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Background: Type 2 Diabetes Mellitus (DM) is a metabolic disorder, treated by insulin and oral hypoglycaemic agents (OHA). Despite treatment, to protect diabetic population from its complications is difficult. So, there is a need for an OHA with different mechanism of action and minimal side effects. Bromocriptine Mesylate QR (Quick release) formulation was approved by FDA for treatment of type 2 DM. Hence, this study was planned to highlight the usefulness of Bromocriptine QR in type 2 diabetes mellitus.Methods: Total 140 patients with type 2 DM were randomized into two groups. The control group was treated with Metformin 500 mg BD (twice daily) and Glipizide 5 mg BD for a period of 3 months. The study group received Bromocriptine quick release 1.6 mg once daily, metformin 500 mg BD and Glipizide 5 mg BD for a period of 3 months. In both control and study groups, fasting blood glucose, postprandial blood glucose was monitored at 0, 1st, 2nd and 3rd month. HbA1C was done at baseline and at the end of 3 months.Results: There was statistically significant decrease in fasting blood glucose, postprandial blood glucose and HbA1C when compared to baseline in both control group (p <0.05) and study group (p <0.05) at the end of 3 months. But the decrease in FBS, PPBS, HbA1C was higher in the study group (p=0.0001) than the control group (p=0.001).Conclusions: In type 2 DM patients, Bromocriptine QR, combined with metformin and Glipizide reduced fasting and postprandial blood glucose and HbA1C significantly compared to metformin and glipizide alone.
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Objective To investigate the effect of sitagliptin in the treatment of elderly patients with type 2 diabetes mellitus complicated with coronary heart disease and its influence on Hcy,irisin and chemerin.Methods From January 2015 to June 2016,600 elderly patients with type 2 diabetes mellitus complicated with coronary heart disease in the Sixth People's Hospital of Cixi were selected and divided into observation group and control group,with 300 cases in each group.The control group received metformin treatment,the observation group was given sitagliptin combined with metformin.Before and after treatment,the blood FBG,HbA1c and BMI,Hcy,irisin and chemerin levels were detected.Results After treatment,the FBG,HbA1 c and BMI levels in the observation group were significantly lower than those in the control group [(6.28 ± 1.43) mmol/L vs.(7.03 ± 1.04) mmol/L,t =5.256;(6.17 ± 1.02) ％ vs.(7.02 ± 0.98) ％,t =7.446;(21.03 ± 2.04) kg/m2 vs.(23.02 ± 1.23) kg/m2,t =14.469] (all P ＜ 0.05).The level of Hcy in the observation group after treatment was significantly lower than that in the control group [(7.48 ± 1.03) μmol/L vs.(10.38 ± 1.74) μmol/L,t =17.868,P ＜ 0.05].After treatment,the blood irisin level in the observation group was significantly higher than that in the control group [(3.28 ± 0.89) μg/mL vs.(2.43 ± 0.38)μg/mL,t =15.213,P ＜ 0.05].After treatment,the chemerin level in the observation group was significantly lower than that in the control group [(210.38 ± 9.84)ng/mL vs.(231.38 ± 10.03)ng/mL,t =24.379,P ＜ 0.05].Conclusion Sitagliptin in the treatment of elderly patients with type 2 diabetes mellitus complicated with coronary heart disease can effectively regulate the levels of Hcy,irisin and chemerin,and improve the curative effect.
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Objective Tocompare the clinical efficacy of Glipizide and Repaglinide in the treatment of newly diagnosed type 2 diabetes (T2DM).Methods The clinical data of 104 patients with newly diagnosed T2DM were retrospectively analyzed,among them,54 cases were treated with Glipizide (group G),and 50 eases were treated with Repaglinide (group R).The levels of FPG,2hPG,HbA1c,TC,TG and HDL-C before and after treatment and HbA1c compliance rates,BMI variation and incidences of hypoglycemia between two groups were compared.Results The levels ofFPG,2hPG and HbA1c after treatment in the two groups were significantly lower than those before treatment (P ＜ 0.05),and there were no significant difference between the groups.There were no significant changes in TG,TC and HDL-C levels before and after treatment in the two groups.There were no significant changes in HbA1c compliance rates between the two groups,and the BMI variation and incidences of hypoglycemia in the group G were significantly lower than those in the group R (P ＜ 0.05).Conclusion BothGlipizide and Repaglinide in the treatment of T2DM can reduce blood glucose effectively,and no significant effect on blood lipids,But Glipizide has more advantages in controlling BMI and reducing hypoglycemia.
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Objective · To explore the relationship between baseline lipid profiles and long-term cardiovascular outcomes after intervention with hypoglycemic drugs metformin and glipizide and to detect lipid components that can predict the long-term cardiovascular effect of metformin and glipizide.Methods· Liquid chromatography-quadrupole time of flight-mass spectrometry (LC-QTOF/MS) was used to measure 119 lipid components in baseline serum for 116 patients with type 2 diabetes (T2DM) and atherosclerotic heart disease (CHD) who were treated with glipizide (56 cases,the glipizide group)or metformin (60 cases,the metformin group).Cardiovascular complex end points (including cardiovascular death,all-cause death,nonfatal myocardial infarction,nonfatal stroke,and arterial revascularization) of all patients were followed up.The relationship between lipid components and cardiovascular complex end points was analyzed with Logistic regression analysis.The category-free net reclassification index (cfNRI) and the integrated discrimination improvement (IDI) were used to evaluate whether lipid components are helpful for predicting the recurrent cardiovascular events.Results· The differences in baseline drug distribution,clinical characteristics,and biochemical indexes between two groups were not statistically significant,except for diuretics use,serum PC (O-34:2) level,and SM (d18:0-24:0) level.Logistic regression analysis showed that baseline ChE (20:4) was a protective factor for recurrent cardiovascular events in the glipizide group (OR=0.87,P=0.039).ChE (20:4) significantly increased the cfNRI and IDI of cardiovascular complex end points by 69％ and 0.07,respectively (P=0.011,P=0.028).Baseline SM (dl 8:1-22:0) was a risk factor for recurrent cardiovascular events in the metformin group and all participants (OR=1.65,P=0.039;OR=1.64,P=0.014).SM (d18:1-22:0) significantly increased the cfNRI of cardiovascular complex end points in the metformin group and all participants by 74％ and 55％,respectively (P=0.012,P=0.005).Conclusion· Of 119 lipid components measured with LC-QTOF/MS,baseline ChE (20:4) is a protective factor and SM (d18:1-22:0) is a risk factor for cardiovascular complex end points in with T2DM and CHD patients after long-term treatment with metformin and glipizide.Both lipid components are helpful for improving the prediction of recurrent cardiovascular events.
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Type 2 diabetes (T2DM) is a progressive insulin secretory defect accompanied by resistance to insulin, and thereby making glycemic control a major concern in the treatment of these patients. Oral drug administration, though a popular option for its non-invasiveness, suffer from poor bioavailability. It could be related to the efflux transport of intestinal P-glycoprotein (Pgp). In the present study, we explored the binding interactions of antidiabetic drugs i.e., sulfonylurea drugs (glimepiride, glipizide, glyburide) and rapid acting insulin secretagogues viz., nateglinide, repaglinide and rosiglitazone; and Pgp inhibitors i.e., Generation I (verapamil and tamoxifen), III (tetradrine and tariquidar), and natural inhibitors (fumagillin and piperine) in mouse Pgp model. Our results revealed that fumagillin piperine and verapamil possess maximum interaction energies with Pgp compared to antidiabetic drugs. These observations elucidate the role of fumagillin and piperine as potential natural compounds which could intervene in the efflux action of Pgp in extruding the antidiabetic drugs and may have implications for increasing efficacy of oral antidiabetic therapy.
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OBJECTIVE:To evaluate the clinical efficacy and safety of triple therapy in the treatment of type 2 diabetes melli-tus(T2DM),and to open up more effective way to treat T2DM. METHODS:76 patients with T2DM were randomly divided into control group and observation group with 38 cases in each group. The control group received conventional therapy,i.e. oral hypo-glycemic agents Glipizide controlled-release tablet 5 mg,qd+Metformin tablets 5 mg,tid. The observation group was treated with triple therapy,i.e. berberine hydrochloride 0.5 g,tid,for 3 months,on the basis of control group. The biochemical index were compared between 2 groups Before and after treatment,including fasting blood glucose (FBG),postprandial 2 h blood glucose (2 h FPG),glycosylated hemoglobin(HbA1c),insulin(FINS),total cholesterol(TC)and triglyceride(TG),high/low density li-poprotein cholesterol (HDL-C/LDL-C),etc.,to evaluate its safety. RESULTS:After treatment,FBG,2 h FPG,HbA1c,FINS, TC and LDL-C of 2 groups and TG of observation group were all decreased significantly,while the level of HDL-C was increased significantly,with statistical significance(P<0.05);FBG,2h FPG,HbA1c,FINS,TC and LDL-C of observation group were im-proved more significantly than control group,the difference was statistically significant(P<0.05). ADR was found in 4 patients of observation group,and the symptoms were relieved after symptomatic treatment. CONCLUSIONS:In the treatment of T2DM,tri-ple therapy can down-regulate blood lipid and blood sugar stably,have definite therapeutic efficacy and little side effect.
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Background: Oxidative stress has an important role in the pathophysiology of diabetes mellitus (DM) Type-II. Oxidative stress has an important role in the progression of DM Type-II and its related complications such as retinopathy, neuropathy and many others. The present study was carried out to evaluate the effect of glipizide therapy on oxidative stress parameters in Type-II DM. Methods: Thirty newly diagnosed diabetes patients were given glipizide therapy on 1st day and continue for 3 months. 30 non-diabetic healthy volunteers served as a control. Plasma malondialdehyde (MDA), superoxide dismutase (SOD) and catalase levels were measured at the time of enrollment and at the end of 3 months of glipizide treatment. Result: The results are analyzed using paired t-test. Plasma MDA was significantly increased, whereas SOD and catalase were significantly reduced in newly diagnosed diabetic patients as compared to control. After 3 months of glipizide therapy, plasma MDA was significantly reduced, whereas SOD and catalase were significantly increased. Conclusion: Glipizide therapy significantly reduced oxidative free radicals and increased antioxidant mechanism, which reduced oxidative stress, progression DM-II and its related complication.
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The aims of this study were to document the post market research of the pharmaceutical industry and the effects of labeling revisions on post market studies and outcomes of oral anti-diabetics. A literature search identified post market studies of metformin, glipizide, and pioglitazone. Labeling revisions in MedWatch® were collected as indicators of the FDA’s response to post market drug safety. Data were analyzed by comparing industry and non-industry sponsored studies for the number of pre- and post-market studies, study sponsorship, drug labeling revisions, and outcomes after the drugs became generic. The number of industry versus non-industry sponsored studies was 149 (49%) and 155 (51%) for metformin; 33 (44%) and 42 (56%) for glipizide; and 85 (80.2%) versus 21 (19.8%) for pioglitazone. The differences in favorable results between industry and non-industry sponsored studies were similar for metformin and glipizide. The number of industry-sponsored studies with favorable results did not significantly increase after metformin or glipizide became generic. Studies sponsored by the manufacturer of glipizide reported significantly more favorable outcomes in comparison to studies sponsored by industry competitors (90% favorable, 10% neutral, 0% unfavorable, P < 0.05). For pioglitazone, significantly more favorable results were reported in industry-sponsored studies (88.2%) as compared to non-industry (66.7%) (p = 0.008) sponsored studies. A significant correlation exists between the number of pioglitazone’s labeling revisions and the number of post market studies (p = 0.008). Post market research is guided by the pharmaceutical industry and by individual researchers’ interests. Pharmaceutical industry-sponsored studies support the favorable use of the patented drug and show unfavorable results of the generic equivalent. A possible correlation exists between drug labeling revisions and the number of post market studies.
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The objective of this study was to develop glipizide microsphere with natural gums. Guar gum and xanthan gum were used separately in different ratios as natural polymers. The microspheres were prepared by orifice ionic gelation method and they were characterized by scanning electron microscopy and particle size analysis. Among six formulations, microspheres of four formulations (F1-F4) were discrete, sphrerical and free flowing. There was an inverse relationship found between the amount of gum and surface smoothness in case of guar gum-containing microspheres while a forward relationship was found between amount of gum and surface smoothness in case of the microspheres containing xanthan gum. The size of the particles increased with increasing amounts of gum. It can be concluded that guar gum and natural gum at a ratio of 1:0.25 and 1:0.5 can be ideal for formulating natural gum based glipizide mucoadhesive microsphere.
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OBJECTIVE: To optimize the formulation of glipizide extended release osmotic pump tablets by using central composite design-response surface methodology. METHODS: Release of gilipizide of 16 h from extended release tablets (Y1) and linear correlation coefficient of cumulative release amount to time (Y2) were used as the evaluation indexes. The effects of three factors, the semipermeable film weight gain (X1), the proportion of HPMC K4M in the push layer (X2) and the proportion of PEG4000 in solid content of semipermeable film coating (X3), on the release of glipizide from the osmotic pump tablets were investigated. The relationship between the two evaluation indexes and three influencing factors was described by multiple linear equations and quadratic polynomials. Corresponding response surfaces were drawn according to the mathematical model and the experimental data of Y1 and Y2, which were then used to obtain the optimal prescription range. Finially the optimal prescription range was verified. RESULTS: Y1 and Y2 had quantitative relationships with the three factors. The optimum prescription was as follows: the range of semipermeable film weight X1 was 20.0%-21.5%, the range of the proportion of HPMC K4M in the push layer X2 was 23.0%-25.5%, and the range of the proportion of PEG4000 in solid content of semipermeable film coating X3 was 5.2%-5.5%. The release curve of the optimized prescription was similar with that of commercial tablets. CONCLUSION: Central composite design-response surface methodology is successfully used to optimize the formulation of glipizide extended release osmotic pump tablets with good prediction ability.
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The aim of present investigation was to enhance the solubility of glipizide (BCS Class II). Glipizide is an oral antidiabetic agent with relatively short elimination half life. Inclusion complex of Glipizide with -cyclodextrin was prepared by kneading method and evaluated for its in-vitro release. Phase solubility studies were performed according to method reported by Higuchi and Connors which was classified as AL type characterized by apparent 1:1 stability constant. The Glipizide & Beta Cyclodextrin found to be compatible which was observed from FTIR spectra of Glipizide - CD Complex. The dissolution study of Glipizide - CD complex shows significant increase in the drug release than pure drug. Matrix Glipizide - CD complex tablet complex equivalent to 10 mg Glipizide were prepared by using Hydroxy propyl methyl cellulose (HPMC), Carboxy methyl cellulose sodium (NaCMC) and Microcrytalline cellulose (MCC). The tablets were evaluated for various tests like hardness, friability, disintegration and in-vitro dissolution studies.
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OBJECTIVE: To establish a simple and sensitive method of high performance liquid chromatography - tandem mass spectrometry (HPLC-MS/MS) for the determination of glipizide in human plasma and to calculate the pharmacokinetic parameters and evaluate the bioequivalence of two glipizide preparations in healthy Chinese volunteers. METHODS: A two-periods, randomized, crossover trial design was used. Twenty-four subjects took the test and reference preparations at the dose of 5 mg, and glipizide plasma concentration was determined by HPLC-MS/MS. Pharmacokinetic parameters were calculated and bioequivalence was evaluated. RESULTS: The mean pharmacokinetic parameters of glipizide after adminstration of 5 mg of test or reference preparations were as follows: ρmax were (251.25±61.94) and (240.13±52.43) μg·L-1, t1/2 were (4.85±1.39) and (5.08±1.76) h, tmax were (3.35±1.22) and (3.38±1.35) h, and AUC0-tn were (1561.44±475.73) and (1588.82±507.40) μg·h·L-1, respectively. CONCLUSION: The HPLC-MS/MS method is sensitive and simple, and can be used for the determination of glipizide plasma concentration. Statistical analysis of the pharmacokinetic parameters in heathy subjects indicated that the two preparations of glipizide are bioequivalent.
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Talinum Triangulare (Family: Portulacaceae) is an herbaceous perennial plant widely grown in tropical regions as a leaf vegetable with a blood-glucose-lowering effect, but its mechanism of action are still unknown. Here we report a hypoglycemic activity of Methanolic Extract of Talinum Triangulare Leaf (METTL) in healthy, glucose loaded and Streptozotocin (STZ)-induced diabetic rats. Animals either healthy or STZ-induced diabetic show significantly lowered blood glucose levels after 2 weeks of METTL treatment (250 mg/kg), it significantly reduced blood glucose levels compared with that in diabetic control rats. Additionally, the increase in blood glucose levels after administration of glucose (1.2 g/kg) in normal rats is significantly decreased and the oral glucose tolerance (OGTT) of STZ-induced diabetic rats is largely improved by METTL treatment. However, co-administration of METTL with glipizide, an oral hypoglycemic drug, it produces synergistic effect. We conclude that METTL has a significant anti hyperglycemic effect. Continuous glucose monitoring is needed in diabetic patients.
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Sixty male SD rats were separately fed by normal diet or high-fat diet.After eight weeks of highfat diet,these rats were injected low dose streptozotocin (30 mg/kg).Diazoxide or glipizide was administered to the diabetic rats for 4 weeks.The results showed that body weight,serum insulin,and insulin sensitive index were decreased in the obese diabetic rats while the fasting blood glucose,total cholesterol,and triglyceride levels were increased compared with the high-fat diet group ( all P＜0.01 ).Consistent with the results of glipizide,diazoxide treatment lowered blood glucose,improved glucose tolerance,and decreased islet cell apoptosis compared with the diabetes mellitus group ( all P＜0.05 ).The results suggest that diazoxide can improve islet function of obese type 2 diabetic rats via decreasing insulin secretion and thus lessening the load on islet cells.
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The purpose of this study was formulation and in vitro evaluation of floating-bioadhesive tablets to lengthen the stay of glipizide in its absorption area. Effervescent tablets were made using chitosan (CH), hydroxypropyl methylcellulose (HPMC), carbopolP934 (CP), polymethacrylic acid (PMA), citric acid, and sodium bicarbonate. Tablets with 5 percent effervescent base had longer lag time than 10 percent. The type of polymer had no significant effect on the floating lag time. All tablets floated atop the medium for 23-24 hr. Increasing carbopolP934 caused higher bioadhesion than chitosan (p < 0.05). All formulations showed a Higuchi, non-Fickian release mechanism. Tablets with 10 percent effervescent base, 80 percent CH/20 percent HPMC, or 80 percent CP/20 percent PMA seemed desirable.
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OBJECTIVES: The aim of the present investigation was to form matrix patches with ethyl cellulose (EC) as the base polymer, polyvinyl pyrrolidone (PVP) as the copolymer, plasticizer with dibutyl phthalate (DBP) or acetyl tributyl citrate (ATBC) and the drug glipizide (gz) by the solvent casting method. Physicochemical properties of the patches and in vitro drug release were determined in a modified Keshary-chien diffusion cell to optimize the patch formulations with the help of experimental data and figures for further studies. TECHNIQUES: EC and PVP of different proportions with different weight percentages of either DBP or ATBC and a fixed amount of glipizide were taken for matrix patch formations. The dried patches were used for measuring their drug contents as well as their thicknesses, tensile strengths, moisture contents and water absorption amounts in percentage. In vitro release amounts at different intervals were measured by UV-spectrophotometer. RESULTS: Drug contents varied from 96 - 99 percent. Thickness and tensile strength varied due to weight variation of the ingredients in the matrix patches. Moisture content and water absorption in wt percent were greater for the patches containing higher amount of PVP due to its hydrophilic nature. Variations in drug release were observed among various formulations. It was found that all of the releases followed diffusion controlled zero order kinetics. Two DBP patches yielded better and more adequate release. CONCLUSIONS: The two formulations with DBP were the preferred choice for making matrix patches for further studies.
O objetivo da presente pesquisa foi formar matrizes para bandagens de liberação transdérmica com etilcelulose (EC) como polímero base, polivinilpirrolidona (PVP), como copolímero, plastificante com ftalato de dibutila (DBP) ou citrato de tributilacetila (ATBC) e o fármaco glipizida (gz) pelo método de evaporação do solvente (moldagem com solvente). As propriedades físico-químicas das bandagens e a liberação do fármaco in vitro na célula de difusão de Keshary-chien modificada foram determinadas para aperfeiçoar as formulações das bandagens com o auxílio de dados experimentais e figuras para estudos posteriores. EC e PVP em diferentes proporções com porcentagens diferentes de massa tanto de DBP quanto de ATBC e quantidade fixa de glipizida foram utilizadas como matrizes para a formação de bandagens de liberação transdérmica. As bandagens secas foram empregadas para medir seus conteúdos em fármaco e, também, a sua espessura, resistência à tensão, conteúdos de umidade e porcentagem de absorção de água. As quantidades liberadas in vitro em diferentes intervalos de tempo foram medidas por espectrofotômetro de UV. Os conteúdos de fármaco variaram de 96 a 99 por cento. A espessura e a resistência à ruptura variaram devido à variação de massa dos componentes da matriz das bandagens. O conteúdo de umidade e a água absorvida, em porcentagem de massa, foram maiores para as bandagens que continham grandes quantidades de PVP devido à sua natureza hidrofílica. As variações na liberação de fármaco foram observadas entre as várias formulações. Todas as liberações seguiram a cinética de difusão controlada de ordem zero. Duas bandagens DBP resultaram em melhor e mais adequada liberação. As duas formulações com DBP foram escolhidas para a preparação de matriz de bandagens para estudos posteriores.
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Drug Delivery Systems , Glipizide/pharmacokinetics , Glipizide/chemistry , Chemical Phenomena , Chronic Disease , Diabetes Mellitus , Metabolic DiseasesABSTRACT
Objective To study the therapeutic effect of co-administrated metformin and rosiglitazone in the treatment of type 2 diabetes mellitus(T2DM).Methods 53 patients with T2DM were divided into 2 groups in random:co-administrated glipizide and metformin(group A)and co-administrated metformin and rosiglitazone(group B).All cases were treated for 6 months.Blood pressure(BP),blood glucose(BG),body mass index(BMI),hemoglobin A1c(HbA1c),insulin,and blood lipid were determined and the HOMA-insulin resistance index(HOMA-IR)was calculated.Results Both treatments were effective on hyperglucose,hypertension,hyperlipidemia and high BMI(P<0.05-0.01),while group B could lower the level of insulin(P<0.05)and HOMA-IR(P<0.01).Conclusions Treatment of co-administrated metformin and rosiglitazone can improve the abnormal carbohydrate and lipid metabolism,higher levels of BP and BMI,and ameliorate insulin resistance.
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Objective To observe the long-tern efficacy and safety of rosiglitazone in treatment of type 2 diabetic pa- tients.Methods 59 patients on a regimen of glipizide or glipizide+mefformin with poor glycaemic control were added rosiglitasone 8mg/d and observed for 3 years,and the dose of glipizide would be reduced 7.5mg/d when FPG
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Objective To investigate whether the combination of glipizide-XL with glucophage was more rational in insulin resistance and insulin secretion in patients with type 2 diabetes mellitus(T2DM).Methods The changes of insulin resistance and insulin secretion were evaluated from variations of IAI(insulin sensitivity index),IR(insulin resistance index.),IS(insulin secretion index)and HBCI(B-ce1l function index)in cases treated with glipigide-XL and glucophage or either for 18 weeks.Results IAI\IR standing for insulin resistance were higher significantly,and IS & HBCI standing for insulin secretion were lower significantly in patients with T2DM than in normal group(P
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Objectives:To study the pharmacokinetics and relative bioavailability of glipizide in healthy male volunteers. Methods:The glipizide concentrations in plasma were determined by HPLC UV. The column: Lichrospher C18 (5 ?m,150 mm?4.6 mm),the mobile phase: methanl∶0.01 mol/L sodium acetale buffer (pH 4.8) (59 ∶41); the flow rate:1 ml/min, the detection wavelength: 225 nm. The test and reference formulations of glipizide were given to 20 healthy male volunteers. Results: The calibration curve was linear within the range of (25～1 000)?g/L, r =0.999 4. The minimum detection limit was 25 ?g/L. The mean recovery was 89.84%, CV of inter day and intra day were no more than 5%.After a single oral dose of 10 mg glipizide test or reference tablet, the main pharmacokinetic parameters AUC 0-15, AUC 0-∞, T max ,C max and t 1/2 were (3 502.78?635.82) , (3 214.23?590.46)?g/( L?h),(3 868.22?699.93), (3 593.94?638.60)?g/(L?h),(3.85?1.44), (3.76?1.13)h, (550.80?110.19), (531.15?148.42)?g/L,(3.57?1.11)h and (3.80?1.06)h ,respectively. The relative bioavailability F 0-15 ,F 0-∞ were (110.6?19.8)% and (108.8?17.9)%. Conclusions: No significant difference exists among the pharmacokinetic parameters for the experimental tablets and the reference. The two formulations were bioequivalent.