Clinical Efficacy Of Adding Liraglutide To Overweight Or Obese Type 2 Diabetic Patients Poorly Controlled With Insulin Aspart 30

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.Method 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.In the experimental group,liraglutide was initiated at a dose of 0.6 mg injected subcutaneously once per day,at the same time insulin doses were reduced,after 1 week liraglutide increased to 1.2 mg/day.In the control group,insulin doses were increased to reach the glycemic targets.body weight(BW),body mass index(BMI),fasting plasma glucose(FPG),2 hour postprandial plasma glucose(2h PPG),blood lipid(TG,TC,LDL-C,HDL-C),blood pressure(BP),glycosylated hemoglobin(Hb A1c),fasting C-peptide(FCP),insulin resistance index(HOMA-IR),β-cell functional index(HOMA-β),daily insulin dose,all hypoglycemic events and the percentage of subjects reaching the composite endpoint(Hb A1c<7% with no weight gain and no hypoglycemia)were observed and recorded in two groups.Results1.At the end of treatment,a total of 57 patients completed the trial(28 cases in the experimental group and 29 cases in the control group).There were no significant difference in baseline data between two groups before treatment(P>0.05),and they were comparable.2.Changes of variables related with body weight and BP,the treatment of experimental group significantly reduced BW,BMI,the mean reductions were 4.52±1.51 kg and 1.56±0.50 kg/m2 respectively(P<0.05),while all of these significantly increased in the control group,the mean increase were 0.67± 1.02 kg and 0.25 ±0.36kg/m2 respectively(P<0.05).No obvious difference was observed in BP of the both two groups compared with baseline(P>0.05).3.The antihyperglycemic effect,FPG,PPG,Hb A1 c were significantly decreased following treatment in both groups(P<0.05),there were not significantly different between the two groups(P>0.05).the treatment of experimental group significantly reduced daily insulin dose(P<0.05),dropped by 67.6%,9 patients came off insulin.while which significantly increased in the control group(P<0.05).4.In blood lipid metabolism,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).No obvious difference was observed in HDL-C of the both two groups compared with baseline(P>0.05).5.Changes of variables related with islet function,FCP and HOMA-IR were significantly decreased,HOMA-β was increased in the experimental group(P<0.05),HOMA-IR was significantly decreased,FCP and HOMA-β was increased in the control group(P<0.05);after 12 weeks of treatment,the differences between FCP and HOMA-IR were statistically significant(P<0.05).6.Comparison of adverse events,no serious adverse events occurred in the two groups.The hypoglycemic events in the experimental group were significantly lower than that in the control group(3.6% vs 27.6%,P<0.05);gastrointestinal symptoms were the most frequent side effects in the experimental group,but these events were mostly mild and transient.No adverse reactions such as abdominal pain,pancreatitis,rash and allergy were found in two groups.7.Hb A1 c target goal,The the percentage of subjects reaching the composite endpoint during 12 weeks treatment was significantly greater in the experimental group than in the control group(57.1% vs 24.1%,P<0.05)although the percentage of subjects achieving Hb A1 c in all subjects was not different between 2 groups(P>0.05).Conclusion1.Addition of liraglutide to overweight or obese,insulin-treated patients led to improvement in glycemic control similar to that achieved by increasing insulin dosage,but with a lower daily insulin dose and greater insulin discontinuation.2.In addition to good control of blood glucose,liraglutide has a significant reduction in body weight and fewer hypoglycemic events,increased the percentage of subjects reaching the composite endpoint,also improve islet β cell function.