메뉴 건너뛰기




Volumn 17, Issue 8, 2015, Pages 726-733

Efficacy and safety of LY2963016 insulin glargine compared with insulin glargine (Lantus®) in patients with type 1 diabetes in a randomized controlled trial: The ELEMENT 1 study

Author keywords

Insulin glargine; LY2963016; Type 1 diabetes

Indexed keywords

GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C; HUMAN INSULIN; INSULIN; INSULIN ANTIBODY; INSULIN ASPART; INSULIN DETEMIR; INSULIN GLARGINE; INSULIN GLULISINE; INSULIN LISPRO; ISOPHANE INSULIN; ANTIDIABETIC AGENT; GLUCOSE BLOOD LEVEL; HEMOGLOBIN A1C PROTEIN, HUMAN; LY2963016 INSULIN GLARGINE;

EID: 84937816371     PISSN: 14628902     EISSN: 14631326     Source Type: Journal    
DOI: 10.1111/dom.12496     Document Type: Article
Times cited : (62)

References (30)
  • 1
    • 0020684912 scopus 로고
    • Human insulin from recombinant DNA technology
    • Johnson IS. Human insulin from recombinant DNA technology. Science 1983; 219: 632-637.
    • (1983) Science , vol.219 , pp. 632-637
    • Johnson, I.S.1
  • 2
    • 77957122152 scopus 로고    scopus 로고
    • The new world of biosimilars: what diabetologists need to know about biosimilar insulins
    • Krämer I, Sauer T. The new world of biosimilars: what diabetologists need to know about biosimilar insulins. Br J Diabetes Vasc Dis 2010; 10: 163-171.
    • (2010) Br J Diabetes Vasc Dis , vol.10 , pp. 163-171
    • Krämer, I.1    Sauer, T.2
  • 6
    • 84937811563 scopus 로고    scopus 로고
    • Accessed 31 March 2015.
    • European Medicines Agency. Abasaglar (previously Abasria). 2014. Available from URL: http://www.ema.europa.eu/ema/index.jsp?curl=/pages/medicines/human/medicines/002835/human_med_001790.jsp&mid=WC0b01ac058001d124. Accessed 31 March 2015.
    • (2014) Abasaglar (previously Abasria)
  • 9
    • 79961107025 scopus 로고    scopus 로고
    • Accessed 31 March 2015.
    • Food and Drug Administration. Biologics Price Competition and Innovation Act. 2009. Available from URL: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM216146.pdf. Accessed 31 March 2015.
    • (2009) Biologics Price Competition and Innovation Act
  • 10
    • 84937814447 scopus 로고    scopus 로고
    • Accessed 31 March 2015.
    • European Medicines Agency. European public assessment report: Abasria. 2014. Available from URL: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002835/WC500175383.pdf. Accessed 31 March 2015.
    • (2014) European public assessment report: Abasria
  • 11
    • 84902264578 scopus 로고    scopus 로고
    • The evolution of insulin glargine and its continuing contribution to diabetes care
    • Hilgenfeld R, Seipke G, Berchtold H, Owens DR. The evolution of insulin glargine and its continuing contribution to diabetes care. Drugs 2014; 74: 911-927.
    • (2014) Drugs , vol.74 , pp. 911-927
    • Hilgenfeld, R.1    Seipke, G.2    Berchtold, H.3    Owens, D.R.4
  • 12
    • 0033766190 scopus 로고    scopus 로고
    • A 16-week comparison of the novel insulin analog insulin glargine (HOE 901) and NPH human insulin used with insulin lispro in patients with type 1 diabetes
    • Raskin P, Klaff L, Bergenstal R etal. A 16-week comparison of the novel insulin analog insulin glargine (HOE 901) and NPH human insulin used with insulin lispro in patients with type 1 diabetes. Diabetes Care 2000; 23: 1666-1671.
    • (2000) Diabetes Care , vol.23 , pp. 1666-1671
    • Raskin, P.1    Klaff, L.2    Bergenstal, R.3
  • 13
    • 0034033028 scopus 로고    scopus 로고
    • Less hypoglycemia with insulin glargine in intensive insulin therapy for type 1 diabetes. U.S. Study Group of Insulin Glargine in Type 1 Diabetes
    • Ratner RE, Hirsch IB, Neifing JL etal. Less hypoglycemia with insulin glargine in intensive insulin therapy for type 1 diabetes. U.S. Study Group of Insulin Glargine in Type 1 Diabetes. Diabetes Care 2000; 23: 639-643.
    • (2000) Diabetes Care , vol.23 , pp. 639-643
    • Ratner, R.E.1    Hirsch, I.B.2    Neifing, J.L.3
  • 18
    • 84979864301 scopus 로고    scopus 로고
    • Comparative subchronic toxicity studies in rats of LY2963016 (LY), an insulin glargine product, with USA sourced Lantus® (US-L) and EU-sourced Lantus® (EU-L)
    • Byrd RA, Blackbourne JL, Schultze AE, Vahle JL. Comparative subchronic toxicity studies in rats of LY2963016 (LY), an insulin glargine product, with USA sourced Lantus® (US-L) and EU-sourced Lantus® (EU-L). Toxicologist 2014; 138: 1650.
    • (2014) Toxicologist , vol.138 , pp. 1650
    • Byrd, R.A.1    Blackbourne, J.L.2    Schultze, A.E.3    Vahle, J.L.4
  • 19
    • 84937813025 scopus 로고    scopus 로고
    • Comparative pharmacokinetics (PK) and pharmacodynamics (PD) of LY2963016 insulin glargine and EU- and U.S.-approved versions of Lantus® insulin glargine in healthy subjects
    • 889-88P
    • Linnebjerg H, Quin Lam EC, Seger ME etal. Comparative pharmacokinetics (PK) and pharmacodynamics (PD) of LY2963016 insulin glargine and EU- and U.S.-approved versions of Lantus® insulin glargine in healthy subjects. Diabetes 2014; 63(Suppl. 1): 889-P.
    • (2014) Diabetes , vol.63
    • Linnebjerg, H.1    Quin Lam, E.C.2    Seger, M.E.3
  • 20
    • 84928559115 scopus 로고    scopus 로고
    • Comparative pharmacokinetics and pharmacodynamics of two insulin glargine products, LY2963016 and Lantus®, in healthy subjects at two dose levels
    • 890-89P
    • Zhang X, Quin Lam EC, Seger ME etal. Comparative pharmacokinetics and pharmacodynamics of two insulin glargine products, LY2963016 and Lantus®, in healthy subjects at two dose levels. Diabetes 2014; 63(Suppl. 1): 890-P.
    • (2014) Diabetes , vol.63
    • Zhang, X.1    Quin Lam, E.C.2    Seger, M.E.3
  • 21
    • 84928572271 scopus 로고    scopus 로고
    • Duration of action of 2 insulin glargine products, LY2963016 and Lantus®, in subjects with type I diabetes mellitus (T1DM)
    • 891-89P
    • Heise T, Zhang X, Quin Lam EC etal. Duration of action of 2 insulin glargine products, LY2963016 and Lantus®, in subjects with type I diabetes mellitus (T1DM). Diabetes 2014; 63(Suppl. 1): 891-P.
    • (2014) Diabetes , vol.63
    • Heise, T.1    Zhang, X.2    Quin Lam, E.C.3
  • 22
    • 84937817049 scopus 로고    scopus 로고
    • Similar efficacy and safety of LY2963016 insulin glargine and insulin glargine (Lantus®) in patients with type 2 diabetes who were insulin-naïve or previously treated with insulin glargine: a randomized, double-blind controlled trial (the ELEMENT 2 study)
    • 2015
    • Rosenstock J, Hollander P, Bhargava A, Ilag LL, Pollom RK, Zielonka JS, Huster WJ, Prince MJ (2015), Similar efficacy and safety of LY2963016 insulin glargine and insulin glargine (Lantus®) in patients with type 2 diabetes who were insulin-naïve or previously treated with insulin glargine: a randomized, double-blind controlled trial (the ELEMENT 2 study). Diabetes, Obesity and Metabolism. 2015; 17: 734-741.
    • (2015) Diabetes, Obesity and Metabolism , vol.17 , pp. 734-741
    • Rosenstock, J.1    Hollander, P.2    Bhargava, A.3    Ilag, L.L.4    Pollom, R.K.5    Zielonka, J.S.6    Huster, W.J.7    Prince, M.J.8
  • 23
    • 0031578033 scopus 로고    scopus 로고
    • Recommendations guiding physicians in biomedical research involving human subjects
    • World Medical Association Declaration of Helsinki. Recommendations guiding physicians in biomedical research involving human subjects. JAMA 1997; 277: 925-926.
    • (1997) JAMA , vol.277 , pp. 925-926
  • 26
    • 27544475840 scopus 로고    scopus 로고
    • Accessed 15 October 2014.
    • European Medicines Agency. Guideline on the choice of the non-inferiority margin. 2005. Available from URL: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003636.pdf. Accessed 15 October 2014.
    • (2005) Guideline on the choice of the non-inferiority margin
  • 28
    • 84937812108 scopus 로고    scopus 로고
    • Accessed 1 April 2015.
    • European Medicines Agency. LANTUS: EPAR - Product information. 2015. Available from URL: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000284/WC500036082.pdf. Accessed 1 April 2015.
    • (2015) LANTUS: EPAR - Product information
  • 29
    • 84937815639 scopus 로고    scopus 로고
    • Accessed 1 April 2015.
    • U.S. National Library of Medicine. LANTUS- insulin glargine injection, solution. Drug label information. 2015. Available from URL: http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a. Accessed 1 April 2015.
    • (2015) LANTUS- insulin glargine injection, solution. Drug label information


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.