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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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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].
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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].
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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
[5]
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 Crossref. Acta Diabetol. 2000;37:41-46 2000
[6]
G. Dailey, J. Rosenstock, R.G. Moses, K. Ways Insulin glulisine provides improved glycemic control in patients with type 2 diabetes Crossref. Diabetes Care. 2004;27:2363-2368 2004
[7]
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 Crossref. Diabet Med. 2000;17:762-770 2000
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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 Crossref. Diabet Med. 2004;21:769-775 2004
[9]

References in context

  • The 4-T Study – a 3-year RCT in 708 insulin-naïve people with type 2 diabetes – did investigate the addition of insulin aspart to insulin detemir: mean HbA1c after 3 years was 6.9% (mean reduction of 1.2% from baseline), with a median rate of hypoglycaemia of 1.7 events/patient/year [9].
    Go to context

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 Crossref. N Engl J Med. 2009;361:1736-1747 2009
[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.
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  • 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
[11]

References in context

  • The primary overall objective of the study was to determine the incidence of serious adverse drug reactions (SADRs), including major hypoglycaemic events, considered related to the study insulin between baseline and final visit.
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  • The sub-groups investigated for this analysis were: 1) participants who were previously treated with a basal insulin and then added meal-time insulin aspart; 2) participants who were previously treated with a premix insulin and who switched to a basal plus prandial insulin regimen including insulin aspart as the meal-time insulin; 3) participants who were previously treated with NPH insulin plus human unmodified insulin as a meal-time insulin and who switched to basal insulin plus insulin aspart; 4) participants who were insulin-naïve who started a basal plus prandial insulin regimen including insulin aspart as the meal-time insulin.
    Go to context

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 Abstract, Full-text, PDF, Crossref. Diabetes Res Clin Pract. 2011;94:364-370 2011
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References in context

  • The primary overall objective of the study was to determine the incidence of serious adverse drug reactions (SADRs), including major hypoglycaemic events, considered related to the study insulin between baseline and final visit.
    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
[13]

References in context

  • Good tolerability of the regimen(s) is confirmed by the health-related quality of life data, where the final levels are consistent with other reports of people with type 2 diabetes in moderate blood glucose control [13], with very useful improvements from baseline that presumably reflect participants’ poor metabolic control at that time and possibly an associated neglect of health care.
    Go to context

P. Clarke, A. Gray, R. Holman Estimating utility values for health states of type 2 diabetic patients using the EQ-5D (UKPDS 62) Med Decis Making. 2002;22:340-349 2002
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J.B. Brown, G.A. Nichols, A. Perry The burden of treatment failure in type 2 diabetes Crossref. Diabetes Care. 2004;27:1535-1540 2004
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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;57:455-460 2007
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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
[17]

References in context

  • As a result, in regressing to the same level, improvements were greatest in the insulin-naïve group (mean HbA1c [SD] change from baseline −2.8 [2.0] % (31 [22] mmol/mol); p<0.001) and smallest in the human multiple injection group (−1.8 [1.6] % (20 [17] mmol/mol); p<0.001).
    Go to context

J. Gordon, R.D. Pockett, A.P. Tetlow, P. McEwan, P.D. Home A comparison of intermediate and long-acting insulins in people with type 2 diabetes starting insulin: an observational database study Crossref. Int J Clin Pract. 2010;64:1609-1618 2010
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K. Khunti, T. Damci, L. Meneghini, C.Y. Pan, J.F. Yale on behalf of the 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
[19]

References in context

  • Improvements in blood lipid profile are known to occur with improvements in blood glucose control secondary to insulin [19], but changes of the order of magnitude seen here generally were from much poorer glucose control again.
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Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993; 329:977-86.
[20]

References in context

  • Diabetes duration of >10 years in the group consisting of prior insulin users is consistent with the need for a more complex insulin regimen, given the progressive nature of islet beta-cell dysfunction in type 2 diabetes [20]; however, what is more unusual is the insulin-naïve sub-group treated with a prandial plus basal insulin regimen ahead of multiple OGLD therapy or a simpler insulin regimen.
    Go to context

R. Turner, C. Cull, R. Holman United Kingdom Prospective Diabetes Study 17: a 9-year update of a randomized, controlled trial on the effect of improved metabolic control on complications in non-insulin-dependent diabetes mellitus Crossref. Ann Intern Med. 1996;124:136-145 1996
[21]

References in context

  • Treatment with insulin aspart ± NPH insulin in a 3-month RCT of 231 people with type 2 diabetes resulted in a mean (SD) HbA1c reduction of 0.91 (1.00) % compared with a 0.73 (0.87) % reduction in participants treated with human insulin ± NPH insulin (p=0.025) [21].
    Go to context

R.G. Bretzel, S. Arnolds, J. Medding, T. Linn A direct efficacy and safety comparison of insulin aspart, human soluble insulin, and human premix insulin (70/30) in patients with type 2 diabetes Crossref. Diabetes Care. 2004;27:1023-1027 2004
[22]

References in context

  • As a result, in regressing to the same level, improvements were greatest in the insulin-naïve group (mean HbA1c [SD] change from baseline −2.8 [2.0] % (31 [22] mmol/mol); p<0.001) and smallest in the human multiple injection group (−1.8 [1.6] % (20 [17] mmol/mol); p<0.001).
    Go to context

  • Improved PPPG control with insulin aspart vs. human insulin both with NPH insulin was also seen in a 12-week crossover study of 21 people with type 2 diabetes [22], although there was no difference in HbA1c between the two insulins.
    Go to context

A. Gallagher, P.D. Home The effect of improved post-prandial blood glucose control on post-prandial metabolism and markers of vascular risk in people with Type 2 diabetes Crossref. Diabetes Res Clin Pract. 2005;67:196-203 2005

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