Background: The aim of this study is to compare the efficacy of intensification of insulin treatment with insulin\r\nglargine and biphasic human insulin in patients with type 2 diabetes on concomitant therapy with oral antidiabetic\r\ndrugs (OAD) in daily clinical practice.\r\nMethods: A retrospective multicentre parallel two-arm study included 301 patients with type 2 diabetes already on\r\ntreatment with biphasic human insulin twice daily (bd) in combination with OAD. Data were collected\r\nretrospectively from 142 patients who had been switched from biphasic human insulin to insulin glargine in a\r\nperiod of 6ââ?¬â??12 months prior to their inclusion (active group) and compared to data collected retrospectively from\r\n159 patients who continued treatment with biphasic human insulin bd for the same time period (control group). Our\r\nprimary objective was to examine the efficacy of the two treatments, assessed as change in HbA1c. Secondary objectives\r\nwere to examine for changes in fasting blood glucose (FBG), body weight, treatment with OAD or fast-acting insulin and\r\nsafety, by assessing the frequency and severity of hypoglycaemic episodes.\r\nResults: At the end of the study there was a significant reduction in HbA1c in both arms. The least squares (LS) mean\r\n[(95% confidence intervals (CI)] reduction in HbA1c was -1.13 (-0.96 to -1.30)% in the active and -0.59 (-0.41to -0.77)%\r\nin the control group [LS mean treatment difference 0.53 (0.31-0.76)%, p < 0.001]. Similarly, fasting blood glucose declined\r\nsignificantly in both arms. The LSmean decline in FBG was -47.02 (-37.89 to -56.14) mg/dl in the active and -19.73\r\n(-11.57 to -27.89) mg/dl in the control group [LS mean treatment difference 27.85 (15.74-39.95) mg/dl, p < 0.001]. No\r\nsignificant difference in hypoglycaemic episodes and in body weight was found. In the active group, more patients\r\nreceived rapid-acting pre-meal insulin and used insulin secretagogues drugs.\r\nConclusions: Glargine alone or in combination with fast acting insulin is more effective in reducing glycaemia than\r\nbiphasic human insulin alone or in combination with fast acting insulin in patients with type 2 diabetes without increase\r\nin hypoglycaemic episodes or body weight.
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