Bebakar W M W, Chow C C, Kadir K A, Suwanwalaikorn S, Vaz J A, Bech O M
Department of Medicine, Hospital Universiti Sains Malaysia, Kelantan, Malaysia.
Diabetes Obes Metab. 2007 Sep;9(5):724-32. doi: 10.1111/j.1463-1326.2007.00743.x. Epub 2007 Jun 26.
To evaluate the efficacy and safety of adding biphasic insulin aspart 30 (BIAsp30; NovoMix 30) to existing oral antidiabetic agents (OADs) vs. optimizing OADs in a subgroup of Western Pacific patients with type 2 diabetes inadequately controlled on oral monotherapy or oral combination therapy.
This 26-week, multi-centre, open-labelled, randomized, two-arm parallel trial consisted of a 2-week screening period, followed by 24 weeks of treatment. Subjects randomized to BIAsp30 treatment (n = 129) received BIAsp30 once daily (o.d.) at dinnertime between Week 2 and Week 14, and those not reaching treatment targets were switched to twice daily (b.i.d.) BIAsp30 at Week 14 (n = 50). Subjects randomized to the OAD-only arm (n = 63) continued with their previous OAD treatment and, in an attempt to reach treatment goals, the dose was optimized (but OAD unchanged) in accordance to local treatment practice and labelling.
Significantly greater reductions in HbA(1c) over Weeks 0-13 with BIAsp30 (o.d.) vs. OAD-only treatment (1.16 vs. 0.58%; p < 0.001), and over Weeks 0-26, with BIAsp30 (o.d.) and BIAsp30 (b.i.d.) treatments vs. OAD-only treatment (1.24 vs. 1.34 vs. 0.67%; p < 0.01). Hypoglycaemic episodes were reported in 54% of the patients in BIAsp30 (o.d. and b.i.d. pooled) and 30% of the patients in OAD-only group. All episodes were minor or symptomatic, except for one in each treatment group, which was major.
Initiating BIAsp30 treatment is a safe and more effective way to improve glycaemic control in Western Pacific patients with type 2 diabetes inadequately controlled with oral monotherapy or oral combination therapy compared with optimizing oral combination therapy alone. In patients not reaching treatment target on BIAsp30 (o.d.), treatment with BIAsp30 (b.i.d.) should be considered.
评估在西太平洋地区口服单药治疗或口服联合治疗血糖控制不佳的2型糖尿病患者亚组中，在现有口服抗糖尿病药物（OAD）基础上加用双相门冬胰岛素30（BIAsp30；诺和锐30）与优化OAD的疗效和安全性。
这项为期26周的多中心、开放标签、随机、双臂平行试验包括2周的筛查期，随后是24周的治疗期。随机接受BIAsp30治疗的受试者（n = 129）在第2周和第14周晚餐时每日一次（o.d.）接受BIAsp30治疗，未达到治疗目标的受试者在第14周改为每日两次（b.i.d.）BIAsp30治疗（n = 50）。随机分配到仅接受OAD治疗组的受试者（n = 63）继续接受之前的OAD治疗，并根据当地治疗实践和标签尝试优化剂量（但OAD不变）以达到治疗目标。
在第0 - 13周，与仅接受OAD治疗相比，BIAsp30（o.d.）治疗组的糖化血红蛋白（HbA(1c)）显著降低更多（1.16%对0.58%；p < 0.001）；在第0 - 26周，与仅接受OAD治疗相比，BIAsp30（o.d.）和BIAsp30（b.i.d.）治疗组的HbA(1c)降低更多（1.24%对1.34%对0.67%；p < 0.01）。BIAsp30治疗组（o.d.和b.i.d.合并）54%的患者报告有低血糖事件，仅接受OAD治疗组为30%。除每个治疗组各有1例严重低血糖事件外，所有事件均为轻度或有症状的。
与单独优化口服联合治疗相比，对于西太平洋地区口服单药治疗或口服联合治疗血糖控制不佳的2型糖尿病患者，起始BIAsp30治疗是改善血糖控制的一种安全且更有效的方法。对于接受BIAsp30（o.d.）治疗未达到治疗目标的患者，应考虑改为BIAsp30（b.i.d.）治疗。
