A Comparative Study On Efficacy And Safety Of Vildagliptin With Metformin And Short-term Intensive Insulin Therapy And Affecting Adipokines In Newly Diagnosed Type2Diabetes

Objective: Given two different antidiabetic therapies for newlydiagnosed type2diabetes(T2DM), one was the vildagliptin with metformin,the other was the short-term intensive insulin therapy. This study was aimedto compare the differences in controlling glucose, secreting insulin, insulinresistances, body weight and adipokines of the two therapies, assess the safetyof the two therapies respectively and compare the differences between the twogroups.Method:32patients of newly diagnosed T2DM were selected, whoseglycosylated hemoglobin(HbA1c) were all above7%. All patients weredrawed off fasting intravenous blood(everybody was fasted12hours) beforeand after the treatment. All fasting blood was measured HbA1c,lipids(including total cholesterol(TC), triglycerides(TG), low-densitylipoprotein cholesterol(LDL-C), high density lipoprotein cholesterol(HDL-C))and adiponectin. At the same time, everybody did oral glucose(75g) tolerancetext(OGTT) or100g standard bread meal, blood samples were collected at0,120minutes, and respectively measured plasma glucose, insulin, fasting and120minutes’ C peptide. Everyone was measured height and body weight. Wecalculated body mass index(BMI), homeostasis model of insulin secretionindex(HOMA-β), homeostasis model of insulin resistance index (HOMA-IR)and insulin action index (IAI). According to the level of HbA1c, all patientswere divided into two groups. The patients whose HbA1c was less than9% were categorized into the group of vildagliptin50mg bid with metformin500mg bid. There were20people(11males,9females) in this group. Theiraverage age was57.4±8.76years, BMI was24.66±2.56kg/m2and HbA1cwas7.89±0.65%and all patients were treated for12weeks. The patientswhose HbA1c was more than or equal to9%were categorized into the groupof short-term intensive insulin therapy of4times insulin injections per dayaccording to2013China Diabetes Guides. There were12people in this group.Their average age was51.83±8.42years, BMI was22.95±2.32kg/m2,HbA1c11.37±1.31%and all patients were treated for12weeks. Werespectively compared the two therapies influenced BMI, blood glucose,HbA1c, adiponectin, fasting and120minutes’ C peptide, HOMA-β,HOMA-IR and IAI after treatment, compared the percentage of theseindicators changes after treatment between the two groups, observed adverseevents and assessed safety of the two therapies. All data was expressed in theform of mean±standard deviation (x—±s). The paired samples t test was usedto compare the data of the same group before and after treatment, whileindependent samples t test was used to compare the data between the twogroups. Wilcoxon test was used to compare the percentage of changesbetween the two groups. All data were analyzed using SPSS19.0statisticalsoftware. It was statistically significant when P <0.05.Results: The two therapies of vildagliptin with metformin and intensiveinsulin therapy can effectively reduce fasting blood glucose,2-hourpostprandial blood glucose and HbA1c (P <0.05). Vildagliptin group indecreasing the magnitude of HbA1c was lower than in the intensive insulingroup (P <0.05), but the two groups in descending magnitude of FPG and2hPG was no significant difference (P>0.05). Compared with before treatment, for the vildagliptin group the levels of HOMA-β and adiponectinsignificantly increased(P <0.05), while HOMA-IR, IAI and fasting and2-hour postprandial C-peptide levels had no significant changes (P>0.05).For the group of intensive insulin the levels of HOMA-β, fasting and2-hourpostprandial C-peptide significantly increased (P <0.05), while HOMA-IR,IAI and adiponectin had no significant change (P>0.05). Intensive insulingroups in improving the percentages of C-peptide and HOMA–β changeswere better than vildagliptin groups (P <0.05) and it had no difference inincreasing the magnitude of the adiponectin between the two groups(P>0.05).Vildagliptin group had no significant effect on BMI (P>0.05), but the groupof intensive insulin was significantly increased in BMI after the treatment (P<0.05). Intensive insulin group in increasing BMI was significant higher thanthe vildagliptin group (P <0.05). There was no significant changes in lipidlevels, liver function and kidney function after the treatment between the twogroups(P>0.05). The vildagliptin group’s adverse effects were less than theintensive insulin therapy group’s, mainly for nausea and constipation, and thepatients could tolerate. There were no hypoglycemia in vildagliptin group, buta total of8times hypoglycemia symptom occurred in intensive insulintherapy group and five of them had records of hypoglycemia.Conclusion: The two therapies can both comprehensively reduce HbA1c,FPG and2hPG; The two therapies could improve pancreatic β-cell function;Vildagliptin group had no effect on body weight in patients withT2DM;There was little of adverse event and low risk of hypoglycemia in theVildagliptin group. Therefore, Vildagliptin with metformin is an effective andsafe hypoglycemic program.