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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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References

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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.
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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 2007
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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 Crossref. Int J Clin Pract. 2009;63:522-531 2009
[7]

References in context

  • Health-related quality of life (HRQoL) was measured using the EQ-5D questionnaire [22] at baseline and after 24 weeks of therapy.
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  • The proportion of patients reaching HbA1c<7.0% [53 mmol/mol] with insulin detemir ± OGLDs was ∼30%, irrespective of prestudy therapy; similar to that reported for the entire A1chieve study cohort (31.8%) [7] and for basal insulin analogue therapy in RCTs [25,26].
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  • The proportion of patients reaching HbA1c<7.0% [53 mmol/mol] with insulin detemir ± OGLDs was ∼30%, irrespective of prestudy therapy; similar to that reported for the entire A1chieve study cohort (31.8%) [7] and for basal insulin analogue therapy in RCTs [25,26].
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  • The proportion of patients reaching HbA1c<7.0% [53 mmol/mol] with insulin detemir ± OGLDs was ∼30%, irrespective of prestudy therapy; similar to that reported for the entire A1chieve study cohort (31.8%) [7] and for basal insulin analogue therapy in RCTs [25,26].
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  • Regionally, both the poor level of glycaemic control at baseline and the magnitude of improvement were remarkably consistent.
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  • Interestingly, in the entire A1chieve study population, although no clinically significant weight change was reported, a larger range was seen (−0.8 and +0.9kg) [7].
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  • Interestingly, in the entire A1chieve study population, although no clinically significant weight change was reported, a larger range was seen (−0.8 and +0.9kg) [7].
    Go to context

  • The A1chieve study, by nature of its design, has a number of limitations that must be considered when interpreting the data [7].
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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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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 Crossref. Diabetes Obes Metab. 2012;14:654-661 2012
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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 Crossref. JAMA. 1999;281:2005-2012 1999
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J. Tibaldi, R.E. Rakel Why, when and how to initiate insulin therapy in patients with type 2 diabetes Crossref. Int J Clin Pract. 2007;61:633-644 2007
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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].
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J.S. Freeman Insulin analog therapy: improving the match with physiologic insulin secretion J Am Osteopath Assoc. 2009;109:26-36 2009
[12]
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 2008
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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) Crossref. Diabetologia. 2012;55:1577-1596 2012
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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.
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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.
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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 Crossref. Diabetes Obes Metab. 2009;11:623-631 2009
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References in context

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 2008
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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 Crossref. Diabetologia. 2008;51:408-416 2008
[19]

References in context

  • Table entry: −1.8 (1.7) [19]
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  • Significant improvements in all measures of glycaemic control were seen regardless of prior insulin regimen, human or analogue, which supports previous findings from a clinical practice [19].
    Go to context

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 Crossref. Diabetes Obes Metab. 2007;9:418-427 2007
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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 Crossref. Int J Clin Pract. 2008;62:659-665 2008
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Shah SN, Litwak L, Haddad J, Chakkarwar PN, Hajjaji I. The A1chieve study: a 60000-person, global, prospective, observational study of basal, meal-time, and biphasic insulin analogs in daily clinical practice. Diabetes Res Clin Pract 2010; 88(Suppl 1):S11-6.
[22]

References in context

  • Table entry: −2.0 (1.6) [22]
    Go to context

  • Health-related quality of life (HRQoL) was measured using the EQ-5D questionnaire [22] at baseline and after 24 weeks of therapy.
    Go to context

EuroQol Group EuroQol – a new facility for the measurement of health-related quality of life Health Policy. 1990;16:199-208 1990
[23]

References in context

L. Meneghini, C. Koenen, W. Weng, J.L. Selam The usage of a simplified self-titration dosing guideline (303 Algorithm) for insulin detemir in patients with type 2 diabetes – results of the randomized, controlled PREDICTIVE 303 study Crossref. Diabetes Obes Metab. 2007;9:902-913 2007
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L.F. Meneghini, A. Dornhorst, S. Sreenan PREDICTIVE Study Group. Once-daily insulin detemir in a cohort of insulin-naïve patients with type 2 diabetes: a sub-analysis from the PREDICTIVE study Crossref. Curr Med Res Opi. 2009;25:1029-1035 2009
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R.R. Holman, S.K. Paul, M.A. Bethel, D.R. Matthews, H.A. Neil 10-year follow-up of intensive glucose control in type 2 diabetes Crossref. N Engl J Med. 2008;359:1577-1589 2008
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P. Raskin, E. Allen, P. Hollander, A. Lewin, R.A. Gabbay, P. Hu, et al. INITIATE Study Group. Initiating insulin therapy in type 2 diabetes: a comparison of biphasic and basal insulin analogs Crossref. Diabetes Care. 2005;28:260-265 2005
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P. Hollander, J. Cooper, J. Bregnhøj, C.B. Pedersen A 52-week, multinational, open-label, parallel-group, noninferiority, treat-to-target trial comparing insulin detemir with insulin glargine in a basal-bolus regimen with mealtime insulin aspart in patients with type 2 diabetes Crossref. Clin Ther. 2008;30:1976-1987 2008

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