每日一次地特胰岛素治疗后空腹血糖达标患者的临床特征分析:SOLVE^(TM)研究中国数据

Clinical characteristics of Chinese patients with type 2 diabetes mellitus who achieved fasting plasma glucose target after 24 weeks treatment of once-daily insulin Detemir:Data from SOLVE^(TM)

目的分析口服降糖药物(OADs)治疗失效的T2DM患者起始加用每日一次地特胰岛素治疗后FPG达标人群的临床特征。方法 SOLVE^(TM)是一项为期24周、多国、开放、非随机的观察性研究,本分析基于SOLVE^(TM)的中国数据,分为FPG达标组(<7.0 mmol/L)和FPG未达标组(≥7.0 mmol/L),比较两组基线特征及加用每日一次地特胰岛素治疗24周后的有效性和安全性指标。结果 FPG达标组(n=1794)和FPG未达标组(n=1073)平均年龄和性别比例相似;FPG达标组糖尿病病程较短,基线时HbA_1c和FPG水平较低,且使用两种以上OADs的患者比例较低。治疗24周后,两组均无重度低血糖发生,轻度低血糖发生率和夜间轻度低血糖发生率相似;与FPG未达标组比较,FPG达标组胰岛素剂量和BMI均较低。结论 OADs治疗失效,且FPG未达标的T2DM患者及时起始每日一次地特胰岛素治疗有助于实现血糖控制达标。

Objective To investigate clinical characteristics of Chinese patients with type 2 diabetes mellitus（T2DM） inadequately controlled with oral anti-diabetic drugs（OAD） who achieved fasting plasma glucose（FPG） target after once-daily insulin detemir in combination with the pre-trial OADs.Methods SOLVE？ was a 24 weeks,multi-national,open-label,non-randomized,observational study.This study compared the baseline characteristics of Chinese patients from SOLVE？ who were divided into two groups based on FPG level（7.0 mmol/L） after 24 weeks treatmentwith insulin detemir once-daily,and the efficacy safety parameters were presented.Results Patients with FPG reaching target（n = 1073） and those with FPG not reaching target（n = 1794） were comparable in age and sex ratio.At baseline,compared to those not reaching FPG target,patients who reached FPG target had significantly shorter diabetes duration[（6.72±5.11） vs（7.65±5.32） year,P〈0.001）],lower HbA_1c[（8.13±l.67）%vs（8.66±1.66）%,P〈0.001）],lower FPG levels[（9.10±2.42） vs（10.24±2.70） mmol/L,P〈0.001）]and lower percentage of patients were using more than two kinds of OADs（8.7%vs 11.9%,P〈0.05）.No major hypoglycaemia occurred and the incidence of minor hypoglycaemia or nocturnal minor hypoglycaemia was similar in the two groups.After 24 weeks of insulin detemir treatment,daily insulin dose[（0.23±0.11） vs（0.26±0.12） U/kg]and body weight[（68.72±11.55） vs（71.17±12.50） kg]in the FPG reaching target group were lower than those in the FPG not reaching target group.Conclusion This study suggests that early initiation of insulin detemir in patients who are inadequately controlled on OADs and do not achieve FPG target may benefit in reaching glycaemic target.