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Evaluation of immunogenicity of LY2963016 insulin glargine compared with Lantus® insulin glargine in patients with type 1 or type 2 diabetes mellitus

Autor: Thomas Blevins, Steve Edelman, R. A. Ortmann, Timothy M. Costigan, Melvin J. Prince, J. S. Zielonka, Mark A. Deeg, Robert J. Konrad, Liza L. Ilag, Robyn K. Pollom, W. J. Huster, Priscilla Hollander

Publikováno v: Diabetes, Obesity & Metabolism

Aims To compare the immunogenicity profiles and the potential effects on clinical outcomes of LY2963016 insulin glargine (LY IGlar) and Lantus® insulin glargine (IGlar), products with identical primary amino acid sequences, in patients with type 1 o

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1b7cd1d91c5af5483c4f4d9e304aab47
http://europepmc.org/articles/PMC4737399

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

Autor: W. J. Huster, Liza L. Ilag, Julio Rosenstock, D. Dahl, Thomas Blevins, Robyn K. Pollom, J. S. Zielonka, Melvin J. Prince

Publikováno v: Diabetes, Obesity and Metabolism. 17:726-733

Aims To compare the efficacy and safety of LY2963016 insulin glargine (LY IGlar) and the reference product (Lantus®) insulin glargine (IGlar) in patients with type 1 diabetes (T1D). Methods This phase III, randomized, open-label, 52-week study enrol

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::f0d0c0ad64c596bab70b26c39d749887
https://doi.org/10.1111/dom.12496

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Autor: Robyn K. Pollom, Liza L. Ilag, Julio Rosenstock, J. S. Zielonka, Priscilla Hollander, Melvin J. Prince, Anuj Bhargava, W. J. Huster

Publikováno v: Diabetes, Obesity and Metabolism. 17:734-741

Aims To compare the efficacy and safety of LY2963016 insulin glargine (LY IGlar) and the reference product (Lantus®) insulin glargine (IGlar) in combination with oral antihyperglycaemic medications in patients with type 2 diabetes (T2D). Methods Thi

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::dfb5347406bc2fb59ea43f7faff6e254
https://doi.org/10.1111/dom.12482

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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

Autor: T C, Blevins, D, Dahl, J, Rosenstock, L L, Ilag, W J, Huster, J S, Zielonka, R K, Pollom, M J, Prince

Publikováno v: Diabetes, obesitymetabolism. 17(8)

To compare the efficacy and safety of LY2963016 insulin glargine (LY IGlar) and the reference product (Lantus®) insulin glargine (IGlar) in patients with type 1 diabetes (T1D).This phase III, randomized, open-label, 52-week study enrolled patients w

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::3ea1fc86a1bc96fccc44807fa91e8df4
https://pubmed.ncbi.nlm.nih.gov/25974640

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Autor: J, Rosenstock, P, Hollander, A, Bhargava, L L, Ilag, R K, Pollom, J S, Zielonka, W J, Huster, M J, Prince

Publikováno v: Diabetes, obesitymetabolism. 17(8)

To compare the efficacy and safety of LY2963016 insulin glargine (LY IGlar) and the reference product (Lantus(®)) insulin glargine (IGlar) in combination with oral antihyperglycaemic medications in patients with type 2 diabetes (T2D).This phase III,

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::f4fbe495567f22e46efc79e32f460218
https://pubmed.ncbi.nlm.nih.gov/25931141

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Antiestrogenic Properties of Raloxifene

Autor: J. A. Neild, Flowers De, Draper Michael William, W. J. Huster, Zerbe Rl

Publikováno v: Pharmacology. 50:209-217

This 21-day, open-label study evaluated the effects of raloxifene and tamoxifen on estrogen-induced changes in serum levels of anterior pituitary hormones (prolactin, luteinizing hormone, and follicle-stimulating hormone), sex steroids (testosterone,

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c59c65d3776eb60d5e6562cc49a40717
https://doi.org/10.1159/000139284

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Endometrial response to raloxifene compared with placebo, cyclical hormone replacement therapy, and unopposed estrogen in postmenopausal women

Autor: G C, Davies, W J, Huster, W, Shen, B, Mitlak, L, Plouffe, A, Shah, F J, Cohen

Publikováno v: Menopause (New York, N.Y.). 6(3)

To determine the endometrial effects of raloxifene 60 mg/day in postmenopausal women as assessed by vaginal bleeding and endometrial thickness.Data from 1157 postmenopausal women were analyzed from a database consisting of four independent, double-bl

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::6688cf19365a09f12c4b6c5009869b02
https://pubmed.ncbi.nlm.nih.gov/10486785

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A framework establishing clear decision criteria for the assessment of drug efficacy

Autor: W J, Huster, G G, Enas

Publikováno v: Statistics in medicine. 17(15-16)

Much has been published on various aspects of data analysis and reporting from clinical trials within the biopharmaceutical environment. This ranges from regulatory guidelines on the format and content of registration dossiers to recommendations on d

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::02f79726b8c0c9ad140cd3fb44afa3fa
https://pubmed.ncbi.nlm.nih.gov/9749450

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Safety and efficacy of terfenadine/pseudoephedrine versus clemastine/phenylpropanolamine in the treatment of seasonal allergic rhinitis

Autor: A T, Segal, C J, Falliers, J A, Grant, W K, Podleski, T R, Woehler, W J, Huster, B, McNutt

Publikováno v: Annals of allergy. 70(5)

A double-blind, randomized, placebo-controlled, parallel trial was conducted to compare the efficacy and safety of terfenadine, 60 mg (immediate-release)/pseudoephedrine hydrochloride, 120 mg (controlled-release) (T/Ps) and clemastine fumarate, 1.34

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::12c17e6ce0caf71570861d701e25d8fc
https://pubmed.ncbi.nlm.nih.gov/8498730

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