Objective To investigate the efficacy and safety of liraglutide monotherapy or in combination with metformin,insulintrophic agents in the treatment for Chinese patients with type 2 diabetes.Methods 60 patients without hypoglycemic agents,114 patients poorly controlled by metformin and 46 by insulintrophic agents,were enrolled in this multi-center,self-controlled and open-labeled clinical study.All patients were initiated with 0.6 mg liraglutide without changing their basal oral hypoglycemia agents and increased 0.6 mg every 2 weeks if fasting blood glucose (FBG) did not reach the criteria.The maximum dosage was 1.8 mg.The treatment lasted for 12 weeks,and the changes of blood glucose,weight and related index before and after treatment were measured.Results After treatment of liraglutide,mean FBG decreased ( 3.25 ± 1.04 ) mmol/L,and mean postprandial glucose decreased ( 4.97 ± 2.35 ) mmol/L( P ＜ 0.01 ).Mean HbAlc reduced from 8.15％ to 7.00％ (decreased by 1.15％);88 cases (40.00％) and 28 cases ( 12.73％ )obtained the glycemic target of HbAlc ＜ 7％ and HbAlc ＜ 6.5％ respectively.The mean body weight decreased 8 kg,about two third decreased by more than 5％ and the rest declined by no less than 10％.The extent of weight decline was dependent on body mass index (BMI) at baseline(x2 =12.102,P =0.017).The mean waist circumference decreased from 96.5 cm to 89.0 cm (P ＜0.0l ).At the same time,systolic blood pressure (SBP) and mean diastolic blood pressure (DBP) decreased ( 5.26 ± 3.11 ) and (3.10 ±2.05) mm Hg separately ( lmm Hg =0.133 kPa,P ＜0.01 ).The incidence of hypoglycemia was 2.73％,and no serious hypoglycemia occurred.Conclusions Liraglutide monotherapy or in combination with metformin,insulintrophic agents is efficient in glycemic control,and beneficial for body weight loss and blood pressure reduction,which also possess a lower incidence of hypoglycemia in Chinese patients with type 2 diabetes.%目的 研究利拉鲁肽单用或与二甲双胍、胰岛素促泌剂联用对中国2型糖尿病患者的有效性和安全性.方法 为多中心、自身对照、开放式临床研究,60例未接受药物治疗、114例已使用二甲双胍、46例已使用胰岛素促泌剂而血糖仍未达标的患者在原治疗基础上,联合利拉鲁肽0.6 mg降糖,并根据空腹血糖是否达标每2 周增加0.6 mg,最大剂量1.8 mg.治疗持续12周,观察治疗前、后血糖、体重等相关指标的变化.结果 利拉鲁肽治疗后,患者的平均空腹血糖下降(3.25±1.04)mmol/L,平均餐后血糖下降(4.97±2.35) mmol/L(P ＜0.01).平均糖化血红蛋白(Hb) Alc由治疗前的8.15％下降至7.00％,下降了1.15％;有88例(40.00％)及28例患者(12.73％)分别达到HbAlc＜7％及HbAlc ＜6.5％的控制目标.患者平均体重下降8 kg,其中约2/3体重下降5％以上,其余体重下降10％以上.体重下降幅度随基线体重指数(BMI)升高而明显升高,基线BMI越高体重下降越明显(x2=12.102,P=0.017).腰围由治疗前平均96.5 cm下降至89.0 cm(P＜0.01).同时患者平均收缩压及舒张压分别下降(5.26±3.11)及(3.10±2.05)mm Hg(1 mm Hg=0.133 kPa,P＜0.01).低血糖发生率为2.73％,且无严重低血糖事件发生.结论 在中国2型糖尿病患者中,应用利拉鲁肽单药治疗或与二甲双胍或胰岛素促泌剂联合治疗,可有效控制血糖、减轻体重、降低血压且低血糖风险小.
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