BackgroundThe aim of this study is to compare the efficacy and safety of once-daily insulin glargine plus gliclazide modified release combination therapy versus twice-daily premixed insulin monotherapy in Chinese type 2 diabetic patients insufficiently controlled by oral antidiabetic agents. MethodsIn a 12-week, multicenter, randomized, parallel-group clinical trial, patients with poor glycaemic control (fasting plasma glucose7.0mmol/L and 7.5%<haemoglobin A(1c)10%) on oral antidiabetic drugs were randomized to the treatment groups for combination therapy (n=52) or monotherapy (n=53). Continuous glucose monitoring was carried out over two 72-h periods, at the beginning and the end of the study, and the data were used to calculate the 24-h mean blood glucose, mean amplitude of glycaemic excursions, standard deviation of blood glucose, and the mean of daily differences. ResultsThe mean haemoglobin A(1c) decrease from baseline to study end was significant for both treatment groups (combination therapy: -1.230.92%; insulin monotherapy: -1.02 +/- 1.04%); moreover, the combination therapy group showed a significantly more robust haemoglobin A(1c) decrease (p=0.0308). Both therapies significantly reduced the 24-h mean blood glucose (both, p<0.001), but neither produced a significant effect on glycaemic variability, calculated as mean amplitude of glycaemic excursions, standard deviation of blood glucose, and mean of daily differences. In addition, the effects on rates of hypoglycaemic episodes were similar between the two therapies. ConclusionsChinese patients with type 2 diabetes inadequately controlled with oral antidiabetic agents attained greater benefit from once-daily insulin glargine plus gliclazide modified release regimen than from a twice-daily premixed insulin regimen. Copyright (c) 2015 John Wiley & Sons, Ltd.