A Study On Efficacy And Safety Of Sitagliptin With Metformin And Affecting Inflammation And Oxidative Stress In Type 2 Diabetes

Objective: The efficacy and safety and the impact on inflammation and oxidative stress were observed in united Sitagliptin and metformin in patients with type 2 diabetes who were inadequately controlled by metformin treated alone.Method: In this self controlled study, 26 patients with type 2 diabetes who were inadequately controlled [glycosylated hemoglobin(HbA1c) ≥7%and ≤10%]with metformin(the doses≥1500mg/d and ≤2000mg/d)for more than 10 weeks,including 15 men 11 women[the mean age 58.27 ± 8.27 years,body mass index(BMI) 24.89 ± 2.86 kg / m2, HbA1 c 8.34 ± 0.87%], were given metformin(the doses≥1500mg/d and ≤2000mg/d) adding sitagliptin100 mg qd for 20 weeks. Before and after treatment, fasting plasma glucose(FPG), 2h postprandial plasma glucose(2hPG), Hb A1 c were determined, at the same time,inflammatory cytokines sensitivity C-reactive protein(hs-CRP), redox indicators superoxide dismutase(SOD) and malondialdehyde(MDA),blood routine examination, kidney function[including serum uric acid(UA)], lipids [including total cholesterol(TC),triglyceride(TG),low density lipoprotein cholesterol(LDL-C), high density lipoprotein cholesterol(HDL-C)], body weight and BMI in all patients were assessed, as well as adverse events in the therapeutic regimen were recorded.All data were expressed as mean ± standard deviation(—x ±s), and paired t-test was used in data comparison before and after treatment.Moreover, thecorrelation of change of blood glucose with hs-CRP, SOD, MDA changes was analysed by using Spearman correlation analysis.All the data were analyzed using statistical software SPSS19.0.It was statistically significant when P <0.05.Results: The leves of FPG(P = 0.004), 2hPG(P = 0.001), HbA1c(P =0.000) and LDL-C(P = 0.002) were effectively reduced, serum uric acid(UA)level(P = 0.006) was increased after treatment program of sitagliptin with metformin in patients with type 2 diabetes who had inadequately controlled with metformin alone,the difference was statistically significant(P <0.05);Compared with before treatment,the levels of hs-CRP(P = 0.001), MDA(P =0.012) were significantly reduced,the levels of SOD(P=0.001) was significantly increased, the difference was statistically significant(P<0.05);No significant difference was found in liver function, kidney function, TG, TC, HDL-C,BMI before and after treatment(P>0.05).Correlation analysis showed that: before and after sitagliptin treatment,the variety of blood glucose was no correlated with changes of hs-CRP, SOD and MDA(P> 0.05). Adverse reactions were mainly manifested as transient diarrhea, but tolerate. No hypoglycemia occurred in all patients.Conclusion: The therapy of sitagliptin with metformin on patients with type 2 diabetes inadequately controlled with metformin alone could comprehensively reduce FPG,2hPG and HbA1 c, obviously reduce hs-CRP and MDA,and increase SOD levels of serum without gain weight and hypoglycemia. For patients with type 2 diabetes(HbA1c≥7% and ≤10%) who had inadequate glycemic control with metformin alone, sitagliptin added to ongoing metformin therapy was efficacious, safe hypoglycemic program, and reduced inflammation and oxidative stress, which was independent of thehypoglycemic effect.