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The aim of the present randomized study was to compare efficacy and safety of an intermediate-acting basal analogue insulin, insulin lispro (Humulin R) with NPH in type 2 diabetes. For the 12-week study, 310 patients were enrolled. The patients were randomized to receive either insulin lispro or NPH insulin in a ratio of 1:1 in a dose-dependent manner. The primary efficacy variable was glycosylated haemoglobin (HbA1c). The secondary efficacy variables were fasting blood glucose (FBG) and postprandial blood glucose (PPG) at weeks 0, 4 and 8. Safety was assessed by means of monitoring and recording of adverse events. At week 12, the patients on insulin lispro showed a significant decrease in HbA1c (9.0 +/- 1.1 to 7.6 +/- 1.1%, P = 0.00) and FBG (10.7 +/- 2.6 to 8.3 +/- 2.5 mmol/l, P = 0.00) and in PPG (15.6 +/- 4.4 to 12.5 +/- 3.8 mmol/l, P = 0.00). However, there was no significant difference between the groups in HbA1c and FBG or PPG at weeks 0, 4 and 8. NPH insulin group showed a significant decrease in FBG (12.1 +/- 3.0 to 8.8 +/- 2.9 mmol/l, P = 0.00) and PPG (18.7 +/- 4.5 to 13.6 +/- 4.3 mmol/l, P = 0.00) at week 8, but did not differ significantly from the patients on l 0b46394aab
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