Raslová K, Bogoev M, Raz I, Leth G, Gall M-A, Hâncu N
Metabolic Center, Institute of Preventive and Clinical Medicine, Limbova 14, 833 01 Bratislava, Slovak Republic.
Diabetes Res Clin Pract. 2004 Nov;66(2):193-201. doi: 10.1016/j.diabres.2004.03.003.
This trial compared the efficacy and safety of basal-bolus therapy using either the soluble basal insulin analogue insulin detemir (IDet) in combination with meal-time rapid-acting analogue insulin aspart (IAsp), or NPH insulin (NPH) in combination with meal-time regular human insulin (HSI). This was a 22-week, multinational, open-labelled, symmetrically randomised, parallel group trial including 395 people with type 2 diabetes (IDet + IAsp: 195, NPH + HSI: 200). At 22 weeks, HbA1c was comparable between treatments (IDet + IAsp: 7.46%, NPH + HSI: 7.52%, P = 0.515) with decreases from baseline of 0.65% and 0.58%, respectively. Treatment with IDet + IAsp was associated with a significantly lower within-person variation in self-measured fasting plasma glucose (FPG) (SD:1.20 versus 1.54 mmol/L, p < 0.001), as well as a lower body weight gain (0.51 versus 1.13 kg, p = 0.038) than with NPH + HSI. The risk of nocturnal hypoglycaemia was 38% lower with IDet + IAsp than with NPH + HSI, but statistical significance was not attained (P = 0.14). The overall safety profile was similar between the two treatments. Basal-bolus treatment with IDet + IAsp is an effective and well tolerated insulin regimen in people with type 2 diabetes, resulting in glycaemic control comparable to that of NPH + HSI, but with the advantages of less weight gain and a lower day-to-day within-person variation in FPG.
本试验比较了基础-餐时胰岛素治疗方案的疗效和安全性，一种方案是使用可溶性基础胰岛素类似物地特胰岛素（IDet）联合餐时速效胰岛素类似物门冬胰岛素（IAsp），另一种方案是使用中性鱼精蛋白锌胰岛素（NPH）联合餐时常规人胰岛素（HSI）。这是一项为期22周的多国、开放标签、对称随机、平行组试验，纳入了395例2型糖尿病患者（IDet + IAsp组：195例，NPH + HSI组：200例）。在22周时，各治疗组间糖化血红蛋白（HbA1c）水平相当（IDet + IAsp组：7.46%，NPH + HSI组：7.52%，P = 0.515），分别较基线水平下降了0.65%和0.58%。与NPH + HSI组相比，IDet + IAsp组患者自我测量的空腹血糖（FPG）的个体内变异显著更低（标准差：1.20 vs 1.54 mmol/L，p < 0.001），体重增加也更少（0.51 vs 1.13 kg，p = 0.038）。IDet + IAsp组夜间低血糖风险比NPH + HSI组低38%，但未达到统计学显著性（P = 0.14）。两种治疗的总体安全性相似。对于2型糖尿病患者，IDet + IAsp基础-餐时胰岛素治疗方案是一种有效且耐受性良好的胰岛素治疗方案，血糖控制效果与NPH + HSI方案相当，但具有体重增加较少和FPG个体内日常变异较低的优点。
