| Objective:In this study,newly diagnosed type 2 diabetes patients were recruited,and the benefits and risks of using dapagliflozin as the initial treatment for type 2 diabetes patients were discussed by comparing the efficacy of acarbose and dapagliflozin after 24 weeks of treatment.Methods:From May 2018 to October 2018,newly diagnosed type 2 diabetes patients in the outpatient department of endocrinology of QiLu Hospital of Shandong University were recruited.A total of 30 patients were screened,and 25 patients were successfully screened and randomly assigned,including 16 patients who were enrolled in the acarbose treatment group(including 1 patient who was lost to follow-up)and 9 patients who were enrolled:in the dapagli:flozin treatment group.Finally,24 patients completed the 24-week drug treatment.All patients were enrolled after 2 weeks of diabetes education,started from the initial dose and reached the maintenance dose(acarbose 100mg po tid;dapagliflozin 10mg po qd)at week 4.Follow-up was conducted at baseline,week 12 and week 24.Height,weight and blood pressure were collected,standard diet(HbAlc,FPG,2hPPG,FINS,2hINS),laboratory parameters(blood routine,urine routine,ALT,AST,TBIL,TC,TG,HDL-C,LDL-C,Cr,BUN,uric acid)and body composition analysis were performed.All data were statistically analyzed using IBM SPSS 25.0 software.Results:1.Baseline comparisonThere were no significant differences between two treatment groups in the proportion of gender,age,weight,BMI,visceral fat area,systolic pressure,diastolic blood pressure,glucose metabolism index(HbAlc,FPG,2 HPPG,FINS,2hINS),blood lipid spectrum(cholesterol,triglycerides,HDL-C,LDL-C)and other laboratory testing index(AST,ALT,TBIL,urea nitrogen,uric acid).There were differences in creatinine and eGFR between the two treatment groups,but no differences in urinary ACR between the two groups.2.Changes in glucose metabolismHbAlc decreased significantly in both two groups after 24 weeks of drug therapy(P<0.01),and the two drugs reduced HbA1c to the same extent(?acarbose vs?dapagliflozin:-2.25±1.34 vs-2.08±1.38%,P=0.78).From the perspective of FPG,there was a significant decrease in the dapagliflozin group after 24 weeks of treatment(P<0.01),suggesting a significant decrease in the effect of dapagliflozin group on FPG(?acarbose vs ?dapagliflozin:-0.82±2.38 vs-1.96±1.25 mmol/L,P=0.19).After 24 weeks,2hPPG in the acarbose treatment group was significantly lower than the baseline(P<0.01),suggesting that acarbose significantly reduced 2hPPG(?acarbose vs Adapagliflozin:-2.43±2.62 vs-2.11±3.93 mmol/L,P=0.81).HOMA-? was improved in both two treatment groups(?acarbose:13.3±17.38;?dapagliflozin:12.86±21.05),while acarbose treatment group had statistical significance compared with the baseline(P<0.05).IOMA-IR decreased significantly only in the dapagliflozin treatment group(P<0.05),and the improvement effect of dapagliflozin on HOMA-IR was significantly better than that of acarbose(Aacarbose vs ?dapagliflozin:0.048±0.74 vs-0.55±0.54,P<0.05).The Gutt index,an indicator of insulin sensitivity,improved from baseline in both treatment groups(Aacarbose:0.08 ±0.14;?dapagliflozin:0.06±0.1),and the improvement of acarbose treatment group was significant(P=0.032).3.Changes in laboratory parametersBoth drugs resulted in a significant increase in HDL-C levels compared with baseline(P<0.05).LDL-C in the acarbose group decreased slightly from baseline(??-0.18±0.51 mmol/L,P=0.171),while LDL-C in the dapagliflozin group increased slightly from baseline(??0.37±0.8 mmol/L,P=0.206).There was a significant decrease of uric acid from baseline in the dapagliflozin group(P=0.038),and there was a significant difference in the effect of the two drugs on uric acid(?acarbose vs Adapagliflozin:17[-34?80]vs-70[-103.5?-1.5]umol/L,P=0.023).4.Changes in body weight,BMI,blood pressureThere were slight decreases in body weight and BMI between the two drugs,and the differences were not statistically significant(body weight:?acarbose =-2.15±4.34 kg;P=0.075;Adapagliflozin=-1.17±3.1kg,P=0.292;BMI:Aacarbose =-0.76± 1.49 kg/m2,P=0.068;?dapagliflozin=-0/42± 1.11 kg/m2,P=0.285).In terms of the effect on blood pressure,both systolic and diastolic blood pressure were increased in the acarbose treatment group compared with the baseline(systolic blood pressure:A=6.53±11.53 mmHg,P<0.05;diastolic blood pressure:0=3.6±7.04 mmHg,P=0.068),and the systolic blood pressure and diastolic blood pressure in the dapagliflozin treatment group remained almost the same as the baseline(systolic blood pressure:?=-1.22± 15.21 mmHg,P=0.816;diastolic blood pressure:?=-0.44± 12.76 mmHg,P=0.919).5.Changes in body compositionAfter 24 weeks of drug therapy,visceral fat area of both treatment groups was significantly decreased from baselline(P<0.05).From the change value of visceral fat area,the two drugs reduced visceral fat area to the same degree(Aacarbose vs?dapagliflozin:-16±25.8 vs-14.8±16.7 cm2,P=0.898).Limb muscle mass and skeletal muscle mass index were slightly decreased in the dapagliflozin group,while the acarbose treatment group was almost flat from baseline.Systemic BMD was slightly decreased in the dapagliflozin group compared witih baseline(?=-0.0058±0.039.g/cm2,P=0.674).Conclusions:1.Acarbose and dapagliflozin were equally effective in reducing HbA1c for newly diagnosed type 2 diabetes patients.2.Both acarbose and dapagliflozin significantly reduced visceral fat area,and the efficacy of the two drugs was comparable.3.The evaluation of muscle(especially in skeletal muscle)combined with bone mineral density,to evaluate the dapagliflozin effect on the fracture,consider that 24 weeks of dapagliflozin does not have a significant impact on the whole body bone mineral density and limb muscle,but the late reducing trend of 24 weeks worth further attention. |
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