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Background: This study was conducted to evaluate the effect of various oral hypoglycemic agents in the control of plasma blood glucose levels among Type 2 diabetes mellitus (T2DM) patients. Aims and Objectives: This study is aimed to evaluate the blood glucose controlling efficacy of various oral hypoglycemic drugs in T2DM patients. Materials and Methods: This randomized and control study was conducted among the cases attending Department of General Medicine at Research cell of Chennai Medical College Hospital and Research Centre, during the period of June 2014 to July 2015. A total of 180 cases were randomly allotted to six groups. Group I was treated with Glibenclamide, Group-II was treated with Glibenclamide + Sitagliptin, Group-III was treated with Glibenclamide + Vildagliptin, Group-IV was treated with Metformin, Group-V was treated with Metformin + Sitagliptin, and Group-VI was treated with Metformin + Vildagliptin. Fasting, postprandial, and glycated hemoglobin (HbA1c) levels were assessed before and at 4, 8, and 12th weeks and the data were analyzed using Statistical Package for the Social Sciences. Results: Fasting and postprandial sugars were significantly reduced in Group V and Group VI during 4th, 8th, and 12th weeks. However, HbA1c levels were significantly reduced after 12 weeks of treatment in Group III, Group V, and Group VI. Conclusion: We conclude that metformin in combination with either Vildagliptin or Sitagliptin can help to reduce fasting, postprandial, and HbA1c levels (both in short-term and in long-term); however, Glibenclamide along with Vildagliptin could reduce only HbA1c levels (long-term alone).
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Background: The lack of vitamin D deficiency has been found to be closely associated with many health problems such as metabolic syndrome, cancer, cardiovascular disease, and type 2 diabetes. This interest has also arisen due to the identification that most cells, along with the pancreatic beta-cells, incorporate the vitamin D receptor. Aims and Objectives: In this study, we tested the potential anti-diabetic effect of cholecalciferol, one of the vitamin D analogs, alone or in combination with vildagliptin in type 2 diabetic rats. Materials and Methods: Type 2 diabetic model rats were induced by intraperitoneal injection of streptozotocin followed by nicotinamide. Rats were assigned into five groups each of six rats divided as follows: Normal (non-diabetic) control (Group A), untreated diabetic group receiving the vehicles only (Group B), cholecalciferol-treated group (Group C), vildagliptin-treated group (Group D), and group receiving a combination of cholecalciferol and vildagliptin (Group E). The treatment course lasted for 1 month. For the estimation of fasting blood sugar, the rats were kept deprived of food overnight and were allowed free access to water. Blood samples were collected from the tail of rat with the help of glucometer. Statistical analysis was performed using SPSS version 20 software. One-way ANOVA test was used to compare the effect of drugs on different group. Post hoc analysis was done using Turkeys HSD (honestly significant difference) test. Differences were considered significant at (P < 0.05). Results: Mean FBS value of vitamin D, vildagliptin, and their combination was 181.50 mg/dl, 95.0 mg/dl, and 84.83 mg/dl on day 28. It showed that the combination of both drugs acquired much closer value of FBS as compared to normal non-diabetic control group and thus achieved normal glucose level more effectively. Furthermore, coadministration showed greater fall in fasting blood glucose at the extent of 61.15% as compared to 56.45% by vildagliptin and 17% by cholecalciferol alone on day 28. Conclusion: Therefore, it may be suggested through this study that vitamin D has blood glucose lowering property and coadministration of vitamin D and vildagliptin potentiate the action of each other.
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Type 2 Diabetes Mellitus (T2DM) is a highly prevalent cardiometabolic disorder in India and is further projected to rise (10.4% by 2030). In newly diagnosed patients, maintaining HbA1c 6.5-7.0% and minimizing glycaemic exposure, particularly during the first year following diagnosis, may be crucial for preventing complications. Early treatment initiation with a synergistic combination of vildagliptin and metformin is one of the many possible combinations to manage type 2 diabetes mellitus. In view of emerging clinical evidence on early initiation of combination therapy than monotherapy with metformin, there is a need for expert consensus on the use of the current approved Fixed Dose Combination (FDC) of Metformin SR + Vildagliptin IR in newly diagnosed diabetic patients. Experts framed final consensus statements based on available scientiûc evidence, experience and collective clinical judgment from practical experience this FDC.
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Background: Type 2 diabetes mellitus (DM) is mainly due to multifactorial of which insulin resistance and deficiency in the incretion are two important pathophysiological factors. Vildagliptin, an oral hypoglycemic agent, acts by inhibiting dipeptidyl peptidase-4 enzyme, often uses as a first line drug along with metformin to enhance outcome. Aim and Objective: The aim of this study was to compare the effectiveness and safety of vildagliptin 50 mg twice daily dose with vildagliptin 100 mg sustained release tablet (SR) once daily in Type 2 DM patients and uncontrolled with metformin monotherapy. Materials and Methods: Adult patients with Type 2 DM fulfilling the inclusion criteria were randomized in two groups. Group 1 patient received metformin 1000 mg/day in two divided dose and tablet vildagliptin 50 mg 2 times daily, while Group 2 patients received metformin 1000 mg/day in two divided dose along with vildagliptin 100 mg SR once daily. Fasting plasma glucose (FPG), postprandial plasma glucose (PPPG), and glycated hemoglobin (HbA1C), were measured at baseline, on week 4, week 8, and week 12 visits. Liver function test (SGOT), SGPT, Serum Bilirubin), kidney function test electrolytes, serum urea, serum creatinine), and body weight also measured in first visit and in 12th week. Results: HbA1C, FPG, and PPPG all three decreased equally at 12 week from their respective baseline values (P < 0.05) in both groups. There is no statistically significant alteration of liver enzymes and in serum bilirubin level from baseline to 12th week in both groups. Conclusion: Vildagliptin 100 mg SR once daily dose is equally effective and safe as 50 mg twice daily dose in terms of reducing HbA1C, FPG, and PPPG when it is used along with metformin 1000 mg.
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Resumen Objetivos. La hemoglobina glicada podría sub-representar las fluctuaciones diarias de la glucemia. Se han propuesto múltiples técnicas para estudiar la variabilidad glucémica con el fin de conocer más claramente el control metabólico de la enfermedad. El objetivo de este estudio es comparar la variabilidad glucémica medida por MAGE y CONGA en el grupo de intervención y control; Además, comparar los resultados de variabilidad glucémica obtenidos antes y 12 semanas después del inicio del tratamiento en ambos grupos. Métodos. Ensayo clínico aleatorizado, multicéntrico, de etiqueta abierta, fase IV. Cuarenta sujetos aleatorizados para recibir vildagliptina más metformina1 o glimepirida más metformina por un periodo de 12 semanas. Se realizaron monitoreos continuos de glicemia antes y después del periodo de tratamiento utilizando dispositivos iPro2. Se compararon los resultados de variabilidad glucémica medida por MAGE, CONGA y DET. Se comparó el perfil de seguridad y tolerabilidad de las intervenciones. Resultados. El uso de GalvusMet® o glimepirida más metformina por 12 semanas en pacientes diabéticos con mal control glucémico se asoció con una reducción estadísticamente significativa de la variabilidad glucémica (Valor p Wilcoxon
AbstractObjectives. Glycosylated hemoglobin could under-represent daily fluctuations in bloodglucose. Multiple techniques have been proposed to study glycemic variability in order to better understand the metabolic control of the disease. The objective of this study is to compare the glycemic variability measured by MAGE and CONGA in the intervention and control group; In addition, compare the glycemic variability results obtained before and 12 weeks after the start of treatment in both groups. Methods. Phase IV, randomized, multicenter, open-label clinical trial.Forty subjects were randomized to receive vildagliptine plus metformin1 or glimepiride plus metformin for a period of 12 weeks. Continuous blood glucose monitoring was performed before and after the treatment period using iPro2 devices. The results of glycemic variability measured by MAGE, CONGA and DET were compared. The safety and tolerability profile of the interventions was compared. Results. The use of GalvusMet®ï¸ or glimepiride plus metformin for 12 weeks in diabetic patients with poorglycemic control was associated with a statistically significant reduction in glycemic variability (Wilcoxon p-value <0.005) and HbA1c (Wilcoxon p-value <0.005) in both groups;however, insufficient evidence was found to determine the superiority of the treatments. No differences were detected in the safety or tolerability profile of the drugs. Conclusions.The results of the study suggest that the evaluated treatment regimens are equivalent. Additional studies are required to determine the clinical significance of the results.
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Humans , Diabetes Mellitus, Type 2 , Disease , Glycemic Control , GlucoseABSTRACT
Vildagliptin is an oral hypoglycemic agent used in the management of diabetes. Some oral antidiabetic drugs have been implicated in reproductive toxicity.The objective of this study was to investigate the effects of daily administration of vildagliptin at different dosages (0.35 mg/kg B.W., 0.70 mg/kg B.W. and 1.40 mg/kg B.W.) to male Wistar rats for 8 weeks. Sperm parameters, serum concentrations of testosterone, follicle stimulating hormone and luteinizing hormone and the histology of the testis of the rats were assessed. Another set of rats were also treated for 8 weeks and allowed to recover and the same parameters were assessed in them. Fertility study was conducted by determining their litter size. The results showed that vildagliptin administration significantly reduced sperm count and motility of the treated rats. It also significantly increased the number of abnormal sperms. Serum level of testosterone was significantly decreased while luteinizing hormone and follicle stimulating hormone levels showed no significant change. The histoarchitecture of the testis of the treated rats appeared visibly normal. The litter size was also significantly reduced. Most of the changes observed were dose dependent. However, these parameters were restored towards normal in the recovery group. Our results suggest that vildagliptin adversely affected sperm parameters, affected litter size and disrupted the pituitary - gonadal axis. These changes were however reversed upon cessation of drug administration.
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Animals , Male , Rats , Sperm Count/classification , Testosterone/agonists , Vildagliptin/administration & dosage , Testis/abnormalities , Fertility/drug effects , Vildagliptin/adverse effectsABSTRACT
ABSTRACT Objective The aim of this randomized comparative study was to assess renal and metabolic effects of vildagliptin in insulin-treated type 2 diabetes (T2DM) patients without overt chronic kidney disease. Subjects and methods We randomized 47 insulin-treated non-proteinuric patients with satisfactory controlled T2DM and estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m 2 either to continue insulin therapy (control) or to receive combined insulin-vildagliptin treatment (VIG group). We assessed eGFR using serum creatinine (eGFRcreat), cystatin C (eGFRcys), and both (eGFRcreat-cys), and urinary creatinine-adjusted excretion of albumin (UACR), type IV collagen (uCol IV/Cr), and neutrophil gelatinase-associated lipocalin (uNGAL/Cr) at baseline and after 6 months of treatment. Results Study groups were comparable in terms of age and sex (60.1 ± 6.1 years and 42.9% men in control group vs. 60.8 ± 5.2 years and 39.1% in VIG group). After 6 months of treatment, there were no significant changes in main assessed parameters in control group. VIG group demonstrated significant decrease in HbA1c, diastolic blood pressure, frequency of hypoglycemia, and high-sensitivity C-reactive protein level as compared to the changes in control group. While eGFRcreat, UACR, and uNGAL/Cr showed no significant changes after vildagliptin addition, eGFRcys, eGFRcreat-cys, and uCol IV/Cr changed significantly in comparison with control group (+7.0% [3.7;13.3]; +5.1% [1.4;8.5]; -32,8% [-55.8;-24.4], respectively, p < 0.01 each). Correlation and regression analysis revealed glucose-independent pattern of these changes. Conclusion Addition of vildagliptin to ongoing insulin therapy in patients with T2DM was associated with a reduction in uCol IV/Cr and an increase in eGFRcys and eGFRcreat-cys, independent of T2DM control parameters.
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Humans , Male , Female , Aged , Diabetes Mellitus, Type 2/drug therapy , Vildagliptin/therapeutic use , Prospective Studies , Hypoglycemic Agents , Insulin , Kidney , Middle AgedABSTRACT
Objective: To investigate and optimize the synthetic process of specific dipeptidyl peptidase-Ⅳ(DPP-Ⅳ)inhibitor vitagliptin. Methods: The aimed synthetic route was conceived by the literature survey according to the advantages and disadvantages of the reported synthetic routes. The key process parameters were determined by the orthogonal test or single factor test for the main intermediates in the speed limiting step. Results: The structures of intermediates and target compound were confirmed by MS and 1H NMR data. The overall yield of the target compound was 38.5%. Conclusion: The synthetic process has the advantages of lower cost, simple operation and mild reaction condition, and the yield has been improved by optimizing the crystallization solvent, which should be more suitable for industrial production.
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Background: The aim of this study was to determine how HbA1c, lipid, renal functions and such parameters were affected in the long term by adding dipeptidyl peptidase-4 inhibitors to the ongoing treatment regimens of patients with Type 2 diabetes mellitus.Methods: The study was conducted in diabetes mellitus outpatient clinic of Kayseri Training and Research Hospital between February 2012 and May 2017, with patients who did not achieve the sufficient success in diabetes their controls at the time of admission. From these patients, those who added (dipeptidyl peptidase-4 inhibitors) to their treatments were selected. Patients were followed up as long as they continued to these new treatments and the parameters at the baseline were compared with final values.Results: A total of 80 diabetic patients were followed in the study. The median age of the patients was 56.08±9.71 years. During this follow-up, an average decrease of 1.03% was noted when patients were compared with 9.53±1.87% of the initial hemoglobin A1c, and 8.50±1.48% of the Hemoglobin A1c values at the end of follow-up. This decrease was statistically significant (p <0.001). However, differences in the initial and final values of the lipid parameters of the patients were not statistically significant.Conclusions: Addition of dipeptidyl peptidase-4 inhibitors to patients' treatments causes significant decreases in Hemoglobin A1c mean values. This decline is long lasting. However, there are no positive or negative effects on biochemical parameters such as lipids, kidney and liver functions.
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Objective To investigate the effect of different hypoglycemic methods on tibial osteotomy (HTO)in patients with diabetes mellitus,and to seek a more scientific and reasonable clinical intervention model.Methods From February 2016 to January 2017,sixty patients with knee osteoarthritis and diabetes mellitus were randomly divided into the control group and the observation group,with 30 cases in each group.Patients in the control group were treated with Acarbose and Aspartic Insulin 30 injection method for blood glucose intervention.Patients in the observation group were treated with vildagliptin and Aspartic Insulin 30 injection.The changes of fasting blood glucose(FPG),postprandial 2 h blood glucose(2 hPG),glycosylated hemoglobin(HbAlc),body mass index(BMI)and other indicators of the two groups were measured before treatment,before surgery and 6 months after surgery,and the adverse reactions of the two groups of patients were compared.Results Repeated measures analysis of variance showed that there were statistically significant differences in FPG and 2 hPG of the two groups collected before treatment,before surgery and 6 months after surgery(F=85.40,617.06; P<0.05).Independent sample t test showed that HbAlc in the control and the observation group((7.9±0.9)%,(7.5±0.8)%)were significantly lower than those before treatment((9.8 ±1.5)%,(9.5±1.2)%)(t=5.95,7.60,P<0.05),at 6 months after surgery,BMI((25.83±1.78)kg/m2) in the observation group was significantly lower than that in the control group((27.35 ± 2.41)kg/m2)(t=2.78,P<0.05).The number of adverse reactions in the observation group was 2 cases(6.67%),significantly lower than that of the control group of 13 cases(43.33%),the difference between the two groups was statistically significant(χ2=10.756,P<0.05).Conclusion Vildagliptin combined with Aspartic Insulin 30 injection can not only effectively control the perioperative blood glucose levels in patients with HTO,but also can help the patients to control the body weight and reduce the incidence of adverse reactions.This method has a positive effect on the recovery of HTO.
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Objective To optimize the process of vildagliptin based on the principle of quality by design(QBD),so as to control the safety and quality of the product. Methods Process route was confirmed through investigating literature and the advantages or disadvantages of each route were discussed. The key process parameters were determined according to the single factor experiments, which were designed by understanding of product process and process controls. Meanwhile, impurities of intermediates were studied and the safety and quality of the product could be guaranteed. Results and Conclusion Industrial process of vildagliptin was developed by the principle of QBD, which can promise the safety and quality of vildagliptin, improve product quality and meet the registration requirements of State Food and Drug Administration(SFDA).
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Objective To optimize the process of vildagliptin based on the principle of quality by design(QBD),so as to con?trol the safety and quality of the product. Methods Process route was confirmed through investigating literature and the advantages or disadvantages of each route were discussed. The key process parameters were determined according to the single factor experiments , which were designed by understanding of product process and process controls. Meanwhile,impurities of intermediates were studied and the safety and quality of the product could be guaranteed. Results and Conclusion Industrial process of vildagliptin was devel?oped by the principle of QBD,which can promise the safety and quality of vildagliptin,improve product quality and meet the registra?tion requirements of State Food and Drug Administration(SFDA).
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Objective:To study the effects and safety of metformin combined with vildagliptin on the glycemic control for patients with newly diagnosed type 2 diabetes mellitus.Methods:60 patients with type 2 diabetes mellitus who were treated from February 2015 to April 2016 were selected and divided into the control group and the observation group according to different treatment methods.The control group was treated with routine treatment.The observation group was treated with vildagliptin based on the control group.The blood glucose,glycosylated hemoglobin,two-hour postprandial blood glucose and serum as well as urinal amylase were measured before and after treatment,and the clinical curative effect of the two groups and the levels of interleukin-6,tumor necrosis factor and C-reactive protein were compared.Results:After treatment,the total effective rate of observation group was 90％,which was significantly higher than that of the control group(66.7％,P＜0.05).After treatment,the serum interleukin-6,tumor necrosis factor,C-reactive protein and fasting blood glucose,glycosylated hemoglobin and postprandial blood glucose levels were significantly lower than those of the control group[(7.63± 1.12)dvs(8.68± 1.30)d;(7.23± 0.95)d vs(7.89± 1.20)d;(11.14± 1.56)d vs(12.12± 1.89)d];[(12.12± 1.89)d vs(ll.20± 1.34)d;(6.89± 0.96)d vs(8.23± 1.10)d;(1.65± 0.23)d vs(3.65± 0.48)d] (P＜0.05).After treatment,the INS level of observation group was significantly lower than that of the control group (P＜0.05) and the GLP-1 level was significantly higher than that of the control group (P＜0.05).Conclusion:Metformin combined with vildagliptin could effectively control the blood glucose of patients with newly diagnosed type 2 diabetes and enhance the safety.
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OBJECTIVE:To establish a method for the determination of related substances in Vildagliptin tablets. METHODS:HPLC method was adopted. The determination was performed on Xterra MS C18 column with mobile phase consisted of [phosphate buffer-water-acetonitrie-methanol(400 : 600 : 15 : 15,V/V/V/V)]-[phosphate buffer-acetonitrile-methanol(400 : 450 : 150,V/V/V)](gra-dient elution)at the flow rate of 1.2 mL/min. The detection wavelength was set at 210 nm and column temperature was 35 ℃. The sample size was 10 μL. RESULTS:The linear ranges were 18.80-188.0 μg/mL for impurity A(r=0.9995),22.64-226.4 μg/mL for impurity B(r=0.9996),21.74-217.4 μg/mL for impurity C(r=0.9997),19.12-191.2 μg/mL for impurity D(r=0.9998). The limits of detection were 4.18,2.68,1.12,1.34 μg/mL,respectively;RSDs of precision,stability and reproducibility tests were lower than 3%;the recoveries of impurity A,B,C and D were 97.9%-103.1%(RSD=2.01%,n=9),98.8%-104.1%(RSD=1.93%,n=9),98.0%-103.6%(RSD=1.81%,n=9),100.8%-104.1%(RSD=0.98%,n=9),respectively. CONCLU-SIONS:The method is simple and accurate,and can be used for the determination of related substances in Vildagliptin tablets.
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Objective To synthesize the impurity of vildagliptin as a reference substance, and optimize its preparation process by the central composite design-response surface methodology. Method The impurity was synthesized from L-proline and 3-amino-1-adamantanol through chloroacetylation, amination, dehydration and substitution. Results The structure of the disubstituted derivative of vildagliptin was verified by IR, 1H-NMR and MS. Conclusion The synthesized compound can be used as the reference substance of the impurity, so the impurity can be controlled. Preparation process gained the application value after it was optimized by the central composite design-response surface methodology.
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Objective To systematically evaluate the correlation between selective dipeptidyl peptidase (DPP)-4 inhibi-tor ,vildagliptin and risk of arthralgia/osteoarthritis .Methods The following databases of PubMed (1978 to February 2016) , the Cochrane Library (Issue 4 ,2015) ,EMbase (1974 to February 2016) ,CBM(1978 to February 2016) ,CNKI(1978 to Feb-ruary 2016) ,VIP(1989 to February 2016) were searched .The randomized controlled trials (RCTs) for vildagliptin related ar-thralgia/osteoarthritis were assessed using the Cochrane Collaboration system .The meta-analysis was performed with RevMan 5 .3 software .Results Ten RCTs were included .Meta-analysis showed that vildagliptin had higher risk of arthralgia/osteoar-thritis than other oral hypoglycemic agents or placebo (RR=1 .24 ,95% CI 1 .08 to 1 .44 ,P=0 .003) .Further analysis indica-ted that patients received different doses of vildagliptin had higher risk of arthralgia/osteoarthritis than the placebo group (RR=1 .35 ,95% CI 1 .02 to 1 .78 ,P=0 .04) .In particular ,the group who took vildagliptin 50mg once daily had significantly higher risk of arthralgia/osteoarthritis than the placebo group (RR=3 .04 ,95% CI 1 .44 to 6 .44 ,P=0 .004) .In comparison of other oral hypoglycemic agents ,the vildagliptin group had higher risk of arthralgia /osteoarthritis (RR=1 .19 ,95% CI 1 .01 to 1 .41 ,P=0 .04) .Conclusion Based on the Meta-analysis results ,vildagliptin increases the risk of arthralgia/osteoarthri-tis .Especially vildagliptin 50mg once daily had two times higher risk than the placebo group .However the long-term safety of vidagliptin still needs to be confirmed by RCTs with larger samples and long term follow-up .
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Objective To observe the efficacy and safety of vildagliptin combined with acarbose in treating type 2 diabetes. Methods 78 patients with type 2 diabetes were divided into two groups to have additional vildagliptin combined with acarbose or acarbose combined with placebo. The clinical efficacy and adverse reactions after 12 weeks were investigated. Results In the treatment group, FBG, 2 h PG and HbA1C declined after treatment (P 0.05). There were either liver and kidney damage (P > 0.05), nor hypoglycemia. Conclusion Vildagliptin combined with acarbose is superior to Acarbose combined with placebo , and it produced no more untoward effect.
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BACKGROUND: The use of dipeptidyl peptidase-4 (DPP-4) inhibitors is increasing among renal transplant patients with diabetes. However, the glucose-lowering efficacies of various DPP-4 inhibitors and their effects on blood cyclosporine levels have not been fully investigated. We compared the glucose-lowering efficacies of DPP 4 inhibitors and evaluate their effects on the blood levels of cyclosporine in renal transplant recipients with diabetes. METHODS: Sixty-five renal allograft recipients who received treatment with DPP-4 inhibitors (vildagliptin, sitagliptin, or linagliptin) following kidney transplant were enrolled. The glucose-lowering efficacies of the DPP-4 inhibitors were compared according to the changes in the hemoglobin A1c (HbA1c) levels after 3 months of treatment. Changes in the trough levels of the cyclosporine were also assessed 2 months after treatment with each DPP-4 inhibitor. RESULTS: HbA1c significantly decreased in the linagliptin group in comparison with other DPP-4 inhibitors (vildagliptin –0.38%±1.03%, sitagliptin –0.53%±0.95%, and linagliptin –1.40±1.34; P=0.016). Cyclosporine trough levels were significantly increased in the sitagliptin group compared with vildagliptin group (30.62±81.70 ng/mL vs. –24.22±53.54 ng/mL, P=0.036). Cyclosporine trough levels were minimally changed in patients with linagliptin. CONCLUSION: Linagliptin demonstrates superior glucose-lowering efficacy and minimal effect on cyclosporine trough levels in comparison with other DPP-4 inhibitors in kidney transplant patients with diabetes.
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Humans , Allografts , Cyclosporine , Diabetes Mellitus , Dipeptidyl-Peptidase IV Inhibitors , Hyperglycemia , Kidney , Kidney Transplantation , Pilot Projects , TransplantationABSTRACT
Introduction: The incidence of diabetes in urban Punjab is on the rise and the number of diabetics is increasing year by year. Material and methods: This 24 week study was designed to compare vildagliptin versus pioglitazone as an add-on therapy in patients of type 2 diabetes mellitus inadequately controlled with metformin alone in Punjabi population. Sixty patients were randomized in two groups to receive either vildagliptin 100 mg (group 1) or pioglitazone 30 mg (group 2) in addition to metformin 1000 mg. The primary efficacy end point was change in FBG, PPG and HbA1c. Secondary end point included lipid profile, body weight and peripheral edema. Results: There was no significant difference between mean reduction in FBG, PPG and HbA1c in both groups. There was significant decrease in mean body weight in group 1 in contrast to significant increase in group 2. Both the treatment groups reported a significant decrease in TG, TC, LDL and increase in HDL. Conclusion: Vildagliptin displays robust efficacy with the added benefits of a much lower risk of peripheral edema, hypoglycemia and no weight gain, making it a promising alternative to pioglitazone as an add-on therapy to metformin in Punjabi population.
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BACKGROUND: The effects of dipeptidyl peptidase-4 inhibitors on adipokines remain obscure. The aim of this study was to evaluate the effect of the addition of vildagliptin on visfatin, an adipokine that represents inflammatory biomarkers of adipose tissue, in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy. METHODS: In this 16-week, double-blind, randomized, parallel-group, placebo-controlled study, 71 patients were randomly assigned to vildagliptin 50 mg twice a day (n = 35) or placebo (n = 36) added to ongoing metformin therapy. Fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), plasma lipids, and visfatin levels were measured at baseline and 16 weeks after treatment. RESULTS: After 16 weeks, significant reduction in HbA1c and FPG was observed with vildagliptin addon treatment compared to placebo (-0.54 +/- 0.52%, P = 0.001 and -14.80 +/- 19.21 mg/dL, P = 0.004, respectively). However, no other clinically meaningful changes in lipid parameters or visfatin were observed. CONCLUSION: Vildagliptin add-on to metformin significantly improved fasting blood glucose and HbA1c. However, in this study, no significant differences in lipid parameters or visfatin level were observed between the two groups.