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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

Nabil K. El Naggar, Pradana Soewondo, Mohammad E. Khamseh, Jian-Wen Chen and Jihad Haddad

Diabetes Research and Clinical Practice, 3, 98, pages 408 - 413

Published online Dec-2012


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1. Introduction

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 [1] and [2] 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 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 . PPG has also been identified as an independent risk factor for diabetic complications such as cardiovascular disease [3] 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 . 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 [4] 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) [5] 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 . 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 [6] and [7] 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 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 . 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 [8] 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 . 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.

References

Label Authors Title Source Year
[3]

References in context

  • PPG has also been identified as an independent risk factor for diabetic complications such as cardiovascular disease [3].
    Go to context

  • In addition, lowering PPG is associated with reduced cardiovascular risk [3].
    Go to context

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 2006
[4]

References in context

  • 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 [4].
    Go to context

  • Baseline data from this study show that post-breakfast PPG was in the range of 12.9–15.1 mmol/l depending on region, well above the IDF recommended PPG target of <9 mmol/l [4].
    Go to context

  • Baseline data from this study show that post-breakfast PPG was in the range of 12.9–15.1 mmol/l depending on region, well above the IDF recommended PPG target of <9 mmol/l [4].
    Go to 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.
[5]

References in context

  • 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) [5].
    Go to context

  • Significant reductions in major and nocturnal hypoglycaemia were also observed in a meta-analysis of trials comparing BIAsp 30 and BHI [5].
    Go to 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 Clin. Ther.. 2009;31:1641-1651 2009
[8]

References in context

  • 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 [8].
    Go to context

  • The A1chieve® study was an international prospective, obser vational, multicentre, open label, non-interventional, 24-week study in people with T2D who were treatment naïve or who had been using anti-diabetic medication other than Novo Nordisk insulin analogues being evaluated and who had started treatment with BIAsp 30, insulin detemir or insulin aspart (alone or in combination) in routine clinical practice [8].
    Go to context

  • This hypothesis was supported by the overall A1chieve® data, which showed minimal body weight gain in association with improved HbA1c, as well as improved blood pressure and lipid profile [8].
    Go to 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 Diabetes Res. Clin. Pract.. 2011;94:352-363 2011

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