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Insulin detemir in the management of type 2 diabetes in non-Western countries: Safety and effectiveness data from the A1chieve observational study

Alexey Zilov, Nabil El Naggar, Siddharth Shah, Chunduo Shen and Jihad Haddad

Diabetes Research and Clinical Practice, 3, 101, pages 317 - 325

Received 24 December 2012, Revised 16 May 2013, Accepted 6 June 2013, Published online Oct-2013


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1. Introduction

The primary aim of diabetes management is to achieve satisfactory levels of glycaemic control, thereby reducing the risk of serious long-term diabetes related complications [1], [2], and [3] x UK Prospective Diabetes Study (UKPDS). Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998;352:837-53. x I.M. Stratton, A.I. Adler, H.A. Neil, D.R. Matthews, S.E. Manley, C.A. Cull, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000;321:405-412 Crossref. x J.A. Dormandy, B. Charbonnel, D.J. Eckland, E. Erdmann, M. Massi-Benedetti, I.K. Moules, et al. PROactive investigators. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial. Lancet. 2005;366:1279-1289 Crossref. . Published data, however, suggest that the majority of people with type 2 diabetes (T2D) worldwide are not achieving the recommended targets set for good glycaemic control [4], [5], [6], [7], and [8] x S. Del Prato, A.M. Felton, N. Munro, R. Nesto, P. Zimmet, B. Zinman. Global Partnership for Effective Diabetes Management. Improving glucose management: ten steps to get more patients with type 2 diabetes to glycaemic goal. Recommendations from the Global Partnership for Effective Diabetes Management. Int J Clin Pract Suppl. 2007;157:47-57 x M.J. Calvert, R.J. McManus, N. Freemantle. Management of type 2 diabetes with multiple oral hypoglycaemic agents or insulin in primary care: retrospective cohort study. Br J Gen Pract. 2007;57(539):455-460 x P. Valensi, M. Benroubi, V. Borzi, J. Gumprecht, R. Kawamori, J. Shaban, et al. IMPROVE Study Group Expert Panel. Initiating insulin therapy with, or switching existing insulin therapy to, biphasic insulin aspart 30/70 (NovoMix 30) in routine care: safety and effectiveness in patients with type 2 diabetes in the IMPROVE observational study. Int J Clin Pract. 2009;63:522-531 Crossref. 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. x K. Khunti, T. Damci, L. Meneghini, C.Y. Pan, J.F. Yale. SOLVE Study Group. Study of Once Daily Levemir (SOLVE™): insights into the timing of insulin initiation in people with poorly controlled type 2 diabetes in routine clinical practice. Diabetes Obes Metab. 2012;14:654-661 Crossref. . The progressive loss of beta-cell function that characterises T2D ideally requires concurrent changes in treatment to allow people to reach and then maintain adequate glycaemic control and most will require insulin therapy to achieve this [9] and [10] x R.C. Turner, C.A. Cull, V. Frighi, R.R. Holman. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). UK Prospective Diabetes Study (UKPDS) Group. JAMA. 1999;281:2005-2012 Crossref. x J. Tibaldi, R.E. Rakel. Why, when and how to initiate insulin therapy in patients with type 2 diabetes. Int J Clin Pract. 2007;61:633-644 Crossref. . Currently, insulin analogues are gaining wide acceptance and are frequently prescribed due to their distinguished pharmacodynamic and pharmacokinetic profile and based on evidence of their effectiveness and safety in clinical trials [11] x J.S. Freeman. Insulin analog therapy: improving the match with physiologic insulin secretion. J Am Osteopath Assoc. 2009;109:26-36 , yet effectual use in the management of glycaemia remains a challenge, particularly in developing countries where there is a sustained rise in prevalence of diabetes.

The introduction of basal insulin is a simple, effective and well-validated choice to start people with T2D on insulin therapy [12] and [13] x J.L. Selam, C. Koenen, W. Weng, L. Meneghini. Improving glycemic control with insulin detemir using the 303 Algorithm in insulin naïve patients with type 2 diabetes: a subgroup analysis of the US PREDICTIVE 303 study. Curr Med Res Opin. 2008;24:11-20 x S.E. Inzucchi, R.M. Bergenstal, J.B. Buse, M. Diamant, E. Ferrannini, M. Nauck, et al. Management of hyperglycaemia 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). Diabetologia. 2012;55:1577-1596 Crossref. . Randomised controlled trials (RCTs) have shown that the basal analogue insulin detemir can effectively improve glycaemic control with a lower risk of hypoglycaemia than with intermediate-acting human insulin NPH [14], [15], [16], and [17] x Hermansen K, Davies M, Derezinski T, Martinez Ravn G, Clauson P, Home P. A 26-week, randomized, parallel, treat-to-target trial comparing insulin detemir with NPH insulin as add-on therapy to oral glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetes Care 2006;29:1269-74. Erratum in: Diabetes Care 2007;30:1035. x Philis-Tsimikas A, Charpentier G, Clauson P, Ravn GM, Roberts VL, Thorsteinsson B. Comparison of once-daily insulin detemir with NPH insulin added to a regimen of oral antidiabetic drugs in poorly controlled type 2 diabetes. Clin Ther 2006;28:1569-81. Erratum in: Clin Ther 2006;28:1967. x L. Blonde, M. Merilainen, V. Karwe, P. Raskin. TITRATE Study Group. Patient-directed titration for achieving glycaemic goals using a once-daily basal insulin analogue: an assessment of two different fasting plasma glucose targets - the TITRATE study. Diabetes Obes Metab. 2009;11:623-631 Crossref. x C. Fajardo Montañana, C. Hernández Herrero, M. Rivas Fernández. Less weight gain and hypoglycaemia with once-daily insulin detemir than NPH insulin in intensification of insulin therapy in overweight Type 2 diabetes patients: the PREDICTIVE BMI clinical trial. Diabet Med. 2008;25:916-923 , and is associated with less weight gain than NPH and the basal insulin analogue glargine [14], [15], [17], and [18] x Hermansen K, Davies M, Derezinski T, Martinez Ravn G, Clauson P, Home P. A 26-week, randomized, parallel, treat-to-target trial comparing insulin detemir with NPH insulin as add-on therapy to oral glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetes Care 2006;29:1269-74. Erratum in: Diabetes Care 2007;30:1035. x Philis-Tsimikas A, Charpentier G, Clauson P, Ravn GM, Roberts VL, Thorsteinsson B. Comparison of once-daily insulin detemir with NPH insulin added to a regimen of oral antidiabetic drugs in poorly controlled type 2 diabetes. Clin Ther 2006;28:1569-81. Erratum in: Clin Ther 2006;28:1967. x C. Fajardo Montañana, C. Hernández Herrero, M. Rivas Fernández. Less weight gain and hypoglycaemia with once-daily insulin detemir than NPH insulin in intensification of insulin therapy in overweight Type 2 diabetes patients: the PREDICTIVE BMI clinical trial. Diabet Med. 2008;25:916-923 x J. Rosenstock, M. Davies, P.D. Home, J. Larsen, C. Koenen, G. Schernthaner. A randomised, 52-week, treat-to-target trial comparing insulin detemir with insulin glargine when administered as add-on to glucose-lowering drugs in insulin-naïve people with type 2 diabetes. Diabetologia. 2008;51:408-416 Crossref. . Complementary evidence from real-life clinical practice in large heterogeneous populations provides further support for the clinical benefits that insulin detemir may offer for insulin-naïve patients with T2D starting basal therapy and for those changing treatment from existing insulin treatment (efficacy, lower risk of hypoglycaemia and less weight gain) [7], [12], [14], [19], and [20] 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. x J.L. Selam, C. Koenen, W. Weng, L. Meneghini. Improving glycemic control with insulin detemir using the 303 Algorithm in insulin naïve patients with type 2 diabetes: a subgroup analysis of the US PREDICTIVE 303 study. Curr Med Res Opin. 2008;24:11-20 x Hermansen K, Davies M, Derezinski T, Martinez Ravn G, Clauson P, Home P. A 26-week, randomized, parallel, treat-to-target trial comparing insulin detemir with NPH insulin as add-on therapy to oral glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetes Care 2006;29:1269-74. Erratum in: Diabetes Care 2007;30:1035. x L.F. Meneghini, K.H. Rosenberg, C. Koenen, M.J. Merilainen, H.J. Lüddeke. Insulin detemir improves glycaemic control with less hypoglycaemia and no weight gain in patients with type 2 diabetes who were insulin naive or treated with NPH or insulin glargine: clinical practice experience from a German subgroup of the PREDICTIVE study. Diabetes Obes Metab. 2007;9:418-427 Crossref. x A. Dornhorst, H.J. Lüddeke, S. Sreenan, P. Kozlovski, J.B. Hansen, B.J. Looij, et al. PREDICTIVE Study Group. Insulin detemir improves glycaemic control without weight gain in insulinnaïve patients with type 2 diabetes: subgroup analysis from the PREDICTIVE study. Int J Clin Pract. 2008;62:659-665 Crossref. .

A1chieve was an observational study designed to examine the safety and clinical effectiveness of insulin analogues in T2D. The global scope of A1chieve, which included 28 countries with different healthcare resources and ethnic diversity, allows insights into regional and country effects on clinical outcomes. The aim of this sub-group analysis is to examine data from people who started treatment with insulin detemir ± oral glucose-lowering drugs (OGLDs) in routine clinical care. Outcomes from patients on different pre-study therapies are compared, along with regional differences.

References

Label Authors Title Source Year
[11]

References in context

  • The primary aim of diabetes management is to achieve satisfactory levels of glycaemic control, thereby reducing the risk of serious long-term diabetes related complications [1–3].
    Go to context

J.S. Freeman Insulin analog therapy: improving the match with physiologic insulin secretion J Am Osteopath Assoc. 2009;109:26-36 2009

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