Safety and effectiveness of insulin analogues in type 2 diabetic patients from Algeria: a sub-analysis of the A1chieve study
Diabetes Research and Clinical Practice, pages S15 - S26
Published online Aug-2013
To determine the safety and effectiveness of insulin analogues in type 2 diabetes (T2D) patients in the Algerian cohort of the A1chieve study and to examine the status of T2D management across different regions in Algeria.
Patients starting therapy with biphasic insulin aspart 30, insulin detemir, insulin aspart (IAsp) or IAsp + basal insulin at their physicians' decision were included. The primary outcome was the incidence of serious adverse drug reactions (SADRs), including major hypoglycaemia. Secondary outcomes included changes from baseline to Week 24 in hypoglycaemia, glycated haemoglobin A1c (HbA1c), fasting plasma glucose (FPG), postprandial plasma glucose (PPPG), weight and quality of life (QoL, evaluated using the EQ-5D questionnaire).
Overall, 1494 patients (mean±SD age: 60.1±10.3 years; body mass index: 28.1±4.9kg/m2; HbA1c: 9.2±1.8%) were enrolled. Poor baseline glucose control was revealed across the different Algerian regions with mean HbA1c varying from 8.9% to 9.6%. Two SADRs were reported during the study. The proportion of patients reporting major hypoglycaemic events decreased from 1.1% at baseline to 0.2% at Week 24 (p = 0.0017). Significant improvements in mean HbA1c (−1.3±2.0%), FPG (−38.8±79.9 mg/dL) and post-breakfast PPPG (−51.4±97.1 mg/dL) were observed in the entire cohort (all p < 0.001). The mean body weight increased by 0.9±3.8kg, while QoL increased by 9.2±16.7 points after 24 weeks.
Insulin analogue therapy was well-tolerated and significantly improved blood glucose control over 24 weeks in the Algerian cohort.
Keywords: Insulin analogues, Algeria, Type 2 diabetes, Insulin aspart, Insulin detemir.
- 1 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.
- 2 E Ginter, V Simko. Type 2 diabetes mellitus, pandemic in 21st century. Adv Exp Med Biol. 2012;771:42-50
- 3 R Malek, F Belateche, S Laouamri, M Hamdi-Cherif, A Touabti, W Bendib, et al. [Prevalence of type 2 diabetes mellitus and glucose intolerance in the Setif area (Algeria)]. Diabetes Metab. 2001;27(2 Pt 1):164-171
- 4 S Zaoui, C Biémont, K Meguenni. [Epidemiology of diabetes in urban and rural regions of Tlemcen (Western Algeria)]. Sante. 2007;17(1):15-21
- 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 G Nicholson, GM Hall. Diabetes mellitus: new drugs for a new epidemic. Br J Anaesth. 2011;107(1):65-73 Crossref.
- 7 P Valensi, M Benroubi, V Borzi, J Gumprecht, R Kawamori, J Shaban, et al., IMPROVE Study Group Expert Panel. The IMPROVE study–a multinational, observational study in type 2 diabetes: baseline characteristics from eight national cohorts. Int J Clin Pract. 2008;62(11):1809-1819 Crossref.
- 8 LN McEwen, D Bilik, SL Johnson, JB Halter, AJ Karter, CM Mangione, et al. Predictors and impact of intensification of antihyperglycemic therapy in type 2 diabetes. Diabetes Care. 2009;32(6):971-976 Crossref.
- 9 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 Crossref.
- 10 K Khunti, S Caputo, T Damci, GJ Dzida, Q Ji, M Kaiser, et al., on behalf of the SOLVE Study Group. The safety and efficacy of adding once-daily insulin detemir to oral hypoglycaemic agents in patients with type 2 diabetes in a clinical practice setting in 10 countries. Diabetes Obes Metab. 2012;14(12):1129-1136 Crossref.
- 11 K Hermansen, M Davies, T Derezinski, G Martinez Ravn, P Clausen, P Home. A 26-week, randomized, parallel, treat-to-target trial comparing insulin detemir with NPH insulin as add-on therapy to oral glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetes Care. 2006;29(6):1269-1274 Crossref.
- 12 TM Chapman, S Noble, KL Goa. Spotlight on insulin aspart in type 1 and 2 diabetes mellitus. Treat Endocrinol. 2003;2(1):71-76 Crossref.
- 13 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.
- 14 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
- 15 SG Swinnen, MP Dain, D Mauricio, JH DeVries, JB Hoekstra, F Holleman. Continuation versus discontinuation of insulin secretagogues when initiating insulin in type 2 diabetes. Diabetes Obes Metab. 2010;12(10):923-925 Crossref.
- 16 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. Diabetes Res Clin Pract. 2011;94(3):364-370 Abstract, Full-text, PDF, Crossref.
- 17 AM Jacobson. Impact of improved glycemic control on quality of life in patients with diabetes. Endocr Pract. 2004;10(6):502-508 Crossref.
- 18 S Barendse, H Singh, BM Frier, J Speight. The impact of hypoglycaemia on quality of life and related patient-reported outcomes in type 2 diabetes: a narrative review. Diabet Med. 2012;29(3):293-302 Crossref.
a Internal Medicine Department, Saâdna University Hospital, Setif, Algeria Internal Medicine Department, Saâdna University Hospital, Setif, Algeria
b Diabetology Endocrinology Department, Nedir University Hospital, Tizi Ouzou, Algeria Diabetology Endocrinology Department, Nedir University Hospital, Tizi Ouzou, Algeria
c Medical Department, Novo Nordisk, Algeria Medical Department, Novo Nordisk, Algeria
d Internal Medicine Department, EHU Oran, Algeria Internal Medicine Department, EHU Oran, Algeria
Corresponding author at: Internal Medicine Department, Saâdna University Hospital, Setif, Algeria. Tel.: +213661352067
© 2013 Published by Elsevier B.V.