Abstract: Objective: To evaluate the efficacy and safety of saxagliptin combined with insulin and insulin used in the treatment of the patients with type 2 diabetes systematically.Methods: CNKI database, VIP database,Wanfang database,CBM database,PubMed and Cochrane Library were searched.The time was from the begining of the databases to Dec 31,2017. The randomized controlled trials (RCT) were selected according to the inclusion and exclusion criteria. Then the qualities of included studies were evaluated and the data was extracted. The Meta-analysis was performed by Review Manager 5.3 and Stata 12.0 softwares.Results: A total of 647 articles were selected initially and 22 articles involving 2 243 patients were included in this Meta-analysis. The results of Meta-analysis of effectiveness indicators showed that compared with insulin used alone(control) group, the HbA1c level(MD=-0.86, 95%CI:-1.03——0.68,P<0.01), FBG level (MD=-0.95, 95%CI:-1.22——0.67,P<0.01), PBG level (MD=-1.28, 95%CI:-1.61——0.94,P<0.01) and level of daily insulin dosage(MD=-16.17, 95%CI:-17.40——14.95,P<0.01) of the patients in saxagliptin combined with insulin(case) group were decreased. The safety analysis results showed that the total incidences of adverse reactions (OR=0.39, 95%CI:0.28-0.52,P<0.01) and the incidence of hypoglycemia (OR=0.31, 95%CI:0.22-0.45,P<0.01) of the patients in case group were lower than those in control group.The funnel-plot of these indicators displayed a symmetrical figure, and there was no publication bias; the sensitivity analysis results showed that there was no difference between all the indicators, and the results were stable.Conclusion: Compared with insulin used alone, saxagliptin combined with insulin therapy has certain advantages to reduce the levels of HbA1c, FPG, PBG of the type 2 diabetes patients and the daily insulin dosage, has high safety and dosen't increase the risk of hypoglycemia and other adverse reactions.

Key words: saxagliptin, insulin, type 2 diabetes mellitus, Meta-analysis