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采用固定的基于体重剂量的门冬胰岛素治疗新诊断2型糖尿病患者的餐后高血糖

Targeting postprandial hyperglycaemia in patients with recently diagnosed type 2 diabetes with a fixed, weight-based dose of insulin Aspart.

作者信息

Gredal Charlotte, Rosenfalck Anne Mette, Dejgaard Anders, Hilsted Jannik

机构信息

Department of Internal Medicine and Clinical Pharmacology, Gentofte University Hospital, Hellerup, Denmark.

出版信息

Scand J Clin Lab Invest. 2008;68(8):739-44. doi: 10.1080/00365510802207982.

Abstract

OBJECTIVE

To assess the effect of substitution of early insulin release with a small weight-based dose of the rapid acting insulin analogue, insulin Aspart (IAsp), on postprandial hyperglycaemia in patients with recently diagnosed type 2 diabetes.

MATERIAL AND METHODS

In a randomized, double-blind, double-dummy design, 20 patients underwent three 3-day periods with injection of IAsp 0.06 IU/kg BW or placebo 30 min before main meals. The effect on blood glucose fluctuations was evaluated using a continuous glucose monitoring system. Efficacy endpoints were time with glucose values above 8 mmol/L and glucose area above 8 mmol/L; safety endpoint was time with glucose values below 4 mmol/L in the last 24 h in the treatment periods.

RESULTS

IAsp significantly reduced the duration of blood glucose values above 8 mmol/L compared with placebo during 24 h (8.1+/-1.4 h versus 12.7+/-1.3 h), (p<0.03). Glucose areas above 8 mmol/L were 0.6+/-0.2 mmol/lxh and 1.2+/-0.2 mmol/lxh for IAsp and placebo, respectively (p<0.001). Two patients (one in each of the IAsp and placebo periods) had two asymptomatic episodes of glucose registration below 4 mmol/L. Patients with HbA(1c) below 7.4 % obtained the greatest reduction in duration of blood glucose values above 8 mmol/L, whereas the decrease in blood glucose increments for patients with HbA(1c) above 7.4 % was not significantly different from placebo.

CONCLUSIONS

A fixed dose of IAsp injected 30 min before mealtimes reduced the postprandial glucose increment in patients with recently diagnosed type 2 diabetes without the risk of hypoglycaemia. Glucose fluctuations in patients with HbA(1c) below 7.4 % improved to near normal level.

摘要

目的

评估以小剂量基于体重的速效胰岛素类似物门冬胰岛素(IAsp)替代早期胰岛素释放对近期诊断的2型糖尿病患者餐后高血糖的影响。

材料与方法

采用随机、双盲、双模拟设计,20例患者在3个为期3天的时间段内,于主餐前30分钟注射0.06 IU/kg体重的IAsp或安慰剂。使用连续血糖监测系统评估对血糖波动的影响。疗效终点为血糖值高于8 mmol/L的时间和血糖高于8 mmol/L的面积;安全终点为治疗期最后24小时血糖值低于4 mmol/L的时间。

结果

与安慰剂相比,IAsp在24小时内显著缩短了血糖值高于8 mmol/L的持续时间(8.1±1.4小时对12.7±1.3小时),(p<0.03)。IAsp和安慰剂的血糖高于8 mmol/L的面积分别为0.6±0.2 mmol/lxh和1.2±0.2 mmol/lxh(p<0.001)。两名患者(IAsp期和安慰剂期各1例)出现两次无症状血糖记录低于4 mmol/L的情况。糖化血红蛋白(HbA1c)低于7.4%的患者血糖值高于8 mmol/L的持续时间缩短最多,而HbA1c高于7.4%的患者血糖增量的降低与安慰剂无显著差异。

结论

餐前三十分注射固定剂量的IAsp可降低近期诊断的2型糖尿病患者的餐后血糖增量,且无低血糖风险。HbA1c低于7.4%的患者血糖波动改善至接近正常水平。

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