Clinical use of Humulin R U-500 insulin in the UK: results of the first Association of British Clinical Diabetologists’ U-500 audit
Keywords:U-500, insulin, type 2 diabetes, weight, hypoglycaemia, ABCD
AbstractHuman soluble insulin Humulin R U-500 has been in use worldwide for marked insulin resistance but is not specifically licensed in the UK. The Association of British Clinical Diabetologists conducted a nationwide audit of Humulin R U-500 to understand its use in the UK. The results show that 67 out of 119 clinicians who responded to the survey are using U-500R. The commonest indication for using it was a high daily insulin dose. These results are the first glimpse of the practical usage of high strength insulin in the UK and may help our approach to patients with high insulin resistance and the use of newly available higher concentration insulins.
De la Pena A, Riddle M, Morrow LA, et al. Pharmacokinetic and pharmacodynamics of high-dose human regular U-500 insulin versus human regular U-100 insulin in healthy obese subjects. Diabetes Care 2011;34:2496–501. http://dx.doi.org/10.2337/dc11-0721
De la Pena A, Ma X, Reddy S, Ovalle F, Bergenstal RM, Jackson JA. Application of PK/PD modelling and simulation to dosing regimen optimisation of high-dose human regular U-500 insulin. J Diabetes Sci Technol 2014;8:821–9. http://dx.doi.org/10.1177/1932296814532326
Jones P, Idris I. The use of U-500 regular insulin in the management of patients with obesity and insulin resistance. Diabetes Obes Metab 2013;15:882–7. http://dx.doi.org/10.1111/dom.12094
Reutrakul S, Wroblewski K, Brown RL. Clinical use of U-500 regular insulin: review and meta-analysis. J Diabetes Sci Technol 2012;6:412–20. http://dx.doi.org/10.1177/193229681200600229
Eby EL, Wang P, Curtis BH, et al. Cost, healthcare resource utilization, and adherence of individuals with diabetes using U-500 or U-100 insulin: a retrospective database analysis. J Med Econ 2013;16:529–38. http://dx.doi.org/10.3111/13696998.2013.772059
Binder C, Brange J. Insulin chemistry and pharmacokinetics. In: Porte D Jr, Sherwin RS (eds). Ellenberg’s and Rifkin’s Diabetes Mellitus. 5th ed. Stamford, CT: Appleton & Lange, 1997, 689.
UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulfonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998;352:837–53. http://dx.doi.org/10.1016/S0140-6736(98)07019-6
Knee TS, Seidensticker DF, Walton JL, Solberg LM, Lasseter DH. A novel use of U-500 insulin for continuous subcutaneous insulin infusion in patients with insulin resistance: a case series. Endocr Pract 2003;9:181–6. http://dx.doi.org/10.4158/EP.9.3.181
Lalej-Bennis D, Selam JL, Fluteau-Nadler S, et al. Extreme insulin resistance: clinical management by external subcutaneous insulin infusion. Diabetes Metab 1997;23:533–6.
Nathan DM, Axelrod L, Flier JS, Carr DB. U-500 insulin in the treatment of antibody-mediated insulin resistance. Ann Intern Med 1981;94:653–6. http://dx.doi.org/10.7326/0003-4819-94-5-653
Boldo A, Comi RJ. Clinical experience with U500 insulin: risks and benefits. Endocr Pract 2012;18:56–61. http://dx.doi.org/10.4158/EP11163.OR
Eby EL, Curtis BH, Gelwicks SC, et al. Initiation of human regular U-500 insulin use is associated with improved glycemic control: a real-world US cohort study. BMJ Open Diabetes Res Care April 30, 2015 3:e000074. http://dx.doi.org/10.1136/bmjdrc-2014-000074
Lane WS. Use of U-500 regular insulin by continuous subcutaneous insulin infusion in patients with type 2 diabetes and severe insulin resistance. Endocr Pract 2006;12:251–6. http://dx.doi.org/10.4158/EP.12.3.251
Bulchandani DG, Konrady T, Hamburg MS. Clinical efficacy and patient satisfaction with U-500 insulin pump therapy in patients with type 2 diabetes. Endocr Pract 2007;13:721–5. http://dx.doi.org/10.4158/EP.13.7.721
Lane WS, Weinrib SL, Rappaport JM, Przestrzelski T. A prospective trial of U500 insulin delivered by Omnipod in patients with type 2 diabetes mellitus and severe insulin resistance. Endocr Pract 2010;16:778–84. http://dx.doi.org/10.4158/EP10014.OR
Lane WS, Weinrib SL, Rappaport JM, Hale CB, Farmer LK, Lane RS. The effect of long-term use of U-500 insulin via continuous subcutaneous infusion on durability of glycemic control and weight in obese, insulin- resistant patients with type 2 diabetes. Endocr Pract 2013;19:196–201. http://dx.doi.org/10.4158/EP12226.OR
Institute for Safe Medication Practices (ISMP). As U-500 insulin safety concerns mount, it’s time to rethink safe use of strengths above U-100. 31 October 2013. In: Acute Care ISMP Medication Safety Alert. Horsham, PA: ISMP. https://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=62
Sanofi. Sanofi receives FDA approval of once-daily basal insulin Toujeo® 2015. http://www.news.sanofi.us/2015-02-25-Sanofi-Receives-FDA-Approval-of-Once-Daily-Basal-Insulin-Toujeo
Cochran E. U-500 insulin: when more with less yields success. Diabetes Spectrum 2009;22:116–22. http://dx.doi.org/10.2337/diaspect.22.2.116
Segal AR, Brunner JE, Burch FT, Jackson JA. Use of concentrated insulin human regular (U-500) for patients with diabetes. Am J Health Syst Pharm 2010;67:1526–35. http://dx.doi.org/10.2146/ajhp090554
Medicines and Healthcare Products Regulatory Agency. High strength, fixed combination and biosimilar insulin products: minimising the risk of medication error. Drug Safety Update 2015:3.
Grant P, Chowdhury TA. Drug therapies in diabetes: delivering individualised treatment. Clin Med 2016 (in press).
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