| Objective: To evaluate the efficacy and safety of dulaglutide(Trulicity,LY2189265)for the treatment of type 2 diabetes mellitus and provide evidence for clinical practice.Methods: Randomized controlled trials(RCTs)of dulaglutide versus placebo for treatment of type 2 diabetes were searched in PubMed,Cochrane Library,Medline,Embase,ClinicalTrails.gov,CNKI,WanFang and VIP.Meta-analysis was performed by using RevMan 5.3.0software.All of the databases were searched from the date of their establishment to December 28,2015.Search terms are dulaglutide,Trulicity,LY2189265,placebo,type 2 Diabetes,T2DM,randomized controlled trial,meta-analysis,systematic review,etc.According to the way of the Cochrane systematic review,two researchers firstly defined the inclusion criteria and exclusion criteria,then viewed the literature,extracted data and assessed quality of the literature independently,finally unified data after cross-checking,perform meta-analysis by using RevMan 5.3.0 software.Results: 6 RCTs involving 2265 patients were included.Interventions of 6 RCT studies behaved slightly different.Patients of the treatment group received subcutaneous injections of once-weekly dulaglutide 0.75 mg,control group was given subcutaneous injections of once-weekly placebo 0.75 mg treatment in 4 RCTs.In 4 RCTs patients of the treatment group received subcutaneous injections of once-weekly dulaglutide 1.5mg,control group was given subcutaneousinjections of once-weekly placebo 1.5mg treatment.Reviewer evaluated the including RCTs' risk of bias according to the Cochrane Manual 5.0.1recommended tool.The results showed low risk of bias for 6 studies.Meta analysis indicated that:(1)Compared with placebo group,dulaglutide provided a greater reduction in hemoglobin A1c(HbA1c),the difference between dulaglutide group and placebo group was statistically significant(WMD=-1.15,95%CI[-1.31,-1.00],P < 0.00001).(2)Compared with placebo,dulaglutide resulted in a significant reduction in fasting blood glucose(FBG),the difference between dulaglutide group and placebo group was statistically significant(WMD=-33.27,95%CI[-36.21,-30.33],P < 0.00001).(3)Compared with placebo,dulaglutide group lead to higher body weight loss,the difference between dulaglutide group and placebo group was statistically significant(WMD=-0.81,95%CI[-1.55,-0.07],P=0.03).(4)The percentage of patients attaining the HbA1 c goal of<7% was significantly higher in dulaglutide group than the placebo group,the difference was statistically significant(RR=2.88,95%CI[2.05,4.06],P < 0.00001).(5)The percentage of patients achieved the HbA1 c target of ?6.5% was significantly higher in dulaglutide group compared with the placebo group(RR=3.29,95%CI[2.33,4.63],P < 0.00001).(6)The improvement of ?-cell function was different between dulaglutide group and placebo group,the difference was statistically significant(WMD=27.51,95%CI[24.12,30.90],P<0.00001).(7)The total incidence of adverse reactions in dulaglutide group and placebo group was similar,the difference was nostatistically significant(RR=1.04,95%CI[0.98,1.11],P=0.21).(8)The incidence of serious adverse events in dulaglutide group and placebo group was similar,the difference was no statistically significant(RR=0.87,95%CI[0.59,1.27],P=0.47).Conclusion: This study evaluated the effectiveness and safety of dulaglutide for treatment of type 2 diabetes.The results of meta-analysis revealed that patients received dulaglutide versus placebo had a significantly greater improvement in HbA1 c,FBG,percentage of patients with HbA1c<7.0%and ?6.5%,?-cell function and so on.The incidence of overall adverse events between dulaglutide group and placebo group during treatment period was no statistical difference.Serious adverse reactions are infrequent.Dulaglutide is effective in treating patients with type 2 diabetes and it was generally well tolerated compared with placebo. |
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