Endocrinology & Metabolism Department, CHU Constantine, Algeria.
Diabetes Res Clin Pract. 2013 Aug;101 Suppl 1:S37-44. doi: 10.1016/S0168-8227(13)70017-2.
To determine the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in Algerian patients with type 2 diabetes initiating insulin or switching from prior insulin therapy.
Insulin-naive and insulin-experienced patients, including prior basal insulin users, starting BIAsp 30 were evaluated in this sub-analysis of the 24-week, open-label, non-interventional A₁chieve study. Clinical safety and effectiveness was evaluated as a part of routine clinical care.
A total of 134 insulin-naive patients initiating BIAsp 30 at a mean dose of 0.44 ± 0.23 U/kg and 283 insulin-experienced patients, including 129 prior basal insulin users, switching from a mean pre-study insulin dose of 0.51 ± 0.23 U/kg to BIAsp 30 (0.54 ± 0.20 U/kg) were evaluated. At Week 24, the average BIAsp 30 dose was 0.60 ± 0.25 U/kg and 0.66 ± 0.24 U/kg in insulin-naive and insulin-experienced patients, respectively. No serious adverse drug reactions were reported. From baseline to Week 24, the proportion of patients experiencing overall hypoglycaemia increased in the insulin-naive group (p = 0.0067) and no significant changes were reported in the insulin-experienced group including prior basal insulin users. Glucose control improved significantly in the insulin-experienced group (p < 0.001) and appeared to improve in the insulin-naive patients and prior basal insulin users as well. Body weight increased significantly in all patients (p < 0.001). Quality of life was positively impacted after 24 weeks of BIAsp 30 therapy.
Initiating or switching to BIAsp 30 therapy in this Algerian cohort was well-tolerated and significantly improved glucose control.
评估在 24 周、开放标签、非干预性 A₁chieve 研究的亚组分析中，双相门冬胰岛素 30（BIAsp 30）在起始胰岛素或从先前胰岛素治疗转换的阿尔及利亚 2 型糖尿病患者中的安全性和有效性。
评估起始 BIAsp 30 的胰岛素初治患者和胰岛素经验患者（包括先前基础胰岛素使用者），这是 24 周、开放标签、非干预性 A₁chieve 研究的亚组分析。临床安全性和有效性是作为常规临床护理的一部分进行评估的。
共评估了 134 例胰岛素初治患者，起始 BIAsp 30 的平均剂量为 0.44 ± 0.23 U/kg，283 例胰岛素经验患者（包括 129 例先前基础胰岛素使用者）从平均预研究胰岛素剂量 0.51 ± 0.23 U/kg转换为 BIAsp 30（0.54 ± 0.20 U/kg）。在第 24 周时，胰岛素初治和胰岛素经验患者的平均 BIAsp 30 剂量分别为 0.60 ± 0.25 U/kg和 0.66 ± 0.24 U/kg。未报告严重药物不良反应。从基线到第 24 周，胰岛素初治组患者总体低血糖的比例增加（p = 0.0067），而胰岛素经验组（包括先前基础胰岛素使用者）未报告显著变化。胰岛素经验组患者的血糖控制显著改善（p < 0.001），且胰岛素初治患者和先前基础胰岛素使用者的血糖控制似乎也有所改善。所有患者的体重均显著增加（p < 0.001）。在接受 24 周 BIAsp 30 治疗后，生活质量得到了积极的影响。
在阿尔及利亚队列中起始或转换为 BIAsp 30 治疗是耐受良好的，显著改善了血糖控制。
