메뉴 건너뛰기




Volumn 52, Issue 7, 2014, Pages 549-563

Effect of food and tablet-dissolution characteristics on the bioavailability of a linagliptin fixed-dose combination with metformin: Evidence from two randomized trials

Author keywords

Fixed dose combination; Linagliptin; Metformin; Type 2 diabetes

Indexed keywords

LINAGLIPTIN PLUS METFORMIN;

EID: 84903990834     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/CP201961     Document Type: Article
Times cited : (6)

References (36)
  • 1
    • 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)
    • CrossRef PubMed
    • Inzucchi SE, BergenstaI RM, Buse JB, Diamant M, Ferrannini E, Nauck M. Peters AL, Tsapas A, Wender R, Matthews DR. 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. CrossRef PubMed.
    • (2012) Diabetes Care , vol.35 , pp. 1364-1379
    • Inzucchi, S.E.1    Bergenstai, R.M.2    Buse, J.B.3    Diamant, M.4    Ferrannini, E.5    Nauck, M.P.A.L.6    Tsapas, A.7    Wender, R.8    Matthews, D.R.9
  • 3
    • 0036272422 scopus 로고    scopus 로고
    • Patient compliance and persistence with anti-hyperglycemic therapy: Evaluation of a population of type 2 diabetic patients
    • Dailey G, Kim MS, Lian JF. Patient compliance and persistence with anti-hyperglycemic therapy: evaluation of a population of type 2 diabetic patients. J Int Med Res. 2002; 30: 71-79. CrossRef PubMed. (Pubitemid 34618725)
    • (2002) Journal of International Medical Research , vol.30 , Issue.1 , pp. 71-79
    • Dailey, G.1    Kim, M.S.2    Lian, J.F.3
  • 4
    • 0036268563 scopus 로고    scopus 로고
    • Adherence to prescribed oral hypoglycaemic medication in a population of patients with Type 2 diabetes: A retrospective cohort study
    • DOI 10.1046/j.1464-5491.2002.00689.x
    • Donnan FT, MacDonald TM. Morris AD. Adherence to prescribed oral hypoglycaemic medica- Tion in a population of patients with Type 2 diabetes: A retrospective cohort study. Diabet Med. 2002; 19: 279-284. CrossRef PubMed. (Pubitemid 34592152)
    • (2002) Diabetic Medicine , vol.19 , Issue.4 , pp. 279-284
    • Donnan, P.T.1    MacDonald, T.M.2    Morris, A.D.3
  • 5
    • 0034878676 scopus 로고    scopus 로고
    • Patient compliance and persistence with antihyperglycemic drug regimens: Evaluation of a Medicaid patient population with type 2 diabetes mellitus
    • DOI 10.1016/S0149-2918(01)80110-7
    • Dailey G, Kim MS, Lian JF. Patient compliance and persistence with antihyperglycemic drug regimens: evaluation of a medicaid patient population with type 2 diabetes mellitus. Clin Ther. 2001; 23: 1311-1320. CrossRef PubMed. (Pubitemid 32804123)
    • (2001) Clinical Therapeutics , vol.23 , Issue.8 , pp. 1311-1320
    • Dailey, G.1    Kim, M.S.2    Lian, J.F.3
  • 6
    • 0344897714 scopus 로고    scopus 로고
    • Greater reductions in A1C in type 2 diabetic patients new to therapy with glyburide/metformin tablets as compared to glyburide co-administered with metformin
    • DOI 10.1046/j.1463-1326.2003.00297.x
    • Blonde L, Wogen J, Kreilick C, Seymour A A. Greater reductions in A1C in type 2 diabetic pa- Tients new to therapy with glyburide/metformin tablets as compared to glyburide co- Administered with metformin. Diabetes Obes Metab. 2003; 5: 424-431. CrossRef PubMed. (Pubitemid 37483604)
    • (2003) Diabetes, Obesity and Metabolism , vol.5 , Issue.6 , pp. 424-431
    • Blonde, L.1    Wogen, J.2    Kreilick, C.3    Seymour, A.A.4
  • 7
    • 55949097996 scopus 로고    scopus 로고
    • Patient adherence and reimbursement amount for antidiabetic fixed-dose combination products compared with dual therapy among texas medicaid recipients
    • CrossRefPubMed
    • Cheong C, Barrier JC, Lawson KA, Johnsrud MT. Patient adherence and reimbursement amount for antidiabetic fixed-dose combination products compared with dual therapy among Texas Medicaid recipients. Clin Ther. 2008; 30: 1893- 1907. CrossRefPubMed.
    • (2008) Clin Ther , vol.30 , pp. 1893-1907
    • Cheong, C.1    Barrier, J.C.2    Lawson, K.A.3    Johnsrud, M.T.4
  • 8
    • 0036211463 scopus 로고    scopus 로고
    • Adherence to oral antidiabetic therapy in a managed care organization: A comparison of monotherapy, combination therapy, and fixed-dose combination therapy
    • DOI 10.1016/S0149-2918(02)85047-0
    • Melikian C, White TJ, Vanderplas A, Dezii CM, Chang E. Adherence to oral antidiabetic therapy in a managed care organization: A comparison of monotherapy, combination therapy, and fixed- dose combination therapy. Clin Ther. 2002; 24: 460-467. CrossRef PubMed. (Pubitemid 34275867)
    • (2002) Clinical Therapeutics , vol.24 , Issue.3 , pp. 460-467
    • Melikian, C.1    White, T.J.2    Vanderplas, A.3    Dezii, C.M.4    Chang, E.5
  • 9
    • 42449099867 scopus 로고    scopus 로고
    • Impact of fixed-dose combination drugs on adherence to prescription medications
    • CrossRef PubMed
    • Pan F, Chemew ME, Fendrick AM. Impact of fixed-dose combination drugs on adherence to prescription medications. J Gen Intern Med. 2008; 23: 611-614. CrossRef PubMed.
    • (2008) J Gen Intern Med , vol.23 , pp. 611-614
    • Pan, F.1    Chemew, M.E.2    Fendrick, A.M.3
  • 10
    • 84858003503 scopus 로고    scopus 로고
    • Linagliptin monotherapy provides superior glycaemic control versus placebo or voglibose with comparable safety in japanese patients with type 2 diabetes: A randomized, placebo and active comparator-controlled, double-blind study
    • CrossRef PubMed
    • Kawamori R, Inagaki N, Araki E, Watada H, Hayashi N, Horie Y, Sarashina A, Gong Y, von Eynatten M, Woerle IU. Dugi KA. Linagliptin monotherapy provides superior glycaemic control versus placebo or voglibose with comparable safety in Japanese patients with type 2 diabetes: A randomized, placebo and active comparator-controlled, double-blind study. Diabetes Obes Metab. 2012; 14: 348-357. CrossRef PubMed.
    • (2012) Diabetes Obes Metab , vol.14 , pp. 348-357
    • Kawamori, R.1    Inagaki, N.2    Araki, E.3    Watada, H.4    Hayashi, N.5    Horie, Y.6    Sarashina, A.7    Gong, Y.8    Von Eynatten, M.9    Woerle, I.U.10    Dugi, K.A.11
  • 11
    • 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
    • CrossRef PubMed
    • Del Prato S, Burnett AH, Huisman H, Neubacher D, Woerle HJ, Dugi KA. 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. CrossRef PubMed.
    • (2011) Diabetes Obes Metab , vol.13 , pp. 258-267
    • Del Prato, S.1    Burnett, A.H.2    Huisman, H.3    Neubacher, D.4    Woerle, H.J.5    Dugi, K.A.6
  • 12
    • 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
    • CrossRefPubMed
    • Forst T, Uhlig-Laske B, Ring A, Graefe-Mody U, Friedrich C, Herbcich K, Woerle HJ, Dugi KA. 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. CrossRefPubMed.
    • (2010) Diabet Med , vol.27 , pp. 1409-1419
    • Forst, T.1    Uhlig-Laske, B.2    Ring, A.3    Graefe-Mody, U.4    Friedrich, C.5    Herbcich, K.6    Woerle, H.J.7    Dugi, K.A.8
  • 13
    • 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
    • CrossRef PubMed
    • Gallwitz B, Rosenstoek J, Ranch T, Bhattacharya S, PateIS, von Eynatten M Dugi KA, Woerle HJ. 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. CrossRef PubMed.
    • (2012) Lancet , vol.380 , pp. 475-483
    • Gallwitz, B.1    Rosenstoek, J.2    Ranch, T.3    Bhattacharya, S.4    Pate, I.S.5    Von Eynatten, M.6    Dugi, K.A.7    Woerle, H.J.8
  • 14
    • 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
    • CrossRef PubMed
    • Haak T, Meinicke T, Jones R, Weber S, von Eynatten M, Woerle HJ. 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. CrossRef PubMed.
    • (2012) Diabetes Obes Metab , vol.14 , pp. 565-574
    • Haak, T.1    Meinicke, T.2    Jones, R.3    Weber, S.4    Von Eynatten, M.5    Woerle, H.J.6
  • 15
    • 80053072352 scopus 로고    scopus 로고
    • Efficacy and safety of linagliptin in persons with type 2 diabetes inadequately controlled by a combination of metformin and sulphonylurea: A 24- week randomized study
    • CrossRef PubMed
    • Owens DR, Swallow R, Dugi KA, Woerle HJ. Efficacy and safety of linagliptin in persons with type 2 diabetes inadequately controlled by a combination of metformin and sulphonylurea: A 24- week randomized study. Diabet Med. 2011; 28: 1352-1361. CrossRef PubMed.
    • (2011) Diabet Med , vol.28 , pp. 1352-1361
    • Owens, D.R.1    Swallow, R.2    Dugi, K.A.3    Woerle, H.J.4
  • 16
    • 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
    • CrossRef PubMed
    • Taskinen MR, Rosenstock J, Tamminen I, Kubiak R, Patel S, Dugi KA, Woerle HJ. 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. CrossRef PubMed.
    • (2011) Diabetes Obes Metab , vol.13 , pp. 65-74
    • Taskinen, M.R.1    Rosenstock, J.2    Tamminen, I.3    Kubiak, R.4    Patel, S.5    Dugi, K.A.6    Woerle, H.J.7
  • 17
    • 84866651423 scopus 로고    scopus 로고
    • Efficacy and safety of linagliptin 2.5 mg twice daily versus 5mg once daily in patients with type 2 diabetes inadequately controlled on metformin: A randomised, double-blind, placebo-controlled trial
    • CrossRef PubMed
    • Ross SA, Rafeiro E, Meinieke T, Toorawa R, Weber-Bom S, Woerle HJ. Efficacy and safety of linagliptin 2.5 mg twice daily versus 5mg 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. CrossRef PubMed.
    • (2012) Curr Med Res Opin , vol.28 , pp. 1465-1474
    • Ross, S.A.1    Rafeiro, E.2    Meinieke, T.3    Toorawa, R.4    Weber-Bom, S.5    Woerle, H.J.6
  • 19
    • 0032883045 scopus 로고    scopus 로고
    • Effects of food on clinical pharmacokinetics
    • DOI 10.2165/00003088-199937030-00003
    • Singh BN. Effects of food on clinical pharmacokinetics. Clin Pharmacokinet. 1999; 37: 213-255. CrossRef PubMed. (Pubitemid 29452756)
    • (1999) Clinical Pharmacokinetics , vol.37 , Issue.3 , pp. 213-255
    • Singh, B.N.1
  • 20
    • 3843097202 scopus 로고    scopus 로고
    • Classification of orally administered drugs on the World Health Organization Model list of Essential Medicines according to the biopharmaceutics classification system
    • DOI 10.1016/j.ejpb.2004.03.001, PII S0939641104000438
    • Lindenberg M, Kopp S, Dressman JB. Classification of orally administered drugs on the World Health Organization Model list of Essential Medicines according to the biopharmaceutics classification system. Eur J Pharm Biopharm. 2004; 58: 265-278. CrossRef PubMed. (Pubitemid 39037234)
    • (2004) European Journal of Pharmaceutics and Biopharmaceutics , vol.58 , Issue.2 , pp. 265-278
    • Lindenberg, M.1    Kopp, S.2    Dressman, J.B.3
  • 21
    • 84903955627 scopus 로고    scopus 로고
    • Last accessed August 16, 2013
    • European Medicines Agency. Trajenta: EPAR Public assessment report. Available at: http://www.ema.europa.eu/docs/en-GB/docuttient-library/EPAR- Publicassessmentreport/human, 002110/WC500115748.pdf. Last accessed August 16, 2013.
    • Trajenta: EPAR Public Assessment Report
  • 22
    • 0004069412 scopus 로고    scopus 로고
    • U.S. Department of Health and Human Services FaDA, Center for Drug Evaluation and Research (CDER). Last accessed August 16, 2013
    • U.S. Department of Health and Human Services FaDA, Center for Drug Evaluation and Research (CDER). Guidance for Industry: food-effect bioavailability and fed bioequivalcncc studies. Available at: http:/www.fda.gov/downloads/regulatoryinformation/guidances/uem126833.pdf. Last accessed August 16, 2013.
    • Guidance for Industry: Food-effect Bioavailability and Fed Bioequivalcncc Studies
  • 23
    • 67650799130 scopus 로고    scopus 로고
    • Evaluation of the potential for steady- state pharmacokinetic and pharmacodynamic in- Teractions between the dpp-4 inhibitor linagliptin and metformin in healthy subjects
    • CrossRef PubMed
    • Graefe-Mody EU, Padula S, Ring A. Withopf B, Dugi KA. Evaluation of the potential for steady- state pharmacokinetic and pharmacodynamic interactions between the DPP-4 inhibitor linagliptin and metformin in healthy subjects. Curr Med Res Opin. 2009; 25: 1963-1972. CrossRef PubMed.
    • (2009) Curr Med Res Opin , vol.25 , pp. 1963-1972
    • Graefe-Mody, E.U.1    Padula, S.2    Ring, A.3    Withopf, B.4    Dugi, K.A.5
  • 24
    • 0003484310 scopus 로고    scopus 로고
    • U.S. Depart men t of Health and Human Services FaDA, Centre for Drug Evaluation and Research (CDER). Last accessed August 16, 2013
    • U.S. Depart men t of Health and Human Services FaDA, Centre for Drug Evaluation and Research (CDER). Guidance for industry: bioanalytical method validation. Available at: http://www.fda.gov/downloadsDrugs/Guidances/ucm070107. pdf. Last accessed August 16, 2013.
    • Guidance for Industry: Bioanalytical Method Validation
  • 25
    • 0003455044 scopus 로고    scopus 로고
    • U.S. Department of Health and Human Services FaDA, Centre for Drug Evaluation and Research (CDER). Last accessed August 16, 2013
    • U.S. Department of Health and Human Services FaDA, Centre for Drug Evaluation and Research (CDER). Guidance for industry: bioavailability and bioequivalence studies for orally administered ding products- general considerations. Available at: http://www.fda.gov/downloads.Drugs/Guidance- CompIianeeRegulatoryInformation/Guidances/ucm070124.pdf Last accessed August 16, 2013.
    • Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Ding Products- General Considerations
  • 26
    • 67649932264 scopus 로고    scopus 로고
    • EMEA) EMA. Last accessed August 16, 2013
    • (EMEA) EMA. Guideline on the Investigation of Bioequivalence. Available at: http://www.ema.europa.eu/docs/enGB/documentlibrary/Scientific-guideline/ 2010/01AVC500070039.pdf Last accessed August 16, 2013.
    • Guideline on the Investigation of Bioequivalence
  • 27
    • 80051653327 scopus 로고    scopus 로고
    • A randomized, open-label, crossover study evaluating the effect of food on the relative bioavailability of linagliptin in healthy subjects
    • CrossRef PubMed
    • Graefe-Mody U, Giessmann T, Ring A, lovirto M, Woerle HJ, A randomized, open-label, crossover study evaluating the effect of food on the relative bioavailability of linagliptin in healthy subjects. Clin Ther, 2011; 33: 1096-1103. CrossRef PubMed.
    • (2011) Clin Ther , vol.33 , pp. 1096-1103
    • Graefe-Mody, U.1    Giessmann, T.2    Ring, A.3    Lovirto, M.4    Woerle, H.J.5
  • 29
    • 33845803595 scopus 로고    scopus 로고
    • Oral antidiabetic drugs: Effect of food on absorption of pioglitazone and metformin from a fixed-dose combination tablet
    • DOI 10.1177/0091270006293756
    • Kcirini A, Slater M, Bradford D, Schwartz L, Laurent A, Oral antidiabetic drugs: effect of food on absorption of pioglitazone and metformin from a fixed-dose combination tablet. J Clin Pharmacol. 2007; 47: 48-55. CrossRef PubMed. (Pubitemid 44973997)
    • (2007) Journal of Clinical Pharmacology , vol.47 , Issue.1 , pp. 48-55
    • Karim, A.1    Slater, M.2    Bradford, D.3    Schwartz, L.4    Laurent, A.5
  • 30
    • 0033730932 scopus 로고    scopus 로고
    • Pharmacokinetics and bioavailability of a metformin/glyburide tablet administered alone and with food
    • PubMed
    • Marathe PH, Arnold ME, Meeker J, Greene DS, Barhhaiya RH. Pharmacokinetics and bioavailability of a metformin/glyburide tablet administered alone and with food. J Clin Pharmacol. 2000; 40: 1494-1502. PubMed.
    • (2000) J Clin Pharmacol , vol.40 , pp. 1494-1502
    • Marathe, P.H.1    Arnold, M.E.2    Meeker, J.3    Greene, D.S.4    Barhhaiya, R.H.5
  • 31
    • 46449083470 scopus 로고    scopus 로고
    • Effect of food on the pharmacokinetics of a vildagliptin/metformin (50/1000 mg) fixed-dose combination tablet in healthy volunteers
    • DOI 10.1185/03007990802114070
    • He YL, Flannery B, Campestrini J, Leon S, Zinny MA, Ligueros-Saylan M, Jarugula V. Effect of food on the pharmacokinetics of a vildagliptin/metformin (50/1000 mg) fixed-dose combination tablet in healthy volunteers. Curr Med Res Opin. 2008; 24: 1703-1709. CrossRef PubMcd. (Pubitemid 351929068)
    • (2008) Current Medical Research and Opinion , vol.24 , Issue.6 , pp. 1703-1709
    • He, Y.-L.1    Flannery, B.2    Campestrini, J.3    Leon, S.4    Zinny, M.A.5    Ligueros-Saylan, M.6    Jarugula, V.7
  • 32
    • 0020603610 scopus 로고
    • Diarrhea and metformin in a diabetic clinic
    • Dandona P, Fonseea V, Mier A, Beckett AG. Diarrhea and metformin in a diabetic clinic. Diabetes Care. 1983; 6: 472-474. CrossRef PubMed. (Pubitemid 13005555)
    • (1983) Diabetes Care , vol.6 , Issue.5 , pp. 472-474
    • Dandona, P.1    Fonseca, V.2    Mier, A.3    Beckett, A.G.4
  • 33
    • 0031472452 scopus 로고    scopus 로고
    • Efficacy of metformin in type II diabetes: Results of a double-blind, placebo-controlled, dose-response trial
    • DOI 10.1016/S0002-9343(97)00254-4, PII S0002934397002544
    • Garber A J, Duncan TG, Goodman A M, Mills DJ, Rohlf JL. Efficacy of metformin in type II diabetes: results of a double-blind, placebo-controlled, dose-response trial. Am J Med. 1997; 103: 491- 497. CrossRef PubMed. (Pubitemid 28018651)
    • (1997) American Journal of Medicine , vol.103 , Issue.6 , pp. 491-497
    • Garber, A.J.1    Duncan, T.G.2    Goodman, A.M.3    Mills, D.J.4    Rohlf, J.L.5
  • 35
    • 84903955643 scopus 로고    scopus 로고
    • Boehringer Ingelheim International GmbH, Last accessed August 16, 2013
    • Boehringer Ingelheim International GmbH, Jenta-dueto™ (linagliptin and metformin hydrochloride) tablets. Available at: http://www.accessdata.fda, gov/drugsatfdadocs/label/2012/201281sOOOlbl, pdf. Last accessed August 16, 2013.
    • Jenta-dueto™ (Linagliptin and Metformin Hydrochloride) Tablets


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.