添加赖脯胰岛素鱼精蛋白混悬液或甘精胰岛素到口服 2 型糖尿病治疗方案中：一项随机试验。

Addition of insulin lispro protamine suspension or insulin glargine to oral type 2 diabetes regimens: a randomized trial.

机构信息

Department of Internal Diseases, Diabetology and Nephrology, Silesian Medical University, Zabrze, Poland.

出版信息

Diabetes Obes Metab. 2010 Oct;12(10):916-22. doi: 10.1111/j.1463-1326.2010.01257.x.

DOI:10.1111/j.1463-1326.2010.01257.x

PMID:20920045

Abstract

AIMS

The addition of basal insulin to existing oral therapy can help patients with type 2 diabetes (T2D) achieve glycaemic targets. This study compares the efficacy and safety of insulin lispro protamine suspension (ILPS) and insulin glargine in insulin-naive patients with T2D and inadequate control on oral antihyperglycaemic medication (OAM).

MATERIALS AND METHODS

An open-label, randomized, multicentre, multinational 24-week study of 471 patients receiving ≥2 OAMs for ≥3 months with a body mass index between 25 and 45 kg/m(2) and HbA1c 7.5-10.0% was conducted. ILPS was injected once or twice daily vs. glargine injected once daily plus prestudy OAMs. Primary objective compared the HbA1c change from baseline.

RESULTS

HbA1c change from baseline to endpoint was similar in both groups [-1.46% (ILPS) and -1.41% (glargine)]. Least-squares mean difference (95% CI) for HbA1c (-0.05 [-0.21, 0.11]%), glycaemic variability (0.06 [-0.06, 0.19] mmol/l) and weight change (-0.01 [-0.61, 0.59] kg) showed non-inferiority (margins of 0.4%, 0.8 mmol/l and 1.5 kg, respectively). Percentages of patients achieving HbA1c <7.0% were 43.8% ILPS and 41.2% glargine. Mean daily insulin dose was 0.39 vs. 0.35 U/kg (p = 0.02) and weight gain was 1.04 vs. 1.07 kg for ILPS vs. glargine (p = 0.98). Overall hypoglycaemia (episodes/patient/year) was similar for ILPS and glargine (24.2 ± 28.8 vs. 23.0 ± 30.9); nocturnal (6.1 ± 10.6 vs. 4.1 ± 9.4, p < 0.001) rates were higher for ILPS. Severe hypoglycaemia was higher for ILPS vs. glargine (n = 9 vs. n = 2; p = 0.04).

CONCLUSIONS

At endpoint, ILPS was non-inferior to glargine in HbA1c change from baseline, but associated with increased risk of hypoglycaemia.

摘要

目的

在现有的口服治疗基础上加用基础胰岛素有助于 2 型糖尿病（T2D）患者达到血糖目标。本研究比较了胰岛素赖脯胰岛素混悬液（ILPS）和甘精胰岛素在接受≥2 种口服降糖药（OAM）治疗≥3 个月且 BMI 在 25-45kg/m²和 HbA1c 为 7.5-10.0%的胰岛素初治 T2D 患者中的疗效和安全性。

材料和方法

这是一项开放标签、随机、多中心、多国 24 周研究，共纳入 471 例接受≥2 种 OAM 治疗≥3 个月且 BMI 在 25-45kg/m²和 HbA1c 为 7.5-10.0%的患者。ILPS 每日 1 次或 2 次注射，甘精胰岛素每日 1 次注射联合研究前 OAM。主要终点比较基线时 HbA1c 的变化。

结果

两组 HbA1c 自基线至终点的变化相似[-1.46%（ILPS）和-1.41%（甘精胰岛素）]。HbA1c 的最小二乘均值差值（95%CI）（0.05[-0.21，0.11]%）、血糖变异性（0.06[-0.06，0.19]mmol/L）和体重变化（-0.01[-0.61，0.59]kg）显示非劣效性（分别为 0.4%、0.8mmol/L 和 1.5kg）。HbA1c<7.0%的患者比例分别为 43.8%的 ILPS 和 41.2%的甘精胰岛素。ILPS 和甘精胰岛素的平均每日胰岛素剂量分别为 0.39 和 0.35 U/kg（p=0.02），体重增加分别为 1.04 和 1.07kg（p=0.98）。ILPS 和甘精胰岛素的总体低血糖（发作/患者/年）相似（24.2±28.8 比 23.0±30.9）；夜间（6.1±10.6 比 4.1±9.4，p<0.001）低血糖发生率更高ILPS。ILPS 组低血糖发生率高于甘精胰岛素组（n=9 比 n=2；p=0.04）。