トラゼンタ錠 5mg

CTD 第２部 資料概要

2.7 臨床概要

2.7.5 参考文献

日本ベーリンガーインゲルハイム株式会社

2.7.5 参考文献 1..................................................................

1. 「2.7.1 生物薬剤学及び関連する分析法の概要」の参考文献 1.......................

2. 「2.7.2 臨床薬理の概要」の参考文献 3...........................................

3. 「2.7.3 臨床的有効性の概要」の参考文献 5.......................................

4. 「2.7.4 臨床的安全性の概要」の参考文献 5.......................................

Table of Contents

2.7.5 参考文献

2.7 臨床概要にて参照した文献を下記に列挙する。文献のコピーは，第 5 部に添付した。

1. 「2.7.1 生物薬剤学及び関連する分析法の概要」の参考文献

R99-0423 Amidon GL, Lennernas H, Shah VP, Crison JR. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res 1995;12(3):413-420.（資料番号：5.4-44）

R01-0476 Guidance for industry: bioanalytical method validation. U.S. Department of Health and Human Services, Food and Drug Administration, 22.05.2001;2001. p.1-22.（資料番号：

4.3-19） R08-0872 Ellis G, Diamandis EP, Giesbrecht EE, Daneman D, Allen LC. An automated

'high-pressure' liquid-chromatographic assay for hemoglobin A1C. Clin Chem 1984;30(11):1746-1752.（資料番号：5.4-17）

R08-0871 Little RR, Rohlfing CL, Tennill AL, Connolly S, Hanson S. Effects of sample storage conditions on glycated emoglobin measurement: evaluation of five different high performance liquid chromatography methods. Diabetes Technol Ther 2007;9(1):36-42.（資料番号：5.4-16）

R09-0454 Variant II Hemoglobin A1c program (instruction manual, August 2005). Hercules: Bio-Rad Laboratories; 2005.（資料番号：5.4-21）

R09-0533 Variant II Turbo Hemoglobin A1c program, Variant II Turbo Hemoglobin A1c program reorder pack, 2000 tests (instruction manual, effective date: February 2006). Hercules: Bio-Rad Laboratories; 2006.（資料番号：5.4-23）

R09-0532 Variant II Hemoglobin A1c program, Variant II Hemoglobin A1c program reorder pack, 1000 tests (instruction manual, effective date: April 2008). Hercules: Bio-Rad Laboratories; 2008.（資料番号：5.4-22）

R09-0453 Little RR, England JD, Wiedmeyer HM, Goldstein DE. Effects of whole blood storage on results for glycosylated hemoglobin as measured by ion-exchange chromatography, affinity chromatography, and colorimetry. Clin Chem 1983;29(6):1113-1115.（資料番

号：5.4-20） R08-0873 Little RR, Rohlfing CL, Wiedmeyer HM, Myers GL, Sacks DB, Goldstein DE, et al. The

National Glycohemoglobin Standardization Program: a five-year progress report. Clin Chem 2001;47(11):1985-1992.（資料番号：5.4-18）

R06-0183 Rohlfing CL, Wiedmeyer HM, Little RR, England JD, Tennill A, Goldstein DE. Defining the relationship between plasma glucose and HbA1c: anlysis of glucose profiles and HbA1c in the Diabetes Control and Complications Trial. Diabetes Care 2002;25(2):275-278.（資料番号：5.4-12）

R04-1239 Trinder P. Determination of glucose in blood using glucose oxidase with an alternative oxygen acceptor. North East Regional Mtg, Newcastle upon Tyne, Oct 1968. Ann Clin Biochem 1969;6:24-27.（資料番号：5.4-9）

Nippon Boehringer Ingelheim Co., Ltd. Linagliptin 2.7.5 参考文献 Page

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R09-2089 Mullins CD, Weis KA, Perfetto EM, Subedi PR, Healey PJ. Triptans for migraine therapy: a comparison based on number needed to treat and doses needed to treat. J Managed Care Pharm 2005;11(5):394-402.（資料番号：5.4-24）

R09-4310 Manley SE, Stratton IM, Clark PM, Luzio SD. Comparison of 11 human insulin assays: implications for clinical investigation and research. Clin Chem 2007;53(5):922-932.（資

料番号：5.4-26） R09-6518 Westgard JO, Miller WG, Allen K, Boone DJ, Caines P, Cooper G, et al. Statistical

quality control for quantitative measurement procedures: principles and definitions; approved guideline - third edition. CLSI document C24-A3. Wayne: Clinical and Laboratory Standards Institute; 2006.（資料番号：5.4-33）

R09-6555 Westgard JO, Barry PL, Hunt MR, Groth T. A multi-rule Shewhart chart for quality control in clinical chemistry. Clin Chem 1981;27(3):493-501.（資料番号：5.4-34）

R09-4329 Robbins DC, Andersen L, Bowsher R, Chance R, Dinesen B, Frank B, et al. Report of the American Diabetes Association's Task Force on Standardization of the Insulin Assay. Diabetes 1996;45:242-256.（資料番号：5.4-27）

R09-4341 Deacon CF, Nauck MA, Meier J, Huecking K, Holst JJ. Degradation of endogenous and exogenous gastric inhibitory polypeptide in healthy and in type 2 diabetic subjects as revealed using a new assay for the intact peptide. J Clin Endocrinol Metab 2000;85(10):3575-3581.（資料番号：5.4-28）

R09-6292 Quantikine human DPPIV/CD260 immunoassay (catalog number DC260): for the quantitative determination of human dipeptidyl peptidase IV (DPPIV) concentrations in cell culture supernates, serum, plasma, saliva, and urine (R & D Systems) (package insert), for research use only, not for use in diagnostic procedures. 2006（資料番号：

5.4-30） P09-09363 Heise T, Graefe-Mody EU, Huettner S, Ring A, Trommeshauser D, Dugi KA.

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(8):786-794.（資料番号：5.4-7）

R03-1179 Committee for Proprietary Medicinal Products (CPMP): note for guidance on the investigation of bioavailability and bioequivalence (CPMP/EWP/QWP/1401/98, London, 26 Jul 2001). In: The European Agency for the Evaluation of Medicinal Products, Evaluation of Medicines for Human Use. London; 2001. p.1-18.（資料番号：5.4-8）

R05-1094 Guidance for industry: bioavailability and bioequivalence studies for orally administered drug products - general considerations (revision 1). In: Rockville: U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER); 2003. p.1-23.（資料番号：5.4-11）

R08-2199 Guidance for industry: food-effect bioavailability and fed bioequivalence studies. Rockville: U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER); 2002.（資料番号：

5.4-4）

Nippon Boehringer Ingelheim Co., Ltd. Linagliptin 2.7.5 参考文献 Page

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R09-6021 Krishna R, Herman G, Wagner JA. Accelerating drug development using biomarkers: a case study with sitagliptin, a novel DPP4 inhibitor for type 2 diabetes. AAPS J 2008;10(2):401-409.（資料番号：5.4-29）

2. 「2.7.2 臨床薬理の概要」の参考文献

R07-4440 Brockmeier D. Tight binding of ramiprilat to ACE: consequences for pharmacokinetic and pharmacodynamic measurements. Int J Clin Pharmacol Ther 1995;33(12):631-638.（資料番号：5.4-15）

P08-06359 Thomas L, Eckhardt M, Langkopf E, Tadayyon M, Himmelsbach F, Mark M. (R)-8-(3-amino-piperidin-1-yl)-7-but-2-ynyl-3-methyl-1-(4-methyl-quinazolin-2-yl methyl)-3,7-dihydro-purine-2,6-dione (BI 1356), a novel xanthine-based dipeptidyl peptidase 4 inhibitor, has a superior potency and longer duration of action compared with other dipeptidyl peptidase-4 inhibitors. J Pharmacol Exp Ther 2008;325(1):175-182.（資

料番号：4.3-1） R07-0393 Guidance for industry: pharmacokinetics in patients with impaired renal function - study

design, data analysis, and impact on dosing and labeling (May 1998). Rockville: U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER); 1998.（資料番号：5.4-14）

R08-2669 Guidance for industry: diabetes mellitus: developing drugs and therapeutic biologics for treatment and prevention (draft guidance, February 2008). Rockville: U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER); 2008.（資料番号：5.4-19）

R10-2435 Wang DS, Jonker JW, Kato Y, Kusuhara H, Schinkel AH, Sugiyama Y. Involvement of organic cation transporter 1 in hepatic and intestinal distribution of metformin. J Pharmacol Exp Ther 2002;302(2):510-515.（資料番号：5.4-40）

R09-6370 Song IS, Shin HJ, Shim EJ, Jung IS, Kim WY, Shon JH, et al. Genetic variants of the organic cation transporter 2 influence the disposition of metformin. Clin Pharmacol Ther 2008;84(5):559-562.（資料番号：5.4-31）

R10-2430 Micronase 1.25, 2.5, and 5 mg tablets (glyburide) (Pfizer), for oral use, Rx only (Unique Selling Proposition (USP), revised January 2009). 2009.（資料番号：5.4-35）

R10-2438 Buse JB, Freeman JLR, Edelman SV, Jovanovic L, McGill JB. Serum 1,5-anhydroglucitol (GlycoMark): a short-term glycemic marker. Diabetes Technol Ther 2003;5(3):355-363.（資料番号：5.4-42）

R10-2437 Yamanouchi T, Ogata N, Tagaya T, Kawasaki T, Sekino N, Funato H, et al. Clinical usefulness of serum 1,5-anhydroglucitol in monitoring glycaemic control. Lancet 1996;347:1514-1518.（資料番号：5.4-41）

Nippon Boehringer Ingelheim Co., Ltd. Linagliptin 2.7.5 参考文献 Page

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R09-4256 Roy RS, Wu J, Eiermann G, Lyons K, He H, Weber A, et al. Plasma DPP-4 inhibition by sitagliptin and other DPP-4 inhibitors correlates with and predicts glucose lowering efficacy. 69th Sci Sess of the American Diabetes Association (ADA), New Orleans, 5 - 9 Jun 2009. Diabetes 2009;58(6)(Suppl).（資料番号：5.4-25）

R05-0781 Clinical pharmacokinetics: concepts and applications. Rowland M, Tozer TN. 3rd ed. Philadelphia: Lippincott Williams & Wilkins; 1995.（資料番号：5.4-10）

P01-05044 Marino MR, Vachharajani NN, Hadjilambris OW. Irbesartan does not affect the pharmacokinetics of simvastatin in healthy subjects. J Clin Pharmacol 2000;40(8):875-879.（資料番号：5.4-2）

P00-02973 Backman JT, Kyrklund C, Kivisto KT, Wang JS, Neuvonen PJ. Plasma concentrations of active simvastatin acid are increased by gemfibrozil. Clin Pharmacol Ther 2000;68(2):122-129.（資料番号：5.4-1）

P04-09679 Bergman AJ, Murphy G, Burke J, Zhao JJ, Valesky R, Liu L, et al. Simvastatin does not have a clinically significant pharmacokinetic interaction with fenofibrate in humans. J Clin Pharmacol 2004;44(9):1054-1062.（資料番号：5.4-3）

P08-09424 Thomas L, Mark M. BI 1356 (proposed tradename Ondero), a novel xanthine-based DPP-4 inhibitor, increases basal GLP-1 and improves glycaemic control in diabetic animals. 68th Sci Sess of the American Diabetes Association (ADA), San Francisco, 6 - 10 Jun 2008. （資料番号：5.4-5）

P09-04157 Zhang Y, Zhang L, Abraham S, Apparaju S, Wu TC, Strong JM, et al. Assessment of the impact of renal impairment on systemic exposure of new molecular entities: evaluation of recent new drug applications. Clin Pharmacol Ther 2009;85(3):305-311.（資料番号：

5.4-6） R10-2511 Guidance for industry: pharmacokinetics in patients with impaired renal function - study

design, data analysis, and impact on dosing and labeling (draft guidance, revision 1, March 2010). http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances ; U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER); 2010.（資料番号：5.4-43）

R10-0834 Kieffer TJ, McIntosh HS, Pederson RA. Degradation of glucose-dependent insulinotropic polypeptide and truncated glucagon-like peptide 1 in vitro and in vivo by dipeptidyl peptidase IV. Endocrinology 1995;136(8):3585-3596.（資料番号：4.3-6）

R10-2432 Kreymann B, Ghatei MA, Williams G, Bloom SR. Glucagon-like peptide-1 7-36: a physiological incretin in man. Lancet 1987;2(8571):1300-1304.（資料番号：5.4-37）

R10-2434 Lankas GR, et al. Dipeptidyl peptidase IV inhibition for the treatment of type 2 diabetes: potential importance of selectivity over dipeptidyl peptidases 8 and 9. Diabetes 2005;54:2988-2994.（資料番号：5.4-39）

R10-2431 Nauck MA, Baller B, Meier JJ. Gastric inhibitory polypeptide and glucagon-like peptide-1 in the pathogenesis of type 2 diabetes. Diabetes 2004;53(Suppl 3):S190-S196.（資料番号：5.4-36）

Nippon Boehringer Ingelheim Co., Ltd. Linagliptin 2.7.5 参考文献 Page

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R10-2433 Meier JJ, Nauck MA. GIP as a potential therapeutic agent Horm Metab Res 2004;36:859-866.（資料番号：5.4-38）

R09-6409 Meier JJ, Nauck MA. Glucagon-like peptide 1(GLP-1) in biology and pathology. Diabetes Metab Res Rev 2005;21:91-117.（資料番号：5.4-32）

R06-2694 Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia 1985;28(7):412-419.（資

料番号：5.4-13）

3. 「2.7.3 臨床的有効性の概要」の参考文献

P08-07949 Elrishi MA, Khunti K, Jarvis J, Davies MJ. The dipeptidyl-peptidase-4 (DPP-4) inhibitors: a new class of oral therapy for patients with type 2 diabetes mellitus. Pract Diabetes Int 2007;24(9):474-482.（資料番号：5.4-45）

R04-2186 The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993;329(14):977-986.（資料番号：

5.4-47） R07-0040 King H, Aubert RE, Herman WH. Global burden of diabetes, 1995 - 2025: prevalence,

numerical estimates, and projections. Diabetes Care 1998;21(9):1414-1431.（資料番号：

5.4-50） R09-6277 Pavo I, Jermendy G, Varkonyi TT, Kerenyi Z, Gyimesi A, Shoustov S, et al. Effect of

pioglitazone compared with metformin on glycemic control and indicators of insulin sensitivity recently diagnosed patients with type 2 diabetes. J Clin Endocrinol Metab 2003;88(4):1637-1645. （資料番号：5.4-53）

R09-6276 Rosenblatt S, Miskin B, Glazer NB, Prince MJ, Robertson KE, Pioglitazone 026 Study Group. The impact of pioglitazone on glycemic control and atherogenic dyslipidemia in patients with type 2 diabetes mellitus. Coronary Artery Dis 2001;12(5):413-423. （資料

番号：5.4-54）

4. 「2.7.4 臨床的安全性の概要」の参考文献

R09-2150 Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, et al. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy. Diabetes Care 2008;31(12):1-11.（資料番号：

5.4-48） R06-0919 Alberti KGMM, Zimmet P, Shaw J. Metabolic syndrome - a new world-wide definition.

A consensus statement from the International Diabetes Federation. Diabetic Med 2006;23:469-480.（資料番号：5.4-49）

R09-5501 Januvia 100 mg film-coated tablets: sitagliptin (Merck Sharp & Dohme) (package leaflet, last approved in August 2009). 2009.（資料番号：5.4-52）

Nippon Boehringer Ingelheim Co., Ltd. Linagliptin 2.7.5 参考文献 Page

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R09-5231 Amaryl (glimepiride tablets) 1, 2, and 4 mg (sanofi-aventis), Rx only (prescribing info, revised May 2009). 2009.（資料番号：5.4-51）

R02-1064 FDA Working Group. CDER-PhRMA-AASLD Conference 2000: clinical white paper, November 2000. CDER-PhRMA-AASLD Conf, 2000. 2000:1-13.（資料番号：5.4-46）

Nippon Boehringer Ingelheim Co., Ltd. Linagliptin 2.7.5 参考文献 Page

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