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 Research and Clinical Practice, 3, 98, pages 408 - 413
Published online Dec-2012
Biphasic insulin preparations provide a convenient way to address both basal and prandial glucose-lowering needs, as they provide both intermediate and rapid/short-acting insulin components in a single injection. Biphasic insulin preparations therefore provide the possibility of a simple approach to address both fasting plasma glucose (FPG) and post-prandial plasma glucose (PPG), which has been shown to be important in order to achieve glycated haemoglobin (HbA1c) targets  and  x L. Monnier, C. Colette. Targeting prandial hyperglycemia: how important is it and how best to do this?. Curr. Diab. Rep.. 2008;8:368-374 Crossref. x H.J. Woerle, C. Neumann, S. Zschau, S. Tenner, A. Irsigler, J. Schirra, et al. Impact of fasting and postprandial glycemia on overall glycemic control in type 2 diabetes Importance of postprandial glycemia to achieve target HbA1c levels. Diabetes Res. Clin. Pract.. 2007;77(2):280-285 Crossref. . PPG has also been identified as an independent risk factor for diabetic complications such as cardiovascular disease  x A. Ceriello, J. Davidson, M. Hanefeld, L. Leiter, L. Monnier, D. Owens, et al. Postprandial hyperglycaemia and cardiovascular complications of diabetes: an update. Nutr. Metab. Cardiovasc. Dis.. 2006;16:453-456 Crossref. . Therefore, clinical guidelines such as those published by the International Diabetes Federation recommend targeting both FPG and PPG at all HbA1c levels in order to achieve glycaemic targets, and to minimise the development of diabetic complications  x International Diabetes Federation. Guideline For Management Of Postmeal Glucose In Diabetes 2011. International Diabetes Federation 2012. Accessed: August 22. Available from: URL: http://www.idf.org/2011-guidelinemanagement- postmeal-glucose-diabetes. .
Biphasic insulin analogue preparations offer a number of advantages over biphasic human insulin (BHI). Biphasic insulin aspart 30 (BIAsp 30; NovoMix® 30, Novo Nordisk) has been shown to provide better control of PPG than BHI 30 in a meta-analysis including data from nine randomised controlled trials (RCTs) in patients with Type 2 diabetes mellitus (T2D)  x J.A. Davidson, A. Liebl, J.S. Christiansen, G. Fulcher, R.J. Ligthelm, P. Brown, et al. Risk for nocturnal hypoglycemia with biphasic insulin aspart 30 compared with biphasic human insulin 30 in adults with type 2 diabetes mellitus: a metaanalysis. Clin. Ther.. 2009;31:1641-1651 Crossref. . The same meta-analysis also demonstrated that BIAsp 30 was associated with a 50% lower rate of major hypoglycaemia and a 55% lower rate of nocturnal hypoglycaemia compared with BHI 30. However, there was a 24% higher risk of daytime hypoglycaemia with BIAsp 30 compared with BHI 30.
In addition to data from RCTs, observational studies such as IMPROVE™ and the Physicians’ Routine Evaluation of Safety and Efficacy of NovoMix® 30 Therapy (PRESENT) study demonstrated that switching from BHI 30 to BIAsp 30 is associated with improved glycaemic control and a reduced risk of hypoglycaemia  and  x S. Shah, M. Benroubi, V. Borzi, J. Gumprecht, R. Kawamori, J. Shaban, et al. 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. Int. J. Clin. Pract.. 2009;63:574-582 Crossref. x M. Shestakova, S.K. Sharma, M. Almustafa, K.W. Min, N. Ayad, S.T. Azar, 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;23:3209-3214 Crossref. . It is important to select insulin therapy according to individual needs and the A1chieve® study is the first observational study that included individuals who were switched to BIAsp 30, insulin detemir (Levemir®, Novo Nordisk) or insulin aspart (NovoRapid®, Novo Nordisk) alone or in combination as part of their routine clinical care  x P. Home, N.E. Naggar, M. Khamseh, G. Gonzalez-Galvez, C. Shen, P. Chakkarwar, 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;94:352-363 Abstract, Full-text, PDF, Crossref. . The aim of this subgroup analysis of the A1chieve® study was to examine data regarding the clinical safety and effectiveness of BIAsp 30 ± oral glucose-lowering drugs (OGLDs) in people with T2D when switching from their previous treatment of BHI 30 ± OGLDs.
|A. Ceriello, J. Davidson, M. Hanefeld, L. Leiter, L. Monnier, D. Owens, et al.||Postprandial hyperglycaemia and cardiovascular complications of diabetes: an update Crossref.||Nutr. Metab. Cardiovasc. Dis.. 2006;16:453-456||2006|
References in context
|International Diabetes Federation. Guideline For Management Of Postmeal Glucose In Diabetes 2011. International Diabetes Federation 2012. Accessed: August 22. Available from: URL: http://www.idf.org/2011-guidelinemanagement- postmeal-glucose-diabetes.|
References in context
|J.A. Davidson, A. Liebl, J.S. Christiansen, G. Fulcher, R.J. Ligthelm, P. Brown, et al.||Risk for nocturnal hypoglycemia with biphasic insulin aspart 30 compared with biphasic human insulin 30 in adults with type 2 diabetes mellitus: a metaanalysis Crossref.||Clin. Ther.. 2009;31:1641-1651||2009|
References in context
|P. Home, N.E. Naggar, M. Khamseh, G. Gonzalez-Galvez, C. Shen, P. Chakkarwar, 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 Abstract, Full-text, PDF, Crossref.||Diabetes Res. Clin. Pract.. 2011;94:352-363||2011|
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