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Safety and effectiveness of biphasic insulin aspart 30 in type 2 diabetes patients switched from biphasic human insulin 30: Results from the Filipino cohort of the A1chieve study

Mary Anne Lim-Abrahan a * , Susan Yu-Gan b, Anand B. Jain c, Leorino M. Sobrepena d and Veronica A. Racho e

Diabetes Research and Clinical Practice, pages S35 - S40

Published online Aug-2013


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Abstract

Aim

To evaluate the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in Filipino patients with type 2 diabetes previously treated with biphasic human insulin 30 (BHI 30). Methods: Safety and effectiveness outcomes were measured in all patients switching from BHI 30 to BIAsp 30 in the Filipino cohort of the 24-week, multinational, prospective, non-interventional A1chieve study.

Results

A total of 111 Filipino patients (mean age ± SD, 57.4±12.8 years; BMI, 25.8±5.6kg/m2) with mean diabetes duration of 9.9±7.1 years switched therapy from BHI 30 to BIAsp 30. The mean pre-study BHI 30 dose was 0.65±0.28 IU/kg and the baseline BIAsp 30 dose was 0.65±0.26 U/kg titrated up to 0.70±0.26 U/kg by Week 24. No serious adverse drug reactions were reported. Overall hypoglycaemia was reduced from 5.62 to 1.98 events/patient-year. Minor and nocturnal hypoglycaemia decreased and no major hypoglycaemia was reported at Week 24. Glucose control improved from baseline to Week 24 (HbA1c, –2.2±2.1% [24±23 mmol/mol]; FPG, –72.0±71.8 mg/dL; PPPG, –145.5±125.4 mg/dL). A total of 24 patients achieved HbA1c levels <7.0% at Week 24 compared to 6 patients reporting this target at baseline. Quality of life was positively impacted at Week 24 (change in visual analogue scores, 15.3±16.9 points).

Conclusion

Switching from BHI 30 to BIAsp 30 improved glycaemic control without increasing the risk of hypoglycaemia.

Keywords: Philippines, Switch therapy, Biphasic insulin aspart 30, Biphasic human insulin 30.


Article Outline

References

  • 1 International Diabetes Federation. IDF Diabetes Atlas. 5th edn. Brussels, Belgium; 2011, updated 14 November 2012.
  • 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 ML Soria, RG Sy, BS Vega, T Ty-Willing, A Abenir-Gallardo, F Velandria, et al. The incidence of type 2 diabetes mellitus in the Philippines: a 9-year cohort study. Diabetes Res Clin Pract. 2009;86(2):130-133 Crossref.
  • 4 M Higuchi. Access to diabetes care and medicines in the Philippines. Asia Pac J Public Health. 2010;22(3 Suppl):96S-102S Crossref.
  • 5 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.
  • 6 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.
  • 7 S Shah, M Benroubi, V Borzi, J Gumprecht, R Kawamori, J Shaban, et al., on behalf of the 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;63:574-582 Crossref.
  • 8 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.
  • 9 K Niswender. Early and aggressive initiation of insulin therapy for type 2 diabetes: What is the evidence?. Clin Diab. 2009;27:60-68 Crossref.
  • 10 M Evans, PM Schumm-Oraeger, J Vora, AB King. A review of modern insulin analogue pharmacokinetic and pharmacodynamic profiles in type 2 diabetes: improvements and limitations. Diabetes Obes Metab. 2011;13(8):677-684 Crossref.
  • 11 JS Christiansen, JA 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. Diabetes Obes Metab. 2003;5(6):446-454 Crossref.
  • 12 K Hermansen, M Colombo, H Storgaard, A ØStergaard, K Kølendorf, S Madsbad. Improved postprandial glycemic control with biphasic insulin aspart relative to biphasic insulin lispro and biphasic human insulin in patients with type 2 diabetes. Diabetes Care. 2002;25(5):883-888 Crossref.
  • 13 M Velojic-Golubovic, D Mikic, M Pesic, D Dimic, S Radenkovic, S Antic. Biphasic insulin aspart 30: better glycemic control than with premixed human insulin 30 in obese patients with type 2 diabetes. J Endocrinol Invest. 2009;32:23-27 Crossref.
  • 14 I Schmoelzer, A de Campo, H Pressl, H Stelzl, P Dittrich, K Oettl, et al. Biphasic insulin aspart compared to biphasic human insulin reduces postprandial hyperlipidemia in patients with type 2 diabetes. Exp Clin Endocrinol Diabetes. 2005;113:176-181 Crossref.
  • 15 H Abrahamian, B Ludvik, G Schernthaner, R Prager, U Zellenka, L Knudsen, et al. Improvement of glucose tolerance in type 2 diabetic patients: traditional vs. modern insulin regimens (results from the Austrian Biaspart Study). Horm Metab Res. 2005;37:684-689
  • 16 BO Boehm, JA Vaz, L Brøndsted, PD Home. Long-term efficacy and safety of biphasic insulin aspart in patients with type 2 diabetes. Eur J Intern Med. 2004;15:496-502 Crossref.
  • 17 D Beran, M Higuchi. Delivering diabetes care in the Philippines and Vietnam: policy and practice issues. Asia Pac J Public Health. 2013;25(1):92-101 Crossref.
  • 18 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.
  • 19 NK El Naggar, P Soewondo, ME Khamseh, J 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
  • 20 JA Davidson, A Liebl, JS Christiansen, G Fulcher, RJ Ligthelm, P Brown, et al. Risk for nocturnal hypoglycemia with biphasic insulin aspart 30 compared with biphasic human insulin 30 in adults with type 2 diabetes mellitus: a meta-analysis. Clin Ther. 2009;31(8):1641-1651 Crossref.
  • 21 PG McNally, JD Dean, AD Morris, PD Wilkinson, G Compion, SR Heller. Using continuous glucose monitoring to measure the frequency of low glucose values when using biphasic insulin aspart 30 compared with biphasic human insulin 30: a double-blind crossover study in individuals with type 2 diabetes. Diabetes Care. 2007;30:1044-1048 Crossref.
  • 22 JP Vandenbroucke. What is the best evidence for determining harms of medical treatment?. CMAJ. 2006;174(5):645-646 Crossref.

Footnotes

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

b Metropolitan Medical Center, Manila, Philippines Metropolitan Medical Center, Manila, Philippines

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

d St. Luke's Medical Centre, Quezon City, Philippines St. Luke's Medical Centre, Quezon City, Philippines

e Medical Towers Davao Doctors Hospital, Davao City, Philippines Medical Towers Davao Doctors Hospital, Davao City, Philippines

* Corresponding author at: University of the Philippines College of Medicine, Manila Doctors Hospital, Rm 804, 667 U.N. Ave. Ermita Manila, Philippines. Tel.: +632 524 3011 loc. 5280 / +639 178 980 251

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