门冬胰岛素30联合二甲双胍血糖控制不佳的2型糖尿病患者加用利拉鲁肽的临床疗效观察

Clinical Efficacy of Adding Liraglutide to Type 2 Diabetic Patients Poorly Controlled with Insulin Aspart 30 and Metformin

目的探讨应用门冬胰岛素30联合二甲双胍血糖控制不佳的超重或肥胖2型糖尿病患者加用利拉鲁肽的临床疗效。方法收治符合研究标准的2型糖尿病患者60例,随机分为试验组(加用利拉鲁肽)和对照组(胰岛素加量),各30例。疗程12周,观察2组患者体重(BW)、体重指数(BMI)、空腹血糖(FPG)、餐后2h血糖(PPG)、血脂(TG、TC、LDL-C、HDL-C)、血压(BP)、糖化血红蛋白(HbA1c)、空腹C肽(FCP)、胰岛素抵抗指数(HOMA-IR)、β细胞功能指数(HOMA-β)、记录胰岛素日用总剂量,低血糖发生事件以及复合终点(Hb A1c<7%+无体重增加+无低血糖的发生)达标率。结果 12周后最终57例患者完成试验。两组患者治疗前后比较,FPG、PPG、Hb A1c、TG、TC、LDL-C均有下降(P<0.05),但组间比较差异无明显统计学意义(P>0.05);试验组患者BW、BMI和日用胰岛素总量均显著下降(P<0.05),而在对照组中均增加(P<0.05);试验组FCP、HOMA-IR降低,HOMA-β增高(P<0.05),且复合终点达标率明显高于对照组(P<0.05)。结论对于门冬胰岛素30治疗血糖控制欠佳的2型糖尿病患者,加用利拉鲁肽与对照组相比可获得类似降糖效果,但其减重作用明显,降低了低血糖的风险,增加复合终点达标率,且改善胰岛β细胞功能。

Objective To evaluate the clinical efficacy of liraglutide combined treatment in overweight or obese type 2 diabetic patients with unsatisfied glycemic control using insulin aspart 30 and metformin. Methods Sixty patients who reached certain criteria with type 2 diabetes were selected,and then were randomly divided into two groups：the experimental group （liraglutide-added group） and the control group （insulin-increasing group）.Each group had 30 cases.Body weight （BW）,body mass index（BMI）,fasting plasma glucose （FPG）,2 hour postprandial glucose （PPG）,blood lipid（TG,TC,LDL-C,HDL-C）,blood pressure（BP）,glycosylated hemoglobin （HbA1c）,fasting C-peptide（FCP）,insulin resistance index （HOMA-IR）,β-cell functional index （HOMA-β）,daily insulin dose,all hypoglycemie events and the percentage of subjects reaching the composite endpoint（HbA1c〈7% with no weight gain and no hypoglycemia） were observed and recorded in two groups. Results After 12 weeks treatment,there were 57 patients finally completed the study.FPG,PPG,HbA1c,TG,TC,LDL-C were significantly decreased following treatment in both groups（P〈0.05）,but were not significantly different between the two groups（P〉0.05）.The treatment of experimental group significantly reduced BW,BMI and daily insulin dose（P〈0.05）,while all of these significantly increased in the control group（P〈0.05）.FCP and HOMA-IR were significantly decreased.HOMA-β was increased in the experimental group （P〈0.05）.The percentage of subjects reaching the composite endpoint was increased in the experimental group and had significantly difference in comparision to the control group（P〈0.05）. Conclusion Adding liraglutide to insulin-treated patients led to improvement in glycemic control similar to that achieved by increasing insulin dosage,but with significant reduction in body weight and fewer hypoglycemic events,also improve islet β cell function.