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02-21-2018 | Insulin aspart | Review | Article

15 Years of Experience with Biphasic Insulin Aspart 30 in Type 2 Diabetes

Journal: Drugs in R&D

Authors: Andreas Liebl, Viswanathan Mohan, Wenying Yang, Krzysztof Strojek, Sultan Linjawi

Publisher: Springer International Publishing

Abstract

Since clinical experience with biphasic insulin aspart 30 (BIAsp 30) in type 2 diabetes mellitus (T2DM) was reviewed in 2012 after 10 years of use worldwide, additional studies have been published that highlight new aspects, including use in real-world populations. Evidence from 35 new studies confirms and builds upon previous work indicating that BIAsp 30 continues to have pharmacodynamic and clinical advantages over biphasic human insulin (BHI 30), including in real-world practice with unselected populations of patients. BIAsp 30 has also been shown to be safe and efficacious as an add-on to dipeptidyl peptidase-4 (DPP-4) inhibitors. Intensification with BIAsp 30 is a safe and effective way to improve glycemic control, and titration performed by patients can achieve results that are at least comparable to those when being guided by healthcare providers. Stepwise intensification using BIAsp 30 is comparable to intensification using a basal–bolus regimen, and twice-daily BIAsp 30 provides similar glycemic control to a basal-plus regimen. Data from large observational studies, in particular, have identified patient-related characteristics that are associated with improved clinical responses, suggesting that earlier initiation and intensification of therapy is warranted. Finally, new health-economic analyses continue to confirm that BIAsp 30 is cost effective versus other therapies such as BHI 30, neutral protamine Hagedorn (NPH), or insulin glargine in both insulin-naïve and insulin-experienced patients. After 15 years of clinical use worldwide, analysis of more recent 5-year data indicates that BIAsp 30 remains a safe, effective, and simple-to-use insulin for initiation and intensification by diabetes specialists and primary care physicians in a variety of patients with T2DM.

Liebl A, Prusty V, Valensi P, Kawamori R, Christiansen JS, Palmer AJ, et al. Ten years of experience with biphasic insulin aspart 30: from drug development to the latest clinical findings. Drugs. 2012;72:1495–520.PubMedPubMedCentral

Ohta A, Suwa T, Sada Y, Kato H, Koganei R, Asai S, et al. Comparison of daily glucose excursion by continuous glucose monitoring between type 2 diabetic patients receiving biphasic insulin aspart 30 or biphasic human insulin 30. J Diabetes Investig. 2011;2:406–11.PubMedPubMedCentral

Li FF, Fu LY, Zhang WL, Su XF, Wu JD, Sun J, et al. Blood glucose fluctuations in type 2 diabetes patients treated with multiple daily injections. J Diabetes Res. 2016;2016:1028945.PubMed

Khunti K, Wolden ML, Thorsted BL, Andersen M, Davies MJ. Clinical inertia in people with type 2 diabetes: a retrospective cohort study of more than 80,000 people. Diabetes Care. 2013;36:3411–7.PubMedPubMedCentral

Rys P, Wojciechowski P, Siejka S, Małecki P, Hak L, Malecki MT. A comparison of biphasic insulin aspart and insulin glargine administered with oral antidiabetic drugs in type 2 diabetes mellitus–a systematic review and meta-analysis. Int J Clin Pract. 2014;68:304–13.PubMed

Yang W, Xu X, Liu X, Yang G, Seino Y, Andersen H, et al. Treat-to-target comparison between once daily biphasic insulin aspart 30 and insulin glargine in Chinese and Japanese insulin-naïve subjects with type 2 diabetes. Curr Med Res Opin. 2013;29:1599–608.PubMed

Berntorp K, Haglund M, Larsen S, Petruckevitch A. Landin-Olsson M; Swedish BIAsp Study Group. Initiation of biphasic insulin aspart 30/70 in subjects with type 2 diabetes mellitus in a largely primary care-based setting in Sweden. Prim Care Diabetes. 2011;5:89–94.PubMed

Mäkelä JK, Schmüser C, Askonen K, Saukkonen T. Starting or switching to biphasic insulin aspart 30 (BIAsp 30) in type 2 diabetes: a multicenter, observational, primary care study conducted in Finland. Diabetes Res Clin Pract. 2012;95:10–8.PubMed

Song KH, Kim JM, Noh JH, Park Y, Son HS, Min KW, et al. Efficacy and safety of biphasic insulin aspart 30/70 in type 2 diabetes suboptimally controlled on oral antidiabetic therapy in Korea: a multicenter, open-label, single-arm study. Diabetes Metab J. 2013;37:117–24.PubMedPubMedCentral

10.

Wolnik B, Hak L. Multicenter, open-label, non-randomized, non-interventional observational study of safety of treatment initiation with a biphasic insulin aspart. Expert Opin Drug Saf. 2013;12:137–44.PubMed

11.

Kawamori R, Valensi P. IMPROVE^TM observational study of biphasic insulin aspart 30/70 in patients with type 2 diabetes mellitus. Expert Rev Endocrinol Metab. 2010;5:507–16.PubMed

12.

Valensi P, Shaban J, Benroubi M, Kawamori R, Borzì V, Shah S, et al. IMPROVE Study Expert Panel. Predictors of achieving HbA(1c) < 7% and no hypoglycaemia 6 months after initiation of biphasic insulin aspart 30 in patients with type 2 diabetes in the IMPROVE study. Curr Med Res Opin. 2013;29:601–9.PubMed

13.

Home P, Naggar NE, Khamseh M, Gonzalez-Galvez G, Shen C, Chakkarwar P, et al. An observational non-interventional study of people with diabetes beginning or changed to insulin analogue therapy in non-Western countries: The A1chieve study. Diabetes Res Clin Pract. 2011;94:352–63.PubMed

14.

Shah SN, Litwak L, Haddad J, Chakkarwar PN, Hajjaji I. The A1chieve study: a 60 000-person, global, prospective, observational study of basal, meal-time, and biphasic insulin analogs in daily clinical practice. Diabetes Res Clin Pract. 2010;88(Suppl. 1):S11–6.PubMed

15.

El Naggar NK, Soewondo P, Khamseh ME, Chen JW, Haddad J. Switching from biphasic human insulin 30 to biphasic insulin aspart 30 in type 2 diabetes is associated with improved glycaemic control and a positive safety profile: results from the A1chieve study. Diabetes Res Clin Pract. 2012;98:408–13.PubMed

16.

Dieuzeide G, Chuang LM, Almaghamsi A, Zilov A, Chen JW, Lavalle-González FJ. Safety and effectiveness of biphasic insulin aspart 30 in people with type 2 diabetes switching from basal-bolus insulin regimens in the A1chieve study. Prim Care Diabetes. 2014;8:111–7.PubMed

17.

Nobels F, D’Hooge D, Crenier L. Switching to biphasic insulin aspart 30/50/70 from biphasic human insulin 30/50 in patients with type 2 diabetes in normal clinical practice: observational study results. Curr Med Res Opin. 2012;28:1017–26 (Erratum in: Curr Med Res Opin. 2012;28:1546).PubMed

18.

Linjawi S, Sothiratnam R, Sari R, Andersen H, Hiort LC, Rao P. The study of once- and twice-daily biphasic insulin aspart 30 (BIAsp 30) with sitagliptin, and twice-daily BIAsp 30 without sitagliptin, in patients with type 2 diabetes uncontrolled on sitagliptin and metformin-The Sit2Mix trial. Prim Care Diabetes. 2015;9:370–6.PubMed

19.

Malek R, Ajili F, Assaad-Khalil SH, Shinde A, Chen JW, Van den Berg E. Similar glucose control with basal-bolus regimen of insulin detemir plus insulin aspart and thrice-daily biphasic insulin aspart 30 in insulin-naive patients with type 2 diabetes: Results of a 50-week randomized clinical trial of stepwise insulin intensification. Diabetes Metab. 2015;41:223–30.PubMed

20.

Vora J, Cohen N, Evans M, Hockey A, Speight J, Whately-Smith C. Intensifying insulin regimen after basal insulin optimization in adults with type 2 diabetes: a 24-week, randomized, open-label trial comparing insulin glargine plus insulin glulisine with biphasic insulin aspart (LanScape). Diabetes Obes Metab. 2015;17:1133–41.PubMed

21.

Riddle MC, Rosenstock J, Vlajnic A, Gao L. 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;16:396–402.PubMed

22.

Jin SM, Kim JH, Min KW, Lee JH, Ahn KJ, Park JH, et al. Basal-prandial versus premixed insulin in patients with type 2 diabetes requiring insulin intensification after basal insulin optimization: a 24-week randomized non-inferiority trial. J Diabetes. 2016;8:405–13.PubMed

23.

Domeki N, Matsumura M, Monden T, Nakatani Y, Aso Y. A randomized trial of step-up treatment with premixed insulin lispro-50/50 vs. aspart-70/30 in patients with type 2 diabetes mellitus. Diabetes Ther. 2014;5:403–13.PubMedPubMedCentral

24.

Fulcher GR, Christiansen JS, Bantwal G, Polaszewska-Muszynska M, Mersebach H, Andersen TH, et al. BOOST: Intensify Premix I Investigators. 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;37:2084–90.PubMed

25.

Kaneko S, Chow F, Choi DS, Taneda S, Hirao K, Park Y, et al. BOOST: Intensify All Trial Investigators. 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;107:139–47.PubMed

26.

Christiansen JS, Niskanen L, Rasmussen S, Johansen T, Fulcher G. Lower rates of hypoglycemia during maintenance treatment with insulin degludec/insulin aspart versus biphasic insulin aspart 30: a combined analysis of two Phase 3a studies in type 2 diabetes. J Diabetes. 2016;8:720–8.PubMed

27.

Niskanen L, Leiter LA, Franek E, Weng J, Damci T, Muñoz-Torres M, 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;167:287–94 (Erratum in: Eur J Endocrinol. 2012;167:453).PubMedPubMedCentral

28.

Taneda S, Hyllested-Winge J, Gall MA, Kaneko S, Hirao K. 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;9:243–7.PubMed

29.

Onishi Y, Yamada K, Zacho J, Ekelund J, Iwamoto Y. Insulin degludec/insulin aspart vs biphasic insulin aspart 30 twice daily in Japanese patients with type 2 diabetes: a randomized controlled trial. J Diabetes Investig. 2017;8:210–7.PubMed

30.

American Diabetes Association. Standards of medical care in diabetes. 2016. http://care.diabetesjournals.org/content/suppl/2015/12/21/39.Supplement_1.DC2/2016-Standards-of-Care.pdf. Accessed 06 Jul 2017.

31.

International Diabetes Federation Clinical Guidelines Task Force. Global guideline for type 2 diabetes. 2012. https://www.idf.org/e-library/guidelines/79-global-guideline-for-type-2-diabetes.html. Accessed 06 Jul 2017.

32.

Davies M, Storms F, Shutler S, Bianchi-Biscay M. Gomis R; ATLANTUS Study Group. Improvement of glycemic control in subjects with poorly controlled type 2 diabetes. Comparison of two treatment algorithms using insulin glargine. Diabetes Care. 2005;28:1282–8.PubMed

33.

Meneghini L, Koenen C, Weng W, Selam JL. The usage of a simplified self-titration dosing guideline (303 Algorithm) for insulin detemir in patients with type 2 diabetes. Results of the randomized, controlled PREDICTIVE 303 study. Diabetes Obes Metab. 2007;9:902–13.PubMed

34.

Gao Y, Luquez C, Lynggaard H, Andersen H, Saboo B. The SimpleMix study with biphasic insulin aspart 30: a randomized controlled trial investigating patient-driven titration versus investigator-driven titration. Curr Med Res Opin. 2014;30:2483–92.PubMed

35.

Yang W, Zhu L, Meng B, Liu Y, Wang W, Ye S, et al. Subject-driven titration of biphasic insulin aspart 30 twice daily is non-inferior to investigator-driven titration in Chinese patients with type 2 diabetes inadequately controlled with premixed human insulin: a randomized, open-label, parallel-group, multicenter trial. J Diabetes Investig. 2016;7:85–93.PubMed

36.

Narita T, Goto T, Suganuma Y, Hosoba M, Morii T, Sato T, et al. Efficacy and safety of patient-directed titration of once-daily pre-dinner premixed biphasic insulin aspart 70/30 injection in Japanese type 2 diabetic patients with oral antidiabetic drug failure: STEP-AKITA study. J Diabetes Investig. 2011;2:63–70.PubMed

37.

Chraibi A, Al-Herz S, Nguyen BD, Soeatmadji DW, Shinde A, Lakshmivenkataraman B, et al. An RCT investigating patient-driven versus physician-driven titration of BIAsp 30 in patients with type 2 diabetes uncontrolled using NPH insulin. Diabetes Ther. 2017;8:767–80. Erratum in: Diabetes Ther. 2017;8:781–2.

38.

Balaji V, Balaji MS, Alexander C, Srinivasan A, Suganthi SR, Thiyagarajah A, et al. Premixed insulin aspart 30 (BIAsp 30) versus premixed human insulin 30 (BHI 30) in gestational diabetes mellitus: a randomized open-label controlled study. Gynecol Endocrinol. 2012;28:529–32.PubMed

39.

Trippe BS, Shepherd MD, Coulter FC, Bhargava A, Brett J, Chu PL, et al. Efficacy and safety of biphasic insulin aspart 70/30 in type 2 diabetes patients of different race or ethnicity (INITIATEplus trial). Curr Med Res Opin. 2012;28:1203–11.PubMed

40.

Borzì V, Benroubi M, Gumprecht J, Kawamori R, Ligthelm R, Shaban J, et al. IMPROVE™ Study Expert Panel. Predictors of postprandial blood glucose response to biphasic insulin analogue therapy. Prim Care Diabetes. 2013;7:63–7.PubMed

41.

Shah S, Zilov A, Malek R, Soewondo P, Bech O, Litwak L. Improvements in quality of life associated with insulin analogue therapies in people with type 2 diabetes: results from the A1chieve observational study. Diabetes Res Clin Pract. 2011;94:364–70.PubMed

42.

Shafie AA, Gupta V, Baabbad R, Hammerby E, Home P. An analysis of the short- and long-term cost-effectiveness of starting biphasic insulin aspart 30 in insulin-naïve people with poorly controlled type 2 diabetes. Diabetes Res Clin Pract. 2014;106:319–27.PubMed

43.

Gupta V, Baabbad R, Hammerby E, Nikolajsen A, Shafie AA. An analysis of the cost-effectiveness of switching from biphasic human insulin 30, insulin glargine, or neutral protamine Hagedorn to biphasic insulin aspart 30 in people with type 2 diabetes. J Med Econ. 2015;18:263–72.PubMed

44.

Farshchi A, Aghili R, Oskuee M, Rashed M, Noshad S, Kebriaeezadeh A, et al. Biphasic insulin aspart 30 vs. NPH plus regular human insulin in type 2 diabetes patients; a cost-effectiveness study. BMC Endocr Disord. 2016;16:35.PubMedPubMedCentral

45.

Evans M, Gundgaard J, Hansen BB. Cost-effectiveness of insulin degludec/insulin aspart versus biphasic insulin aspart in patients with type 2 diabetes from a Danish health-care perspective. Diabetes Ther. 2016;7:809–23.PubMedPubMedCentral

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