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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

Aims Evaluate the safety and efficacy of once‐daily insulin detemir initiated in routine clinical practice in patients with type 2 diabetes mellitus inadequately controlled with oral hypoglycaemic agents (OHAs). Methods This large observational study was conducted in 10 countries. Adverse event data...

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Published in:Diabetes, obesity & metabolism obesity & metabolism, 2012-12, Vol.14 (12), p.1129-1136
Main Authors: Khunti, K., Caputo, S., Damci, T., Dzida, G. J., Ji, Q., Kaiser, M., Karnieli, E., Liebl, A., Ligthelm, R. J., Nazeri, A., Orozco-Beltran, D., Pan, C., Ross, S. A., Svendsen, A. L., Vora, J., Yale, J.-F., Meneghini, L. F.
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Language:English
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Summary:Aims Evaluate the safety and efficacy of once‐daily insulin detemir initiated in routine clinical practice in patients with type 2 diabetes mellitus inadequately controlled with oral hypoglycaemic agents (OHAs). Methods This large observational study was conducted in 10 countries. Adverse event data (including hypoglycaemia) and glycaemic control were recorded before and 24 weeks following insulin initiation while patients continued routine clinical management. Results In this study, 17 374 patients (53% male) were included. Mean pre‐insulin values (±s.d.) were: age 62 ± 12 years; body mass index (BMI) 29.3 ± 5.4 kg/m2; diabetes duration 10 ± 7 years; haemoglobin A1c (HbA1c) 8.9 ± 1.6%. During the study, 27 patients experienced serious adverse drug reaction, severe hypoglycaemic events or both; and there were 31 episodes of severe hypoglycaemia in 21 patients. After 24 weeks, HbA1c was 7.5 ± 1.2% (change of −1.3%; p 
ISSN:1462-8902
1463-1326
DOI:10.1111/j.1463-1326.2012.01665.x