Subcutaneous semaglutide (NN9535) for the treatment of type 2 diabetes

References

• American Diabetes Association. Standards of medical care in diabetes-2017 abridged for primary care providers. Clin Diabetes. 2017 Jan;35(1):5–26. PubMed PMID: 28144042; PubMed Central PMCID: PMCPMC5241768.
   PubMedGoogle 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 Nov 11;368(9548):1696–1705. PubMed PMID: 17098089.
   PubMed Web of Science ®Google Scholar
• Flint A, Raben A, Astrup A, et al. Glucagon-like peptide 1 promotes satiety and suppresses energy intake in humans. J Clin Invest. 1998 Feb 01;101(3):515–520. PubMed PMID: 9449682; PubMed Central PMCID: PMCPMC508592.
   PubMed Web of Science ®Google Scholar
• Willms B, Werner J, Holst JJ, et al. Gastric emptying, glucose responses, and insulin secretion after a liquid test meal: effects of exogenous glucagon-like peptide-1 (GLP-1)-(7-36) amide in type 2 (noninsulin-dependent) diabetic patients. J Clin Endocrinol Metab. 1996 Jan;81(1):327–332. PubMed PMID: 8550773.
   PubMed Web of Science ®Google Scholar
• 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 May;55(5):497–504. PubMed PMID: 25475122; PubMed Central PMCID: PMCPMC4418331.
   PubMed Web of Science ®Google Scholar
• Gotfredsen CF, Molck AM, Thorup I, et al. The human GLP-1 analogs liraglutide and semaglutide: absence of histopathological effects on the pancreas in nonhuman primates. Diabetes. 2014 Jul;63(7):2486–2497. PubMed PMID: 24608440.
   PubMed Web of Science ®Google Scholar
• Jensen L, Helleberg H, Roffel A, et al. Absorption, metabolism and excretion of the GLP-1 analogue semaglutide in humans and nonclinical species. Eur J Pharm Sci. 2017 Jun 15;104:31–41. PubMed PMID: 28323117.
   PubMed Web of Science ®Google Scholar
• Arold G, Kupcova V, Jensen L, et al. Pharmacokinetics and tolerability of semaglutide in subjects with hepatic impairment. Diabetologia. 2017 Sep;60:S380–S381. PubMed PMID: WOS:000408315002162; English.
   Web of Science ®Google Scholar
• Marbury TC, Flint A, Jacobsen JB, et al. Pharmacokinetics and tolerability of a single dose of semaglutide, a human glucagon-like peptide-1 analog, in subjects with and without renal impairment. Clin Pharmacokinet. 2017 Mar 27 PubMed PMID: 28349386. DOI:10.1007/s40262-017-0528-2.
   Web of Science ®Google Scholar
• Demmel V, Sandberg-Schaal A, Jacobsen JB, et al. Absence of QTc prolongation with semaglutide: a thorough QT/QTc study in healthy subjects. Eur Heart J. 2017 August 1;38(suppl_1):ehx493P5349.
   Google Scholar
• Hausner H, Derving Karsbol J, Holst AG, et al. Effect of Semaglutide on the pharmacokinetics of metformin, warfarin, atorvastatin and digoxin in healthy subjects. Clin Pharmacokinet. 2017 Nov;56(11):1391–1401. PubMed PMID: 28349387.
   PubMed Web of Science ®Google Scholar
• Kapitza C, Dahl K, Jacobsen JB, et al. Effects of semaglutide on beta cell function and glycaemic control in participants with type 2 diabetes: a randomised, double-blind, placebo-controlled trial. Diabetologia. 2017 Aug;60(8):1390–1399. PubMed PMID: 28526920; PubMed Central PMCID: PMCPMC5491562.
   PubMed Web of Science ®Google Scholar
• Hjerpsted JB, Flint A, Brooks A, et al. Semaglutide improves postprandial glucose and lipid metabolism, and delays first-hour gastric emptying in subjects with obesity. Diabetes Obes Metab. 2017 Sep 23 PubMed PMID: 28941314. DOI:10.1111/dom.13120.
   Web of Science ®Google Scholar
• Nauck MA, Petrie JR, Sesti G, et al. A phase 2, randomized, dose-finding study of the novel once-weekly human GLP-1 analog, semaglutide, compared with placebo and open-label liraglutide in patients with type 2 diabetes. Diabetes Care. 2016 Feb;39(2):231–241. PubMed PMID: 26358288.
   PubMed Web of Science ®Google Scholar
• 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 Apr;5(4):251–260. PubMed PMID: 28110911.
   PubMed Web of Science ®Google Scholar
• Ahren B, Masmiquel L, Kumar H, et al. Efficacy and safety of once-weekly semaglutide versus once-daily sitagliptin as an add-on to metformin, thiazolidinediones, or both, in patients with type 2 diabetes (SUSTAIN 2): a 56-week, double-blind, phase 3a, randomised trial. Lancet Diabetes Endocrinol. 2017 May;5(5):341–354. PubMed PMID: 28385659.
   PubMed Web of Science ®Google Scholar
• Ahmann A, Capehorn M, Charpentier G, et al. Efficacy and safety of once-weekly semaglutide vs exenatide ER after 56 weeks in subjects with type 2 diabetes (SUSTAIN 3). Diabetes Res Clin Pract. 2016;120S1:S40–S64 S51.
   Google Scholar
• Aroda V, Bain SC, Cariou B, et al. Efficacy and safety of once-weekly semaglutide versus oncedaily insulin glargine in insulin-naïve subjects with type 2 diabetes (SUSTAIN 4). Diabetes Res Clin Pract. 2016;120S1:S40–S64 S51.
   Google Scholar
• 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 May;5(5):355–366. PubMed PMID: 28344112.
   PubMed Web of Science ®Google Scholar
• Conway R, Rodbard H, Linglay I, et al. Efficacy and safety of semaglutide once-weekly vs. Placebo as add-on to basal insulin alone or in combination with metformin in subjects with type 2 diabetes (SUSTAIN 5). Can J Diabetes. 2016;40:S27–S74.
   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 Nov 10;375(19):1834–1844. PubMed PMID: 27633186.
   PubMed Web of Science ®Google Scholar
• Seino Y, Terauchi Y, Osonoi T, et al. Safety and efficacy of semaglutide once weekly vs sitagliptin once daily, both as monotherapy in Japanese people with type 2 diabetes. Diabetes Obes Metab. 2017 Aug 08 PubMed PMID: 28786547. DOI:10.1111/dom.13082.
   Web of Science ®Google Scholar
• ClinicialTrials.gov. A trial comparing the safety and efficacy of semaglutide once weekly in monotherapy or in combination with one OAD in Japanese subjects with type 2 diabetes (SUSTAIN™). [cited 2017 Nov 3]. Available from: https://clinicaltrials.gov/ct2/show/NCT02207374
   Google Scholar
• Molinder H, Agreus L, Kjellstrom L, et al. How individuals with the irritable bowel syndrome describe their own symptoms before formal diagnosis. Upsala J Med Sci. 2015 Oct 2;120(4):276–279. PubMed PMID: WOS:000365684900007; English.
   PubMed Web of Science ®Google Scholar
• Rayner CK, Jones KL, Wu TZ, et al. Gut feelings about diabetes and GLP-1 receptor agonists: lessons to be learnt from studies in functional gastrointestinal disorders. Diabetes Obes Metab. 2017 Mar;19(3):309–312. PubMed PMID: WOS:000394785200001; English.
   PubMed Web of Science ®Google Scholar
• Novo nordisk files for regulatory approval of once-weekly semaglutide with the FDA for the treatment of type 2 diabetes [Internet]. [cited 2018 Jan 31]. Available from: http://press.novonordisk-us.com/2016-12-05-Novo-Nordisk-Files-for-Regulatory-Approval-of-Once-Weekly-Semaglutide-with-the-FDA-for-the-Treatment-of-Type-2-Diabetes; 2016
   Google Scholar
• Novo Nordisk receives positive 16-0 vote from FDA Advisory Committee in favor of approval for semaglutide [Internet]. 2017. [cited 2018 Jan 31]. Available from: http://press.novonordisk-us.com/2017-10-18-Novo-Nordisk-receives-positive-16-0-vote-from-FDA-Advisory-Committee-in-favor-of-approval-for-semaglutide
   Google Scholar
• 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 Jan;38(1):140–149. PubMed PMID: 25538310.
   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 Apr;2(4):289–297. PubMed PMID: 24703047.
   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. Lancet. 2008 Oct 04;372(9645):1240–1250. PubMed PMID: 18782641.
   PubMed Web of Science ®Google Scholar
• Grimm M, Han J, Weaver C, et al. Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials. Postgrad Med. 2013 May;125(3):47–57. PubMed PMID: 23748506.
   PubMed Web of Science ®Google Scholar
• Owens DR, Traylor L, Dain MP, et al. Efficacy and safety of basal insulin glargine 12 and 24 weeks after initiation in persons with type 2 diabetes: a pooled analysis of data from treatment arms of 15 treat-to-target randomised controlled trials. Diabetes Res Clin Pract. 2014 Nov;106(2):264–274. PubMed PMID: 25195151.
   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 Jul 28;375(4):311–322. PubMed PMID: 27295427; PubMed Central PMCID: PMCPMC4985288.
   PubMed Web of Science ®Google Scholar
• Arg L, Wing RR. Long-term effects of a lifestyle intervention on weight and cardiovascular risk factors in individuals with type 2 diabetes mellitus: four-year results of the look AHEAD trial. Arch Intern Med. 2010 Sep 27;170(17):1566–1575. PubMed PMID: 20876408; PubMed Central PMCID: PMCPMC3084497.
   PubMedGoogle Scholar
• Rosenstock J, Raccah D, Koranyi L, et al. Efficacy and safety of lixisenatide once daily versus exenatide twice daily in type 2 diabetes inadequately controlled on metformin: a 24-week, randomized, open-label, active-controlled study (GetGoal-X). Diabetes Care. 2013 Oct;36(10):2945–2951. PubMed PMID: 23698396; PubMed Central PMCID: PMCPMC3781502.
   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). Lancet. 2009 Jul 04;374(9683):39–47. PubMed PMID: 19515413.
   PubMed Web of Science ®Google Scholar
• Potts JE, Gray LJ, Brady EM, et al. The effect of glucagon-like peptide 1 receptor agonists on weight loss in type 2 diabetes: a systematic review and mixed treatment comparison meta-analysis. PLoS One. 2015;10(6):e0126769. PubMed PMID: 26121478; PubMed Central PMCID: PMCPMC4487255.
   PubMed Web of Science ®Google Scholar