利拉鲁肽联合甘精胰岛素与基础-餐时胰岛素强化治疗对新诊断2型糖尿病的疗效及安全性比较

目的比较利拉鲁肽联合甘精胰岛素与基础-餐时胰岛素强化治疗对新诊断2型糖尿病的疗效及安全性。方法采用前瞻性设计,选取2019年1月至2020年6月在福建医科大学附属泉州第一医院内分泌科住院的新诊断2型糖尿病患者150例,根据随机数字表法将纳入患者按1∶1随机分为利拉鲁肽联合甘精胰岛素组(试验组,75例)及基础-餐时胰岛素组(对照组,75例)。基础-餐时胰岛素组三餐前注射门冬胰岛素,睡前注射甘精胰岛素,给予强化治疗4周。主要研究终点为血糖达标时间,次要终点为第4周时体重较基线改变、稳态模型评估胰岛素抵抗指数(HOMA-IR)变化及低血糖情况。分别采用t检验、配对t检验、协方差分析及χ2检验进行统计分析。结果试验组和对照组分别有72和73例。试验组共有3例(4.0%)发生4次低血糖,对照组有10例(13.3%)发生14次低血糖,差异具有统计学意义(χ²=4.227,P=0.040)。经强化治疗4周后,试验组血糖达标时间为(6.0±1.8)d,对照组为(5.6±1.7)d,差异无统计学意义(t=1.396,P=0.165)。第4周结束时,试验组体重较基线下降(1.61±0.73)kg,差异有统计学意义(t=2.224,P=0.029),对照组体重较基线上升(1.15±0.81)kg,差异无统计学意义(t=1.413,P=0.162)。试验组HOMA-IR较基线下降6.24±0.34,对照组HOMA-IR较基线下降5.80±0.29,差异均有统计学意义(t=18.642、19.853,均P<0.01)。采用协方差分析发现,利拉鲁肽联合甘精胰岛素可以较基础-餐时胰岛素方案进一步改善HOMA-IR(F=2.620,P=0.027)。结论利拉鲁肽联合甘精胰岛素不仅对新诊断2型糖尿病的疗效不劣于基础-餐时胰岛素强化治疗方案,且还具有减轻体重、减少低血糖风险以及改善胰岛素抵抗的优势。

Comparison of liraglutide plus insulin glargine and basal-bolus insulin intensive therapy for efficacy and safety in newly diagnosed type 2 diabetes mellitus

Objective To investigate the efficacy and safety of liraglutide plus insulin glargine and basal-bolus insulin intensive therapy in newly diagnosed type 2 diabetes mellitus(T2DM),respectively.Methods In this 4-week randomized prospective pilot study,150 newly diagnosed T2DM patients were recruited from January 2019 to June 2020 in the Department of Endocrinology,Quanzhou First Hospital Affiliated to Fujian Medical University.According to the random number table method,these patients were randomly assigned to liraglutide plus insulin glargine therapy group(experimental group,75 cases),and basal-bolus insulin intensive therapy group(control group,75 cases.Asparagine insulin was injected before three meals and glargine insulin was injected before going to bed)by 1∶1 matching.The primary endpoint was the time of glycaemic control.The secondary endpoint was changes in body weight from baseline,homeostasis model assessment of insulin resistance(HOMA-IR),and hypoglycemia at the 4th week.Statistical analysis was performed using independent-samples t test,paired-samples t test,covariance analysis,and Chi-square test.Results Ultimately,there were 72 cases in the experimental group and 73 cases in the control group.Three patients(4.0%)in the experimental group had hypoglycemia for 4 times,while 10 patients(13.3%)in the control group had hypoglycemia for 14 times(χ²=4.227,P=0.040).The time of glycaemic control in the experimental group was(6.0±1.8)days and(5.6±1.7)days in the control group,but this statistical difference was not significant(t=1.396,P=0.165).After 4-week treatment,the weight significantly decreased by(1.61±0.73)kg from baseline in the experimental group,there was no significant statistical difference(t=2.224,P=0.029),while in the control group,the weight increased by(1.15±0.81)kg(t=1.413,P=0.162).HOMA-IR significantly decreased by 6.24±0.34 from baseline(t=18.642,P<0.01)in the experimental group,and HOMA-IR decreased by 5.80±0.29 from baseline(t=19.853,P<0.01)in the control group.Compared with the control group,HOMA-IR was improved in the experiment group could further improve(F=2.620,P=0.027)by the use of covariance analysis.Conclusions Liraglutide plus insulin glargine therapy is not inferior to basal-bolus insulin intensive therapy for newly diagnosed T2DM.Moreover,liraglutide plus insulin glargine therapy has the advantage of weight loss,reducing hypoglycemia risk,and improving insulin resistance in newly diagnosed T2DM.