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The effectiveness and safety of beginning insulin aspart together with basal insulin in people with type 2 diabetes in non-Western nations: Results from the A1chieve observational study

Philip D. Home, Zafar A. Latif, Guillermo González-Gálvez, Vinay Prusty and Zanariah Hussein

Diabetes Research and Clinical Practice, 3, 101, pages 326 - 332

Received 3 January 2013, Revised 15 May 2013, Accepted 6 June 2013, Published online Oct-2013


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1. Introduction

Type 2 diabetes is a progressive disease and insulin therapy is needed in most people to ensure continuing adequacy of blood glucose control [1] x R.C. Turner, C.A. Cull, V. Frighi, R.R. Holman. UK Prospective Diabetes Study (UKPDS) Group. Glycaemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). JAMA. 1999;281:2005-2012 Crossref. . Initially, basal insulin can be effective in many people with type 2 diabetes for maintenance of control, but in some people post-prandial glucose levels remain elevated or will be elevated as endogenous insulin further declines. Addition of a meal-time insulin is consequently indicated in order to provide better postprandial glucose control. Controlling postprandial glucose is important, even at high levels of HbA1c (>10.0% [86 mmol/mol]), when basal insulin has not been optimised, given that it can contribute up to 30% of overall glucose control [2] x L. Monnier, H. Lapinski, C. Collette. Contributions of fasting and postprandial glucose increments to the overall diurnal hyperglycaemia of type 2 diabetic patients: variations with increasing levels of HbA1c. Diabetes Care. 2003;26:881-885 Crossref. . Adding a meal-time insulin to basal insulin therapy is advocated by type 2 diabetes treatment guidelines as a method that allows the “most precise and flexible” insulin regimen [3] x S.E. Inzucchi, R.M. Bergenstal, J.B. Buse, M. Diamant, E. Ferrannini, M. Nauck, et al. American Diabetes Association (ADA); European Association for the Study of Diabetes (EASD). Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012;35:1364-1379 Crossref. .

Insulin analogues have been designed to provide more physiological pharmacokinetic/pharmacodynamic profiles compared with conventional human insulins [4] x J. Brange, U. Ribel, J.F. Hansen, G. Dodson, M.T. Hansen, S. Havelund, et al. Monomeric insulins obtained by protein engineering and their medical implications. Nature. 1988;333:679-682 Crossref. . Rapidacting insulin analogues have a quicker onset and shorter duration of action than unmodified human insulin [4] x J. Brange, U. Ribel, J.F. Hansen, G. Dodson, M.T. Hansen, S. Havelund, et al. Monomeric insulins obtained by protein engineering and their medical implications. Nature. 1988;333:679-682 Crossref. , and this has resulted in superior postprandial glucose control in randomised controlled trials (RCTs) [5] and [6] x A.M. Rosenfalck, P. Thorsby, L. Kjems, K. Birkeland, A. Dejgaard, K.F. Hanssen, et al. Improved postprandial glycaemic control with insulin Aspart in type 2 diabetic patients treated with insulin. Acta Diabetol. 2000;37:41-46 Crossref. x G. Dailey, J. Rosenstock, R.G. Moses, K. Ways. Insulin glulisine provides improved glycemic control in patients with type 2 diabetes. Diabetes Care. 2004;27:2363-2368 Crossref. . Insulin aspart is one such rapid-acting insulin analogue. RCTs have shown it to be well tolerated and effective in people with type 1 or type 2 diabetes [7], [8], and [9] x P.D. Home, A. Lindholm, A. Riis. European Insulin Aspart Study Group. Insulin aspart vs. human insulin in the management of long-term blood glucose control in Type 1 diabetes mellitus: a randomized controlled trial. Diabet Med. 2000;17:762-770 Crossref. x S.R. Heller, S. Colagiuri, S. Vaaler, B.H. Wolffenbuttel, K. Koelendorf, H.H. Friberg, et al. Hypoglycaemia with insulin aspart: a double-blind, randomised, crossover trial in subjects with Type 1 diabetes. Diabet Med. 2004;21:769-775 Crossref. x R.R. Holman, A.J. Farmer, M.J. Davies, J.C. Levy, J.L. Darbyshire, J.F. Keenan, et al. 4-T Study Group. Three-year efficacy of complex insulin regimens in type 2 diabetes. N Engl J Med. 2009;361:1736-1747 Crossref. , but few studies have examined the use of insulin aspart in routine clinical practice in people with type 2 diabetes.

The A1chieve study investigated insulin analogue use in people with type 2 diabetes across four continents in the non-Western world [10] x P. Home, N. El 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. , and recruited 66,726 participants. The aim of the study was to expand the knowledge of the clinical safety and effectiveness of insulin analogues in a large and diverse population from a globally-broad variety of clinical care situations; overall results of the A1chieve study have been published previously [10] and [11] x P. Home, N. El 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. x S. Shah, A. Zilov, R. Malek, P. Soewondo, O. Bech, L. Litwak. 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;94:364-370 Abstract, Full-text, PDF, Crossref. .

In this A1chieve sub-group analysis, the aim was to closely examine populations beginning insulin aspart together with any basal insulin. Because the study was so large, useful numbers are available for many different sub-groups.

References

Label Authors Title Source Year
[1]

References in context

  • Type 2 diabetes is a progressive disease and insulin therapy is needed in most people to ensure continuing adequacy of blood glucose control [1].
    Go to context

R.C. Turner, C.A. Cull, V. Frighi, R.R. Holman UK Prospective Diabetes Study (UKPDS) Group. Glycaemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49) Crossref. JAMA. 1999;281:2005-2012 1999
[2]

References in context

  • Controlling postprandial glucose is important, even at high levels of HbA1c (>10.0% [86 mmol/mol]), when basal insulin has not been optimised, given that it can contribute up to 30% of overall glucose control [2].
    Go to context

L. Monnier, H. Lapinski, C. Collette Contributions of fasting and postprandial glucose increments to the overall diurnal hyperglycaemia of type 2 diabetic patients: variations with increasing levels of HbA1c Crossref. Diabetes Care. 2003;26:881-885 2003
[3]

References in context

  • Type 2 diabetes is a progressive disease and insulin therapy is needed in most people to ensure continuing adequacy of blood glucose control [1].
    Go to context

  • Treatment guidelines do suggest that if a person with type 2 diabetes presents with HbA1c>10.0% (86 mmol/mol), then insulin should be recommended early on, but our patient group was >7 years from diagnosis [3].
    Go to context

S.E. Inzucchi, R.M. Bergenstal, J.B. Buse, M. Diamant, E. Ferrannini, M. Nauck, et al. American Diabetes Association (ADA); European Association for the Study of Diabetes (EASD). Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) Crossref. Diabetes Care. 2012;35:1364-1379 2012
[4]

References in context

  • Rapidacting insulin analogues have a quicker onset and shorter duration of action than unmodified human insulin [4], and this has resulted in superior postprandial glucose control in randomised controlled trials (RCTs) [5,6].
    Go to context

  • Rapidacting insulin analogues have a quicker onset and shorter duration of action than unmodified human insulin [4], and this has resulted in superior postprandial glucose control in randomised controlled trials (RCTs) [5,6].
    Go to context

J. Brange, U. Ribel, J.F. Hansen, G. Dodson, M.T. Hansen, S. Havelund, et al. Monomeric insulins obtained by protein engineering and their medical implications Crossref. Nature. 1988;333:679-682 1988
[10]

References in context

  • The A1chieve study investigated insulin analogue use in people with type 2 diabetes across four continents in the non-Western world [10], and recruited 66,726 participants.
    Go to context

  • Confirmed major, minor and nocturnal hypoglycaemic events were as defined previously [10].
    Go to context

P. Home, N. El 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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