A Phase I Study on the Pharmacokinetics and Pharmacodynamics of DJT1116PG, a Novel Selective Inhibitor of Sodium-Glucose Cotransporter Type 2, in Healthy Individuals at Steady State

    • Cho N.H.
    • Shaw J.E.
    • Karuranga S.
    • et al.

    IDF Diabetes Atlas: global estimates of diabetes prevalence for 2017 and projections for 2045.

    Diabetes Res Clin Pract. 2018; 138: 271-281

    • Bashier A.
    • Bin Hussain A.
    • Abdelgadir E.
    • Alawadi F.
    • Sabbour H.
    • Chilton R.

    Consensus recommendations for management of patients with type 2 diabetes mellitus and cardiovascular diseases.

    Diabetol Metab Syndr. 2019; 11: 80

    • Yang W.
    • Lu J.
    • Weng J.
    • et al.

    China national diabetes and metabolic disorders study group. Prevalence of diabetes among men and women in China.

    N Engl J Med. 2010; 362: 1090-1101

    • Ojha A.
    • Ojha U.
    • Mohammed R.
    • Chandrashekar A.
    • Ojha H.

    Current perspective on the role of insulin and glucagon in the pathogenesis and treatment of type 2 diabetes mellitus.

    Clin Pharmacol. 2019; 11: 57-65

  • Treatment and diagnosis of diabetes mellitus and its complication: advanced approaches.

    Mini Rev Med Chem. 2015; 15: 1132-1133

    • Nathan D.M.
    • Buse J.B.
    • Davidson M.B.
    • et al.

    Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the study of diabetes.

    Diabetes Care. 2009; 32: 193-203

  • CDA 2008 Clinical Practice Guidelines Steering Committee. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes: response to Nathan et al.

    Diabetes Care. 2009; 32 (): e34

  • The mechanisms and therapeutic potential of SGLT2 inhibitors in diabetes mellitus.

    Annu Rev Med. 2015; 66: 255-270

    • Liu B.
    • Wang Y.
    • Zhang Y.
    • Yan B.

    Mechanisms of protective effects of SGLT2 inhibitors in cardiovascular disease and renal dysfunction.

    Curr Top Med Chem. 2019; 19: 1818-1849

  • Pharmacodynamics, efficacy and safety of sodium-glucose co-transporter type 2 (SGLT2) inhibitors for the treatment of type 2 diabetes mellitus.

    Drugs. 2015; 75: 33-59

    • Schumm-Draeger P.M.
    • Burgess L.
    • Korányi L.
    • Hruba V.
    • Hamer-Maansson J.E.
    • de Bruin T.W.

    Twice-daily dapagliflozin co-administered with metformin in type 2 diabetes: a 16-week randomized, placebo-controlled clinical trial.

    Diabetes Obes Metab. 2015; 17: 42-51

    • Bailey C.J.
    • Gross J.L.
    • Pieters A.
    • Bastien A.
    • List J.F.

    Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo-controlled trial.

    Lancet. 2010; 375: 2223-2233

    • Nomura S.
    • Sakamaki S.
    • Hongu M.
    • et al.

    Discovery of canagliflozin, a novel C-glucoside with thiophene ring, as sodium-dependent glucose cotransporter 2 inhibitor for the treatment of type 2 diabetes mellitus.

    J Med Chem. 2010; 53: 6355-6360

    • Sha S.
    • Devineni D.
    • Ghosh A.
    • et al.

    Canagliflozin, a novel inhibitor of sodium glucose co-transporter 2, dose dependently reduces calculated renal threshold for glucose excretion and increases urinary glucose excretion in healthy subjects.

    Diabetes Obes Metab. 2011; 13: 669-672

    • Donnan J.R.
    • Grandy C.A.
    • Chibrikov E.
    • et al.

    Comparative safety of the sodium glucose co-transporter 2 (SGLT2) inhibitors: a systematic review and meta-analysis.

    BMJ Open. 2019; 9e022577

    • Zou P.
    • Yu Y.
    • Zheng N.
    • et al.

    Applications of human pharmacokinetic prediction in first-in-human dose estimation.

    AAPS J. 2012; 14: 262-281

    • Zhang H.
    • Zhu X.
    • Li X.
    • et al.

    Pharmacokinetics and pharmacodynamics of rongliflozin, a novel selective inhibitor of sodium-glucose co-transporter-2, in people with type 2 diabetes mellitus.

    Diabetes Obes Metab. 2019; ()https://doi.org/10.1111/dom.13887

    • Komoroski B.
    • Vachharajani N.
    • Feng Y.
    • Li L.
    • Kornhauser D.
    • Pfister M.

    Dapagliflozin, a novel, selective SGLT2 inhibitor, improved glycemic control over 2 weeks in patients with type 2 diabetes mellitus.

    Clin Pharmacol Ther. 2009; 85: 513-519

  • LOWESS: a program for smoothing scatterplots by robust locally weighted regression.

    The Am Statistician. 1981; 35: 54

    • Tobita H.
    • Sato S.
    • Miyake T.
    • Ishihara S.
    • Kinoshita Y.

    Effects of dapagliflozin on body composition and liver tests in patients with nonalcoholic steatohepatitis associated with type 2 diabetes mellitus: a prospective, open-label, uncontrolled study.

    Curr Ther Res Clin Exp. 2017; 87: 13-19

    • Feng Y.
    • Zhang L.
    • Komoroski B.
    • Pfister M.

    Population pharmacokinetic analysis of dapagliflozin in healthy subjects and patients with type 2 diabetes mellitus.

    Clin Pharmacol Ther. 2010; 83: S93

    • Zhang H.
    • Zhu X.
    • Li Q.
    • et al.

    Clinical evaluation of efficacy, tolerability and pharmacokinetics of yimitasvir phosphate in patients infected with hepatitis C virus.

    J Pharm Pharmacol. 2018; 70: 855-864

    • Zhang H.
    • Li Q.
    • Zhu X.
    • et al.

    Association of variability and pharmacogenomics with bioequivalence of gefitinib in healthy male subjects.

    Front Pharmacol. 2018; 9: 849

    • Rave K.
    • Nosek L.
    • Posner J.
    • Heise T.
    • Roggen K.
    • van Hoogdalem E.J.

    Renal glucose excretion as a function of blood glucose concentration in subjects with type 2 diabetes–results of a hyperglycaemic glucose clamp study.

    Nephrol Dial Transpl. 2006; 21: 2166-2171

    • Terauchi Y.
    • Utsunomiya K.
    • Yasui A.
    • et al.

    Safety and efficacy of empagliflozin as add-on therapy to GLP-1 receptor agonist (liraglutide) in Japanese patients with type 2 diabetes mellitus: a randomised, double-blind, parallel-group Phase 4 study.

    Diabetes Ther. 2019; 10: 951-963

    • Kasichayanula S.
    • Liu X.
    • Pe Benito M.
    • et al.

    The influence of kidney function on dapagliflozin exposure, metabolism and pharmacodynamics in healthy subjects and in patients with type 2 diabetes mellitus.

    Br J Clin Pharmacol. 2013; 76: 432-444

    • Kasichayanula S.
    • Chang M.
    • Hasegawa M.
    • et al.

    Pharmacokinetics and pharmacodynamics of dapagliflozin, a novel selective inhibitor of sodium-glucose co-transporter type 2, in Japanese subjects without and with type 2 diabetes mellitus.

    Diabetes Obes Metab. 2011; 13: 357-365

    • Devineni D.
    • Curtin C.R.
    • Polidori D.
    • et al.

    Pharmacokinetics and pharmacodynamics of canagliflozin, a sodium glucose co-transporter 2 inhibitor, in subjects with type 2 diabetes mellitus.

    J Clin Pharmacol. 2013; 53: 601-610

    • Garcia-Ropero A.
    • Badimon J.J.
    • Santos-Gallego C.G.

    The pharmacokinetics and pharmacodynamics of SGLT2 inhibitors for type 2 diabetes mellitus: the latest developments.

    Expert Opin Drug Metab Toxicol. 2018; 14: 1287-1302

    • Toyama T.
    • Neuen B.L.
    • Jun M.
    • et al.

    Effect of SGLT2 inhibitors on cardiovascular, renal and safety outcomes in patients with type 2 diabetes mellitus and chronic kidney disease: a systematic review and meta-analysis.

    Diabetes Obes Metab. 2019; 21: 1237-1250

    • Samukawa Y.
    • Mutoh M.
    • Chen S.
    • Mizui N.

    Mechanism-based pharmacokinetic-pharmacodynamic modeling of luseogliflozin, a sodium glucose Co-transporter 2 inhibitor, in Japanese patients with type 2 diabetes mellitus.

    Biol Pharm Bull. 2017; 40: 1207-1218

    • Cefalo C.M.A.
    • Cinti F.
    • Moffa S.
    • et al.

    Sotagliflozin, the first dual SGLT inhibitor: current outlook and perspectives.

    Cardiovasc Diabetol. 2019; 18: 20

    • Chichger H.
    • Cleasby M.E.
    • Srai S.K.
    • Unwin R.J.
    • Debnam E.S.
    • Marks J.

    Experimental type II diabetes and related models of impaired glucose metabolism differentially regulate glucose transporters at the proximal tubule brush border membrane.

    Exp Physiol. 2016; 101: 731-742

    • Kasichayanula S.
    • Liu X.
    • Lacreta F.
    • Griffen S.C.
    • Boulton D.W.

    Clinical pharmacokinetics and pharmacodynamics of dapagliflozin, a selective inhibitor of sodium-glucose co-transporter type 2.

    Clin Pharmacokinet. 2014; 53: 17-27

    • Zhang M.
    • Zhang L.
    • Wu B.
    • Song H.
    • An Z.
    • Li S.

    Dapagliflozin treatment for type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials.

    Diabetes Metab Res Rev. 2014; 30: 204-221

  • Comments are closed.