Hai Al Jamea Hospital, Jeddah, Jeddah 21433, The Kingdom of Saudi Arabia.
Diabetes Res Clin Pract. 2012 Dec;98(3):408-13. doi: 10.1016/j.diabres.2012.09.043.
This A1chieve® study subgroup analysis examined clinical safety and effectiveness of biphasic insulin aspart 30 (BIAsp30) ±OGLDs in 6323 individuals with T2D, switching from biphasic human insulin 30 (BHI30) ±OGLDs.
A1chieve was a 24-week, international, prospective, observational, multi-centre, open-label study in individuals with T2D starting treatment with BIAsp30, insulin detemir or insulin aspart as part of routine clinical care.
Mean baseline (SD) dose BHI was 0.56 (0.25) IU/kg. BIAsp30 was initiated at 0.57 (0.25) U/kg; the daily dose was 0.62 (0.28)U/kg by Week 24. Switching from BHI30 to BIAsp30 was associated with significant mean reduction in HbA1c of 1.7% [-18 mmol/mol] (1.6) from a baseline of 9.1% [76 mmol/mol] (p<0.001); FPG and PPG were also significantly reduced (p<0.001). Major hypoglycaemic episodes decreased from 0.69 events/patient/year at baseline to 0.03 events/patient/year at Week 24. Minor hypoglycaemia decreased from 5.31 to 2.04 events/patient/year from baseline to study-end. Five serious adverse drug reactions (hypoglycaemia) were reported by five individuals (0.1%). Mean bodyweight increased by 0.1 (3.3)kg from baseline to 24 weeks. Improved self-reported quality of life was observed.
Switching from BHI30 to BIAsp30 in individuals with T2D is associated with improvement in glycaemic control and reduced rates of hypoglycaemia, without tolerability or safety issues.
这项 A1chieve®研究亚组分析检查了在 6323 名 2 型糖尿病患者中,从双相人胰岛素 30(BHI30)±OGLD 转换为双相门冬胰岛素 30(BIAsp30)±OGLD 的临床安全性和有效性。
A1chieve 是一项为期 24 周的国际性、前瞻性、观察性、多中心、开放标签研究,纳入了开始接受 BIAsp30、地特胰岛素或门冬胰岛素治疗的 2 型糖尿病患者,这些治疗是常规临床护理的一部分。
平均基线(SD)剂量 BHI 为 0.56(0.25)IU/kg。起始剂量为 0.57(0.25)U/kg;第 24 周时,每日剂量为 0.62(0.28)U/kg。从 BHI30 转换为 BIAsp30 与 HbA1c 显著降低 1.7%[-18mmol/mol](1.6)相关,基线值为 9.1%[76mmol/mol](p<0.001);空腹血糖和餐后血糖也显著降低(p<0.001)。主要低血糖事件从基线时的 0.69 次/患者/年降至第 24 周时的 0.03 次/患者/年。轻度低血糖从基线时的 5.31 次/患者/年降至研究结束时的 2.04 次/患者/年。5 名患者(0.1%)报告了 5 例严重药物不良反应(低血糖)。从基线到 24 周,平均体重增加 0.1(3.3)kg。观察到自我报告的生活质量改善。
在 2 型糖尿病患者中,从 BHI30 转换为 BIAsp30 可改善血糖控制,降低低血糖发生率,且无耐受性或安全性问题。