University of the Philippines College of Medicine, Manila, Philippines.
Diabetes Res Clin Pract. 2013 Apr;100 Suppl 1:S35-40. doi: 10.1016/S0168-8227(13)70008-1.
To evaluate the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in Filipino patients with type 2 diabetes previously treated with biphasic human insulin 30 (BHI 30).
Safety and effectiveness outcomes were measured in all patients switching from BHI 30 to BIAsp 30 in the Filipino cohort of the 24-week, multinational, prospective, non-interventional A₁chieve study.
A total of 111 Filipino patients (mean age ± SD, 57.4 ± 12.8 years; BMI, 25.8 ± 5.6 kg/m(2)) with mean diabetes duration of 9.9 ± 7.1 years switched therapy from BHI 30 to BIAsp 30. The mean pre-study BHI 30 dose was 0.65 ± 0.28 IU/kg and the baseline BIAsp 30 dose was 0.65 ± 0.26 U/kg titrated up to 0.70 ± 0.26 U/kg by Week 24. No serious adverse drug reactions were reported. Overall hypoglycaemia was reduced from 5.62 to 1.98 events/patient-year. Minor and nocturnal hypoglycaemia decreased and no major hypoglycaemia was reported at Week 24. Glucose control improved from baseline to Week 24 (HbA1c, -2.2 ± 2.1% [24 ± 23 mmol/mol]; FPG, -72.0 ± 71.8 mg/dL; PPPG, -145.5 ± 125.4 mg/dL). A total of 24 patients achieved HbA1c levels <7.0% at Week 24 compared to 6 patients reporting this target at baseline. Quality of life was positively impacted at Week 24 (change in visual analogue scores, 15.3 ± 16.9 points).
Switching from BHI 30 to BIAsp 30 improved glycaemic control without increasing the risk of hypoglycaemia.
评估在先前接受过双时相人胰岛素 30 治疗的菲律宾 2 型糖尿病患者中,使用双时相门冬胰岛素 30(BIAsp 30)的安全性和有效性。
在多国、前瞻性、非干预性 A₁chieve 研究的菲律宾队列中,所有从 BHI 30 转换为 BIAsp 30 的患者均测量了安全性和有效性结局。
共有 111 名菲律宾患者(平均年龄±标准差,57.4±12.8 岁;BMI,25.8±5.6kg/m²),糖尿病病程平均为 9.9±7.1 年,将治疗方案从 BHI 30 转换为 BIAsp 30。研究前 BHI 30 的平均剂量为 0.65±0.28IU/kg,基线 BIAsp 30 剂量为 0.65±0.26U/kg,到第 24 周时滴定至 0.70±0.26U/kg。未报告严重药物不良反应。总体低血糖事件从 5.62 次/患者年减少至 1.98 次/患者年。轻度和夜间低血糖减少,第 24 周时未报告重度低血糖。从基线到第 24 周,血糖控制得到改善(HbA1c,-2.2±2.1%[24±23mmol/mol];FPG,-72.0±71.8mg/dL;PPPG,-145.5±125.4mg/dL)。与基线时报告该目标的 6 例患者相比,第 24 周时有 24 例患者达到 HbA1c<7.0%。第 24 周时生活质量得到了积极的影响(视觉模拟评分变化,15.3±16.9 分)。
从 BHI 30 转换为 BIAsp 30 改善了血糖控制,而不会增加低血糖的风险。