Clinical review of the efficacy and safety of oral semaglutide in patients with type 2 diabetes compared with other oral antihyperglycemic agents and placebo

References

• Lindenfeld J, Jessup M. ‘Drugs don’t work in patients who don’t take them’ (C. Everett Koop, MD, US Surgeon General, 1985). Eur J Heart Fail. 2017;19(11):1412–1413.
   PubMed Web of Science ®Google Scholar
• Davidson JA. The increasing role of primary care physicians in caring for patients with type 2 diabetes mellitus. Mayo Clin Proc. 2010;85(12 Suppl):S3–S4.
   PubMedGoogle Scholar
• American Diabetes Association. 9. Pharmacologic approaches to glycemic treatment: Standards of Medical Care in Diabetes 2020. Diabetes Care. 2020;43(Suppl 1):S98–S110.
   PubMed Web of Science ®Google Scholar
• 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(1):107–139.
   PubMed Web of Science ®Google Scholar
• Drucker DJ, Nauck MA. The incretin system: glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors in type 2 diabetes. Lancet. 2006;368(9548):1696–1705.
   PubMed Web of Science ®Google Scholar
• Morales J, Assumpcao-Morales M. The use of SGLT2 inhibitors and GLP-1 receptor agonists, a worthwhile physiologic combination in managing type 2 diabetes while reducing cardiovascular risk. J Cardiol Curr Res. 2019;12:104–110.
   Google Scholar
• Hernandez AF, Green JB, Janmohamed S, et al. Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial. Lancet. 2018;392(10157):1519–1529.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Neal B, Perkovic V, Mahaffey KW, et al. Canagliflozin and cardiovascular and renal events in type 2 diabetes. N Engl J Med. 2017;377(7):644–657.
   PubMed Web of Science ®Google Scholar
• Zinman B, Wanner C, Lachin JM, et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015;373(22):2117–2128.
   PubMed Web of Science ®Google Scholar
• 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;394:121–130.
   PubMed Web of Science ®Google Scholar
• Santos Cavaiola T, Kiriakov Y, Reid T. Primary care management of patients with type 2 diabetes: overcoming inertia and advancing therapy with the use of injectables. Clin Ther. 2019;41(2):352–367.
   PubMed Web of Science ®Google Scholar
• Dibonaventura MD, Wagner JS, Girman CJ, et al. Multinational internet-based survey of patient preference for newer oral or injectable type 2 diabetes medication. Patient Prefer Adherence. 2010;4:397–406.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Novo Nordisk. Rybelsus® (oral semaglutide) approved for the treatment of adults with type 2 diabetes in the EU, 2020 [cited 2020 May 25]. Available from: https://www.novonordisk.ca/content/dam/Canada/AFFILIATE/www-novonordisk-ca/News/Health-Canada-approves-RYBELSUS-semaglutide-tablets-FINAL-April-9-EN.pdf
   Google Scholar
• Novo Nordisk. Health Canada approves Rybelsus® (semaglutide tablets) the first and only GLP-1 analogue in a pill for the treatment of adults with type 2 diabetes. 2020 [cited 2020 May 25]. Available from: https://www.novonordisk.com/media/news-details.2277630.html
   Google Scholar
• 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
   Google Scholar
• 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.
   Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Rodbard HW, Rosenstock J, Canani LH, et al. Oral semaglutide versus empagliflozin in patients with type 2 diabetes uncontrolled on metformin: the PIONEER 2 trial. Diabetes Care. 2019;42(12):2272–2281.
   PubMed Web of Science ®Google Scholar
• Pieber TR, Bode B, Mertens A, et al. Efficacy and safety of oral semaglutide with flexible dose adjustment versus sitagliptin in type 2 diabetes (PIONEER 7): a multicentre, open-label, randomised, phase 3a trial. Lancet Diabetes Endocrinol. 2019;7(7):528–539.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Wright EE, Aroda VA. 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. Postgrad Med. 2020;132(S2):26–36.
   Google Scholar
• 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.
   Google Scholar
• Wang Y, Perri M. A systematic review of patient-reported satisfaction with oral medication therapy in patients with type 2 diabetes. Value Health. 2018;21(11):1346–1353.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Hussein H, Zaccardi F, Khunti K, et al. Efficacy and tolerability of sodium-glucose co-transporter-2 inhibitors and glucagon-like peptide-1 receptor agonists: a systematic review and network meta-analysis. Diabetes Obes Metab. 2020;22(7):1035–1046.
   PubMed Web of Science ®Google Scholar
• Hansen BB, Hertz CL, Tarp-Johansen MJ. Patient treatment satisfaction and study staff perceptions of oral semaglutide for the treatment of type 2 diabetes (abstract). Value Health. 2019;22(Suppl 3):PDB117.
   Google Scholar
• Look AHEAD Research Group. Impact of intensive lifestyle intervention on depression and health-related quality of life in type 2 diabetes: the LookAHEAD trial. Diabetes Care. 2014;37(6):1544–1553.
   PubMed Web of Science ®Google Scholar
• Bettge K, Kahle M, Abd El Aziz MS, et al. Occurrence of nausea, vomiting and diarrhoea reported as adverse events in clinical trials studying glucagon-like peptide-1 receptor agonists: a systematic analysis of published clinical trials. Diabetes Obes Metab. 2017;19(3):336–347.
   PubMed Web of Science ®Google Scholar
• Abd El Aziz M, Cahyadi O, Meier JJ, et al. Incretin-based glucose-lowering medications and the risk of acute pancreatitis and malignancies: a meta-analysis based on cardiovascular outcomes trials. Diabetes Obes Metab. 2020;22(4):699–704.
   PubMed Web of Science ®Google Scholar
• Bethel MA, Patel RA, Merrill P, et al. Cardiovascular outcomes with glucagon-like peptide-1 receptor agonists in patients with type 2 diabetes: a meta-analysis. Lancet Diabetes Endocrinol. 2018;6(2):105–113.
   PubMed Web of Science ®Google Scholar
• Nreu B, Dicembrini I, Tinti F, et al. Cholelithiasis in patients treated with glucagon-like peptide-1 receptor: an updated meta-analysis of randomized controlled trials. Diabetes Res Clin Pract. 2020;161:108087.
   PubMed Web of Science ®Google Scholar
• Yau JW, Rogers SL, Kawasaki R, et al. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care. 2012;35(3):556–564.
   PubMed Web of Science ®Google Scholar
• American Diabetes Association. 11. Microvascular complications and foot care: Standards of Medical Care in Diabetes 2020. Diabetes Care. 2020;43(Suppl 1):S135–S151.
   PubMed Web of Science ®Google Scholar
• Carls GS, Tuttle E, Tan RD, et al. Understanding the gap between efficacy in randomized controlled trials and effectiveness in real-world use of GLP-1 RA and DPP-4 therapies in patients with type 2 diabetes. Diabetes Care. 2017;40(11):1469–1478.
   PubMed Web of Science ®Google Scholar
• Edelman SV, Polonsky WH. Type 2 diabetes in the real world: the elusive nature of glycemic control. Diabetes Care. 2017;40(11):1425–1432.
   PubMed Web of Science ®Google Scholar
• García-Pérez LE, Alvarez M, Dilla T, et al. Adherence to therapies in patients with type 2 diabetes. Diabetes Ther. 2013;4(2):175–194.
   PubMed Web of Science ®Google Scholar
• 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.
   Google Scholar