Initiating or switching to biphasic insulin aspart 30 in type 2 diabetes patients from Algeria: a sub-analysis of the A1chieve study
Diabetes Research and Clinical Practice, pages S37 - S44
Published online Aug-2013
To determine the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in Algerian patients with type 2 diabetes initiating insulin or switching from prior insulin therapy.
Insulin-naive and insulin-experienced patients, including prior basal insulin users, starting BIAsp 30 were evaluated in this sub-analysis of the 24-week, open-label, non-interventional A1chieve study. Clinical safety and effectiveness was evaluated as a part of routine clinical care.
A total of 134 insulin-naive patients initiating BIAsp 30 at a mean dose of 0.44±0.23 U/kg and 283 insulin-experienced patients, including 129 prior basal insulin users, switching from a mean pre-study insulin dose of 0.51±0.23U/kg to BIAsp 30 (0.54±0.20U/kg) were evaluated. At Week 24, the average BIAsp 30 dose was 0.60±0.25 U/kg and 0.66±0.24U/kg in insulin-naive and insulin-experienced patients, respectively. No serious adverse drug reactions were reported. From baseline to Week 24, the proportion of patients experiencing overall hypoglycaemia increased in the insulin-naive group (p = 0.0067) and no significant changes were reported in the insulin-experienced group including prior basal insulin users. Glucose control improved significantly in the insulin-experienced group (p < 0.001) and appeared to improve in the insulin-naive patients and prior basal insulin users as well. Body weight increased significantly in all patients (p < 0.001). Quality of life was positively impacted after 24 weeks of BIAsp 30 therapy.
Initiating or switching to BIAsp 30 therapy in this Algerian cohort was well-tolerated and significantly improved glucose control.
Keywords: Biphasic insulin aspart 30, Insulin-naive, Basal insulin, Algeria.
- 1 International Diabetes Federation. IDF Diabetes Atlas. 5th ed. 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
- 3 M Belhadj, R Malek, A Boudiba, E Lezzar, D Roula, F Sekkal, et al. DiabCare Algérie. Médecine des maladies Métaboliques. 2010;4(1):1-5
- 4 A Boudiba, S Mimouni-Zerguini. Improving care and prevention for people with diabetes in Algeria. Diabetes Voice. 2008;53(2):19-21
- 5 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
- 6 A Liebl, V Prusty, P Valensi, R Kawamori, JS Christiansen, AJ Palmer, et al. Ten years of experience with biphasic insulin aspart 30: from drug development to the latest clinical findings. Drugs. 2012;72(11):1495-1520
- 7 P Raskin, E Allen, P Hollander, A Lewin, RA Gabbay, P Hu, et al. Initiating insulin therapy in type 2 diabetes: a comparison of biphasic and basal insulin analogs. Diabetes Care. 2005;28:260-265
- 8 C Kilo, N Mezitis, R Jain, J Mersey, J McGill, P Raskin. Starting patients with type 2 diabetes on insulin therapy using once-daily injections of biphasic insulin aspart 70/30, biphasic human insulin 70/30, or NPH insulin in combination with metformin. J Diabetes Complications. 2003;17:307-313
- 9 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;5:446-454
- 10 A Ceriello, J Davidson, M Hanefeld, L Leiter, L Monnier, D Owens, et al., International Prandial Glucose Regulation Study Group. Postprandial hyperglycaemia and cardiovascular complications of diabetes: an update. Nutr Metab Cardiovasc Dis. 2006;16(7):453-456
- 11 E Selvin, S Marinopoulos, G Berkenblit, T Rami, FL Brancati, NR Powe, et al. Metaanalysis: glycosylated hemoglobin and cardiovascular disease in diabetes mellitus. Ann Intern Med. 2004;141:421-431
- 12 Q Qiao, J Tuomilehto, K Borch-Johnsen. Post-challenge hyperglycaemia is associated with premature death and macrovascular complications. Diabetologia. 2003;46(Suppl. 1):M17-M21
- 13 K Strojek, WM Bebakar, DT Khutsoane, M Pesic, A Smahelová, HF Thomsen, et al. Once-daily initiation with biphasic insulin aspart 30 versus insulin glargine in patients with type 2 diabetes inadequately controlled with oral drugs: an open-label, multinational RCT. Curr Med Res Opin. 2009;25:2887-2894
- 14 RJ Ligthelm, T Gylvin, T DeLuzio, P Raskin. A comparison of twice-daily biphasic insulin aspart 70/30 and once-daily insulin glargine in persons with type 2 diabetes mellitus inadequately controlled on basal insulin and oral therapy: a randomized, open-label study. Endocr Pract. 2011;17:41-50
- 15 J Gumprecht, M Benroubi, V Borzi, R Kawamori, J Shaban, S Shah, et al., on behalf of the IMPROVE Study Group Expert Panel. Intensification to biphasic insulin aspart 30/70 (BIAsp 30, NovoMix 30) can improve glycaemic control in patients treated with basal insulins: a subgroup analysis of the IMPROVE observational study. Int J Clin Pract. 2009;63:966-972
- 16 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
- 17 HC Jang, S Guler, M Shestakova, on behalf of the PRESENT Study Group. When glycaemic targets can no longer be achieved with basal insulin in type 2 diabetes, can simple intensification with a modern premixed insulin help? Results from a subanalysis of the PRESENT study. Int J Clin Pract. 2008;62:1013-1018
- 18 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;23:3209-3214
- 19 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 A(1)chieve study. Diabetes Res Clin Pract. 2012;98(3):408-413
- 20 K Niswender. Early and aggressive initiation of insulin therapy for type 2 diabetes: What is the evidence?. Clin Diab. 2009;27:60-68
- 21 A Wright, ACF Burden, RB Paisey, CA Cill, RR Holman, the UK Prospective Diabetes Study Group. Sulphonylurea inadequacy: efficacy of addition of insulin over 6 years in patients with type 2 diabetes in the UK. Prospective Diabetes Study (UKPDS 57). Diabetes Care. 2002;25:330-336
- 22 AA Riedel, H Heien, J Wogen, CA Plauschinat. Secondary failure of glycemic control for patients adding thiazolidinedione or sulphonylurea therapy to metformin regimen. Am J Manag Care. 2007;13:457-463
a Endocrinology & Metabolism Department, CHU Constantine, Algeria Endocrinology & Metabolism Department, CHU Constantine, Algeria
b Internal Medicine Department, EHU Oran, Algeria Internal Medicine Department, EHU Oran, Algeria
c Medical Department, Novo Nordisk, Algeria Medical Department, Novo Nordisk, Algeria
d Internal Medicine Department, Nedir University Hospital, Tizi Ouzou, Algeria Internal Medicine Department, Nedir University Hospital, Tizi Ouzou, Algeria
e Internal Medicine Department, CHU Tlemcen, Algeria Internal Medicine Department, CHU Tlemcen, Algeria
Corresponding author at: Endocrinology & Metabolism Department, CHU Constantine, Algeria. Tel.: +213772421437
© 2013 Published by Elsevier B.V.