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Objective: To analyse the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in a Jordanian subgroup of the 24-week, non-interventional A1chieve study. Methods: A total of 509 Jordanian patients with type 2 diabetes (392 insulin-naive and 117 insulin-experienced) starting BIAsp30, alone or in combination with oral glucose-lowering drugs, were included. Safety and effectiveness outcomes were analysed over 24 weeks. Results: Patients had a mean age of 55.8 years, body mass index of 28.8 kg/m2 and diabetes duration of 9.4 years at baseline. Two serious adverse drug reactions of hypoglycaemia were reported. The proportion of patients who reported major hypoglycaemic events decreased (2.4% at baseline vs. 0.2% at Week 24, p = 0.0039). The proportion of patients reporting overall hypoglycaemia increased marginally (6.3% at baseline vs. 9.9% at Week 24, p = 0.0378), primarily attributed to a rise in minor and nocturnal hypoglycaemia reported in insulin-naive patients. From baseline to Week 24, the mean ± SD glycated haemoglobin A1c level decreased from 9.8% ± 1.4% to 7.4% ± 0.9% (p < 0.001). Significant reductions after 24 weeks were also noted in the mean fasting plasma glucose, postprandial plasma glucose, lipids, systolic blood pressure and quality of life (all p < 0.001), while the mean body weight increased by 1.8 ± 6.5 kg (p < 0.001). Conclusion: Overall, BIAsp 30 therapy was well-tolerated and resulted in improved glycaemic control in this Jordanian subgroup over 24 weeks.
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Haddad, J. , Haddad, F. , Nasser, R. , Al-Shudifat, A. , Annabi, F. , Sandalci, L. and Al-Kilani, M. (2014) Biphasic Insulin Aspart 30 Therapy in Insulin-Naïve and Insulin-Experienced Patients with Type 2 Diabetes: Results from the Jordanian Subgroup of the A1chieve Study. Journal of Diabetes Mellitus, 4, 379-387. doi: 10.4236/jdm.2014.44051.
|||Rawal, L.B., Tapp, R.J., Williams, E.D., Chan, C., Yasin, S. and Oldenburg, B. (2012) Prevention of Type 2 Diabetes and Its Complications in Developing Countries: A Review. International Journal of Behavioral Medicine, 19, 121-133. http://dx.doi.org/10.1007/s12529-011-9162-9|
|||International Diabetes Federation (2011) International Diabetes Federation (IDF) Diabetes Atlas. 5th Edition, IDF, Brussels.|
|||Zindah, M., Belbeisi, A., Walke, H. and Mokdad, A.H. (2008) Obesity and Diabetes in Jordan: Findings from the Behavioral Risk Factors Surveillance System, 2004. Preventing Chronic Disease, 5, A17.|
|||Khattab, M., Khader, Y.S., Al-Khawaldeh, A. and Ajlouni, K. (2010) Factors Associated with Poor Glycemic Control among Patients with Type 2 Diabetes. Journal of Diabetes and Its Complications, 24, 84-89. http://dx.doi.org/10.1016/j.jdiacomp.2008.12.008|
|||Inzucchi, S.E., Bergenstal, R.M., Buse, J.B., Diamant, M., Ferrannini, E., Nauck, M., et al. (2012) 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, 55, 1577-1596. http://dx.doi.org/10.1007/s00125-012-2534-0|
|||Brunton, S. (2009) Safety and Effectiveness of Modern Insulin Therapy: The Value of Insulin Analogs. Consultant, 49, S13-S19.|
|||Halimi, S., Raskin, P., Liebl, A., Kawamori, R., Fulcher, G. and Yan, G. (2005) Efficacy of Biphasic Insulin Aspart in Patients with Type 2 Diabetes. Clinical Therapeutics, 27, S57-S74.
|||Davidson, J., Vexiau, P., Cucinotta, D., Vaz, J. and Kawamori, R. (2005) Biphasic Insulin Aspart 30: Literature Review of Adverse Events Associated with Treatment. Clinical Therapeutics, 27, S75-S88. http://dx.doi.org/10.1016/j.clinthera.2005.11.022|
|||Davidson, J.A., Liebl, A., Christiansen, J.S., Fulcher, G., Ligthelm, R.J., Brown, P., et al. (2009) 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. Clinical Therapeutics, 31, 1641-1651.
|||Liebl, A., Prusty, V., Valensi, P., Kawamori, R., Christiansen, J.S., Palmer, A.J., Balschmidt, P., Ligthelm, R. and Mohan, V. (2012) Ten Years of Experience with Biphasic Insulin Aspart 30: From Drug Development to the Latest Clinical Findings. Drugs, 72, 1495-1520.
|||Home, P., Naggar, N.E., Khamseh, M., Gonzalez-Galvez, G., Shen, C., Chakkarwar, P., et al. (2011) An Observational Non-Interventional Study of Patients with Diabetes Beginning or Changed to Insulin Analogue Therapy in Non-Western Countries: The A1chieve Study. Diabetes Research and Clinical Practice, 94, 352-363. http://dx.doi.org/10.1016/j.diabres.2011.10.021|
|||Stratton, I.M., Adler, A.I., Neil, H.A., Matthews, D.R., Manley, S.E., Cull, C.A., et al. (2000) Association of Glycaemia with Macrovascular and Microvascular Complications of Type 2 Diabetes (UKPDS 35): Prospective Observational Study. British Medical Journal, 321, 405-412.
|||Abdel-Aal, N.M., Ahmad, A.T., Froelicher, E.S., Batieha, A.M., Hamza, M.M. and Ajlouni, K.M. (2008) Prevalence of Dyslipidemia in Patients with Type 2 Diabetes in Jordan. Saudi Medical Journal, 29, 1423-1428.|
|||Braun, A., Samann, A., Kubiak, T., Zieschang, T., Kloos, C., Müller, U.A., et al. (2008) Effects of Metabolic Control, Patient Education and Initiation of Insulin Therapy on the Quality of Life of Patients with Type 2 Diabetes Mellitus. Patient Counselling and Health Education, 73, 50-59.