参考文献/References:
[1]Xu Y,Wang L,He J,et al.Prevalence and control of diabetes in Chineseadults[J].JAMA,2013,310(9):948-959.
[2]Rosenwasser R F,Sultan S,Sutton D,et al.SGLT-2 inhibitors and their potential in the treatment of diabetes[J].Diabetes Metab Syndr Obes,2013,6:453-467.
[3]Elkinson S,Scott L J.Canagliflozin:first global approval[J].Drugs,2013,73(9):979-88.
[4]Babu A.Canagliflozin for the treatment of type 2 diabetes[J].Drugs Today(Barc),2013,49(6):363-376.
[5]Inagaki N,Kondo K,Yoshinari T,et al.Efficacy and safety of canagliflozin inJapanese patients with type 2 diabetes:a randomized,double-blind,placebo-controlled,12-week study[J].Diabetes Obes Metab,2013,15(12):1136-1145.
[6]Stenlo¨f K,Cefalu W T,Kim K A,et al.Long-term efficacy and safety of canagliflozin monotherapy in patients with type 2 diabetes inadequately controlled with diet and exercise:findings from the 52-week CANTATA-M study[J].Curr Med Res Opin,2014,30(2):163-175.
[7]Wilding J P,Charpentier G,Hollander P,et al.Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea:a randomised trial[J].Int J Clin Pract,2013,67(12):1267-1282.
[8]Yale J F,Bakris G,Cariou B,et al.Efficacy and safety of canagliflozin insubjects with type 2 diabetes and chronic kidney disease[J].Diabetes Obes Metab,2013,15(5):463-473.
[9]Sinclair A,Bode B,Harris S,et al.Efficacy and safety of canagliflozin compared with placebo in older patients with type 2 diabetes mellitus:a pooled analysis of clinical studies[J].BMC Endocr Disord,2014,14(1):37.
[10]Schernthaner G,Gross J L,Rosenstock J,et al.Canagliflozin compared withsitagliptin for patients with type 2 diabetes who do not have adequate glycemiccontrol with metformin plus sulfonylurea:a 52-week randomized trial[J].Diabetes Care,2013,36(9):2508-2515.
[11]Lavalle-González F J,Januszewicz A,Davidson J,et al.Efficacy and safetyof canagliflozin compared with placebo and sitagliptin in patients with type 2 diabetes on background metformin monotherapy:a randomised trial[J].Diabetologia,2013,56(12):2582-2592.
[12]Cefalu W T,Leiter L A,Yoon K H,et al.Efficacy and safety of canagliflozinversus glimepiride in patients with type 2 diabetes inadequately controlled withmetformin(CANTATA-SU):52 week results from a randomised,double-blind,phase 3non-inferiority trial[J].Lancet,2013,382(9896):941-950.
[13]Polidori D,Mari A,Ferrannini E,et al.Canagliflozin,a sodium glucose co-transporter 2 inhibitor,improves model-based indices of beta cell function in patients with type 2 diabetes[J].Diabetologia,2014,57(5):891-901.
[14]Paisley A N,Yadav R,Younis N,et al.Dapagliflozin:a review on efficacy,clinical effectiveness and safety[J].Expert Opin Investig Drugs,2013,22(1):131-140.
[15]Abdul-Ghani M A,DeFronzo R A.Dapagliflozin for the treatment of type 2 diabetes[J].Expert Opin Pharmacother,2013,14(12):1695-1703.
[16]Ji L,Ma J,Li H,et al.Dapagliflozin as monotherapy in drug-naive Asian patients with type 2 diabetes mellitus:a randomized,blinded,prospective phase Ⅲ study[J].Clin Ther,2014,36(1):84-100.
[17]Kohan D E,Fioretto P,Tang W,et al.Long-term study of patients with type 2diabetes and moderate renal impairment shows that dapagliflozin reduces weightand blood pressure but does not improve glycemic control[J].Kidney Int,2014,85(4):962-971.
[18]Jabbour S A,Hardy E,Sugg J,et al.Dapagliflozin is effective as add-ontherapy to sitagliptin with or without metformin:a 24-week,multicenter,randomized,double-blind,placebo-controlled study[J].Diabetes Care,2014,37(3):740-750.
[19]Goring S,Hawkins N,Wygant G,et al.Dapagliflozin compared with other oral anti-iabetes treatments when added to metformin monotherapy:a systematic reviewand network meta-analysis[J].Diabetes Obes Metab,2014,16(5):433-442.
[20]Sun Y N,Zhou Y,Chen X,et al.The efficacy of dapagliflozin combined with hypoglycaemic drugs in treating type 2 diabetes mellitus:meta-analysis of randomised controlled trials[J].BMJ Open,2014,4(4):e004619.
[21]Reilly T P,Graziano M J,Janovitz E B,et al.Carcinogenicity risk assessmentsupports the chronic safety of dapagliflozin,an inhibitor of sodium-glucose co-transporter 2,in the treatment of type 2 diabetes mellitus[J].Diabetes Ther,2014,5(1):73-96.
[22]Astellas Pharma Inc.News Release.Approval of Suglat○R Tablets,a Selective SGLT2 Inhibitor for Treatment of Type 2 Diabetes,in Japan[EB/OL].
[2014-01-17].http:∥www.astellas.com/en/corporate/news/detail/approval-of- suglat-tablets-a-s.html.
[23]Imamura M,Nakanishi K,Suzuki T,et al.Discovery of ipragliflozin(ASP1941):A novel C-glucoside with benzothiophene structure as a potent and selective sodium glucose co-transporter 2(SGLT2)inhibitor for the treatment of type 2 diabetes mellitus[J].Bioorg Med Chem,2012,20(10):3263-3279.
[24]Tahara A,Kurosaki E,Yokono M,et al.Effects of SGLT2 selective inhibitoripragliflozin on hyperglycemia,hyperlipidemia,hepatic steatosis,oxidative stress,inflammation,and obesity in type 2 diabetic mice[J].Eur J Pharmacol,2013,715(1-3):246-255.
[25]Tahara A,Kurosaki E,Yokono M,et al.Antidiabetic effects of SGLT2-selective inhibitor ipragliflozin in streptozotocin-nicotinamide-induced mildly diabetic mice[J].J Pharmacol Sci,2012,120(1):36-44.
[26]Yokono M,Takasu T,Hayashizaki Y,et al.SGLT2 selective inhibitor ipragliflozin reduces body fat mass by increasing fatty acid oxidation in high-fatdiet-induced obese rats[J].Eur J Pharmacol,2014,727:66-74.
[27]Kadokura T,Saito M,Utsuno A,et al.Ipragliflozin(ASP1941),a selective sodium-dependent glucose cotransporter 2 inhibitor,safely stimulates urinary glucose excretion without inducing hypoglycemia in healthy Japanese subjects[J].Diabetol Int,2011,2(4):172-182.
[28]Veltkamp S A,Kadokura T,Krauwinkel W J,et al.Effect of ipragliflozin(ASP1941),a novel selective sodium-dependent glucose co-transporter 2 inhibitor,on urinary glucose excretion in healthy subjects[J].Clin Drug Investig,2011,31(12):839-851.
[29]Schwartz S L,Akinlade B,Klasen S,et al.Safety,pharmacokinetic,and pharmacodynamic profiles of ipragliflozin(ASP1941),a novel and selective inhibitorof sodium-dependent glucose co-transporter 2,in patients with type 2 diabetesmellitus[J].Diabetes Technol Ther,2011,13(12):1219-1227.
[30]Fonseca V A,Ferrannini E,Wilding J P,et al.Active-and placebocontrolleddose-finding study to assess the efficacy,safety,and tolerability of multiple doses of ipragliflozin in patients with type 2 diabetes mellitus[J].J DiabetesComplicat,2013,27(3):268-273.
[31]Kashiwagi A,Takinami Y,Kazuta K,et al.Ipragliflozin improved glycaemic control with additional benefits of reductions of body weight and blood pressure inJapanese patients with type 2 diabetes mellitus:BRIGHTEN Study[J].Diabetologia,2011,54:S68-S69.
[32]Kawano H,Kashiwagi A,Kazuta K,et al.Long-term safety,tolerability and efficacy of ipragliflozin in Japanese patients with type 2 diabetes mellitus:Ignite[J].Diabetes,2012,61:A610.
[33]Goto K,Kashiwagi A,Kazuta K,et al.Ipragliflozin reduces A1C and body weight in type 2 diabetes patients who have inadequate glycemic control on metforminalone:Illuminate study[J].Diabetes,2012,61:A269.
[34]Wilding J P H,Ferrannini E,Fonseca V A,et al.Efficacy and safety of ipragliflozin in patients with type 2 diabetes inadequately controlled on metformin:adose-finding study[J].Diabetes Obes Metab,2013,15(5):403-409.
[35]Kashiwagi A,Shiga T,Akiyama N,et al.Ipragliflozin reduced HbA1c and body weight in Japanese type 2 diabetes patients who have inadequate glycaemic controlon sulfonylurea or pioglitazone alone[J].Diabetologia,2012,55:S302-S303.
[36]Taisho Pharmaceutical Holdings Co,Ltd.Acquisition of Manufacturing and Marketing Approval in Japan for SGLT2 Inhibitor Lusefi○R Tablets 2.5 mg and Lusefi○R Tablets 5 mg[EB/OL].
[2014-03-24].http:∥www.taisho-holdings.co.jp/en/release/2014/2014032401-e.pdf.
[37]Yamamoto K,Uchida S,Kitano K,et al.TS-071 is a novel,potent and selectiverenal sodium-glucose cotransporter 2(SGLT2)inhibitor with anti-hyperglycaemic activity[J].Br J Pharmacol,2011,164(1):181-191.
[38]Sasaki T,Seino Y,Fukatsu A,et al.Safety,Pharmacokinetics,and pharmacodynamics of single and multiple luseogliflozin dosing in healthy Japanese males:A randomized,single-blind,placebo-controlled trial[J].Adv Ther,2014,31(3):345-361.
[39]Sasaki T,Seino Y,Samukawa Y,et al.Effects of Gender and Age on the Pharmacokinetics and Pharmacodynamics of Luseogliflozin(TS-071),a Selective SGLT2 Inhibitor[C]∥Annual Meeting and Scientific Sessions of the American Diabetes Association.Philadelphia:American Diabetes Association(Abs 1069-P),2012.
[40]Seino Y,Sasaki T,Fukatsu A,et al.TS-071,a Novel and Selective SGLT2 Inhibitor,Improved Glycemic Control and Decreased Body Weight in 12-Week Study of Japanese Patients with Type 2 Diabetes Mellitus[C]∥Annual Meeting and Scientific Sessions of the American Diabetes Association.San Diego:American Diabetes Association(Abs 0998-P),2011.
[41]Taisho Pharmaceutical Co,Ltd.Results of Phase 3 Long-Term AdministrationClinical Trials of SGLT2 Inhibitor Luseogliflozin Hydrate(TS-071)in Japan Targeting Type 2 Diabetes Mellitus Patients Announced at World Diabetes Congress ofIDF[EB/OL].
[2013-12-03].http:∥www.taisho-holdings.co.jp/en/release/2013/-2013120301-e.html.
[42]Seino Y,Sasaki T,Fukatsu A,et al.Luseogliflozin,a selective SGLT2 inhibitor,improves glycemic control as monotherapy in Japanese patients with T2DM[C]∥World Diabetes Congress.Melbourne:International Diabetes Federation(Abs P-1472),2013.
[43]Sasaki T,Seino Y,Fukatsu A,et al.Consistent efficacy of add-on combination of luseogliflozin with conventional oral antidiabetic drugs in Japanese patients with T2DM[C]∥World Diabetes Congress.Melbourne:International Diabetes Federation(Abs P-1471).
[44]Barnett A H,Mithal A,Manassie J,et al.Efficacy and safety of empagliflozinadded to existing antidiabetes treatment in patients with type 2 diabetes and chronic kidney disease:a randomised,double-blind,placebo-controlled trial[J].Lancet Diabetes Endocrinol,2014,doi:10.1016/S2213-8587(13)70208-0.
[45]Nagata T,Fukuzawa T,Takeda M,et al.Tofogliflozin,a novel sodium-glucose co-transporter 2 inhibitor,improves renal and pancreatic function in db/db mice[J].Br J Pharmacol,2013,170(3):519-531.
[46]Nucci G,Amin N B,Wang X,et al.The sodium glucose co-transporter-2(SGLT2)inhibitor,PF04971729,provides multi-faceted improvements in diabetic patientsinadequately controlled on metform[J].Diabetologia,2011,54(Suppl):S347.
[47]Zambrowicz B,Freiman J,Brown P M,et al.LX4211,a dual SGLT1/SGLT2 inhibitor,improved glycemic control in patients with type 2 diabetes in a randomized,placebo-controlled trial[J].Clin Pharmacol Ther,2012,92(2):158-169.
[48]Theracos Inc.Theracos reports positive outcomes from a 96-week Phase 2 study of THR1442,a highly specific SGLT2 inhibitor,for the treatment of Type 2 Diabetes[EB/OL].
[2014-03-17].http:∥www.theracos.com/theracos-reports-positive-outcomes-from-a-96-week-phase-2-study-of- thr1442-a-highly-specific-sglt2-inhibitor-for- the-treatment-of-type-2-diabetes/.