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Volumn 64, Issue 5, 2014, Pages 269-275

Bioequivalence of linagliptin 5 mg once daily and 25 mg twice daily: Pharmacokinetics and pharmacodynamics in an open-label crossover trial

Author keywords

diabetes; fixed dose combination; linagliptin; metformin; pharmacodynamics; pharmacokinetics

Indexed keywords

DIPEPTIDYL PEPTIDASE IV; LINAGLIPTIN; ANTIDIABETIC AGENT; DIPEPTIDYL PEPTIDASE IV INHIBITOR; PURINE DERIVATIVE; QUINAZOLINE DERIVATIVE;

EID: 84899947620     PISSN: 21949379     EISSN: 21949387     Source Type: Journal    
DOI: 10.1055/s-0033-1357144     Document Type: Article
Times cited : (6)

References (26)
  • 1
    • 84855185039 scopus 로고    scopus 로고
    • Standards of medical care in diabetes - 2012
    • American Diabetes Association 01
    • American Diabetes Association Standards of medical care in diabetes - 2012. Diabetes Care: 2012; 35 01 S11 S63
    • (2012) Diabetes Care , vol.35
  • 3
    • 83755173502 scopus 로고    scopus 로고
    • Efficacy and safety of linagliptin (Tradjenta) in adults with type-2 diabetes mellitus
    • Freeman M. K. Efficacy and safety of linagliptin (Tradjenta) in adults with type-2 diabetes mellitus. P T: 2011; 36 807 842
    • (2011) P T , vol.36 , pp. 807-842
    • Freeman, M.K.1
  • 4
    • 78851472527 scopus 로고    scopus 로고
    • Effect of linagliptin monotherapy on glycaemic control and markers of β-cell function in patients with inadequately controlled type 2 diabetes: A randomized controlled trial
    • Del Prato S., Barnett A. H., Huisman H. et al. Effect of linagliptin monotherapy on glycaemic control and markers of β-cell function in patients with inadequately controlled type 2 diabetes: a randomized controlled trial. Diabetes Obes Metab: 2011; 13 258 267
    • (2011) Diabetes Obes Metab , vol.13 , pp. 258-267
    • Del Prato, S.1    Barnett, A.H.2    Huisman, H.3
  • 5
    • 84864721471 scopus 로고    scopus 로고
    • Linagliptin for type 2 diabetes mellitus: A review of the pivotal clinical trials
    • McGill J. B. Linagliptin for type 2 diabetes mellitus: a review of the pivotal clinical trials. Ther Adv Endocrinol Metab: 2012; 3 113 124
    • (2012) Ther Adv Endocrinol Metab , vol.3 , pp. 113-124
    • McGill, J.B.1
  • 6
    • 84866268783 scopus 로고    scopus 로고
    • Management of hyperglycemia in type 2 diabetes: A patient-centered approach: Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)
    • Inzucchi S. E., Bergenstal R. M., Buse J. B. et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care: 2012; 35 1364 1379
    • (2012) Diabetes Care , vol.35 , pp. 1364-1379
    • Inzucchi, S.E.1    Bergenstal, R.M.2    Buse, J.B.3
  • 8
    • 78649691630 scopus 로고    scopus 로고
    • Safety and efficacy of linagliptin as add-on therapy to metformin in patients with type 2 diabetes: A randomized, double-blind, placebo-controlled study
    • Taskinen M. R., Rosenstock J., Tamminen I. et al. Safety and efficacy of linagliptin as add-on therapy to metformin in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled study. Diabetes Obes Metab: 2011; 13 65 74
    • (2011) Diabetes Obes Metab , vol.13 , pp. 65-74
    • Taskinen, M.R.1    Rosenstock, J.2    Tamminen, I.3
  • 9
    • 84862813117 scopus 로고    scopus 로고
    • Initial combination of linagliptin and metformin improves glycaemic control in type 2 diabetes: A randomized, double-blind, placebo-controlled study
    • Haak T., Meinicke T., Jones R. et al. Initial combination of linagliptin and metformin improves glycaemic control in type 2 diabetes: a randomized, double-blind, placebo-controlled study. Diabetes Obes Metab: 2012; 14 565 574
    • (2012) Diabetes Obes Metab , vol.14 , pp. 565-574
    • Haak, T.1    Meinicke, T.2    Jones, R.3
  • 10
    • 79953044464 scopus 로고    scopus 로고
    • Linagliptin (BI 1356), a potent and selective DPP-4 inhibitor, is safe and efficacious in combination with metformin in patients with inadequately controlled Type 2 diabetes
    • Forst T., Uhlig-Laske B., Ring A. et al. Linagliptin (BI 1356), a potent and selective DPP-4 inhibitor, is safe and efficacious in combination with metformin in patients with inadequately controlled Type 2 diabetes. Diabet Med: 2010; 27 1409 1419
    • (2010) Diabet Med , vol.27 , pp. 1409-1419
    • Forst, T.1    Uhlig-Laske, B.2    Ring, A.3
  • 11
    • 84864757433 scopus 로고    scopus 로고
    • 2-year efficacy and safety of linagliptin compared with glimepiride in patients with type 2 diabetes inadequately controlled on metformin: A randomised, double-blind, non-inferiority trial
    • Gallwitz B., Rosenstock J., Rauch T. et al. 2-year efficacy and safety of linagliptin compared with glimepiride in patients with type 2 diabetes inadequately controlled on metformin: a randomised, double-blind, non-inferiority trial. Lancet: 2012; 380 475 483
    • (2012) Lancet , vol.380 , pp. 475-483
    • Gallwitz, B.1    Rosenstock, J.2    Rauch, T.3
  • 12
    • 84862563647 scopus 로고    scopus 로고
    • Glycemic effectiveness and medication adherence with fixed-dose combination or coadministered dual therapy of antihyperglycemic regimens: A meta-analysis
    • Han S., Iglay K., Davies M. J. et al. Glycemic effectiveness and medication adherence with fixed-dose combination or coadministered dual therapy of antihyperglycemic regimens: a meta-analysis. Curr Med Res Opin: 2012; 28 969 977
    • (2012) Curr Med Res Opin , vol.28 , pp. 969-977
    • Han, S.1    Iglay, K.2    Davies, M.J.3
  • 13
    • 70249112853 scopus 로고    scopus 로고
    • Boehringer Ingelheim Tradjenta (linagliptin), September
    • Boehringer Ingelheim Tradjenta (linagliptin). US Prescribing Information, September: 2012
    • (2012) US Prescribing Information
  • 15
    • 84861683713 scopus 로고    scopus 로고
    • Clinical pharmacokinetics and pharmacodynamics of linagliptin
    • Graefe-Mody U., Retlich S., Friedrich C. Clinical pharmacokinetics and pharmacodynamics of linagliptin. Clin Pharmacokinet: 2012; 51 411 427
    • (2012) Clin Pharmacokinet , vol.51 , pp. 411-427
    • Graefe-Mody, U.1    Retlich, S.2    Friedrich, C.3
  • 16
    • 77955809148 scopus 로고    scopus 로고
    • Impact of target-mediated drug disposition on Linagliptin pharmacokinetics and DPP-4 inhibition in type 2 diabetic patients
    • Retlich S., Duval V., Graefe-Mody U. et al. Impact of target-mediated drug disposition on Linagliptin pharmacokinetics and DPP-4 inhibition in type 2 diabetic patients. J Clin Pharmacol: 2010; 50 873 885
    • (2010) J Clin Pharmacol , vol.50 , pp. 873-885
    • Retlich, S.1    Duval, V.2    Graefe-Mody, U.3
  • 17
    • 58149247983 scopus 로고    scopus 로고
    • Concentration-dependent plasma protein binding of the novel dipeptidyl peptidase 4 inhibitor BI 1356 due to saturable binding to its target in plasma of mice, rats and humans
    • Fuchs H., Tillement J. P., Urien S. et al. Concentration-dependent plasma protein binding of the novel dipeptidyl peptidase 4 inhibitor BI 1356 due to saturable binding to its target in plasma of mice, rats and humans. J Pharm Pharmacol: 2009; 61 55 62
    • (2009) J Pharm Pharmacol , vol.61 , pp. 55-62
    • Fuchs, H.1    Tillement, J.P.2    Urien, S.3
  • 18
    • 67649998759 scopus 로고    scopus 로고
    • Pharmacokinetics, pharmacodynamics and tolerability of multiple oral doses of linagliptin, a dipeptidyl peptidase-4 inhibitor in male type 2 diabetes patients
    • Heise T., Graefe-Mody E. U., Hüttner S. et al. Pharmacokinetics, pharmacodynamics and tolerability of multiple oral doses of linagliptin, a dipeptidyl peptidase-4 inhibitor in male type 2 diabetes patients. Diabetes Obes Metab: 2009; 11 786 794
    • (2009) Diabetes Obes Metab , vol.11 , pp. 786-794
    • Heise, T.1    Graefe-Mody, E.U.2    Hüttner, S.3
  • 19
    • 79955022470 scopus 로고    scopus 로고
    • The oral DPP-4 inhibitor linagliptin significantly lowers HbA1c after 4 weeks of treatment in patients with type 2 diabetes mellitus
    • Forst T., Uhlig-Laske B., Ring A. et al. The oral DPP-4 inhibitor linagliptin significantly lowers HbA1c after 4 weeks of treatment in patients with type 2 diabetes mellitus. Diabetes Obes Metab: 2011; 13 542 550
    • (2011) Diabetes Obes Metab , vol.13 , pp. 542-550
    • Forst, T.1    Uhlig-Laske, B.2    Ring, A.3
  • 21
    • 84899906562 scopus 로고    scopus 로고
    • Improvements nonparametric methods to estimate the time to reach the steady state
    • Abstract presented as a poster at the, Martin-Luther-University Halle-Wittenberg, Halle, Germany; March 5-6 (Accessed December 7, 2012) (German)
    • th Konferenz der SAS Anwender in Forschung und Entwicklung (KSFE; Conference of SAS users in research and development), Martin-Luther-University Halle-Wittenberg, Halle, Germany; March 5-6, 2009. http://www.ksfe2009.uni-halle.de/abstracts/Weyhmueller.pdf?Donnerstag,%205. %20M%E4rz%202009%2011:30,%A0%A0HS%20XXIII (Accessed December 7, 2012) (German)
    • (2009) th Konferenz der SAS Anwender in Forschung und Entwicklung (KSFE; Conference of SAS Users in Research and Development)
    • Ring, A.1    Weyhmüller, M.2
  • 22
    • 84859438114 scopus 로고    scopus 로고
    • Safety and tolerability of linagliptin: A pooled analysis of data from randomized controlled trials in 3572 patients with type 2 diabetes mellitus
    • Schernthaner G., Barnett A. H., Emser A. et al. Safety and tolerability of linagliptin: a pooled analysis of data from randomized controlled trials in 3572 patients with type 2 diabetes mellitus. Diabetes Obes Metab: 2012; 14 470 478
    • (2012) Diabetes Obes Metab , vol.14 , pp. 470-478
    • Schernthaner, G.1    Barnett, A.H.2    Emser, A.3
  • 23
    • 84866651423 scopus 로고    scopus 로고
    • Efficacy and safety of linagliptin 2.5 mg twice daily versus 5 mg once daily in patients with type 2 diabetes inadequately controlled on metformin: A randomised, double-blind, placebo-controlled trial
    • Ross S. A., Rafeiro E., Meinicke T. et al. Efficacy and safety of linagliptin 2.5 mg twice daily versus 5 mg once daily in patients with type 2 diabetes inadequately controlled on metformin: a randomised, double-blind, placebo-controlled trial. Curr Med Res Opin: 2012; 28 1465 1474
    • (2012) Curr Med Res Opin , vol.28 , pp. 1465-1474
    • Ross, S.A.1    Rafeiro, E.2    Meinicke, T.3
  • 24
    • 84899940363 scopus 로고    scopus 로고
    • Linagliptin fixed-dose combination with metformin is bioequivalent to loose-pill combination therapy (Presented at the American College of Clinical Pharmacy - Annual Meeting, Hollywood, FL; Oct 21-24, 2012; Abstract #208)
    • Buschke S., Ring A., Friedrich C. et al. Linagliptin fixed-dose combination with metformin is bioequivalent to loose-pill combination therapy (Presented at the American College of Clinical Pharmacy - Annual Meeting, Hollywood, FL; Oct 21-24, 2012; abstract #208). Pharmacotherapy: 2012; 32 e238
    • (2012) Pharmacotherapy , vol.32
    • Buschke, S.1    Ring, A.2    Friedrich, C.3
  • 26
    • 77952118055 scopus 로고    scopus 로고
    • Boehringer Ingelheim (Accessed February 8, 2013)
    • Boehringer Ingelheim Jentadueto SUMMARY OF PRODUCT CHARACTERISTICS. 2012. Available at http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product- Information/human/002279/WC500130969.pdf (Accessed February 8, 2013)
    • (2012) Jentadueto SUMMARY of PRODUCT CHARACTERISTICS


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.