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An observational non-interventional study of people with diabetes beginning or changed to insulin analogue therapy in non-Western countries: The A1chieve study

Philip Home, Nabil El Naggar, Mohammed Khamseh, Guillermo Gonzalez-Galvez, Chunduo Shen, Praful Chakkarwar and Wenying Yang

Diabetes Research and Clinical Practice, Issue 3, Volume 94, pages 352 - 363

Received 20 September 2011, Revised 10 October 2011, Accepted 13 October 2011, Published online Nov-2011


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References

Label Authors Title Source Year
[1]
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
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A. Wright, A.C. Felix Burden, R.B. Paisey, C.A. Cull, R.R. Holman, for the UK Prospective Diabetes Study Group Sulfonylurea inadequacy. Efficacy of addition of insulin over 6 years in patients with type 2 diabetes in the UK Prospective Diabetes Study (UKPDS 57) Crossref. Diabetes Care. 2002;25:330-336 2002
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References in context

  • Furthermore, suboptimal glycaemic control commonly persists even in insulin users [3].
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S. Gough, K.B. Frandsen, A.D. Toft Failure of insulin monotherapy in patients with type 2 diabetes: a population-based study Diabetes. 2006;55(Suppl. 1):A114 2006
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M. Davies The reality of glycaemic control in insulin treated diabetes: defining the clinical challenges Crossref. Int J Obes Relat Metab Disord. 2004;28(Suppl. 2):S14-S22 2004
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H.J. Lüddeke, S. Sreenan, S. Aczel, S. Maxeiner, M. Yenigun, P. Kozlovski, et al. PREDICTIVE – a global, prospective observational study to evaluate insulin detemir treatment in types 1 and 2 diabetes: baseline characteristics and predictors of hypoglycaemia from the European cohort Diabetes Obes Metab. 2007;9:428-434 2007
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References in context

  • This result is not unexpected, similar findings with regard to pre-study treatment regimen having been reported in the IMPROVE observational study of 52,419 people from 11 countries with T2D starting or switching to biphasic insulin aspart as part of routine clinical care [6].
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P. Valensi, M. Benroubi, V. Borzi, J. Gumprecht, R. Kawamori, J. Shaban, et al. The IMPROVE study—a multinational, observational study in type 2 diabetes: baseline characteristics from eight national cohorts Crossref. Int J Clin Pract. 2008;62:1809-1819 2008
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References in context

  • It is known that when therapies are actively assessed, titrated and increased in number, glycaemic targets are more likely to be achieved [7].
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A.J. Garber, J. Wahlen, T. Wahl, P. Bressler, R. Braceras, E. Allen, et al. Attainment of glycaemic goals in type 2 diabetes with once-, twice-, or thrice-daily dosing with biphasic insulin aspart 70/30 (the 1-2-3 study) Crossref. Diabetes Obes Metab. 2006;8:58-66 2006
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S.H. Saydah, J. Fradkin, C.C. Cowie Poor control of risk factors for vascular disease among adults with previously diagnosed diabetes Crossref. JAMA. 2004;291:335-342 2004
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J.B. Saaddine, B. Cadwell, E.W. Gregg, M.M. Engelgau, F. Vinicor, G. Imperatore, et al. Improvements in diabetes processes of care and intermediate outcomes: United States, 1988–2002 Crossref. Ann Intern Med. 2006;144:465-474 2006
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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 Crossref. BMJ. 2000;321:405-412 2000
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M. Peyrot, R.R. Rubin, T. Lauritzen, S.E. Skovlund, F.J. Snoek, D.R. Matthews, et al. International DAWN Advisory Panel. Resistance to insulin therapy among patients and providers: results of the cross-national Diabetes Attitudes, Wishes, and Needs (DAWN) study Crossref. Diabetes Care. 2005;28:2673-2679 2005
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M. Korytkowski When oral agents fail: practical barriers to starting insulin Crossref. Int J Obes Relat Metab Disord. 2002;26(Suppl. 3):S18-S24 2002
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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 Diabetic Med. 2008;25:916-923 2008
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A. Philis-Tsimikas, G. Charpentier, P. Clauson, G.M. Ravn, V.L. Roberts, B. Thorsteinsson Comparison of once-daily insulin detemir with NPH insulin added to a regimen of oral antidiabetic drugs in poorly controlled type 2 diabetes Crossref. [Erratum in: Clin Ther 2006;28:1967] Clin Ther. 2006;28:1569-1581 2006
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K. Hermansen, M. Davies, T. Derezinski, G. Martinez Ravn, P. Clauson, P. Home 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 Crossref. [Erratum in: Diabetes Care 2007;30:1035] Diabetes Care. 2006;29:1269-1274 2006
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A. Liebl, R. Prager, K. Binz, M. Kaiser, R. Bergenstal, B. Gallwitz Comparison of insulin analog regimens in people with type 2 diabetes mellitus in the PREFER Study: a randomized controlled trial Crossref. Diabetes Obes Metab. 2009;11:45-52 2009
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L. Meneghini, H. Mersebach, S. Kumar, A.L. Svendsen, K. Hermansen A comparison of two intensification regimens with rapid-acting insulin aspart in type 2 diabetes inadequately controlled by once-daily insulin detemir and oral antidiabetes drugs: the STEP-Wise™ randomized study Endocr Pract. 2011;6:1-26 2011
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S.K. Sharma, M. Al-Mustafa, S.J. Oh, S.T. Azar, M. Shestakova, S. Guler, J.A. Vaz Biphasic insulin aspart 30 treatment in patients with type 2 diabetes poorly controlled on prior diabetes treatment: results from the PRESENT study Crossref. Curr Med Res Opin. 2008;24:645-652 2008
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A. Dornhorst, H.J. Lüddeke, C. Koenen, M. Meriläinen, A. King, A. Robinson, et al. Transferring to insulin detemir from NPH insulin or insulin glargine in type 2 diabetes patients on basal-only therapy with oral antidiabetic drugs improves glycaemic control and reduces weight gain and risk of hypoglycaemia: 14-week follow-up data from PREDICTIVE Diabetes Obes Metab. 2008;10:75-81 2008
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H.M. Krumholz Outcomes research: generating evidence for best practice and policies Crossref. Circulation. 2008;118:309-318 2008
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S. MacMahon, R. Collins Reliable assessment of the effects of treatment on mortality and major morbidity. II: observational studies Crossref. Lancet. 2001;357:455-462 2001
[22]
W. Yang, A. Zilov, P. Soewondo, O.M. Bech, F. Sekkal, P.D. Home Observational studies: going beyond the boundaries of randomized clinical trials Abstract, Full-text, PDF, Crossref. Diabetes Res Clin Pract. 2010;88S:S3-S9 2010
[23]

References in context

  • This was a 24-week, international, prospective, multicentre, non-interventional, observational study of people with T2D who had begun using basal insulin detemir (Levemir®, Novo Nordisk, Denmark), bolus insulin aspart (NovoRapid®, Novo Nordisk) and biphasic insulin aspart 30 (NovoMix® 30, Novo Nordisk), alone or in combination, to evaluate their clinical safety and effectiveness in routine clinical use outside the Western economies [23].
    Go to context

S.N. Shah, L. Litwak, J. Haddad, P.N. Chakkarwar, I. Hajjaji The A1chieve study: a 60,000-person, global, prospective, observational study of basal, meal-time, and biphasic insulin analogs in daily clinical practice Abstract, Full-text, PDF, Crossref. Diabetes Res Clin Pract. 2010;88(Suppl. 1):S11-S16 2010
[24]
B.O. Boehm, P.D. Home, C. Behrend, N.M. Kamp, A. Lindholm Premixed insulin aspart 30 vs. premixed human insulin 30/70 twice daily: a randomized trial in type 1 and type 2 diabetic patients Crossref. Diabetic Med. 2002;19:393-399 2002
[25]
J.S. Christiansen, J.A. Vaz, Z. Metelko, M. Bogoev, I. Dedov Twice daily biphasic insulin aspart improves postprandial glycaemic control more effectively than twice daily NPH insulin, with low risk of hypoglycaemia, in patients with type 2 diabetes Crossref. Diabetes Obes Metab. 2003;5:446-454 2003
[26]

References in context

  • Body weight gain in 6 months with an HbA1c improvement of around 22mmol/mol (2.0%) or more would be expected to be around 4kg [26], due to amelioration of urinary glycosuria and glucose concentration-driven glucose metabolism [27]; that this did not occur would suggest that participants and advising healthcare teams took advantage of the starting of insulin analogues to enhance self-care behaviours.
    Go to context

H. Yki-Järvinen Combination therapies with insulin in type 2 diabetes Diabetes Care. 2001;24:758-767 2001
[27]

References in context

  • Body weight gain in 6 months with an HbA1c improvement of around 22mmol/mol (2.0%) or more would be expected to be around 4kg [26], due to amelioration of urinary glycosuria and glucose concentration-driven glucose metabolism [27]; that this did not occur would suggest that participants and advising healthcare teams took advantage of the starting of insulin analogues to enhance self-care behaviours.
    Go to context

B. Ravikumar, P.E. Carey, J.E. Snaar, D.K. Deelchand, D.B. Cook, R.D. Neely, et al. Real-time assessment of postprandial fat storage in liver and skeletal muscle in health and type 2 diabetes Am J Physiol Endocrinol Metab. 2005;288:E789-E797 2005
[28]

References in context

  • While improvements in glycaemic control are usually associated with an increased risk of hypoglycaemia [28], the global cohort from this study reported a decrease in the rate of all hypoglycaemic episodes from 3.1 events/person-year at baseline to 1.6 events/person-year in the 4 weeks before the end of the study.
    Go to context

UK Prospective Diabetes Study (UKPDS) Group 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;352:837-853 1998
[29]
A.J. Martorella Iatrogenic hypoglycemia in patients with type 2 diabetes: comparison of insulin analog premixes and human insulin premixes Crossref. Postgrad Med. 2011;123:7-16 2011

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