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Supplement: introducing oral semaglutide and the PIONEER program to primary care

Clinical review of the efficacy and safety of oral semaglutide in patients with type 2 diabetes considered for injectable GLP-1 receptor agonist therapy or currently on insulin therapy

ORCID Icon & ORCID Icon
Pages 26-36 | Received 01 Jun 2020, Accepted 16 Jul 2020, Published online: 08 Sep 2020

References

  • American Diabetes Association. 9. Pharmacologic approaches to glycemic treatment: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020;43(Suppl 1):S98–S110.
  • Garber AJ, Handelsman Y, Grunberger G, et al. Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm – 2020 executive summary. Endocr Pract. 2020;26:107–139.
  • Wallia A, Molitch ME. Insulin therapy for type 2 diabetes mellitus. JAMA. 2014;311(22):2315–2325.
  • Erpeldinger S, Rehman MB, Berkhout C, et al. Efficacy and safety of insulin in type 2 diabetes: meta-analysis of randomised controlled trials. BMC Endocr Disord. 2016;16(1):39.
  • Liu SC, Tu YK, Chien MN, et al. Effect of antidiabetic agents added to metformin on glycaemic control, hypoglycaemia and weight change in patients with type 2 diabetes: a network meta-analysis. Diabetes Obes Metab. 2012;14(9):810–820.
  • Zaccardi F, Dhalwani NN, Dales J, et al. Comparison of glucose-lowering agents after dual therapy failure in type 2 diabetes: a systematic review and network meta-analysis of randomized controlled trials. Diabetes Obes Metab. 2018;20(4):985–997.
  • Buse JB, Wexler DJ, Tsapas A, et al. 2019 update to: management of hyperglycemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2020;43(2):487–493.
  • Brunton SA, Wysham CH. GLP-1 receptor agonists in the treatment of type 2 diabetes: role and clinical experience to date. Postgrad Med. 2020;132(S2):3–14.
  • Ozempic® (semaglutide) prescribing information [updated Jan 2020; cited 2020 May 25]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209637s003lbl.pdf
  • Kapitza C, Nosek L, Jensen L, et al. Semaglutide, a once-weekly human GLP-1 analog, does not reduce the bioavailability of the combined oral contraceptive, ethinylestradiol/levonorgestrel. J Clin Pharmacol. 2015;55(5):497–504.
  • Lau J, Bloch P, Schaffer L, et al. Discovery of the once-weekly glucagon-like peptide-1 (GLP-1) analogue semaglutide. J Med Chem. 2015;58:7370–7380.
  • Ahmann AJ, Capehorn M, Charpentier G, et al. Efficacy and safety of once-weekly semaglutide versus exenatide ER in subjects with type 2 diabetes (SUSTAIN 3): a 56-week, open-label, randomized clinical trial. Diabetes Care. 2018;41(2):258–266.
  • Aroda VR, Bain SC, Cariou B, et al. Efficacy and safety of once-weekly semaglutide versus once-daily insulin glargine as add-on to metformin (with or without sulfonylureas) in insulin-naive patients with type 2 diabetes (SUSTAIN 4): a randomised, open-label, parallel-group, multicentre, multinational, phase 3a trial. Lancet Diabetes Endocrinol. 2017;5(5):355–366.
  • Aroda VR, Ahmann A, Cariou B, et al. Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes: insights from the SUSTAIN 1-7 trials. Diabetes Metab. 2019;45(5):409–418.
  • Pratley RE, Aroda VR, Lingvay I, et al. Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial. Lancet Diabetes Endocrinol. 2018;6(4):275–286.
  • Sorli C, Harashima SI, Tsoukas GM, et al. Efficacy and safety of once-weekly semaglutide monotherapy versus placebo in patients with type 2 diabetes (SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group, multinational, multicentre phase 3a trial. Lancet Diabetes Endocrinol. 2017;5:251–260.
  • Witkowski M, Wilkinson L, Webb N, et al. A systematic literature review and network meta-analysis comparing once-weekly semaglutide with other GLP-1 receptor agonists in patients with type 2 diabetes previously receiving 1-2 oral anti-diabetic drugs. Diabetes Ther. 2018;9(3):1149–1167.
  • Witkowski M, Wilkinson L, Webb N, et al. A systematic literature review and network meta-analysis comparing once-weekly semaglutide with other GLP-1 receptor agonists in patients with type 2 diabetes previously receiving basal insulin. Diabetes Ther. 2018;9(3):1233–1251.
  • Marso SP, Bain SC, Consoli A, et al. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. N Engl J Med. 2016;375(19):1834–1844.
  • Rybelsus® (semaglutide) prescribing information [updated Jan 2020; cited 2020 May 25]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213182s000,213051s001lbl.pdf
  • Buckley ST, Bækdal TA, Vegge A, et al. Transcellular stomach absorption of a derivatized glucagon-like peptide-1 receptor agonist. Sci Transl Med. 2018;10(467):eaar7047.
  • Trulicity® (dulaglutide) prescribing information [updated Feb 2020; cited 2020 May 25]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125469s033lbl.pdf
  • Victoza® (liraglutide) prescribing information [updated Jun 2019; cited 2020 May 25]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022341s031lbl.pdf
  • Gerstein HC, Colhoun HM, Dagenais GR, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Lancet. 2019;394(10193):121–130.
  • Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2016;375(4):311–322.
  • Byetta® (exenatide) prescribing information [updated Feb 2020; cited 2020 May 25]. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021773s043lbl.pdf
  • Bydureon® (exenatide extended-release) prescribing information [updated Feb 2020; cited 2020 May 25]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022200s030lbl.pdf
  • Adlyxin® (lixisenatide) prescribing information [updated Jan 2020; cited 2020 May 25]. Available from: http://products.sanofi.us/Adlyxin/Adlyxin.pdf
  • Davies M, Pieber TR, Hartoft-Nielsen ML, et al. Effect of oral semaglutide compared with placebo and subcutaneous semaglutide on glycemic control in patients with type 2 diabetes: a randomized clinical trial. JAMA. 2017;318:1460–1470.
  • Husain M, Birkenfeld AL, Donsmark M, et al. Oral semaglutide and cardiovascular outcomes in patients with type 2 diabetes. N Engl J Med. 2019;381(9):841–851.
  • Mosenzon O, Miller EM, Warren ML. Oral semaglutide in patients with type 2 diabetes and cardiovascular disease, renal impairment, or other comorbidities, and in older patients. Postgrad Med. 2020;132(S2):37–47.
  • Pratley R, Amod A, Hoff ST, et al. Oral semaglutide versus subcutaneous liraglutide and placebo in type 2 diabetes (PIONEER 4): a randomised, double-blind, phase 3a trial. Lancet. 2019;394(10192):39–50.
  • Zinman B, Aroda VR, Buse JB, et al. Efficacy, safety, and tolerability of oral semaglutide versus placebo added to insulin with or without metformin in patients with type 2 diabetes: the PIONEER 8 trial. Diabetes Care. 2019;42(12):2262–2271.
  • Lavernia F, Blonde L. Clinical review of the efficacy and safety of oral semaglutide in patients with type 2 diabetes compared with other oral antihyperglycemic agents and placebo. Postgrad Med. 2020;132(S2):15–25.
  • Aroda VR, Saugstrup T, Buse JB, et al. Incorporating and interpreting regulatory guidance on estimands in diabetes clinical trials: the PIONEER 1 randomized clinical trial as an example. Diabetes Obes Metab. 2019;21(10):2203–2210.
  • Htike ZZ, Zaccardi F, Papamargaritis D, et al. Efficacy and safety of glucagon-like peptide-1 receptor agonists in type 2 diabetes: a systematic review and mixed-treatment comparison analysis. Diabetes Obes Metab. 2017;19(4):524–536.
  • Lyseng-Williamson KA. Glucagon-like peptide-1 receptor analogues in type 2 diabetes: their use and differential features. Clin Drug Investig. 2019;39(8):805–819.
  • 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.
  • Brunton SA, Mosenzon O, Wright EE. Integrating oral semaglutide into clinical practice in primary care: for whom, when, and how? Postgrad Med. 2020;132(S2):48–60.
  • Vilsbøll T, Bain SC, Leiter LA, et al. Semaglutide, reduction in glycated haemoglobin and the risk of diabetic retinopathy. Diabetes Obes Metab. 2018;20(4):889–897.
  • Tonin FS, Rotta I, Mendes AM, et al. Network meta-analysis: a technique to gather evidence from direct and indirect comparisons. Pharm Pract (Granada). 2017;15(1):943.
  • Nuhoho S, Gupta J, Hansen BB, et al. Orally administered semaglutide versus GLP-1RAs in patients with type 2 diabetes previously receiving 1-2 oral antidiabetics: systematic review and network meta-analysis. Diabetes Ther. 2019;10(6):2183–2199.
  • Bækdal TA, Borregaard J, Donsmark M, et al. Evaluation of the effects of water volume with dosing and post-dose fasting period on pharmacokinetics of oral semaglutide (abstract). Diabetes. 2017;66(Suppl 1):1179–P.
  • Maarbjerg SJ, Borregaard J, Breitschaft A, et al. Evaluation of the effect of food on the pharmacokinetics of oral semaglutide. Presented at the American Diabetes Association, San Diego, California, 9–13 June 2017.
  • Aroda VR, Rosenstock J, Terauchi Y, et al. PIONEER 1: randomized clinical trial of the efficacy and safety of oral semaglutide monotherapy in comparison with placebo in patients with type 2 diabetes. Diabetes Care. 2019;42(9):1724–1732.
  • Rosenstock J, Allison D, Birkenfeld AL, et al. Effect of additional oral semaglutide vs sitagliptin on glycated hemoglobin in adults with type 2 diabetes uncontrolled with metformin alone or with sulfonylurea: the PIONEER 3 randomized clinical trial. JAMA. 2019;321(15):1466–1480.
  • Mosenzon O, Blicher TM, Rosenlund S, et al. Efficacy and safety of oral semaglutide in patients with type 2 diabetes and moderate renal impairment (PIONEER 5): a placebo-controlled, randomised, phase 3a trial. Lancet Diabetes Endocrinol. 2019;7(7):515–527.
  • Bucheit JD, Pamulapati LG, Carter N, et al. Oral semaglutide: a review of the first oral glucagon-like peptide 1 receptor agonist. Diabetes Technol Ther. 2020;22(1):10–18.
  • Mansfield C, Sikirica MV, Pugh A, et al. Patient preferences for attributes of type 2 diabetes mellitus medications in Germany and Spain: an online discrete-choice experiment survey. Diabetes Ther. 2017;8(6):1365–1378.
  • Reid TS. Practical use of glucagon-like peptide-1 receptor agonist therapy in primary care. Clin Diabetes. 2013;31(4):148–157.