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Volumn 156, Issue 7, 2015, Pages 2417-2428

Chronic toxicity and carcinogenicity studies of the long-acting GLP-1 receptor agonist dulaglutide in rodents

Author keywords

[No Author keywords available]

Indexed keywords

CALCITONIN; CALCIUM; DULAGLUTIDE; ANTIDIABETIC AGENT; GLP1R PROTEIN, HUMAN; GLP1R PROTEIN, MOUSE; GLP1R PROTEIN, RAT; GLUCAGON LIKE PEPTIDE; GLUCAGON LIKE PEPTIDE 1 RECEPTOR; GLUCAGON RECEPTOR; GLUCAGON-LIKE PEPTIDE-1 RECEPTOR; HYBRID PROTEIN; IMMUNOGLOBULIN FC FRAGMENT; PROTEIN P21;

EID: 84937597858     PISSN: 00137227     EISSN: 19457170     Source Type: Journal    
DOI: 10.1210/en.2014-1722     Document Type: Article
Times cited : (21)

References (33)
  • 1
    • 84879231610 scopus 로고    scopus 로고
    • A critical analysis of the clinical use of incretin-based therapies: The benefits by far outweigh the potential risks
    • Nauck M. A critical analysis of the clinical use of incretin-based therapies: the benefits by far outweigh the potential risks. Diabetes Care. 2013;36:2126-2132.
    • (2013) Diabetes Care , vol.36 , pp. 2126-2132
    • Nauck, M.1
  • 2
    • 75149143476 scopus 로고    scopus 로고
    • Glucagon-like peptide 1 and glucose-dependent insulinotropic polypeptide: New advances
    • Asmar M, Holst JJ. Glucagon-like peptide 1 and glucose-dependent insulinotropic polypeptide: new advances. Curr Opin Endocrinol Diabetes Obes. 2010;17:57-62.
    • (2010) Curr Opin Endocrinol Diabetes Obes , vol.17 , pp. 57-62
    • Asmar, M.1    Holst, J.J.2
  • 3
    • 0027391607 scopus 로고
    • Preserved incretin activity of glucagon-like peptide 1 [7-36 amide] but not of synthetic human gastric inhibitory polypeptide in patients with type 2 diabetes mellitus
    • Nauck MA, Heimesaat MM, Orskov C, Holst JJ, Ebert R, Creutzfeldt W. Preserved incretin activity of glucagon-like peptide 1 [7-36 amide] but not of synthetic human gastric inhibitory polypeptide in patients with type 2 diabetes mellitus. J Clin Invest. 1993;91:301-307.
    • (1993) J Clin Invest , vol.91 , pp. 301-307
    • Nauck, M.A.1    Heimesaat, M.M.2    Orskov, C.3    Holst, J.J.4    Ebert, R.5    Creutzfeldt, W.6
  • 4
    • 84857422717 scopus 로고    scopus 로고
    • GLP-1 receptor agonists and the thyroid: C-cell effects in mice are mediated via the GLP-1 receptor and not associated with RET activation
    • Madsen LW, Knauf JA, Gotfredsen C, et al. GLP-1 receptor agonists and the thyroid: C-cell effects in mice are mediated via the GLP-1 receptor and not associated with RET activation. Endocrinology. 2012;153:1538-1547.
    • (2012) Endocrinology , vol.153 , pp. 1538-1547
    • Madsen, L.W.1    Knauf, J.A.2    Gotfredsen, C.3
  • 5
    • 77950228684 scopus 로고    scopus 로고
    • Glucagon-like peptide-1 receptor agonists activate rodent thyroid C-cells causing calcitonin release and C-cell proliferation
    • Knudsen L, Madsen LW, Andersen S, et al. Glucagon-like peptide-1 receptor agonists activate rodent thyroid C-cells causing calcitonin release and C-cell proliferation. Endocrinology. 2010;151:1473-1486.
    • (2010) Endocrinology , vol.151 , pp. 1473-1486
    • Knudsen, L.1    Madsen, L.W.2    Andersen, S.3
  • 6
    • 84857384966 scopus 로고    scopus 로고
    • Accessed August 6, 2013
    • European Medicines Agency. Assessment report for Victoza. 2009. http://www.ema.europa.eu/docs/en-GB/document-library/EPAR---Public-assessment-report/human/001026/WC500050016.pdf. Accessed August 6, 2013.
    • (2009) Assessment Report for Victoza
  • 7
    • 84937563813 scopus 로고    scopus 로고
    • Accessed August 6, 2013
    • European Medicines Agency. Bydureon: EPAR - European Public Assessment Report. 2011. http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/document/document-detail.jsp?webContentId=WC500108239&mid=WC0b01ac058009a3dc. Accessed August 6, 2013.
    • (2011) Bydureon: EPAR - European Public Assessment Report
  • 8
    • 0008348082 scopus 로고    scopus 로고
    • Accessed June 5, 2013
    • European Medicines Agency. European Public Assessment Report: Lyxumia. 2012. http://www.ema.europa.eu/docs/en-GB/document-library/EPAR---Public-assessment-report/human/002445/WC500140449.pdf. Accessed June 5, 2013.
    • (2012) European Public Assessment Report: Lyxumia
  • 9
    • 84875702681 scopus 로고    scopus 로고
    • On-target effects of GLP-1 receptor agonists on thyroid C-cells in rats and mice
    • Rosol TJ. On-target effects of GLP-1 receptor agonists on thyroid C-cells in rats and mice. Toxicol Pathol. 2013;41:303-309.
    • (2013) Toxicol Pathol , vol.41 , pp. 303-309
    • Rosol, T.J.1
  • 11
    • 84878185729 scopus 로고    scopus 로고
    • A critical analysis of the clinical use of incretin-based therapies: Are the GLP-1 therapies safe?
    • Butler PC, Elashoff M, Elashoff R, Gale EA. A critical analysis of the clinical use of incretin-based therapies: are the GLP-1 therapies safe? Diabetes Care. 2013;36:2118-2125.
    • (2013) Diabetes Care , vol.36 , pp. 2118-2125
    • Butler, P.C.1    Elashoff, M.2    Elashoff, R.3    Gale, E.A.4
  • 12
    • 84855346848 scopus 로고    scopus 로고
    • Accessed July 28, 2014
    • Food and Drug Administration. Victoza (liraglutide injection): human relevance of rodent thyroid C-cell tumors. 2009. http://www.fda.gov/downloads/AdvisoryCommittees/Committees%20MeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM151129.pdf. Accessed July 28, 2014.
    • (2009) Victoza (Liraglutide Injection): Human Relevance of Rodent Thyroid C-Cell Tumors
  • 13
    • 79952284556 scopus 로고    scopus 로고
    • GLP-1 and calcitonin concentration in humans: Lack of evidence of calcitonin release from sequential screening in over 5000 subjects with type 2 diabetes or nondiabetic obese subjects treated with the human GLP-1 analog, liraglutide
    • Hegedüs L, Moses AC, Zdravkovic M, Le Thi T, Daniels GH. GLP-1 and calcitonin concentration in humans: lack of evidence of calcitonin release from sequential screening in over 5000 subjects with type 2 diabetes or nondiabetic obese subjects treated with the human GLP-1 analog, liraglutide. J Clin Endocrinol Metab. 2011;96:853-860.
    • (2011) J Clin Endocrinol Metab , vol.96 , pp. 853-860
    • Hegedüs, L.1    Moses, A.C.2    Zdravkovic, M.3    Le Thi, T.4    Daniels, G.H.5
  • 14
    • 79953032228 scopus 로고    scopus 로고
    • LY2189265, a long-acting glucagon-like peptide-1 analogue, showed a dose-dependent effect on insulin secretion in healthy subjects
    • Barrington P, Chien JY, Tibaldi F, Showalter HD, Schneck K, Ellis B. LY2189265, a long-acting glucagon-like peptide-1 analogue, showed a dose-dependent effect on insulin secretion in healthy subjects. Diabetes Obes Metab. 2011;13:434-438.
    • (2011) Diabetes Obes Metab , vol.13 , pp. 434-438
    • Barrington, P.1    Chien, J.Y.2    Tibaldi, F.3    Showalter, H.D.4    Schneck, K.5    Ellis, B.6
  • 15
    • 77952756104 scopus 로고    scopus 로고
    • Engineering and characterization of the long-acting glucagon-like peptide-1 analogue LY2189265, an Fc fusion protein
    • Glaesner W, Vick AM, Millican R, et al. Engineering and characterization of the long-acting glucagon-like peptide-1 analogue LY2189265, an Fc fusion protein. Diabetes Metab Res Rev. 2010;26:287-296.
    • (2010) Diabetes Metab Res Rev , vol.26 , pp. 287-296
    • Glaesner, W.1    Vick, A.M.2    Millican, R.3
  • 16
    • 79953065066 scopus 로고    scopus 로고
    • A 5-week study of the pharmacokinetics and pharmacodynamics of LY2189265, a novel, long-acting glucagon-like peptide-1 analogue, in patients with type 2 diabetes
    • Barrington P, Chien JY, Showalter HD, et al. A 5-week study of the pharmacokinetics and pharmacodynamics of LY2189265, a novel, long-acting glucagon-like peptide-1 analogue, in patients with type 2 diabetes. Diabetes Obes Metab. 2011;13:426-433.
    • (2011) Diabetes Obes Metab , vol.13 , pp. 426-433
    • Barrington, P.1    Chien, J.Y.2    Showalter, H.D.3
  • 17
    • 84937598580 scopus 로고    scopus 로고
    • Effects of dulaglutide on thyroid C-cells and serum calcitonin in male monkeys
    • Vahle J, Byrd R, Blackbourne J, et al. Effects of dulaglutide on thyroid C-cells and serum calcitonin in male monkeys. Endocrinology. 2015;156(7):2409-2416.
    • (2015) Endocrinology , vol.156 , Issue.7 , pp. 2409-2416
    • Vahle, J.1    Byrd, R.2    Blackbourne, J.3
  • 19
    • 0017670041 scopus 로고
    • Trend and homogeneity analyses of proportions and life table data
    • Thomas DG, Breslow N, Gart JJ. Trend and homogeneity analyses of proportions and life table data. Comput Biomed Res. 1977;10:373-381.
    • (1977) Comput Biomed Res , vol.10 , pp. 373-381
    • Thomas, D.G.1    Breslow, N.2    Gart, J.J.3
  • 20
    • 0019291735 scopus 로고
    • Guidelines for simple, sensitive significance tests for carcinogenic effects in long-term animal experiments
    • Peto R, Pike MC, Day NE, et al. Guidelines for simple, sensitive significance tests for carcinogenic effects in long-term animal experiments. IARC Monogr Eval Carcinog Risk Chem Hum Suppl. 1980;(suppl 2):311-426.
    • (1980) IARC Monogr Eval Carcinog Risk Chem Hum Suppl , pp. 311-426
    • Peto, R.1    Pike, M.C.2    Day, N.E.3
  • 21
    • 0021999911 scopus 로고
    • A FORTRAN program for testing trend and homogeneity in proportions
    • Thakur AK, Berry KJ, Mielke PW. A FORTRAN program for testing trend and homogeneity in proportions. Comput Programs Biomed. 1985;19:229-233.
    • (1985) Comput Programs Biomed , vol.19 , pp. 229-233
    • Thakur, A.K.1    Berry, K.J.2    Mielke, P.W.3
  • 22
    • 0016759979 scopus 로고
    • Tests for trend in life table analysis
    • Tarone RE. Tests for trend in life table analysis. Biometrika. 1975;62:679-682.
    • (1975) Biometrika , vol.62 , pp. 679-682
    • Tarone, R.E.1
  • 24
    • 0025222171 scopus 로고
    • Exact versus asymptotic tests of trend of tumor prevalence in tumorigenicity experiments: A comparison of P values for small frequency of tumors
    • Ali MW. Exact versus asymptotic tests of trend of tumor prevalence in tumorigenicity experiments: a comparison of P values for small frequency of tumors. Drug Inf J. 1990;24:727-737.
    • (1990) Drug Inf J , vol.24 , pp. 727-737
    • Ali, M.W.1
  • 26
    • 84937602217 scopus 로고    scopus 로고
    • Accessed January 29, 2015
    • United States Food and Drug Administration. Tanzeum pharmacology review. 2013. http://www.accessdata.fda.gov/drugsatfda-docs/nda/2014/125431Orig1s000PharmR.pdf. Accessed January 29, 2015.
    • (2013) Tanzeum Pharmacology Review
  • 27
    • 0026773681 scopus 로고
    • Age-related differences in basal and calcium-stimulated plasma calcitonin levels in female rats
    • Tsai CL, Pu HF, Lau CP, Wang PS, Liu TK. Age-related differences in basal and calcium-stimulated plasma calcitonin levels in female rats. Am J Physiol. 1992;262(5 Pt 1):E557-E560.
    • (1992) Am J Physiol , vol.262 , Issue.5 , pp. E557-E560
    • Tsai, C.L.1    Pu, H.F.2    Lau, C.P.3    Wang, P.S.4    Liu, T.K.5
  • 28
    • 33644618433 scopus 로고    scopus 로고
    • The biology of incretin hormones
    • Drucker DJ. The biology of incretin hormones. Cell Metab. 2006;3:153-165.
    • (2006) Cell Metab , vol.3 , pp. 153-165
    • Drucker, D.J.1
  • 29
    • 34250635159 scopus 로고    scopus 로고
    • GLP-1 receptor expression in human tumors and human normal tissues: Potential for in vivo targeting
    • Körner M, Stöckli M, Waser B, Reubi JC. GLP-1 receptor expression in human tumors and human normal tissues: potential for in vivo targeting. J Nucl Med. 2007;48:736-743.
    • (2007) J Nucl Med , vol.48 , pp. 736-743
    • Körner, M.1    Stöckli, M.2    Waser, B.3    Reubi, J.C.4
  • 30
    • 0028074806 scopus 로고
    • Pituitary adenylate cyclase-activating polypeptide receptors of types I and II and glucagon-like peptide-I receptors are expressed in the rat medullary carcinoma of the thyroid cell line 6/23
    • Vertongen P, Ciccarelli E, Woussen-Colle MC, De Neef P, Robberecht P, Cauvin A. Pituitary adenylate cyclase-activating polypeptide receptors of types I and II and glucagon-like peptide-I receptors are expressed in the rat medullary carcinoma of the thyroid cell line 6/23. Endocrinology. 1994;135:1537-1542.
    • (1994) Endocrinology , vol.135 , pp. 1537-1542
    • Vertongen, P.1    Ciccarelli, E.2    Woussen-Colle, M.C.3    De Neef, P.4    Robberecht, P.5    Cauvin, A.6
  • 31
    • 84871686739 scopus 로고    scopus 로고
    • GLP-1 receptor activation indirectly reduces hepatic lipid accumulation but does not attenuate development of atherosclerosis in diabetic male ApoE(-/-) mice
    • Panjwani N, Mulvihill EE, Longuet C, et al. GLP-1 receptor activation indirectly reduces hepatic lipid accumulation but does not attenuate development of atherosclerosis in diabetic male ApoE(-/-) mice. Endocrinology. 2013;154:127-139.
    • (2013) Endocrinology , vol.154 , pp. 127-139
    • Panjwani, N.1    Mulvihill, E.E.2    Longuet, C.3
  • 32
    • 84871675071 scopus 로고    scopus 로고
    • The glucagon-like peptide-1 receptor - Or not?
    • Pyke C, Knudsen LB. The glucagon-like peptide-1 receptor - or not? Endocrinology. 2013;154:4-8.
    • (2013) Endocrinology , vol.154 , pp. 4-8
    • Pyke, C.1    Knudsen, L.B.2
  • 33
    • 84937570423 scopus 로고    scopus 로고
    • Safety and efficacy of dulaglutide vs sitagliptin after 104 weeks in type 2 diabetes (AWARD-5)
    • Guerci B, Weinstock R, Umpierrez G, et al. Safety and efficacy of dulaglutide vs sitagliptin after 104 weeks in type 2 diabetes (AWARD-5). Diabetologia. 2013;56(suppl 1):S367.
    • (2013) Diabetologia , vol.56 , pp. S367
    • Guerci, B.1    Weinstock, R.2    Umpierrez, G.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.