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Switching from biphasic human insulin to biphasic insulin aspart 30 in type 2 diabetes: Results from the ASEAN subgroup of the A1chieve study

Zanariah Hussein a * , Mary Anne Lim-Abrahan b, Anand B. Jain c, Su Yen Goh d and Pradana Soewondo e

Diabetes Research and Clinical Practice, pages S24 - S29

Published online Aug-2013


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Abstract

Aim

To evaluate the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in ASEAN type 2 diabetes (T2D) patients switched from biphasic human insulin (BHI) in the non-interventional 24-week A1chieve study.

Methods

Indonesian, Malaysian, Filipino and Singaporean patients switched from BHI to BIAsp 30 at their physicians’ discretion were included. The incidence of serious adverse drug reactions (SADRs), including major hypoglycaemia was the primary endpoint. Changes in hypoglycaemia, glycated haemoglobin A1c (HbA1c), fasting plasma glucose (FPG), postprandial plasma glucose (PPPG), lipids, body weight and systolic blood pressure were also evaluated. Quality of life (QoL) was measured using the EQ-5D questionnaire.

Results

For the 465 patients included (mean±SD age: 56±10.3 years, diabetes duration: 9.7±7.1 years, baseline HbA1c: 9.4±1.8%), the mean pre-study BHI dose was 0.62±0.28 IU/kg and 63.4% were dosing BHI twice daily (bid). The mean baseline BIAsp 30 dose was 0.65±0.27U/kg, titrated up to 0.71±0.28U/kg over 24 weeks, and most patients continued bid dosing. No SADRs or major hypoglycaemic episodes were reported. The proportion of patients reporting overall hypoglycaemia decreased significantly from 10.8% at baseline to 3.4% at Week 24 (p < 0.0001). Significant improvements in glycaemic control were noted (HbA1c: –1.4±1.7%, FPG: –56.7±72.5 mg/dL, post-breakfast PPPG: –84.8±82.8 mg/dL, p < 0.001). Mean QoL improved by +6.6±14.6 points (p < 0.001).

Conclusion

BIAsp 30 was well-tolerated and significantly increased glycaemic control in this ASEAN subgroup poorly controlled on BHI.

Keywords: Biphasic insulin aspart, Biphasic human insulin, ASEAN, Type 2 diabetes.


Article Outline

References

  • 1 E Paz-Pacheco. Diabetes Clinical Practice Guidelines (CPGs) for the ASEAN region: Country initiatives for collectively enhanced diabetes care in the region. JAFES. 2011;26(1):36-37 Crossref.
  • 2 DR Whiting, L Guariguata, C Weil, J Shaw. IDF diabetes atlas: global estimates of the prevalence of diabetes for 2011 and 2030. Diabetes Res Clin Pract. 2011;94(3):311-321 Crossref.
  • 3 SE Inzucchi, RM Bergenstal, JB 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(6):1577-1596 Crossref.
  • 4 IM Stratton, AI Adler, HA Neil, DR Matthews, SE Manley, CA Cull, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000;32:405-412 Crossref.
  • 5 RK Campbell. Recommendations for improving adherence to type 2 diabetes mellitus therapy – focus on optimizing insulin-based therapy. Am J Manag Care. 2012;18(Suppl 3):S55-S61
  • 6 A Liebl, V Prusty, P Valensi, R Kawamori, JS Christiansen, AJ Palmer. Ten years of experience with biphasic insulin aspart 30: from drug development to the latest clinical findings. Drugs. 2012;72(11):1495-1520 Crossref.
  • 7 S Heller. Reducing hypoglycaemia with insulin analogues. Int J Obes Relat Metab Disord. 2002;26(Suppl 3):S31-S36 Crossref.
  • 8 T Heise, L Heinemann, U Hövelmann, B Brauns, L Nosek, HL Haahr. Biphasic insulin aspart 30/70: pharmacokinetics and pharmacodynamics compared with once-daily biphasic human insulin and basal–bolus therapy. Diabetes Care. 2009;32(8):1431-1433 Crossref.
  • 9 AJ Garber, R Ligthelm, JS Christiansen, A Liebl. Premixed insulin treatment for type 2 diabetes: analogue or human?. Diabetes Obes Metab. 2007;9(5):630-639 Crossref.
  • 10 P Home, NE Naggar, M Khamseh, G Gonzalez-Galvez, C Shen, P Chakkarwar, et al. An observational non-interventional study of patients 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.
  • 11 NK Naggar, P Soewondo, ME Khamseh, JW Chen, J Haddad. Switching from biphasic human insulin 30 to biphasic insulin aspart 30 in type 2 diabetes is associated with improved glycaemic control and a positive safety profile: Results from the A1chieve study. Diabetes Res Clin Pract. 2012;98(3):408-413 Abstract, Full-text, PDF, Crossref.
  • 12 S Shah, M Benroubi, V Borzi, J Gumprecht, R Kawamori, J Shaban, et al., IMPROVE Study Group Expert Panel. Safety and effectiveness of biphasic insulin aspart 30/70 (NovoMix 30) when switching from human premix insulin in patients with type 2 diabetes: subgroup analysis from the 6-month IMPROVE observational study. Int J Clin Pract. 2009;63(4):574-582 Crossref.
  • 13 M Mafauzy, Z Hussein, SP Chan. The status of diabetes control in Malaysia: results of DiabCare 2008. Med J Malaysia. 2011;66(3):175-181
  • 14 WR Lee, HS Lim, AC Thai, WL Chew, S Emmanuel, LG Goh, et al., Diabcare Singapore Local Working Group, Diabetic Society of Singapore. A window on the current status of diabetes mellitus in Singapore – the Diabcare-Singapore 1998 study. Singapore Med J. 2001;42(11):501-507
  • 15 P Soewondo, S Soegondo, K Suastika, A Pranoto, DW Soeatmadji, A Tjokroprawiro. The DiabCare Asia 2008 study – Outcomes on control and complications of type 2 diabetic patients in Indonesia. Med J Indones. 2010;19:235-244 Crossref.
  • 16 DM Nathan, JB Buse, MB Davidson, RJ Heine, RR Holman, R Sherwin, et al. Management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2006;29:1963-1972 Crossref.
  • 17 M Shestakova, SK Sharma, M Almustafa, KW Min, N Ayad, ST Azar, et al. Transferring type 2 diabetes patients with uncontrolled glycaemia from biphasic human insulin to biphasic insulin aspart 30: experiences from the PRESENT study. Curr Med Res Opin. 2007;23(12):3209-3214 Crossref.
  • 18 AJ 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). Diabetes Obes Metab. 2006;8(1):58-66 Crossref.

Footnotes

a Hospital Putrajaya, Putrajaya, Malaysia Hospital Putrajaya, Putrajaya, Malaysia

b University of the Philippines College of Medicine, Manila, Philippines University of the Philippines College of Medicine, Manila, Philippines

c Novo Nordisk Pharma Malaysia Sdn Bhd, Kuala Lumpur, Malaysia Novo Nordisk Pharma Malaysia Sdn Bhd, Kuala Lumpur, Malaysia

d Department of Endocrinology, Singapore General Hospital, Singapore Department of Endocrinology, Singapore General Hospital, Singapore

e Sp-PD-KEMO, University of Indonesia, Jakarta, Indonesia Sp-PD-KEMO, University of Indonesia, Jakarta, Indonesia

* Corresponding author at: Department of Medicine, Hospital Putrajaya, Presint 7, 62250 Putrajaya, W.P. Putrajaya, Malaysia. Tel.: +6012 290 7136

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