Clinical considerations for use of insulin degludec/insulin aspart in Japanese patients

References

• IDF diabetes atlas. 7th ed. [Internet]. International Diabetes Federation; 2015. [cited 2016 Mar]. Available from: www.diabetesatlas.org/resources/2015-atlas.html
   Google Scholar
• Khunti K, Wolden ML, Thorsted BL, et al. Clinical inertia in people with type 2 diabetes: a retrospective cohort study of more than 80,000 people. Diabetes Care. 2013;36:3411–3417.
   PubMed Web of Science ®Google Scholar
• Home P, Riddle M, Cefalu WT, et al. Insulin therapy in people with type 2 diabetes: opportunities and challenges? Diabetes Care. 2014;37:1499–1508.
   PubMed Web of Science ®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;38:140–149.
   PubMed Web of Science ®Google Scholar
• The Japan diabetes society: treatment guide for diabetes 2016–2017. [cited 2016 Nov 15]. Available from: http://www.jds.or.jp/modules/en/index.php?content_id=34. Japanese.
   Google Scholar
• Holman RR, Farmer AJ, Davies MJ, et al. Three-year efficacy of complex insulin regimens in type 2 diabetes. N Engl J Med. 2009;361:1736–1747.
   PubMed Web of Science ®Google Scholar
• Buse JB, Wolffenbuttel BH, Herman WH, et al. DURAbility of basal versus lispro mix 75/25 insulin efficacy (DURABLE) trial 24-week results: safety and efficacy of insulin lispro mix 75/25 versus insulin glargine added to oral antihyperglycemic drugs in patients with type 2 diabetes. Diabetes Care. 2009;32:1007–1013.
   PubMed Web of Science ®Google Scholar
• Buse JB, Wolffenbuttel BH, Herman WH, et al. The durability of basal versus Lispro mix 75/25 insulin efficacy (DURABLE) trial: comparing the durability of lispro mix 75/25 and glargine. Diabetes Care. 2011;34:249–255.
   PubMed Web of Science ®Google Scholar
• Ishii H, Iwamoto Y, Tajima N. An exploration of barriers to insulin initiation for physicians in Japan: findings from the Diabetes Attitudes, Wishes and Needs (DAWN) JAPAN study. PLoS One. 2012;7:e36361.
   PubMed Web of Science ®Google Scholar
• Peyrot M, Barnett AH, Meneghini LF, et al. Insulin adherence behaviours and barriers in the multinational global attitudes of patients and physicians in insulin therapy study. Diabet Med. 2012;29:682–689.
   PubMed Web of Science ®Google Scholar
• Kalra S. Insulin degludec aspart: the first co-formulation of insulin analogues. Diabetes Ther. 2014;5:65–72.
   PubMed Web of Science ®Google Scholar
• Atkin S, Javed Z, Fulcher G. Insulin degludec and insulin aspart: novel insulins for the management of diabetes mellitus. Ther Adv Chronic Dis. 2015;6:375–388.
   PubMed Web of Science ®Google Scholar
• Sanofi. Lantus® Prescribing Information [cited 2016 Nov 30]. Available from: http://products.sanofi.us/lantus/lantus.html
   Google Scholar
• Jonassen I, Havelund S, Hoeg-Jensen T, et al. Design of the novel protraction mechanism of insulin degludec, an ultra-long-acting basal insulin. Pharm Res. 2012;29:2104–2114.
   PubMed Web of Science ®Google Scholar
• Cengiz E, Swan KL, Tamborlane WV, et al. The alteration of aspart insulin pharmacodynamics when mixed with detemir insulin. Diabetes Care. 2012;35:690–692.
   PubMed Web of Science ®Google Scholar
• Ma Z, Parkner T, Christiansen JS, et al. IDegAsp: a novel soluble insulin analogs combination. Expert Opin Biol Ther. 2012;12:1533–1540.
   PubMed Web of Science ®Google Scholar
• Kumar A, Awata T, Bain S, et al. Clinical use of the co-formulation of insulin degludec and insulin aspart. Int J Clin Pract. 2016;70:657–667.
   PubMed Web of Science ®Google Scholar
• Havelund S, Ribel U, Hubálek F, et al. Investigation of the physico-chemical properties that enable co-formulation of basal insulin degludec with fast-acting insulin aspart. Pharm Res. 2015;32:2250–2258.
   PubMed Web of Science ®Google Scholar
• Haahr H, Fita EG, Heise T. A review of insulin degludec/insulin aspart: pharmacokinetic and pharmacodynamic properties and their implications in clinical use. Clin Pharmacokinet. 2017;56:339–354.
   PubMed Web of Science ®Google Scholar
• Heise T, Hermanski L, Nosek L, et al. Insulin degludec: four times lower pharmacodynamic variability than insulin glargine under steady-state conditions in type 1 diabetes. Diabetes Obes Metab. 2012;14:859–864.
   PubMed Web of Science ®Google Scholar
• Gough SC, Harris S, Woo V, et al. Insulin degludec: overview of a novel ultra long acting basal insulin. Diabetes Obes Metab. 2013;15:301–309.
   PubMed Web of Science ®Google Scholar
• Ikushima I, Kaku K, Hirao K, et al. Pharmacokinetic and pharmacodynamic properties of insulin degludec in Japanese patients with type 1 diabetes mellitus reflect similarities with Caucasian patients. J Diabetes Invest. 2016;7:270–275.
   PubMed Web of Science ®Google Scholar
• Heise T, Nosek L, Roepstorff C, et al. Distinct prandial and basal glucose-lowering effects of insulin degludec/insulin aspart (IDegAsp) at steady state in subjects with type 1 diabetes mellitus. Diabetes Ther. 2014;5:255–265.
   PubMed Web of Science ®Google Scholar
• Haahr H, Sasaki T, Bardtrum L, et al. Insulin degludec/insulin aspart in Japanese patients with type 1 diabetes mellitus: distinct prandial and basal glucose-lowering effects. J Diabetes Invest. 2016;7:574–580.
   PubMed Web of Science ®Google Scholar
• Heise T, Korsatko S, Nosek L, et al. Steady state is reached within 2-3 days of once-daily administration of degludec, a basal insulin with an ultralong duration of action. J Diabetes. 2016;8:132–138.
   PubMed Web of Science ®Google Scholar
• Hirsch IB, Bode B, Courreges JP, et al. Insulin degludec/insulin aspart administered once daily at any meal, with insulin aspart at other meals versus a standard basal-bolus regimen in patients with type 1 diabetes: a 26-week, phase 3, randomized, open-label, treat-to-target trial. Diabetes Care. 2012;35:2174–2181.
   PubMed Web of Science ®Google Scholar
• Kumar A, Franek E, Wise J, et al. Efficacy and safety of once-daily insulin degludec/insulin aspart versus insulin glargine (U100) for 52 weeks in insulin-naïve patients with type 2 diabetes: a randomized controlled trial. PLoS One. 2016;11. DOI:10.1371/journal.pone.0163350
   Web of Science ®Google Scholar
• Onishi Y, Ono Y, Rabøl R, et al. Superior glycaemic control with once-daily insulin degludec/insulin aspart versus insulin glargine in Japanese adults with type 2 diabetes inadequately controlled with oral drugs: a randomized, controlled phase 3 trial. Diabetes Obes Metab. 2013;15:826–832.
   PubMed Web of Science ®Google Scholar
• Kaneko S, Chow F, Choi DS, et al. Insulin degludec/insulin aspart versus biphasic insulin aspart 30 in Asian patients with type 2 diabetes inadequately controlled on basal or pre-/self-mixed insulin: a 26-week, randomised, treat-to-target trial. Diabetes Res Clin Pract. 2015;107:139–147.
   PubMed Web of Science ®Google Scholar
• Novo Nordisk clinical trial report. Trial ID: NN5401-3597 [cited Dec 2016]. Available from: http://novonordisk-trials.com/Website/pdf/registry/9752-3597-ctr-redacted.pdf
   Google Scholar
• Fulcher GR, Christiansen JS, Bantwal G, et al. Comparison of insulin degludec/insulin aspart and biphasic insulin aspart 30 in uncontrolled, insulin-treated type 2 diabetes: a phase 3a, randomized, treat-to-target trial. Diabetes Care. 2014;37:2084–2090.
   PubMed Web of Science ®Google Scholar
• Christiansen JS, Niskanen L, Rasmussen S, et al. Lower rates of hypoglycemia during maintenance treatment with IDegAsp versus BIAsp 30: a combined analysis of two phase 3a studies in type 2 diabetes. J Diabetes. 2016;8:720–728.
   PubMed Web of Science ®Google Scholar
• Rodbard HW, Cariou B, Pieber TR, et al. Treatment intensification with an insulin degludec (IDeg)/insulin aspart (IAsp) co-formulation twice daily compared with basal IDeg and prandial IAsp in type 2 diabetes: a randomized, controlled phase III trial. Diabetes Obes Metab. 2016;18:274–280.
   PubMed Web of Science ®Google Scholar
• Kumar S, Jang HC, Demirağ Guvener N, et al. Efficacy and safety of once-daily insulin degludec/insulin aspart compared with once-daily insulin glargine in participants with Type 2 diabetes: a randomized, treat-to-target study. Diabet Med. 2017;34:180–188.
   PubMed Web of Science ®Google Scholar
• Taneda S, Hyllested-Winge J, Gall MA, et al. Insulin degludec/insulin aspart versus biphasic insulin aspart 30 twice daily in insulin-experienced Japanese subjects with uncontrolled type 2 diabetes: subgroup analysis of a Pan-Asian, treat-to-target Phase 3 Trial. J Diabetes. 2017;9:243–247.
   PubMed Web of Science ®Google Scholar
• Hirsch IB, Franek E, Mersebach H, et al. Safety and efficacy of insulin degludec/insulin aspart with bolus mealtime insulin aspart compared with standard basal-bolus treatment in people with Type 1 diabetes: 1-year results from a randomized clinical trial (BOOST® T1). Diabet Med. 2017;34:167–173.
   PubMed Web of Science ®Google Scholar
• Novo Nordisk Pharma Ltd. Ryzodeg® Japanese product insert. 2015 Oct.
   Google Scholar
• Park SW, Bebakar WMW, Hernandez PG, et al. Insulin degludec/insulin aspart once daily in Type 2 diabetes: a comparison of simple or stepwise titration algorithms (BOOST®: SIMPLE USE). Diabet Med. 2017;34:174–179.
   PubMed Web of Science ®Google Scholar
• Ryzodeg® prescribing information. Novo Nordisk A/S. Bagsvaerd (Denmark). [cited 2017 Sep 25]. Available from: http://www.novo-pi.com/ryzodeg7030.pdf
   Google Scholar
• Ryzodeg® Summary of Product Characteristics. Novo Nordisk A/S. Bagsvaerd (Denmark). [cited 2017 Sep 25]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002499/WC500139011.pdf
   Google Scholar
• Japan Diabetes Society (JDS)/Japan Geriatrics Society (JGS) Joint Committee on Improving Care for Elderly Patients with Diabetes’. Committee report: glycemic targets for elderly patients with diabetes. J Diabetes Investig. 2017;8:126–128.
   PubMed Web of Science ®Google Scholar