2,790
Views
4
CrossRef citations to date
0
Altmetric
Drug Profiles

IDegAsp (insulin degludec + insulin aspart) for the management of type 2 diabetes: current status

, &
Pages 103-111 | Received 31 Jul 2015, Accepted 20 Jan 2016, Published online: 26 Feb 2016

References

  • Skyler JS. Effects of glycemic control on diabetes complications and on the prevention of diabetes. Clin Diabetes. 2004;22(4):162–166.
  • DeFronzo RA. Current issues in the treatment of type 2 diabetes. Overview of newer agents: where treatment is going. Am J Med. 2010;123(3 Suppl):S38–48.
  • Gross JL, Azevedo MJD, Silveiro SP, et al. Diabetic nephropathy: diagnosis, prevention, and treatment. Diabetes Care. 2005;28(1):164–176.
  • Stratton IM, Kohner EM, Aldington SJ, et al. UKPDS 50: risk factors for incidence and progression of retinopathy in type II diabetes over 6 years from diagnosis. Diabetologia. 2001;44(2):156–163.
  • Boulton AJM, Vinik AI, Arezzo JC, et al. Diabetic neuropathies: a statement by the American Diabetes Association. Diabetes Care. 2005;28(4):956–962.
  • Muntner P, Wildman RP, Reynolds K, et al. Relationship between HbA1c level and peripheral arterial disease. Diabetes Care. 2005;28(8):1981–1987.
  • Turner R, Cull C, Holman R. United Kingdom Prospective Diabetes Study 17: a 9-year update of a randomized, controlled trial on the effect of improved metabolic control on complications in non-insulin-dependent diabetes mellitus. Ann Intern Med. 1996;124(1_Part_2):136–145.
  • Holman RR, Sourij H, Califf RM. Cardiovascular outcome trials of glucose-lowering drugs or strategies in type 2 diabetes. Lancet. 2014;383(9933):2008–2017.
  • Holman RR, Paul SK, Bethel MA, et al. Long-term follow-up after tight control of blood pressure in type 2 diabetes. N Engl J Med. 2008;359(15):1565–1576.
  • Hemmingsen B, Lund SS, Gluud C, et al. Intensive glycaemic control for patients with type 2 diabetes: systematic review with meta-analysis and trial sequential analysis of randomised clinical trials. BMJ. 2011;343:d6898.
  • 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(1):140–149.
  • Yki-Järvinen H, Kauppinen-Mäkelin R, Tiikkainen M, et al. Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study. Diabetologia. 2006;49(3):442–451.
  • Garber AJ. Insulin intensification strategies in type 2 diabetes: when one injection is no longer sufficient. Diabetes Obes Metab. 2009;11(Suppl 5):14–18.
  • Kushner JA. The role of aging upon β cell turnover. J Clin Invest. 2013;123(3):990–995.
  • Wang J-S, Tu S-T, Lee I-T, et al. Contribution of postprandial glucose to excess hyperglycaemia in Asian type 2 diabetic patients using continuous glucose monitoring. Diabetes Metab Res Rev. 2011;27(1):79–84.
  • International Diabetes Federation (IDF). IDF Guideline for the management of postmeal glucose; 2015; [ cited 2015 Jun 23]. Available from: http://www.idf.org/webdata/docs/Guideline_PMG_final.pdf
  • Saisho Y. Glycemic variability and oxidative stress: a link between diabetes and cardiovascular disease? Int J Mol Sci. 2014;15(10):18381–18406.
  • Sprague JE, Arbeláez AM. Glucose counterregulatory responses to hypoglycemia. Pediatr Endocrinol Rev. 2011;9(1):463–473.
  • Riddle MC, Rosenstock J, Vlajnic A, et al. Randomized, 1-year comparison of three ways to initiate and advance insulin for type 2 diabetes: twice-daily premixed insulin versus basal insulin with either basal-plus one prandial insulin or basal-bolus up to three prandial injections. Diabetes Obes Metab. 2014;16(5):396–402.
  • Chow E, Bernjak A, Williams S, et al. Risk of cardiac arrhythmias during hypoglycemia in patients with type 2 diabetes and cardiovascular risk. Diabetes. 2014;63(5):1738–1747.
  • Prázný M. [Mild hypoglycaemia is common in type 2 diabetic patients treated with insulin analogues in the Czech Republic and the patients are concerned about it: results of a GAPP2TM survey (Global Attitudes of Physicians and Patient)]. Vnitr̆ní Lékar̆ství. 2015;61(3):267–273.
  • Parekh WA, Ashley D, Chubb B, et al. The “Local Impact of Hypoglycaemia Tool (LIHT)” for estimating the economic impact of hypoglycaemic episodes in national, local and user-defined populations. Presented at the 50th Annual Meeting of the European Association for the Study of Diabetes (EASD); 2014 September 15–19; Vienna, Austria. [Internet]. [ cited 2015 Jul 23]. Available from: http://www.easdvirtualmeeting.org/resources/17320
  • Garber AJ, Ligthelm R, Christiansen JS, et al. Premixed insulin treatment for type 2 diabetes: analogue or human? Diabetes Obes Metab. 2007;9(5):630–639.
  • Christiansen JS, Liebl A, Davidson JA, et al. Mid- and high-ratio premix insulin analogues: potential treatment options for patients with type 2 diabetes in need of greater postprandial blood glucose control. Diabetes Obes Metab. 2010;12(2):105–114.
  • International Diabetes Federation (IDF). IDF Global guideline for type 2 diabetes; 2012; [ cited 2015 Jun 23]. Available from: http://www.idf.org/sites/default/files/IDF-Guideline-for-Type-2-Diabetes.pdf
  • 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 J Br Diabet Assoc. 2012;29(5):682–689.
  • Lepore M, Pampanelli S, Fanelli C, et al. Pharmacokinetics and pharmacodynamics of subcutaneous injection of long-acting human insulin analog glargine, NPH insulin, and ultralente human insulin and continuous subcutaneous infusion of insulin lispro. Diabetes. 2000;49(12):2142–2148.
  • Evans M, Schumm-Draeger PM, Vora J, et al. A review of modern insulin analogue pharmacokinetic and pharmacodynamic profiles in type 2 diabetes: improvements and limitations. Diabetes Obes Metab. 2011;13(8):677–684.
  • Cengiz E, Swan KL, Tamborlane WV, et al. The alteration of aspart insulin pharmacodynamics when mixed with detemir insulin. Diabetes Care. 2012;35(4):690–692.
  • Ma Z, Parkner T, Christiansen JS, et al. IDegAsp: a novel soluble insulin analogs combination. Expert Opin Biol Ther. 2012;12(11):1533–1540.
  • Heise T, Heinemann L. Rapid and long-acting analogues as an approach to improve insulin therapy: an evidence-based medicine assessment. Curr Pharm Des. 2001;7(14):1303–1325.
  • Novo Nordisk. IDegAsp SmPC; 2014; [ cited 2015 June 23]. Available from: http://ec.europa.eu/health/documents/community-register/2013/20130121124986/anx_124986_en.pdf
  • 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(8):2104–2114.
  • 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(7):2250–2258.
  • 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(1):255–265.
  • Kurtzhals P, Heise T, Strauss HM, et al. Multi-hexamer formation is the underlying basis for the ultra-long glucose-lowering effect of insulin degludec. Diabetologia. 2011;54(Suppl):S426.
  • Heise T, Hovelmann U, Nosek L, et al. Insulin degludec has a two-fold longer half-life and a more consistent pharmacokinetic profile compared with insulin glargine. Endocr Abstr. 2012;28:P188.
  • 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(9):859–864.
  • Nosek L, Heise T, Klein O, et al. IDegAsp produces dose-proportional glucose-lowering effect in subjects with type 1 diabetes. Poster presented at EASD; 2013 September 23–27; Barcelona, Spain. Poster 1041
  • Pieber TR, Korsatko S, Deller S, et al. The distinct prandial and basal pharmacodynamics of IDegAsp observed in younger adults are preserved in elderly subjects with type 1 diabetes. Diabetes. 2013;62(Suppl 1):A237–933P.
  • Heise T, Tack CJ, Cuddihy R, et al. A new-generation ultra-long-acting basal insulin with a bolus boost compared with insulin glargine in insulin-naive people with type 2 diabetes: a randomized, controlled trial. Diabetes Care. 2011;34(3):669–674.
  • Liebl A, Davidson J, Mersebach H, et al. A novel insulin combination of insulin degludec and insulin aspart achieves a more stable overnight glucose profile than insulin glargine: results from continuous glucose monitoring in a proof-of-concept trial. J Diabetes Sci Technol. 2013;7(5):1328–1336.
  • Niskanen L, Leiter LA, Franek E, et al. Comparison of a soluble co-formulation of insulin degludec/insulin aspart vs biphasic insulin aspart 30 in type 2 diabetes: a randomised trial. Eur J Endocrinol. 2012;167(2):287–294.
  • 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(9):826–832.
  • Franek E, Haluzík M, Canecki Varžić S, et al. IDegAsp provides superior FPG control and reduced hypoglycemia vs BIAsp 30 in insulin-naïve adults with type 2 diabetes: A randomized phase 3 trial. Poster presented at EASD; 2014 16–19 September. Poster 931.
  • 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(8):2084–2090.
  • 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(1):139–147.
  • Vaag A, Sandahl-Christiansen J, Niskanen L, et al. Lower rates of overall, nocturnal and severe hypoglycemia during maintenance treatment with IDegAsp vs biphasic insulin aspart 30 in patients with type 2 diabetes mellitus: A meta-analysis. Presented at EASD; 2013 September 23–27; Barcelona, Spain. Oral presentation 187
  • Cooper JG, Pieber TR, Cariou B, et al. Treatment intensification with IDegAsp BID vs IDeg OD plus IAsp in insulin-treated patients with type 2 diabetes: A randomized, controlled phase 3 trial. Presented at EASD, 2014 September 16–19; Vienna, Austria. Oral presentation 147
  • Rodbard HW, Pieber TR, Cariou B, et al. Treatment intensification with IDegAsp BID vs IDeg OD plus IAsp in insulin-treated patients with type 2 diabetes: a randomised, controlled phase 3 trial. Poster presented at IDF-WPR; 2014 November 21–24. Poster PO343
  • Novo Nordisk. Insulin degludec and insulin aspart FDA briefing document. Insulin degludec and insulin degludec/insulin aspart treatment to improve glycemic control in patients with diabetes mellitus; [ cited 2015 June 23]. Available from: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM327017.pdf
  • Riddle MC, Rosenstock J, Gerich J. Insulin Glargine 4002 study investigators. The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care. 2003;26(11):3080–3086.
  • 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(18):1736–1747.
  • Holman RR, Thorne KI, Farmer AJ, et al. Addition of biphasic, prandial, or basal insulin to oral therapy in type 2 diabetes. N Engl J Med. 2007;357(17):1716–1730.
  • Gough SCL, Bode B, Woo V, et al. Efficacy and safety of a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with its components given alone: results of a phase 3, open-label, randomised, 26-week, treat-to-target trial in insulin-naive patients with type 2 diabetes. Lancet Diabetes Endocrinol. 2014;2(11):885–893.
  • Davies MJ, Gagliardino JJ, Gray LJ, et al. Real-world factors affecting adherence to insulin therapy in patients with type 1 or type 2 diabetes mellitus: a systematic review. Diabet Med J Br Diabet Assoc. 2013;30(5):512–524.
  • Bremer JP, Jauch-Chara K, Hallschmid M, et al. Hypoglycemia unawareness in older compared with middle-aged patients with type 2 diabetes. Diabetes Care. 2009;32(8):1513–1517.

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.