课件：糖尿病的胰岛素治疗-补充与替代.ppt

* # - at week 28, before breakfast BG values for glargine were significantly lower than in the NovoMix 20 group (p=0.0124) - at week 28, BG values before lunch, before dinner, after dinner and at bedtime were significantly lower for NovoMix 30 compared with glargine:before lunch, p=0.0002before dinner, p=0.0443after dinner, p0.0001at bedtime, p0.0001 * * 预混胰岛素类似物诺和锐?30与预混人胰岛素30R的区别在于: 诺和锐?30中含有诺和锐?30的是30%的门冬胰岛素和70%的精蛋白结合的结晶门冬胰岛素 预混人胰岛素30R中含有的是30%的可溶性人胰岛素和70%的中效胰岛素(NPH),正是由于它们预混成份的不同使得它们在药代及药效学上有着明显的区别. * * ANA 038 Comparison of the efficacy and safety of NovoMix? 30 and BHI 30 in a twice-daily meal-related regimen, in a mixed population of patients with type 1 and type 2 diabetes. In this 12-week, randomised, open labelled, parallel-group comparison, 294 adult male and female subjects who had been using insulin in a twice-daily regimen were randomised to receive NovoMix? 30, injected within 10 minutes before breakfast and dinner (n = 143), or BHI 30 injected approximately 30 minutes prior to breakfast and dinner (n = 151). Of these, 140 patients were exposed to NovoMix 30, and 151 were expose to BHI 30. Three patients withdrew from the study after randomisation, but before exposure, as it was found that had not been treated with insulin for the required minimum of 2 years. The treatment comparison, which used HbA1c after 12 weeks as the primary efficacy endpoint, was based on a non-inferiority criterion for the difference between the two biphasic insulins All pharmacokinetic and pharmacodynamic endpoints were similarly analysed on the basis of a null hypothesis that there was no difference between treatments. Safety and tolerability of the two regimens was evaluated by measurement of the frequency, severity and timing of hypoglycaemic episodes. * ANA 038 Summary: Blood glucose concentration was significantly lower after breakfast and dinner, before lunch and at bedtime in the NovoMix? 30 group. Analysis of 8-point blood glucose profiles revealed significa