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Volumn 38, Issue 12, 2015, Pages 2226-2233

Comparison of the Pharmacokinetics and pharmacodynamics of LY2963016 insulin glargine and EU- And US-Approved versions of lantus insulin glargine in healthy subjects: Three randomized euglycemic clamp studies

Author keywords

[No Author keywords available]

Indexed keywords

INSULIN GLARGINE; ANTIDIABETIC AGENT; GLUCOSE BLOOD LEVEL; LY2963016 INSULIN GLARGINE;

EID: 84962360228     PISSN: 01495992     EISSN: 19355548     Source Type: Journal    
DOI: 10.2337/dc14-2623     Document Type: Article
Times cited : (77)

References (23)
  • 1
    • 84962410541 scopus 로고    scopus 로고
    • [Internet], Available from, Accessed 21 July 2014
    • Lantus [Internet], 2014. Available from http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Information/human/000284/WC500036082.pdf. Accessed 21 July 2014.
    • (2014) Lantus
  • 4
    • 65349105267 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration. [Internet], Available from, Accessed 7 August 2015
    • U.S. Food and Drug Administration. Applications covered by Section 505(b)(2) [Draft Guidance] [Internet], 1999. Available from http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm079345.pdf Accessed 7 August 2015.
    • (1999) Applications Covered by Section 505(b)(2) [Draft Guidance]
  • 5
    • 84962390960 scopus 로고    scopus 로고
    • European Medicines Agency., Available from, Accessed 29 January 2015
    • European Medicines Agency. Assessment report: Abasria [Internet], 2014. Available from http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Public-assessment-report/human/002835/WC500175383.pdfAccessed 29 January 2015.
    • (2014) Assessment Report: Abasria [Internet]
  • 6
    • 84928576980 scopus 로고    scopus 로고
    • Similar efficacy and safety with ly2963016 insulin glargine compared with lantus insulin glargine in patients with t1dm: The element 1 study (Abstract)
    • Blevins T, Dahl D, Rosenstock J, et al. Similar Efficacy and Safety with LY2963016 Insulin Glargine Compared with Lantus Insulin Glargine in Patients with T1DM: The ELEMENT 1 Study (Abstract). Diabetes 2014;63(Suppl. 1):A19.
    • (2014) Diabetes , vol.63 , pp. A19
    • Blevins, T.1    Dahl, D.2    Rosenstock, J.3
  • 7
    • 84928547217 scopus 로고    scopus 로고
    • Similar efficacy and safety with LY2963016 insulin glargine compared with lantus insulin glargine in patients with T2DM: The ELEMENT 2 study (ABSTRACT)
    • Suppl. 1
    • Rosenstock J, Hollander P, Bhargava A, et al. Similar Efficacy and Safety with LY2963016 Insulin Glargine Compared with Lantus Insulin Glargine in Patients with T2DM: The ELEMENT 2 Study (Abstract). Diabetes 2014;63(Suppl. 1):A17.
    • (2014) Diabetes , vol.63 , pp. A17
    • Rosenstock, J.1    Hollander, P.2    Bhargava, A.3
  • 9
    • 38349006256 scopus 로고    scopus 로고
    • Current approaches for assessing insulin sensitivity and resistance in vivo: Advantages, limitations, and appropriate usage
    • Muniyappa R, Lee S, Chen H, Quon MJ. Current approaches for assessing insulin sensitivity and resistance in vivo: Advantages, limitations, and appropriate usage. Am J Physiol Endocrinol Metab 2008;294:E15-E26.
    • (2008) Am J Physiol Endocrinol Metab , vol.294 , pp. E15-E26
    • Muniyappa, R.1    Lee, S.2    Chen, H.3    Quon, M.J.4
  • 11
    • 84869824367 scopus 로고    scopus 로고
    • Metabolism of insulin glargine after repeated daily subcutaneous injections in subjects with type 2 diabetes
    • Lucidi P, Porcellati F, Rossetti P, et al. Metabolism of insulin glargine after repeated daily subcutaneous injections in subjects with type 2 diabetes. Diabetes Care 2012;35: 2647-2649.
    • (2012) Diabetes Care , vol.35 , pp. 2647-2649
    • Lucidi, P.1    Porcellati, F.2    Rossetti, P.3
  • 13
    • 77954637421 scopus 로고    scopus 로고
    • The type 1 diabetes physio lab platform: A validated physiologically based mathematical model of pathogenesis in the non-obese diabetic mouse
    • Shoda L, Kreuwel H, Gadkar K, et al. The Type 1 Diabetes Physio Lab Platform: A validated physiologically based mathematical model of pathogenesis in the non-obese diabetic mouse. Clin Exp Immunol 2010;161:250-267.
    • (2010) Clin Exp Immunol , vol.161 , pp. 250-267
    • Shoda, L.1    Kreuwel, H.2    Gadkar, K.3
  • 14
    • 84961289782 scopus 로고    scopus 로고
    • Single-dose new insulin glargine 300 U/ML provides prolonged, stable glycaemic control in Japanese and European people with type 1 diabetes
    • Shiramoto M, Eto T, Irie S, et al. Single-dose new insulin glargine 300 U/ml provides prolonged, stable glycaemic control in Japanese and European people with type 1 diabetes. Diabetes Obes Metab 2015;17:254-260.
    • (2015) Diabetes Obes Metab , vol.17 , pp. 254-260
    • Shiramoto, M.1    Eto, T.2    Irie, S.3
  • 15
    • 26244459804 scopus 로고    scopus 로고
    • Pharmacokinetic and glucodynamic variability: Assessment of insulin glargine, NPH insulin and insulin ultralente in healthy volunteers using a euglycaemic clamp technique
    • Scholtz HE, Pretorius SG, Wessels DH, Becker RH. Pharmacokinetic and glucodynamic variability: Assessment of insulin glargine, NPH insulin and insulin ultralente in healthy volunteers using a euglycaemic clamp technique. Diabetologia 2005;48:1988-1995.
    • (2005) Diabetologia , vol.48 , pp. 1988-1995
    • Scholtz, H.E.1    Pretorius, S.G.2    Wessels, D.H.3    Becker, R.H.4
  • 16
    • 84901918304 scopus 로고    scopus 로고
    • Glargine metabolism over 24 h following its subcutaneous injection in patients with type 2 diabetes mellitus: A dose-response study
    • Lucidi P, Porcellati F, Candeloro P, et al. Glargine metabolism over 24 h following its subcutaneous injection in patients with type 2 diabetes mellitus: A dose-response study. Nutr Metab Cardiovasc Dis 2014;24:709-716.
    • (2014) Nutr Metab Cardiovasc Dis , vol.24 , pp. 709-716
    • Lucidi, P.1    Porcellati, F.2    Candeloro, P.3
  • 17
    • 84869780310 scopus 로고    scopus 로고
    • Plasma exposure to insulin glargine and its metabolites M1 and M2 after subcutaneous injection of therapeutic and supratherapeutic doses of glargine in subjects with type 1 diabetes
    • Bolli GB, Hahn AD, Schmidt R, et al. Plasma exposure to insulin glargine and its metabolites M1 and M2 after subcutaneous injection of therapeutic and supratherapeutic doses of glargine in subjects with type 1 diabetes. Diabetes Care 2012;35:2626-2630.
    • (2012) Diabetes Care , vol.35 , pp. 2626-2630
    • Bolli, G.B.1    Hahn, A.D.2    Schmidt, R.3
  • 18
    • 2542576404 scopus 로고    scopus 로고
    • Lower within-subject variability of insulin detemir in comparison to insulin and insulin glargine in people with type 1 diabetes
    • Heise T, Nosek L, Rønn BB, et al. Lower within-subject variability of insulin detemir in comparison to NPH insulin and insulin glargine in people with type 1 diabetes. Diabetes 2004; 53:1614-1620.
    • (2004) Diabetes , vol.53 , pp. 1614-1620
    • Heise, T.1    Nosek, L.2    Rønn, B.B.3
  • 19
    • 0033661254 scopus 로고    scopus 로고
    • Pharmacokinetics and pharmacodynamics of subcutaneous injection of long-acting human insulin analog glargine, NPH insulin, and ultralente human insulin and continuous subcutaneous infusion of insulin lispro
    • Lepore M, Pampanelli S, Fanelli C, et al. Pharmacokinetics and pharmacodynamics of subcutaneous injection of long-acting human insulin analog glargine, NPH insulin, and ultralente human insulin and continuous subcutaneous infusion of insulin lispro. Diabetes 2000;49: 2142-2148.
    • (2000) Diabetes , vol.49 , pp. 2142-2148
    • Lepore, M.1    Pampanelli, S.2    Fanelli, C.3
  • 20
    • 84928572271 scopus 로고    scopus 로고
    • Duration of action of 2 insulin glargine products, LY2963016 and lantus, in subjects with type I diabetes mellitus (Abstract)
    • Heise T, Zhang X, Lam ECQ, et al. Duration of action of 2 insulin glargine products, LY2963016 and Lantus, in subjects with type I diabetes mellitus (Abstract). Diabetes 2014;63(Suppl. 1):A228.
    • (2014) Diabetes , vol.63 , pp. A228
    • Heise, T.1    Zhang, X.2    Lam, E.C.Q.3
  • 22
    • 67649932264 scopus 로고    scopus 로고
    • European Medicines Agency. [Internet], Available from, Accessed 7 May 2015
    • European Medicines Agency. Guideline on the investigation of bioequivalence [Internet], 2010. Available from http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2010/01/WC500070039.pdf Accessed 7 May 2015.
    • (2010) Guideline on the Investigation of Bioequivalence
  • 23
    • 84962359159 scopus 로고    scopus 로고
    • Center for drug evaluation and research
    • U.S. Food and Drug Administration, Lantus [Internet], Available from, Accessed 21 October 2014
    • U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Clinical pharmacology and biopharmaceutic review: Lantus [Internet], 2000. Available from http://www.accessdata.fda.gov/drugsatfda-docs/nda/2000/21081-Lantus-biopharmr.pdf. Accessed 21 October 2014.
    • (2000) Clinical Pharmacology and Bio Pharmaceutic Review


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.