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• W2798494090 abstract "To the Editor: In his letter to Diabetologia [1], P. D. Home highlights the difficulties of achieving optimal glycaemic control with insulins. While good glycaemic control was achievedwith insulin (endpoint HbA1c about 7.0% on average) in the several recently published trials identified by Home [1], other trials have reported less than optimal results, particularly for insulin mixtures [2, 3]. Subjects in the treat-to-target trial conducted by Janka et al. [3] achieved a mean endpoint HbA1c of 7.49% with human NPH insulin 70/30. Subjects treated with biphasic insulin aspart 30 in the study conducted by Boehm et al. [2] achieved a mean HbA1c of 8.15% at endpoint. Incidentally, this study [2] was used as a reference when designing our non-inferiority study [4]. Most of the treat-to-target trials demonstrate that it is possible to achieve substantial improvements in glycaemic control when insulin titration algorithms are strictly enforced and exceptional follow-up efforts (often weekly patient contacts) are made in a clinical trial setting. But when very similar approaches are used, some trials (even when conducted by the same sponsor) still achieve quite different results. For example, Rosenstock et al. [5] observed an endpoint HbA1c of 7.8% in a meta-analysis of glargine trials, whereas an endpoint HbA1c of 7.0% was reported in the treat-to-target trial performed by Riddle et al. [6]. How variation observed in clinical research reflects variation in clinical practice remains to be seen. The endpoint insulin dose of 24 IU/day reported in our current non-inferiority study [4] is lower than would be expected with a forced titration schedule. As outlined in the article, a forced titration schedule was not used [4]; rather, investigators were instructed to use fasting and postprandial glycaemic targets as a guide while seeking to achieve an optimal balance between glycaemic control and risk of hypoglycaemia as dictated by best clinical practice. It is not entirely clear why the physicians, who had to decide on these issues according to the perceived best interest of their patients, did not suggest higher insulin doses. Our data do not allow a more detailed analysis of potential reasons. We cannot fully exclude the possibility that study physicians interested in performing this trial were biased towards avoiding hypoglycaemia rather than achieving optimal glycaemic control (as exenatide might have been presumed to have an advantage over insulin treatment in this respect). We also cannot entirely exclude the possibility that there was Diabetologia (2007) 50:1563–1564 DOI 10.1007/s00125-007-0680-6" @default.
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• W2798494090 date "2007-04-21" @default.
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• W2798494090 title "Response to comment on: Nauck MA, Duran S, Kim D et al (2007) A comparison of twice-daily exenatide and biphasic insulin aspart in patients with type 2 diabetes who were suboptimally controlled with sulfonylurea and metformin: a non-inferiority study. Diabetologia 50:259–267" @default.
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• W2798494090 doi "https://doi.org/10.1007/s00125-007-0680-6" @default.
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