메뉴 건너뛰기




Volumn 2, Issue 1, 2013, Pages

Pharmacometric approaches to guide dose selection of the novel GPR40 agonist TAK-875 in subjects with type 2 diabetes mellitus

Author keywords

[No Author keywords available]

Indexed keywords

ANTIDIABETIC AGENT; DIPEPTIDYL PEPTIDASE IV INHIBITOR; HEMOGLOBIN A1C; TAK 875; UNCLASSIFIED DRUG;

EID: 84881120148     PISSN: None     EISSN: 21638306     Source Type: Journal    
DOI: 10.1038/psp.2012.23     Document Type: Article
Times cited : (12)

References (37)
  • 1
    • 2342466734 scopus 로고    scopus 로고
    • Global Prevalence of Diabetes: Estimates for the year 2000 and projections for 2030
    • DOI 10.2337/diacare.27.5.1047
    • Wild, S., Roglic, G., Green, A., Sicree, R. & King, H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care 27, 1047-1053 (2004). (Pubitemid 38579764)
    • (2004) Diabetes Care , vol.27 , Issue.5 , pp. 1047-1053
    • Wild, S.1    Roglic, G.2    Green, A.3    Sicree, R.4    King, H.5
  • 3
    • 79960614571 scopus 로고    scopus 로고
    • American Diabetic Association (2011). Accessed 1 March 2012
    • American Diabetic Association. National Diabetes Fact Sheet, 2011. .(2011). Accessed 1 March 2012.
    • (2011) National Diabetes Fact Sheet
  • 4
    • 0347133334 scopus 로고    scopus 로고
    • Poor control of risk factors for vascular disease among adults with previously diagnosed diabetes
    • DOI 10.1001/jama.291.3.335
    • Saydah, S.H., Fradkin, J. & Cowie, C.C. Poor control of risk factors for vascular disease among adults with previously diagnosed diabetes. JAMA 291, 335-342 (2004). (Pubitemid 38101606)
    • (2004) Journal of the American Medical Association , vol.291 , Issue.3 , pp. 335-342
    • Saydah, S.H.1    Fradkin, J.2    Cowie, C.C.3
  • 5
    • 77956500937 scopus 로고    scopus 로고
    • Discovery of TAK-875: A potent, selective, and orally bioavailable GPR40 agonist
    • Negoro N. et al. Discovery of TAK-875: a potent, selective, and orally bioavailable GPR40 agonist. ACS Med. Chem. Lett. 1, 290-294 (2010).
    • (2010) ACS Med. Chem. Lett , vol.1 , pp. 290-294
    • Negoro, N.1
  • 6
    • 80053138180 scopus 로고    scopus 로고
    • TAK-875, an orally available G protein-coupled receptor 40/free fatty acid receptor 1 agonist, enhances glucose-dependent insulin secretion and improves both postprandial and fasting hyperglycemia in type 2 diabetic rats
    • Tsujihata, Y. et al. TAK-875, an orally available G protein-coupled receptor 40/free fatty acid receptor 1 agonist, enhances glucose-dependent insulin secretion and improves both postprandial and fasting hyperglycemia in type 2 diabetic rats. J. Pharmacol. Exp. Ther. 339, 228-237 (2011).
    • (2011) J. Pharmacol. Exp. Ther , vol.339 , pp. 228-237
    • Tsujihata, Y.1
  • 7
    • 84863208301 scopus 로고    scopus 로고
    • Safety, tolerability, pharmacokinetics, and pharmacodynamic properties of the GPR40 agonist TAK-875: Results from a double-blind, placebocontrolled single oral dose rising study in healthy volunteers
    • Naik, H. et al. Safety, tolerability, pharmacokinetics, and pharmacodynamic properties of the GPR40 agonist TAK-875: results from a double-blind, placebocontrolled single oral dose rising study in healthy volunteers. J. Clin. Pharmacol. 52, 1007-1016 (2012).
    • (2012) J. Clin. Pharmacol , vol.52 , pp. 1007-1016
    • Naik, H.1
  • 8
    • 80053185708 scopus 로고    scopus 로고
    • Pharmacokinetics, safety and tolerability of single and multiple doses of TAK-875, a novel GPR40 agonist, in Japanese healthy male subjects
    • Matsuno K., Hirayama M., Araki T., Dote N., Kondo T. & Nakamura K. Pharmacokinetics, safety and tolerability of single and multiple doses of TAK-875, a novel GPR40 agonist, in Japanese healthy male subjects. Diabetes 59, A193 (2010).
    • (2010) Diabetes , vol.59
    • Matsuno, K.1    Hirayama, M.2    Araki, T.3    Dote, N.4    Kondo, T.5    Nakamura, K.6
  • 9
    • 84862589520 scopus 로고    scopus 로고
    • A multiple-ascending-dose study to evaluate safety, pharmacokinetics, and pharmacodynamics of a novel GPR40 agonist, TAK-875, in subjects with type 2 diabetes
    • Leifke, E. et al. A multiple-ascending-dose study to evaluate safety, pharmacokinetics, and pharmacodynamics of a novel GPR40 agonist, TAK-875, in subjects with type 2 diabetes. Clin. Pharmacol. Ther. 92, 29-39 (2012).
    • (2012) Clin. Pharmacol. Ther , vol.92 , pp. 29-39
    • Leifke, E.1
  • 10
    • 84859625938 scopus 로고    scopus 로고
    • TAK-875 versus placebo or glimepiride in type 2 diabetes mellitus: A phase 2, randomised, double-blind, placebo-controlled trial
    • Burant, C.F. et al. TAK-875 versus placebo or glimepiride in type 2 diabetes mellitus: a phase 2, randomised, double-blind, placebo-controlled trial. Lancet 379, 1403-1411 (2012).
    • (2012) Lancet , vol.379 , pp. 1403-1411
    • Burant, C.F.1
  • 11
    • 0032731634 scopus 로고    scopus 로고
    • Gender-related differences in pharmacokinetics and their clinical significance
    • DOI 10.1046/j.1365-2710.1999.00246.x
    • Tanaka, E. Gender-related differences in pharmacokinetics and their clinical significance. J. Clin. Pharm. Ther. 24, 339-346 (1999). (Pubitemid 29520783)
    • (1999) Journal of Clinical Pharmacy and Therapeutics , vol.24 , Issue.5 , pp. 339-346
    • Tanaka, E.1
  • 12
    • 54049096401 scopus 로고    scopus 로고
    • Gender has a small but statistically significant effect on clearance of CYP3A substrate drugs
    • Greenblatt, D.J. & von Moltke, L.L. Gender has a small but statistically significant effect on clearance of CYP3A substrate drugs. J. Clin. Pharmacol. 48, 1350-1355 (2008).
    • (2008) J. Clin. Pharmacol , vol.48 , pp. 1350-1355
    • Greenblatt, D.J.1    Von Moltke, L.L.2
  • 13
    • 77955789254 scopus 로고    scopus 로고
    • A model for glucose, insulin, and beta-cell dynamics in subjects with insulin resistance and patients with type 2 diabetes
    • Ribbing, J., Hamrén, B., Svensson, M.K. & Karlsson, M.O. A model for glucose, insulin, and beta-cell dynamics in subjects with insulin resistance and patients with type 2 diabetes. J. Clin. Pharmacol. 50, 861-872 (2010).
    • (2010) J. Clin. Pharmacol , vol.50 , pp. 861-872
    • Ribbing, J.1    Hamrén, B.2    Svensson, M.K.3    Karlsson, M.O.4
  • 14
    • 33745779941 scopus 로고    scopus 로고
    • A mechanism-based disease progression model for comparison of long-term effects of pioglitazone, metformin and gliclazide on disease processes underlying Type 2 Diabetes Mellitus
    • de Winter, W. et al. A mechanism-based disease progression model for comparison of long-term effects of pioglitazone, metformin and gliclazide on disease processes underlying Type 2 Diabetes Mellitus. J. Pharmacokinet. Pharmacodyn. 33, 313-343 (2006).
    • (2006) J. Pharmacokinet. Pharmacodyn , vol.33 , pp. 313-343
    • De Winter, W.1
  • 15
    • 57449120900 scopus 로고    scopus 로고
    • Model-based development of a PPARgamma agonist, rivoglitazone, to aid dose selection and optimize clinical trial designs
    • Rohatagi, S. et al. Model-based development of a PPARgamma agonist, rivoglitazone, to aid dose selection and optimize clinical trial designs. J. Clin. Pharmacol. 48, 1420-1429 (2008).
    • (2008) J. Clin. Pharmacol , vol.48 , pp. 1420-1429
    • Rohatagi, S.1
  • 16
    • 77954887591 scopus 로고    scopus 로고
    • Pharmacokinetics and pharmacodynamics of inhaled GLP-1 (MKC253): Proof-of-concept studies in healthy normal volunteers and in patients with type 2 diabetes
    • Marino, M.T. et al. Pharmacokinetics and pharmacodynamics of inhaled GLP-1 (MKC253): proof-of-concept studies in healthy normal volunteers and in patients with type 2 diabetes. Clin. Pharmacol. Ther. 88, 243-250 (2010).
    • (2010) Clin. Pharmacol. Ther , vol.88 , pp. 243-250
    • Marino, M.T.1
  • 17
    • 0037327319 scopus 로고    scopus 로고
    • Population PKPD modelling of the long-term hypoglycaemic effect of gliclazide given as a once-A-day modified release (MR) formulation
    • DOI 10.1046/j.1365-2125.2003.01751.x
    • Frey, N., Laveille, C., Paraire, M., Francillard, M., Holford, N.H. & Jochemsen, R. Population PKPD modelling of the long-term hypoglycaemic effect of gliclazide given as a once-a-day modified release (MR) formulation. Br. J. Clin. Pharmacol. 55, 147-157 (2003). (Pubitemid 36240273)
    • (2003) British Journal of Clinical Pharmacology , vol.55 , Issue.2 , pp. 147-157
    • Frey, N.1    Laveille, C.2    Paraire, M.3    Francillard, M.4    Holford, N.H.G.5    Jochemsen, R.6
  • 18
    • 33644922728 scopus 로고    scopus 로고
    • Effect of increasing duration of diabetes mellitus type 2 on glycated hemoglobin and insulin sensitivity
    • Verma, M., Paneri, S., Badi, P. & Raman, P.G. Effect of increasing duration of diabetes mellitus type 2 on glycated hemoglobin and insulin sensitivity. Indian J. Clin. Biochem. 21, 142-146 (2006).
    • (2006) Indian J. Clin. Biochem , vol.21 , pp. 142-146
    • Verma, M.1    Paneri, S.2    Badi, P.3    Raman, P.G.4
  • 19
    • 77649091668 scopus 로고    scopus 로고
    • American Association of Clinical Endocrinologists medical guidelines for clinical practice for the management of diabetes mellitus
    • Rodbard, H.W. et al. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the management of diabetes mellitus. Endocr. Pract. 13SUPPL. 1, 1-68 (2007).
    • (2007) Endocr. Pract , vol.13 , Issue.SUPPL. 1 , pp. 1-68
    • Rodbard, H.W.1
  • 20
    • 60449089649 scopus 로고    scopus 로고
    • 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
    • Nathan, D.M. 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 32, 193-203 (2009).
    • (2009) Diabetes Care , vol.32 , pp. 193-203
    • Nathan, D.M.1
  • 21
    • 0031927337 scopus 로고    scopus 로고
    • A placebo-controlled, randomized study of glimepiride in patients with type 2 diabetes mellitus for whom diet therapy is unsuccessful
    • Schade, D.S., Jovanovic, L. & Schneider, J. A placebo-controlled, randomized study of glimepiride in patients with type 2 diabetes mellitus for whom diet therapy is unsuccessful. J. Clin. Pharmacol. 38, 636-641 (1998). (Pubitemid 28354902)
    • (1998) Journal of Clinical Pharmacology , vol.38 , Issue.7 , pp. 636-641
    • Schade, D.S.1    Jovanovic, L.2    Schneider, J.3
  • 22
    • 0030945291 scopus 로고    scopus 로고
    • Efficacy, safety, and dose-response characteristics of glipizide gastrointestinal therapeutic system on glycemic control and insulin secretion in NIDDM: Results of two multicenter, randomized, placebo-controlled clinical trials
    • Simonson, D.C., Kourides, I.A., Feinglos, M., Shamoon, H. & Fischette, C.T. Efficacy, safety, and dose-response characteristics of glipizide gastrointestinal therapeutic system on glycemic control and insulin secretion in NIDDM. Results of two multicenter, randomized, placebo-controlled clinical trials. The Glipizide Gastrointestinal Therapeutic System Study Group. Diabetes Care 20, 597-606 (1997). (Pubitemid 27143421)
    • (1997) Diabetes Care , vol.20 , Issue.4 , pp. 597-606
    • Simonson, D.C.1    Kourides, I.A.2    Feinglos, M.3    Shamoon, H.4    Fischette, C.T.5
  • 23
    • 84881144029 scopus 로고    scopus 로고
    • Bridgewater NJ Sanofi-Aventis
    • Amaryl [package insert]. Bridgewater, NJ; Sanofi-Aventis, 2012.
    • (2012) Amaryl [Package Insert]
  • 24
    • 33845489598 scopus 로고    scopus 로고
    • Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy in patients with type 2 diabetes mellitus
    • Raz, I., Hanefeld, M., Xu, L., Caria, C., Williams-Herman, D. & Khatami, H. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy in patients with type 2 diabetes mellitus. Diabetologia 49, 2564-2571 (2006).
    • (2006) Diabetologia , vol.49 , pp. 2564-2571
    • Raz, I.1    Hanefeld, M.2    Xu, L.3    Caria, C.4    Williams-Herman, D.5    Khatami, H.6
  • 26
    • 80052551137 scopus 로고    scopus 로고
    • Safety and efficacy of vildagliptin versus placebo in patients with type 2 diabetes and moderate or severe renal impairment: A prospective 24-week randomized placebo-controlled trial
    • Lukashevich, V., Schweizer, A., Shao, Q., Groop, P.H. & Kothny, W. Safety and efficacy of vildagliptin versus placebo in patients with type 2 diabetes and moderate or severe renal impairment: a prospective 24-week randomized placebo-controlled trial. Diabetes. Obes. Metab. 13, 947-954 (2011).
    • (2011) Diabetes. Obes. Metab , vol.13 , pp. 947-954
    • Lukashevich, V.1    Schweizer, A.2    Shao, Q.3    Groop, P.H.4    Kothny, W.5
  • 27
    • 74549198914 scopus 로고    scopus 로고
    • Prinston NJ; Bristol-Myers Squibb Company
    • Onglyza [package insert], Prinston, NJ; Bristol-Myers Squibb Company, 2011.
    • (2011) Onglyza [Package Insert]
  • 28
    • 84880222278 scopus 로고    scopus 로고
    • Whitehouse Station NJ; Merck & Co
    • Januvia [package insert], Whitehouse Station, NJ; Merck & Co, 2012.
    • (2012) Januvia [Package Insert]
  • 29
    • 78449268717 scopus 로고    scopus 로고
    • Nonmem, ICON Development Solutions, Ellicott City, MD
    • Nonmem. NONMEM Users Guide: Introduction to NONMEM 7. (ICON Development Solutions, Ellicott City, MD, 2010).
    • (2010) NONMEM Users Guide: Introduction to NONMEM 7.
  • 30
    • 45549108317 scopus 로고    scopus 로고
    • Pharmacokinetic/pharmacodynamic modelling in diabetes mellitus
    • DOI 10.2165/00003088-200847070-00001
    • Landersdorfer, C.B. & Jusko, W.J. Pharmacokinetic/pharmacodynamic modelling in diabetes mellitus. Clin. Pharmacokinet. 47, 417-448 (2008). (Pubitemid 351861956)
    • (2008) Clinical Pharmacokinetics , vol.47 , Issue.7 , pp. 417-448
    • Landersdorfer, C.B.1    Jusko, W.J.2
  • 31
    • 0035997893 scopus 로고    scopus 로고
    • Pharmacokinetic-pharmacodynamic modelling of insulin: Comparison of indirect pharmacodynamic response with effect-compartment link models
    • DOI 10.1211/0022357021779131
    • Lin, S. & Chien, Y.W. Pharmacokinetic-pharmacodynamic modelling of insulin: comparison of indirect pharmacodynamic response with effect-compartment link models. J. Pharm. Pharmacol. 54, 791-800 (2002). (Pubitemid 34649465)
    • (2002) Journal of Pharmacy and Pharmacology , vol.54 , Issue.6 , pp. 791-800
    • Lin, S.1    Chien, Y.W.2
  • 32
    • 0034954242 scopus 로고    scopus 로고
    • Assessment of actual significance levels for covariate effects in NONMEM
    • DOI 10.1023/A:1011527125570
    • Wählby, U., Jonsson, E.N. & Karlsson, M.O. Assessment of actual significance levels for covariate effects in NONMEM. J. Pharmacokinet. Pharmacodyn. 28, 231-252 (2001). (Pubitemid 32643366)
    • (2001) Journal of Pharmacokinetics and Pharmacodynamics , vol.28 , Issue.3 , pp. 231-252
    • Wahlby, U.1    Jonsson, E.N.2    Karlsson, M.O.3
  • 34
    • 81355142150 scopus 로고    scopus 로고
    • Model-based metaanalysis for comparative efficacy and safety: Application in drug development and beyond
    • Mandema, J.W., Gibbs, M., Boyd, R.A., Wada, D.R. & Pfister, M. Model-based metaanalysis for comparative efficacy and safety: application in drug development and beyond. Clin. Pharmacol. Ther. 90, 766-769 (2011).
    • (2011) Clin. Pharmacol. Ther , vol.90 , pp. 766-769
    • Mandema, J.W.1    Gibbs, M.2    Boyd, R.A.3    Wada, D.R.4    Pfister, M.5
  • 35
    • 81355139589 scopus 로고    scopus 로고
    • Therapeutic index of anticoagulants for prevention of venous thromboembolism following orthopedic surgery: A dose-response metaanalysis
    • Mandema, J.W., Boyd, R.A. & DiCarlo, L.A. Therapeutic index of anticoagulants for prevention of venous thromboembolism following orthopedic surgery: a dose-response metaanalysis. Clin. Pharmacol. Ther. 90, 820-827 (2011).
    • (2011) Clin. Pharmacol. Ther , vol.90 , pp. 820-827
    • Mandema, J.W.1    Boyd, R.A.2    Dicarlo, L.A.3
  • 36
    • 81355123266 scopus 로고    scopus 로고
    • A dose-response meta- analysis for quantifying relative efficacy of biologics in rheumatoid arthritis
    • Mandema, J.W., Salinger, D.H., Baumgartner, S.W. & Gibbs, M.A. A dose-response meta- analysis for quantifying relative efficacy of biologics in rheumatoid arthritis. Clin. Pharmacol. Ther. 90, 828-835 (2011).
    • (2011) Clin. Pharmacol. Ther , vol.90 , pp. 828-835
    • Mandema, J.W.1    Salinger, D.H.2    Baumgartner, S.W.3    Gibbs, M.A.4
  • 37
    • 84878248309 scopus 로고    scopus 로고
    • Model-based meta-analysis of the hba1c lowering effect of pf-04971729 a sodium glucose co-transporter-2 inhibitor (sglt2i) in comparison with other sglt2i and anti-diabetic agents ADA
    • [Abstract]
    • Mandema J., Sweeney K., Terra S. & Sahasrabudhe V. Model-Based Meta-Analysis of the HbA1c Lowering Effect of PF-04971729, a Sodium Glucose Co-Transporter-2 Inhibitor (SGLT2i), in Comparison with Other SGLT2i and Anti-Diabetic Agents (ADA). [Abstract]. Diabetes 61 SUPPL. 1, A1015 (2012).
    • (2012) Diabetes , vol.61 , Issue.SUPPL. 1
    • Mandema, J.1    Sweeney, K.2    Terra, S.3    Sahasrabudhe, V.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.