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Aim To evaluate the reno-proteetion of saxagliptin combined with metformin in mice with T2DM anrl its relationship with redox balance.Meth¬ods C57BL/6J mice were fed with high fat diet and injected with low dose STZ intraperitoneally to establish T2DM mouse model.Then they were randomly divided into T2DM group, glibenclamide group ( Gli group), metformin group ( Met group) , saxagliptin group ( Sax group) and saxagliptin + metformin group ( S + M group) , and normal control group ( NC group) with 8 mice in each group.Eight weeks after intervention the mice were weighed.Blood, urine and renal tissue sam¬ples were collected to measure GHbA,c, FBG, Alb, 8-OHdG, 8-iso-PG, SOD, GSH, GSSG and Ucr.The pathological morphology of renal tissues in each group was observed.Results Saxagliptin combined with metformin reduced significantly the levels of Alb/Ucr ( UACR) , 8-0HdG/Ucr( UOCR) , 8-iso-PG/Ucr( UP- CR) , increased the activity of SOD and GSH/GSSG ratio, and improved the pathological changes of renal tissues, which were superior to those in Met group and Sax group.Conclusions Saxagliptin combined with metformin have a synergistic protective effect on the kidneys of type 2 diabetic mice.The mechanism is partly related to alleviating oxidative stress and impro¬ving redox balance in vivo.
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@#In order to evaluate the consistency of the release behavior between the self-made saxagliptin and metformin hydrochloride sustained-release tablets and the reference preparations in vitro, the similarity of the dissolution curves between the self-made preparations and the reference preparations in four dissolution mediums: HCl (pH 1.0), acetate buffer saline (pH 4.5), phosphate buffer saline (pH 6.8) and pure water, and the gel morphology and strength of the self-made preparations and the reference preparations in the HCl (pH 1.0) solution medium were compared.Results showed that in four dissolution mediums, the dissolution rates of saxagliptin in the self-made preparations and the reference preparations at 15 min were greater than 85%, and the ?2 similarity factors of metformin hydrochloride were 89, 83, 80, 86, all greater than 50, so the dissolution of the self-made preparations was consistent with those of the reference preparations.The volume expansion rate, water absorption rate and erosion rate were consistent with those of the reference preparations, and the gel strength of the self-made preparations was the same as that of the reference preparations.The in vitro release behaviors of the self-made preparations and the reference preparations are consistent, which provide a good guarantee for bioequivalence.
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OBJECTIVE：To provide method reference for scientifically eva luating the rationality of the use of saxagliptin . METHODS：Based on the drug instructions ，clinical guidelines ，clinical pathways ，related references ，clinical endocrinology department and pharmaceutical experts of a hospital jointly discussed and formulated the evaluation criteria for the rationality of the use of saxagliptin. AHP method was used to assign weights to various indexes of evaluation criteria ；TOPSIS method was used to analyze the use of saxagliptin of 106 cases in the hospital during Nov. 2018-Apr. 2019 retrospectively and evaluate rational drug use. RESULTS ：A total of 6 primary indicators and 12 secondary indicators were established. The first three indicators with a relatively high index weight were indications （with a weight of 0.25），dose and adjustment of administration （with a weight of 0.21）and frequency of administration （with a weight of 0.15）. Among 106 cases，39.6％ of drug use were reasonable ，51.0％ were basically reasonable and 9.4％ were unreasonable. Evaluation results made by weighted TOPSIS were consistent with the actual situation. CONCLUSIONS ：TOPSIS method weighted by AHP is reasonable and feasible for evaluating the rationality of saxagliptin use.
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Objective: To develop and validate a sensitive liquid chromatography-electrospray ionization-tandem mass spectrometric (LC-ESI-MS/MS) technique for the quantification of dapagliflozin and saxagliptin in plasma by linagliptin as internal standard. Methods: Chromatography was achieved on hypersil C18 (50 mmx4 mm) 5 µ analytical column with 0.1% formic acid and acetonitrile (25:75 V/V) as mobile phase at 0.7 ml/min flow rate. Dapagliflozin, saxagliptin, and linagliptin were detected at m/z 409.14/135.0, m/z 316.2/180.13 and m/z 472.54/456.21 respectively. Drugs and internal standard were extracted by LLE (liquid-liquid extraction). Results: Developed technique was validated over 0.5-1500.0 ng/ml linear concentration range for dapagliflozin and 2.00-2000.0 ng/ml for saxagliptin. This method established with intra-batch and inter-batch precision within 2.44-8.12% and 1.25-7.14 % for dapagliflozin and 1.84-7.5 % and 1.02–6.00 % for saxagliptin. This method established with intra-batch and inter-batch accuracy for dapagliflozin within 98.86-103% and 96.98-102 % respectively and for saxagliptin within 98.05-109.06 % and 97.00-104.00 % respectively. Conclusion: Both dapagliflozin and saxagliptin were stable during three freeze-thaw cycles, long term and bench-top stability studies. The developed method was useful for the routine analysis of dapagliflozin and saxagliptin simultaneously in plasma samples.
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Objective: To evaluate the antioxidant, immunomodulatory and anti-inflammatory activities of pyrrolidine dithiocarbamate and saxagliptin in rats with thioacetamide-induced ulcerative colitis. Methods: Animals were orally administered with a vehicle, sulfasalazine (500 mg/kg), pyrrolidine dithiocarbamate (100 mg/kg), and saxagliptin (10 mg/kg) for two weeks. Ulcerative colitis was induced by a single intrarectal instillation of thioacetamide on day 8. Colon samples were collected to assess mitogen-activated protein kinase (MAPK), phosphorylated extracellular signal-regulated kinase (ERK), cAMP response element-binding protein (CREB), interleukin-12 (IL-12), caspase-3, β-defensin, inducible nitric oxide synthase (iNOS) and glucagon like peptide-1 (GLP-1). Moreover, histopathological examination was performed. Results: Rats treated with thioacetamide caused increases in colonic MAPK, phosphorylated ERK, CREB, caspase-3, IL-12, β-defensin, iNOS, as well as decreases in body weight and GLP-1. In addition, distortion of colonic structure was found by histopathological examination. Pyrrolidine dithiocarbamate and saxagliptin mitigated colitis severity by improving body weight decrease and GLP-1, and reducing colonic MAPK, phosphorylated ERK, CREB, caspase-3, IL-12, β-defensin and iNOS. Conclusions: Pyrrolidine dithiocarbamate and saxagliptin are efficient against thioacetamide induced colitis through improving inflammatory and oxidative changes.
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To evaluate the antioxidant, immunomodulatory and anti-inflammatory activities of pyrrolidine dithiocarbamate and saxagliptin in rats with thioacetamide-induced ulcerative colitis. Methods: Animals were orally administered with a vehicle, sulfasalazine (500 mg/kg), pyrrolidine dithiocarbamate (100 mg/kg), and saxagliptin (10 mg/kg) for two weeks. Ulcerative colitis was induced by a single intrarectal instillation of thioacetamide on day 8. Colon samples were collected to assess mitogen-activated protein kinase (MAPK), phosphorylated extracellular signal-regulated kinase (ERK), cAMP response element-binding protein (CREB), interleukin-12 (IL-12), caspase-3, β-defensin, inducible nitric oxide synthase (iNOS) and glucagon like peptide-1 (GLP-1). Moreover, histopathological examination was performed. Results: Rats treated with thioacetamide caused increases in colonic MAPK, phosphorylated ERK, CREB, caspase-3, IL-12, β-defensin, iNOS, as well as decreases in body weight and GLP-1. In addition, distortion of colonic structure was found by histopathological examination. Pyrrolidine dithiocarbamate and saxagliptin mitigated colitis severity by improving body weight decrease and GLP-1, and reducing colonic MAPK, phosphorylated ERK, CREB, caspase-3, IL-12, β-defensin and iNOS.Conclusions: Pyrrolidine dithiocarbamate and saxagliptin are efficient against thioacetamide induced colitis through improving inflammatory and oxidative changes.
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A simple, sensitive, precise, accurate and robust high performance liquid chromatographic method has been developed for simultaneous estimation of saxagliptin (SAXA) and dapagliflozin (DAPA) in pharmaceutical formulation. Design of experiments (DoE) was applied for multivariate optimization of the experimental conditions of RP-HPLC method. Risk assessment was performed to identify the critical method parameters. Three independent factors; mobile phase composition, flow rate and column temperature were used to design mathematical models. Central composite design (CCD) was used to study the response surface methodology and to study in depth the effects of these independent factors. Desirability function was used to simultaneously optimize the retention time and resolution of SAXA and DAPA. The optimized and predicted data from contour diagram consisted of acetonitrile and ortho phosphoric acid (0.1%) in the ratio of 50:50 respectively, at a flow rate of 0.98 ml/min and column temperature 31.4 °C. Using these optimum conditions baseline separation of both drugs with good resolution and run time of less than 6 min were achieved. The optimized assay conditions were validated according to ICH guidelines. Hence, the results clearly showed that Quality by design approach could be successfully applied to optimize RP-HPLC method for simultaneous estimation of SAXA and DAPA.
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Pharmaceutical Preparations/classification , Chromatography, High Pressure Liquid/methods , Diabetes Mellitus, Type 2/classification , Tablets/administration & dosage , Dosage Forms , Process Optimization/methodsABSTRACT
Objective; To evaluate the efficacy and safety of saxagliptin combined with insulin and insulin used in the treatment of the patients with type 2 diabetes systematically. Methods: CNKI database, VIP database, Wanfang database, CBM database, PubMed and Cochrane Library were searched. The time was from the begining of the databases to Dec 31, 2017. The randomized controlled trials (RCT) were selected according to the inclusion and exclusion criteria. Then the qualities of included studies were evaluated and the data was extracted. The Metaanalysis was performed by Review Manager 5. 3 and Stata 12. 0 softwares. Results: A total of 647 articles were selected initially and 22 articles involving 2 243 patients were included in this Meta-analysis. The results of Metaanalysis of effectiveness indicators showed that compared with insulin used alone (control) group, the HbAlc level (MD=-0. 86, 95%CI: -1.03- -0.68, P<0. 01), FBG level (MD=-0. 95, 95%CI: -1.22- -0.67, P< 0.01), PBG level (MD=-1. 28, 95%CI: -1.61- -0.94, P<0. 01) and level of daily insulin dosage (MD = - 16.17, 95%CI: -17.40- -14.95, P<0. 01) of the patients in saxagliptin combined with insulin (case) group were decreased. The safety analysis results showed that the total incidences of adverse reactions (OR = 0. 39, 95% Cl: 0.28-0.52, P<0. 01) and the incidence of hypoglycemia (OR=0. 31, 95%CI: 0. 22-0. 45, P<0. 01) of the patients in case group were lower than those in control group. The funnel-plot of these indicators displayed a symmetrical figure, and there was no publication bias; the sensitivity analysis results showed that there was no difference between all the indicators, and the results were stable. Conclusion; Compared with insulin used alone, saxagliptin combined with insulin therapy has certain advantages to reduce the levels of HbAlc, FPG, PBG of the type 2 diabetes patients and the daily insulin dosage, has high safety and dosen't increase the risk of hypoglycemia and other adverse reactions.
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Objective To observe the effect and efficacy of DPP-4 inhibitor saxagliptin on nonalcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus.Methods Forty patients with newly diagnosed with type 2 diabetes complicated with NAFLD were divided into two groups:the saxagliptin group and the metformin group.On the basis of dietary and exercise therapies,the saxagliptin group received 0.005 g of saxagliptin daily and the metformin treatment group received 0.85-1.70 g of metformin daily.The levels of glycosylated hemoglobin(HbA1 c),triglyceride (TG),blood pressure (BP),alanine aminotransferase (ALT),liver CT and liver/spleen CT were observed before and 3 months after treatment.Results After treatment for 3 months,the TG,ALT,liver CT and liver / spleen CT of the metformin group and the saxagliptin group were significantly higher than those before treatment(P＜0.05).There was no significant difference in the TG,ALT and liver CT values between the two groups(P＞ 0.05).Conclusion In the state of diabetes mellitus complicate with nonalcoholic fatty liver,saxagliptin has a certain effect on relieving fatty liver.
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To explore the clinical effect of saxagliptin on release of peripheral blood neutrophil-to-lymphocyte ratio(NLR)in elder patients with type 2 diabetes mellitus. A total of 110 newly-diagnosed elder patients with type 2 diabetes were assigned into 2 groups(both n=55). Trial group was treated with exercise-diet therapy and saxagliptin at 5 mg/d(SG group),while control group with exercise-diet therapy and repaglinide(RG group). NLR were evaluated in both groups before treatment without significant difference(P>0.05). After 12 weeks'treatment, NLR were both lowered. Decrease of NLR in SG group was more significant than that of RG group(P<0.05).
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[Summary] There is a complementary or synergistic action of saxagliptin and metformin when used in combination. Combination therapy with saxagliptin and metformin can effectively reduce blood glucose and body weight with a low risk of hypoglycemia in patients with diabetes. Additionally,the cardiovascular safety of saxagliptin has been confirmed by the SAVOR study,whereas a cardiovascular protective effect of metformin has been demonstrated by the UKPDS study. As being taken orally once daily,saxagliptin and metformin extended-release fix-dose combination tablet can further improve patients′compliance and adherence. According to the guidelines,this tablet could be recommended as the initial treatment for newlydiagnosed type 2 diabetes with HbA1 c higher than 7. 5%,or in those with inadequately glycemic control under metformin monotherapy.
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Objective To establish a method to determine genotoxic impurities in saxagliptin bulk drug. Methods The gas chromatography(GC) was carried out with INNOWAX capillary column. The inlet temperature was 120°C. The injection volume was 5 µl and separation ratio was 1:10. The column temperature was programmed: the initial temperature was 70°C, maintained for 1 min, raised to 190°C with a rate of 16 °C/min, and then maintained for another 5 min. The detector was flame ionization detector(FID), with temperature of 250°C. The carrying gas was N2 with the flow rate of 1 ml/min. Methanol was used as solvent for saxagliptin. Results Methyl mesylate, ethyl mesylate and isopropyl mesylate could be separated completely with good linear relationship between 2.44- 36.6, 2.38-35.7 and 2.46-36.9 µg/ml, respectively. The average recovery was 96.94%, 95.96% and 105.47%(n=9), respectively. Conclusion This method is simple, reproducible and accurate enough for the determination of genotoxic impurities in saxagliptin bulk drug.
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Saxagliptin, a novel antihyperglycemic agent belonging to dipeptidyl peptidase-4 (DPP-4) inhibitor, was developed by Bristol-Myers Squibb and AstraZeneca. It has the merit of obvious hypoglycemic activity, less side effect, good treatment compliance and remarkably high safety, and is widely applied to treatment of type 2 diabetes. In this paper, we review the synthetic methods of the key intermediate (S)-N-Boc-3-hydroxyadamantylglycine (compound 3) as well as its two important compounds 3-hydroxy-1-acetyladamantane (1) and 2-(3-hydroxy-1-adamant-yl)-2-oxoacetic acid (2) and briefly discuss their advantages and disadvantages.
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OBJECTIVE: To systematically evaluate the economics of saxagliptin for treatment of type 2 diabetes mellitus. METHODS: PubMed, Embase, Cochrane Library, NHS EED, CNKI, Wanfang and CBM were systematically searched. Literatures were screened according to pre-defined inclusion criteria. The quality of included studies were evaluated by CHEERS statement and the economic results were systematically analyzed. RESULTS: Eight cost-effectiveness analyses were included, one of which was conducted in China. Patients among the studies all had blood glucose non-adeguately controlled by monotherapy. When added on to metformin, saxagliptin was cost-effective compared with sulfonylureas (glipizide and glimepiride) and thiazolidinediones (pioglitazone and rosiglitazone). When added on to metformin or sulfonylureas, saxagliptin was cost-effective compared with NPH insulin. CONCLUSION: Saxagliptin represents a cost-effective option in treatment of type 2 diabetes mellitus patients with non-adequately controlled blood glucose after monotherapy.
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Objective Saxagliptin regulates the level of blood glucose by selectively inhibiting high-performance dipeptidyl peptidase 4, but its action mechanism is not yet clear .This study was to investigate the effect of the novel hypoglycemic agent Saxaglip -tin on the expression of long non-coding RNA (LncRNA) metastasis-associated lung adenocarcinoma transcript 1 (MALAT1) and its target gene products transforming growth factor-β1 ( TGF-β1 ) in human umbilical vein endothelial cells ( HUVECs) stimulated by high glucose. Methods HUVECs were cultured in with D-glucose (D-GS) at the concentrations of 5.5, 10, 20, and 30 mmol/L and Saxagliptin at 0, 0.01, 0.1, 1, and 10μmol/L.The best concentrations of D-GS and Saxagliptin were determined as 30 mmol/L and 1 μmol/L, respectively.The HUVECs were divided into four groups:control (5.5 mmol/L D-GS), Saxagliptin (5.5 mmol/L D-GS+1 μmol/L Saxagliptin ) , high glucose ( 30 mmol/L D-GS ) , and high glucose +Saxagliptin (30 mmol/L D-GS +1μmol/L Saxaglip-tin), all cultured for 24 hours.Then the expressions of MALAT1 and TGF-β1 mRNA in the cells were detected by qRT-PCR, that of the TGF-β1 protein determined by Western blot , and the level of TGF-β1 in the supernatant measured by ELISA . Results The expressions of LncRNA-MALAT1 and TGF-β1 were significantly increased in the high glucose group as compared with the control ( 8.65 ±0.70 vs1.00 ±0.00 and 1.36 ±0.07 vs 1.00 ±0.00, P<0.01) but markedly inhibited in the high glucose +Saxagliptin group in compari-son with the high glucose group (2.17 ±0.24 vs 8.65 ±0.70 and 1.15 ±0.02 vs 1.36 ±0.07, P<0.05). Conclusion High glu-cose can induce the overexpression of LncRNA-MALAT1 and its target gene products TGF-β1 in HUVECs and cause damage to the cells, while Saxagliptin can significantly suppress this effect .
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Saxagliptin,a novel antihyperglycemic agent belonging to dipeptidyl peptidase-4(DPP-4)inhibitor,was devel?oped by Bristol-Myers Squibb and AstraZeneca. It has the merit of obvious hypoglycemic activity,less side effect,good treatment com?pliance and remarkably high safety,and is widely applied to treatment of type 2 diabetes. In this paper,we review the synthetic meth?ods of the key intermediate(S)-N-Boc-3-hydroxyadamantylglycine(compound 3)as well as its two important compounds 3-hydroxy-1-acetyladamantane(1)and 2-(3-hydroxy-1-adamant-yl)-2-oxoacetic acid(2)and briefly discuss their advantages and disadvantages.
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Objective To explore the efficacy of saxagliptin in the treatment of failed glycemic control of patients with type 2 diabetes mellitus on the basis of established treatments.Methods 172 cases of failed glycemic control of patients with type 2 diabetes mellitus from June 2013 to December 2014 in department of endocrinology of the first hospital of Ningbo were selected and received health education of 8 weeks, then received saxagliptin on the basis of established treatments for a consecutive treatment of 12 weeks.The HbA1c, fasting blood glucose ( FBG), 2-hours postprandial blood glucose (2hPBG), body mass index (BMI), insulin dosage and adverse event were observed.Results The FBG,HbA1c and 2hPBG after treatment of 12 weeks were significantly lower than those pre-treatment[(7.1 ±2.0)vs.(8.3 ±1.6)mmol/L,(10.2 ±2.3)vs.(15.2 ±2.9)mmol/L,(7.0 ±1.5) vs.(8.0 ±1.7)%], with significant difference (all P <0.05), while there was no significant difference in BMI between pre-and post-treatment [(24.4 ±3.0)vs.(24.9 ±2.7)kg/m2].The insulin dose after treatment of 12 weeks was significantly lower than that pre-treatment[(22.6 ±7.9)vs. (32.3 ±8.2) U/d], with significant difference (P <0.05).There were two patients dropout because of the intolerable digestive tract symptom. Conclusion The adding of saxagliptin could control FBG,2hPBG and HbA1c effectively and decrease insulin dose, without gaining weight in the treatment of failed glycemic control of patients with type 2 diabetes mellitus on the basis of established treatments.
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Objective To establish a method to determine genotoxic impurities in saxagliptin bulk drug. Methods The gas chromatography(GC)was carried out with INNOWAX capillary column. The inlet temperature was 120℃. The injection volume was 5μl and separation ratio was 1∶10. The column temperature was programmed:the initial temperature was 70℃,maintained for 1 min, raised to 190℃with a rate of 16℃/min,and then maintained for another 5 min. The detector was flame ionization detector(FID),with temperature of 250℃. The carrying gas was N2 with the flow rate of 1 ml/min. Methanol was used as solvent for saxagliptin. Results Methyl mesylate,ethyl mesylate and isopropyl mesylate could be separated completely with good linear relationship between 2.44-36.6,2.38-35.7 and 2.46-36.9μg/ml,respectively. The average recovery was 96.94%,95.96%and 105.47%(n=9),respectively. Conclusion This method is simple,reproducible and accurate enough for the determination of genotoxic impurities in saxagliptin bulk drug.
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Objective To observe the effect of saxagliptin combined insulin four times to strengthen the vola-tility on blood glucose variability in patients with type 1 diabetes.Methods According to random number table meth-od,60 patients with type 1 diabetes were divided into DPP4 group(28 cases)and the control group(32 cases).The control group was given insulin four times to strengthen the volatility(insulin aspart/insulin lispro +insulin glargine /insulin detemir),the DPP4 group on the basis of insulin four times to strengthen the volatility plus the saxagliptin 5mg/d,all patients into the group after1 -3D and 13 -15D using CGMS(Medtronic)continuously monitor the blood glucose.Results (1)Within the group comparison:the DPP4 group:1 -3d after treatment:MAGE and SDBG,MBG, LAGE,PT10.0,PT3.9 were lower than before treatment,including MAGE [(6.91 ±1.63)mmol/L vs.(6.31 ± 1.42)mmol/L,t =0.993],SDBG[(2.63 ±0.81)mmol/L vs.(2.41 ±0.51)mmol/L,t =0.751],MBG[(11.51 ± 1.24)mmol/L vs.(10.87 ±2.01)mmol/L,t =1.077],LAGE[(9.43 ±1.73)mmol/L vs.(8.56 ±1.97)mmol/L, t =1.125],PT10.0[(12.99 ±5.61)% vs.(9.66 ±5.03)%,t =1.427],PT3.9[(5.51 ±2.43)% vs.(5.07 ± 2.44)%,t =1.141],there were statistically significant differences compared with before treatment(all P 0.05);13 -15d after treatment:MAGE[(6.88 ±1.49)mmol/L vs.(2.97 ±0.86)mmol/L,t =3.021],SDBG[(2.77 ±0.73)mmol/L vs.(1.12 ±0.43)mmol/L,t =1.964],MBG [(11.67 ±1.46)mmol/L vs.(7.44 ±0.93)mmol/L,t =2.760],LAGE[(9.55 ±1.77)mmol/L vs.(6.53 ±1.21)mmol/L, t =2.409],PT10.0[(13.58 ±5.14)% vs.(4.72 ±2.37)%,t =2.657],PT3.9[(5.36 ±2.05)% vs.(3.05 ± 2.60)%,t =1.840]were decreased,there were statistically significant differences compared with before treatment (P 0.05 );13 -15d after treatment:MAGE [(6.91 ±1.63 )mmol/L vs.(6.07 ± 1.36)mmol/L,t =1.223],SDBG[(2.63 ±0.81)mmol/L vs.(1.91 ±0.93)mmol/L,t =0.984],MBG[(11.51 ± 1.24)mmol/L vs.(8.82 ±1.13)mmol/L,t =1.808],LAGE[(9.43 ±1.73)mmol/L vs.(7.06 ±1.57)mmol/L, t =1.963],PT10.0[(12.99 ±5.61)% vs.(6.74 ±3.35)%,t =2.012],PT3.9[(5.51 ±2.43)% vs.(4.73 ± 2.57)%,t =1.541]were decreased,there were statistically significant differences in MBG,LAGE,PT10.0 compared with before treatment(all P <0.05).Group comparision:1 -3d after treatment:the DPP4 group:MAGE[(4.81 ± 1.15)mmol/L vs.(6.31 ±1.42)mmol/L,t =2.351],SDBG[(2.14 ±0.69)mmol/L vs.(2.41 ±0.51)mmol/L, t =1.332],MBG[(9.76 ±1.58)mmol/L vs.(10.87 ±2.01)mmol/L,t =0.856],LAGE[(7.74 ±1.88)mmol/L vs.(8.56 ±1.97)mmol/L,t =2.102],PT10.0 [(7.47 ±4.96)% vs.(9.66 ±5.03)%,t =2.667],PT3.9 [(4.64 ±2.14)% vs.(5.07 ±2.44)%,t =1.890]were all significantly lower than the control group,there were statistically significant differences in MAGE,LAGE,PT10.0 between the two groups(all P <0.05).13 -15d after treatment:the above indictors,the DPP 4 group was decreased obviously compared with the control group,MAGE [(2.97 ±0.86)mmol/L vs.(6.07 ±1.36)mmol/L,t =2.854],SDBG[(1.12 ±0.43)mmol/L vs.(1.91 ± 0.93)mmol/L,t =2.328],MBG[(7.44 ±0.93)mmol/L vs.(8.82 ±1.13)mmol/L,t =2.125],LAGE[(6.53 ± 1.21)mmol/L vs.(7.06 ±1.57)mmol/L,t =2.111],PT10.0[(4.72 ±2.37)% vs.(6.74 ±3.35)%,t =2.312] and PT3.9 [(3.05 ±2.60)% vs.(4.73 ±2.57)%,t =2.237],there were statistically significant differences between the two groups (P <0.05 or P <0.01).Conclusion The combination of DPP4 inhibitors and insulin four renforcement can improve blood glucose fluctuation in patients with type 1 diabetes,reduce the dosage of insulin and not increase incidence of hypoglycemic events.
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It has been shown that compared with metformin monotherapy, an early combination treatment of saxagliptin and metformin significantly improves glycemic control with no increase in adverse effects in type 2 diabetic patients. The efficacy and safety profiles of saxagliptin/metformin fixed dose combination products are similar to those of the two-drug combination therapy, with lower frequency of administration and better compliance. Therefore, we believe that this drug will bring benefits to more type 2 diabetic patients in China.