • Tuttle KR, McKinney TD, Davidson JA, et al. Effects of once-weekly dulaglutide on kidney function in patients with type 2 diabetes in phase II and III clinical trials. Diabetes Obes Metab. 2017;19:436–441.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.