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Items: 1 to 50 of 98

1.

Model-based characterization of the relationship between dapagliflozin systemic exposure and HbA1c response in patients with type 1 diabetes mellitus.

Parkinson J, Tang W, Åstrand M, Melin J, Ekholm E, Hamrén B, Boulton DW.

Diabetes Obes Metab. 2019 Feb 12. doi: 10.1111/dom.13664. [Epub ahead of print]

PMID:
30756462
2.

Reduction of Cardiovascular Risk and Improved Estimated Glomerular Filtration Rate by SGLT2 Inhibitors, Including Dapagliflozin, Is Consistent Across the Class: An Analysis of the Placebo Arm of EXSCEL.

Clegg LE, Heerspink HJL, Penland RC, Tang W, Boulton DW, Bachina S, Fox RD, Fenici P, Thuresson M, Mentz RJ, Hernandez AF, Holman RR.

Diabetes Care. 2019 Feb;42(2):318-326. doi: 10.2337/dc18-1871. Epub 2018 Dec 6.

PMID:
30523029
4.

Pharmacokinetics and pharmacodynamics of dapagliflozin in combination with insulin in Japanese patients with type 1 diabetes.

Watada H, Shiramoto M, Ueda S, Tang W, Asano M, Thorén F, Kim H, Yajima T, Boulton DW, Araki E.

Diabetes Obes Metab. 2018 Nov 30. doi: 10.1111/dom.13593. [Epub ahead of print]

PMID:
30499157
5.

Urinary glucose excretion after dapagliflozin treatment: An exposure-response modelling comparison between Japanese and non-Japanese patients diagnosed with type 1 diabetes mellitus.

Sokolov V, Yakovleva T, Ueda S, Parkinson J, Boulton DW, Penland RC, Tang W.

Diabetes Obes Metab. 2018 Nov 19. doi: 10.1111/dom.13586. [Epub ahead of print]

PMID:
30456904
6.

Evaluation of renal and cardiovascular protection mechanisms of SGLT2 inhibitors: model-based analysis of clinical data.

Hallow KM, Greasley PJ, Helmlinger G, Chu L, Heerspink HJ, Boulton DW.

Am J Physiol Renal Physiol. 2018 Nov 1;315(5):F1295-F1306. doi: 10.1152/ajprenal.00202.2018. Epub 2018 Jul 18.

PMID:
30019930
7.

Exenatide effects on gastric emptying rate and the glucose rate of appearance in plasma: A quantitative assessment using an integrative systems pharmacology model.

Voronova V, Zhudenkov K, Penland RC, Boulton DW, Helmlinger G, Peskov K.

Diabetes Obes Metab. 2018 Aug;20(8):2034-2038. doi: 10.1111/dom.13326. Epub 2018 May 9.

PMID:
29663628
8.

Bioequivalence of Dapagliflozin/Metformin Extended-release Fixed-combination Drug Product and Single-component Dapagliflozin and Metformin Extended-release Tablets in Healthy Russian Subjects.

Khomitskaya Y, Tikhonova N, Gudkov K, Erofeeva S, Holmes V, Dayton B, Davies N, Boulton DW, Tang W.

Clin Ther. 2018 Apr;40(4):550-561.e3. doi: 10.1016/j.clinthera.2018.02.006. Epub 2018 Mar 14.

PMID:
29548719
9.

Interaction Between the Sodium-Glucose-Linked Transporter 2 Inhibitor Dapagliflozin and the Loop Diuretic Bumetanide in Normal Human Subjects.

Wilcox CS, Shen W, Boulton DW, Leslie BR, Griffen SC.

J Am Heart Assoc. 2018 Feb 10;7(4). pii: e007046. doi: 10.1161/JAHA.117.007046.

10.

Why do SGLT2 inhibitors reduce heart failure hospitalization? A differential volume regulation hypothesis.

Hallow KM, Helmlinger G, Greasley PJ, McMurray JJV, Boulton DW.

Diabetes Obes Metab. 2018 Mar;20(3):479-487. doi: 10.1111/dom.13126. Epub 2017 Nov 15.

PMID:
29024278
11.

Nonclinical and clinical pharmacology evidence for cardiovascular safety of saxagliptin.

Pollack PS, Chadwick KD, Smith DM, Billger M, Hirshberg B, Iqbal N, Boulton DW.

Cardiovasc Diabetol. 2017 Sep 13;16(1):113. doi: 10.1186/s12933-017-0595-6. Review.

12.

Lack of a Pharmacokinetic Interaction Between Saxagliptin and Dapagliflozin in Healthy Subjects: A Randomized Crossover Study.

Vakkalagadda B, Lubin S, Reynolds L, Liang D, Marion AS, LaCreta F, Boulton DW.

Clin Ther. 2016 Aug;38(8):1890-9. doi: 10.1016/j.clinthera.2016.07.005. Epub 2016 Aug 2.

PMID:
27491280
13.

Bioequivalence and food effect of heat-stressed and non-heat-stressed dapagliflozin 2.5- and 10-mg tablets.

LaCreta F, Griffen SC, Liu X, Smith C, Hines C, Volk K, Tejwani R, Boulton DW.

Int J Pharm. 2016 Sep 10;511(1):288-295. doi: 10.1016/j.ijpharm.2016.07.017. Epub 2016 Jul 12.

PMID:
27418571
14.

Comparison of the exposure-response relationship of dapagliflozin in adult and paediatric patients with type 2 diabetes mellitus.

Parkinson J, Tang W, Johansson CC, Boulton DW, Hamrén B.

Diabetes Obes Metab. 2016 Jul;18(7):685-92. doi: 10.1111/dom.12647.

PMID:
27299483
15.

Pharmacokinetics and pharmacodynamics of dapagliflozin in children and adolescents with type 2 diabetes mellitus.

Tirucherai GS, LaCreta F, Ismat FA, Tang W, Boulton DW.

Diabetes Obes Metab. 2016 Jul;18(7):678-84. doi: 10.1111/dom.12638.

PMID:
27291448
16.

Clinical Pharmacokinetics and Pharmacodynamics of Saxagliptin, a Dipeptidyl Peptidase-4 Inhibitor.

Boulton DW.

Clin Pharmacokinet. 2017 Jan;56(1):11-24. doi: 10.1007/s40262-016-0421-4. Review.

PMID:
27282159
17.

Bioequivalence of saxagliptin/dapagliflozin fixed-dose combination tablets compared with coadministration of the individual tablets to healthy subjects.

Vakkalagadda B, Vetter ML, Rana J, Smith CH, Huang J, Karkas J, Boulton DW, LaCreta F.

Pharmacol Res Perspect. 2016 Jan 12;3(6):e00201. doi: 10.1002/prp2.201. eCollection 2015 Dec.

18.

Model-Based Phase 3 Dose Selection for HIV-1 Attachment Inhibitor Prodrug BMS-663068 in HIV-1-Infected Patients: Population Pharmacokinetics/Pharmacodynamics of the Active Moiety, BMS-626529.

Landry I, Zhu L, Abu Tarif M, Hruska M, Sadler BM, Pitsiu M, Joshi S, Hanna GJ, Lataillade M, Boulton DW, Bertz RJ.

Antimicrob Agents Chemother. 2016 Apr 22;60(5):2782-9. doi: 10.1128/AAC.02503-15. Print 2016 May.

19.

Fed and Fasted Single-dose Assessment of Bioequivalence of Dapagliflozin and Metformin Extended-release Fixed-dose Combination Tablets Relative to Single-component Dapagliflozin and Metformin Extended-release Tablets in Healthy Subjects.

Boulton DW, Chang M, Griffen SC, Kitaura C, Lubin S, Pollack A, LaCreta F.

Clin Ther. 2016 Jan 1;38(1):99-109. doi: 10.1016/j.clinthera.2015.11.010. Epub 2015 Dec 9.

PMID:
26682500
20.

Comparison of the pharmacokinetics and pharmacodynamics of dapagliflozin in patients with type 1 versus type 2 diabetes mellitus.

Tang W, Leil TA, Johnsson E, Boulton DW, LaCreta F.

Diabetes Obes Metab. 2016 Mar;18(3):236-40. doi: 10.1111/dom.12594. Epub 2016 Jan 8.

PMID:
26510924
21.

Bioequivalence, Food Effect, and Steady-State Assessment of Dapagliflozin/Metformin Extended-release Fixed-dose Combination Tablets Relative to Single-component Dapagliflozin and Metformin Extended-release Tablets in Healthy Subjects.

Chang M, Liu X, Cui D, Liang D, LaCreta F, Griffen SC, Lubin S, Quamina-Edghill D, Boulton DW.

Clin Ther. 2015 Jul 1;37(7):1517-28. doi: 10.1016/j.clinthera.2015.05.004. Epub 2015 Jun 3.

PMID:
26048185
22.

Selective reaction monitoring of negative electrospray ionization acetate adduct ions for the bioanalysis of dapagliflozin in clinical studies.

Ji QC, Xu X, Ma E, Liu J, Basdeo S, Liu G, Mylott W, Boulton DW, Shen JX, Stouffer B, Aubry AF, Arnold ME.

Anal Chem. 2015 Mar 17;87(6):3247-54. doi: 10.1021/ac5037523. Epub 2015 Feb 24.

PMID:
25671589
23.

Use of systems pharmacology modeling to elucidate the operating characteristics of SGLT1 and SGLT2 in renal glucose reabsorption in humans.

Lu Y, Griffen SC, Boulton DW, Leil TA.

Front Pharmacol. 2014 Dec 10;5:274. doi: 10.3389/fphar.2014.00274. eCollection 2014.

24.

Evaluation of 4β-Hydroxycholesterol as a Clinical Biomarker of CYP3A4 Drug Interactions Using a Bayesian Mechanism-Based Pharmacometric Model.

Leil TA, Kasichayanula S, Boulton DW, LaCreta F.

CPT Pharmacometrics Syst Pharmacol. 2014 Jun 25;3:e120. doi: 10.1038/psp.2014.18.

25.

Validation of 4β-hydroxycholesterol and evaluation of other endogenous biomarkers for the assessment of CYP3A activity in healthy subjects.

Kasichayanula S, Boulton DW, Luo WL, Rodrigues AD, Yang Z, Goodenough A, Lee M, Jemal M, LaCreta F.

Br J Clin Pharmacol. 2014 Nov;78(5):1122-34. doi: 10.1111/bcp.12425.

26.

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

Kasichayanula S, Liu X, Lacreta F, Griffen SC, Boulton DW.

Clin Pharmacokinet. 2014 Jan;53(1):17-27. doi: 10.1007/s40262-013-0104-3. Review.

PMID:
24105299
27.

Pharmacokinetic and pharmacodynamic properties of single- and multiple-dose of dapagliflozin, a selective inhibitor of SGLT2, in healthy Chinese subjects.

Yang L, Li H, Li H, Bui A, Chang M, Liu X, Kasichayanula S, Griffen SC, Lacreta FP, Boulton DW.

Clin Ther. 2013 Aug;35(8):1211-1222.e2. doi: 10.1016/j.clinthera.2013.06.017. Epub 2013 Aug 2.

PMID:
23910664
28.

A Nonlinear Mixed Effects Pharmacokinetic Model for Dapagliflozin and Dapagliflozin 3-O-glucuronide in Renal or Hepatic Impairment.

van der Walt JS, Hong Y, Zhang L, Pfister M, Boulton DW, Karlsson MO.

CPT Pharmacometrics Syst Pharmacol. 2013 May 8;2:e42. doi: 10.1038/psp.2013.20.

29.

Use of low-dose clinical pharmacodynamic and pharmacokinetic data to establish an occupational exposure limit for dapagliflozin, a potent inhibitor of the renal sodium glucose co-transporter 2.

Gould JC, Kasichayanula S, Shepperly DC, Boulton DW.

Regul Toxicol Pharmacol. 2013 Oct;67(1):89-97. doi: 10.1016/j.yrtph.2013.07.002. Epub 2013 Jul 11.

PMID:
23851069
30.

Characterization of renal glucose reabsorption in response to dapagliflozin in healthy subjects and subjects with type 2 diabetes.

DeFronzo RA, Hompesch M, Kasichayanula S, Liu X, Hong Y, Pfister M, Morrow LA, Leslie BR, Boulton DW, Ching A, LaCreta FP, Griffen SC.

Diabetes Care. 2013 Oct;36(10):3169-76. doi: 10.2337/dc13-0387. Epub 2013 Jun 4.

31.

Bioequivalence of saxagliptin/metformin immediate release (IR) fixed-dose combination tablets and single-component saxagliptin and metformin IR tablets in healthy adult subjects.

Upreti VV, Keung CF, Boulton DW, Chang M, Li L, Tang A, Hsiang BC, Quamina-Edghill D, Frevert EU, Lacreta FP.

Clin Drug Investig. 2013 May;33(5):365-74. doi: 10.1007/s40261-013-0075-z.

PMID:
23549864
32.

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

Kasichayanula S, Liu X, Pe Benito M, Yao M, Pfister M, LaCreta FP, Humphreys WG, Boulton DW.

Br J Clin Pharmacol. 2013 Sep;76(3):432-44. doi: 10.1111/bcp.12056.

33.

Effects of rifampin and mefenamic acid on the pharmacokinetics and pharmacodynamics of dapagliflozin.

Kasichayanula S, Liu X, Griffen SC, Lacreta FP, Boulton DW.

Diabetes Obes Metab. 2013 Mar;15(3):280-3. doi: 10.1111/dom.12024. Epub 2012 Nov 19.

PMID:
23061428
34.

Lack of a pharmacokinetic drug-drug interaction between lithium and valproate when co-administered with aripiprazole.

Boulton DW, Kollia GD, Mallikaarjun S, Kornhauser DM.

J Clin Pharm Ther. 2012 Oct;37(5):565-70. doi: 10.1111/j.1365-2710.2012.01331.x.

PMID:
22943745
35.

Targeting renal glucose reabsorption for the treatment of type 2 diabetes mellitus using the SGLT2 inhibitor dapagliflozin.

Jabbour SA, Whaley JM, Tirmenstein M, Poucher SM, Reilly TP, Boulton DW, Saye J, List JF, Parikh S.

Postgrad Med. 2012 Jul;124(4):62-73. doi: 10.3810/pgm.2012.07.2569. Review.

PMID:
22913895
36.

Simultaneous oral therapeutic and intravenous ¹⁴C-microdoses to determine the absolute oral bioavailability of saxagliptin and dapagliflozin.

Boulton DW, Kasichayanula S, Keung CF, Arnold ME, Christopher LJ, Xu XS, Lacreta F.

Br J Clin Pharmacol. 2013 Mar;75(3):763-8. doi: 10.1111/j.1365-2125.2012.04391.x.

37.

Effect of saxagliptin on the pharmacokinetics of the active components of Ortho-Cyclen(®), a combined oral contraceptive containing ethinyl estradiol and norgestimate, in healthy women.

Upreti VV, Hsiang CB, Li L, Xu X, LaCreta FP, Boulton DW.

Diabetes Obes Metab. 2012 Dec;14(12):1155-7. doi: 10.1111/j.1463-1326.2012.01635.x. Epub 2012 Jul 9.

PMID:
22776778
38.

Characterization of the in vitro and in vivo metabolism and disposition and cytochrome P450 inhibition/induction profile of saxagliptin in human.

Su H, Boulton DW, Barros A Jr, Wang L, Cao K, Bonacorsi SJ Jr, Iyer RA, Humphreys WG, Christopher LJ.

Drug Metab Dispos. 2012 Jul;40(7):1345-56. doi: 10.1124/dmd.112.045450. Epub 2012 Apr 10.

PMID:
22496391
39.

Liquid chromatography and tandem mass spectrometry method for the quantitative determination of saxagliptin and its major pharmacologically active 5-monohydroxy metabolite in human plasma: method validation and overcoming specific and non-specific binding at low concentrations.

Xu XS, Demers R, Gu H, Christopher LJ, Su H, Cojocaru L, Boulton DW, Kirby M, Stouffer B, Humphreys WG, Arnold ME.

J Chromatogr B Analyt Technol Biomed Life Sci. 2012 Mar 15;889-890:77-86. doi: 10.1016/j.jchromb.2012.01.033. Epub 2012 Feb 6.

PMID:
22349123
40.

Biowaiver approach for biopharmaceutics classification system class 3 compound metformin hydrochloride using in silico modeling.

Crison JR, Timmins P, Keung A, Upreti VV, Boulton DW, Scheer BJ.

J Pharm Sci. 2012 May;101(5):1773-82. doi: 10.1002/jps.23063. Epub 2012 Feb 14.

PMID:
22334460
41.

Two-way pharmacokinetic interaction studies between saxagliptin and cytochrome P450 substrates or inhibitors: simvastatin, diltiazem extended-release, and ketoconazole.

Patel CG, Li L, Girgis S, Kornhauser DM, Frevert EU, Boulton DW.

Clin Pharmacol. 2011;3:13-25. doi: 10.2147/CPAA.S15227. Epub 2011 Jun 22.

42.

Lack of pharmacokinetic interactions between dapagliflozin and simvastatin, valsartan, warfarin, or digoxin.

Kasichayanula S, Chang M, Liu X, Shyu WC, Griffen SC, LaCreta FP, Boulton DW.

Adv Ther. 2012 Feb;29(2):163-77. doi: 10.1007/s12325-011-0098-x. Epub 2012 Jan 19.

PMID:
22271159
43.

A pharmacometric approach to quantify the impact of chronic kidney disease and hemodialysis on systemic drug exposure: application to saxagliptin.

Zhang L, Boulton DW, Pfister M.

J Clin Pharmacol. 2012 Jan;52(1 Suppl):126S-33S. doi: 10.1177/0091270011415627.

PMID:
22232748
44.

Influence of hepatic impairment on the pharmacokinetics and safety profile of dapagliflozin: an open-label, parallel-group, single-dose study.

Kasichayanula S, Liu X, Zhang W, Pfister M, LaCreta FP, Boulton DW.

Clin Ther. 2011 Nov;33(11):1798-808. doi: 10.1016/j.clinthera.2011.09.011. Epub 2011 Oct 26.

PMID:
22030444
45.

Bioequivalence of saxagliptin/metformin extended-release (XR) fixed-dose combination tablets and single-component saxagliptin and metformin XR tablets in healthy adult subjects.

Boulton DW, Smith CH, Li L, Huang J, Tang A, LaCreta FP.

Clin Drug Investig. 2011;31(9):619-30. doi: 10.2165/11590290-000000000-00000.

PMID:
21819160
46.

Effect of rifampicin on the pharmacokinetics and pharmacodynamics of saxagliptin, a dipeptidyl peptidase-4 inhibitor, in healthy subjects.

Upreti VV, Boulton DW, Li L, Ching A, Su H, Lacreta FP, Patel CG.

Br J Clin Pharmacol. 2011 Jul;72(1):92-102. doi: 10.1111/j.1365-2125.2011.03937.x.

47.

The effects of age and gender on the pharmacokinetics and pharmacodynamics in healthy subjects of the plasminogen activator, lanoteplase.

Vachharajani NN, Raymond RH, Shyu WC, Stouffer BC, Boulton DW.

Br J Clin Pharmacol. 2011 Nov;72(5):775-86. doi: 10.1111/j.1365-2125.2011.04003.x.

48.

Effect of a high-fat meal on the pharmacokinetics of dapagliflozin, a selective SGLT2 inhibitor, in healthy subjects.

Kasichayanula S, Liu X, Zhang W, Pfister M, Reele SB, Aubry AF, LaCreta FP, Boulton DW.

Diabetes Obes Metab. 2011 Aug;13(8):770-3. doi: 10.1111/j.1463-1326.2011.01397.x.

PMID:
21435141
49.

Influence of renal or hepatic impairment on the pharmacokinetics of saxagliptin.

Boulton DW, Li L, Frevert EU, Tang A, Castaneda L, Vachharajani NN, Kornhauser DM, Patel CG.

Clin Pharmacokinet. 2011 Apr;50(4):253-65. doi: 10.2165/11584350-000000000-00000.

PMID:
21348538
50.

Saxagliptin, a potent, selective inhibitor of DPP-4, does not alter the pharmacokinetics of three oral antidiabetic drugs (metformin, glyburide or pioglitazone) in healthy subjects.

Patel CG, Kornhauser D, Vachharajani N, Komoroski B, Brenner E, Handschuh del Corral M, Li L, Boulton DW.

Diabetes Obes Metab. 2011 Jul;13(7):604-14. doi: 10.1111/j.1463-1326.2011.01381.x.

PMID:
21332626

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