Safety and effectiveness of biphasic insulin aspart 30/70 (NovoMix 30) when switching from human premix insulin in patients with type 2 diabetes: subgroup analysis from the 6-month IMPROVE observational study

S Shah, M Benroubi, V Borzi, J Gumprecht, R Kawamori, J Shaban, M Shestakova, Y Wenying, P Valensi, IMPROVE Study Group Expert Panel, S Shah, M Benroubi, V Borzi, J Gumprecht, R Kawamori, J Shaban, M Shestakova, Y Wenying, P Valensi, IMPROVE Study Group Expert Panel

Abstract

Aims: IMPROVE is an open-label, multinational, non-randomised, 26-week observational study designed to evaluate the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in routine clinical practice. Here, we report data for patients switching to BIAsp 30 from human premixed insulin.

Methods: Patients (n = 3856) with type 2 diabetes previously receiving human premixed insulin with or without oral antidiabetic drugs were eligible for inclusion. Demographic data, efficacy end-points (HbA(1c), fasting blood glucose and postprandial blood glucose) and safety end-points (serious adverse drug reactions, hypoglycaemia and adverse events) were collected at baseline and final visit. A subgroup analysis of mean dose change was also undertaken.

Results: Switching patients to BIAsp 30 resulted in significant improvements in glycaemic control combined with a reduced risk of hypoglycaemia. Patients who reached the HbA(1c) target (< 7%) had shorter diabetes duration, lower HbA(1c) at baseline and needed less insulin. Over 30% of patients were able to reach this target without experiencing hypoglycaemia over the 26-week period. Compared with asymmetric dose switching, unit-for-unit switching resulted in the highest proportion of patients reaching HbA(1c) target and incurred the least amount of dose titration.

Conclusions: A unit-for-unit switch is the most effective as well as the simplest approach when transferring patients from biphasic human insulin 30 to BIAsp 30.

Figures

Figure 1
Figure 1
Rates of major (left) and minor (right) hypoglycaemia were lower at the final visit compared with the baseline visit in the main cohort. ***p

References

    1. Walley T, Hughes D, Kendall H. Trends and influences on use of antidiabetic drugs in England, 1992–2003. Pharmacoepidemiol Drug Saf. 2005;14:769–73.
    1. IDF Clinical Guidelines Task Force . Global Guideline for Type 2 diabetes. Brussels: International Diabetes Federation; 2007. [accessed December 2008]. .
    1. AACE American Association of Clinical Endocrinologists medical guidelines for clinical practice for the management of diabetes mellitus. Endocr Pract. 2007;13(Suppl. 1):4–68.
    1. Boehm BO, Home PD, Kamp BNM, Lindholm A. Premixed insulin aspart 30 vs. premixed human insulin 30/70 twice daily: a randomized trial in type 1 and type 2 diabetic patients. Diabet Med. 2002;19:393–9.
    1. Hermansen K, Colombo M, Storgaard H, Østergaard A, Kølendorf K, Madsbad S. Improved postprandial glycemic control with biphasic insulin aspart relative to biphasic insulin lispro and biphasic human insulin in patients with type 2 diabetes. Diabetes Care. 2002;25:883–8.
    1. Garber AJ, Ligthelm R, Christiansen JS, Liebl A. Premixed insulin treatment for type 2 diabetes: analogue or human? Diabetes Obes Metab. 2007;9:630–9.
    1. Jacobsen LV, Søgaard B, Riis A. Pharmacokinetics and pharmacodynamics of a premixed formulation of soluble and protamine-retarded insulin aspart. Eur J Clin Pharmacol. 2000;56:399–403.
    1. Malone JK, Woodworth JR, Arora V, et al. Improved postprandial glycemic control with Humalog Mix75/25 after a standard test meal in patients with type 2 diabetes mellitus. Clin Ther. 2000;22:222–30.
    1. Velojic-Golubovic M, Mikic D, Pesic M, Dimic D, Radenkovic S, Antic S. Biphasic insulin aspart 30: better glycaemic control than with premixed human insulin 30 in obese patients with type 2 diabetes. J Endo Invest. 2009 in press.
    1. Raskin P, Allen E, Hollander P, et al. Initiating insulin therapy in type 2 diabetes: a comparison of biphasic and basal insulin analogs. Diabetes Care. 2005;28:260–5.
    1. Kann P, Wascher T, Zackova V, et al. Starting insulin therapy in type 2 diabetes: twice-daily biphasic insulin aspart 30 plus metformin versus once-daily insulin glargine plus glimepiride. Exp Clin Endocrinol Diabetes. 2006;114:527–32.
    1. Liebl A, Prager R, Binz K, et al. Comparison of insulin analogue regimens in people with type 2 diabetes in the PREFER study: a randomized controlled trial. Diabetes Obes Metab. 2009;11:45–52.
    1. Garber A, Wahlen J, Wahl T, et al. Attainment of glycaemic goals in type 2 diabetes with once-, twice-, or thrice-daily dosing with biphasic insulin aspart 70/30 (The 1-2-3 study) Diabetes Obes Metab. 2006;8:58–66.
    1. Shestakova M, Sharma SK, Almustafa M, et al. Transferring type 2 diabetes patients with uncontrolled glycaemia from biphasic human insulin to biphasic insulin aspart 30: experiences from the PRESENT study. Curr Med Res Opin. 2007;23:3209–14.
    1. Valensi P, Benroubi M, Borzi V, et al. The IMPROVE™ study – a multinational, observational study in type 2 diabetes: baseline characteristics from eight national cohorts. Int J Clin Pract. 2008;62:1809–19.
    1. Brod M, Skovlund SE, Wittrup-Jensen KU. Measuring the impact of diabetes through patient report of treatment satisfaction, productivity and symptom experience. Qual Life Res. 2006;15:481–91.
    1. Weyer C, Heise T, Heinemann L. Insulin aspart in a 30/70 premixed formulation. Pharmacodynamic properties of a rapid-acting insulin analog in stable mixture. Diabetes Care. 1997;20:1612–4.
    1. Ligthelm RJ, Borzì V, Gumprecht J, Kawamori R, Wenying Y, Valensi P. Importance of observational studies in clinical practice. Clin Ther. 2007;29(Special issue):1284–92.
    1. Gao Y, Guo XH, Vaz JA, PRESENT Study Group Biphasic insulin aspart 30 treatment improves glycaemic control in patients with type 2 diabetes in a clinical practice setting: Chinese PRESENT study. Diabetes Obes Metab. 2009;11:33–40.
    1. Sharma SK, Joshi SR, Kumar A, et al. Efficacy, safety and acceptability of biphasic insulin aspart 30 in Indian patients with type 2 diabetes: results from the PRESENT Study. JAPI. 2008;56:859–63.
    1. American Diabetes Association Standards of medical care in diabetes. Diabetes Care. 2008;31(Suppl. 1):S12–54.
    1. Nathan DM, Buse JB, Davidson MB, et al. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy. A consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2008;31:1–11.
    1. Davies M. The reality of glycaemic control in insulin treated diabetes: defining the clinical challenges. Int J Obes. 2004;28(Suppl. 2):S14–22.
    1. Brown JB, Nichols GA. Slow response of glycemic control in type 2 diabetes mellitus. Am J Manag Care. 2003;9:213–7.
    1. Brod M, Cobden D, Lammert M, Bushnell D, Raskin P. Examining correlates of treatment satisfaction for injectable insulin in type 2 diabetes: lessons learned from a clinical trial comparing biphasic and basal analogues. Health Qual Life Outcomes. 2007;5:8.
    1. Palmer JL, Gibbs M, Scheijbeler HW, et al. Cost-effectiveness of switching to biphasic insulin aspart in poorly-controlled type 2 diabetes patients in China. Adv Ther. 2008;25:752–74.

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