Efficacy and Safety of Mulberry Twig Alkaloids Tablet for Treatment of Type 2 Diabetes:A Randomized,Double-Blind,Placebo-Controlled Multicenter Clinical Study

Objective:To assess the efficacy and safety of mulberry twig alkaloids(Sangzhi alkaloids,SZ-A)for treatment of type 2 diabetes in a randomized,double-blind,placebo-controlled multicenter clinical trial.Methods:A total of 200 patients were randomized to receive SZ-A(n=100)or placebo(n=100)for 16 weeks.The data analysis system for electronic data capture clinical trial central randomization system was used for randomization and dispensing of drugs.The primary outcome was the change in glycosylated hemoglobin(Hb A1c)level.The secondary outcome included the proportions of cases with Hb A1c<7.0%and Hb A1c<6.5%,fasting blood glucose(FBG),postprandial blood glucose(PBG),area under curve for the PBG(AUC_(0-2h)),body weight,and body mass index(BMI).Adverse events(AEs),severe adverse events(SAEs),treatment-related adverse events(TAEs),gastrointestinal disorders(GDs),blood pressure,routine blood tests,and liver and kidney function were monitored.Results:Compared with baseline,the change of Hb A1c at week 16 was-0.80%(95%CI:-0.98%to-0.62%)and-0.09%(95%CI:-0.27%to 0.09%)in SZ-A group and placebo group,respectively.The proportion of patients with Hb A1c<7%and<6.5%was higher in the SZ-A group than in the placebo group(46.8%vs.21.6%and 29.9%vs.10.8%).The observed values and changes in FBG,1 h-PBG,2 h-PBG,and AUC_(0-2h) differed significantly between groups(P<0.001),but differences were not significant in body weight and BMI(P>0.05).The incidence rates of AEs,TAEs,and GDs differed significantly between groups(P=0.010,P=0.005,and P=0.006,respectively),whereas the incidence rates of SAEs showed no significant differences between groups(P=1.000).Conclusion:SZ-A are effective and safe for treatment of type 2 diabetes.