Výsledky vyhledávání - "Karin Wernicke-Panten"

Efficacy, Safety, and Immunogenicity of Insulin Aspart Biosimilar SAR341402 Compared with Originator Insulin Aspart in Adults with Diabetes (GEMELLI 1): A Subgroup Analysis by Prior Type of Mealtime Insulin

Autor: Bhaswati Mukherjee, Suzanne Pierre, Edward Franek, Viral N. Shah, Karita Sadeharju, Karin Wernicke-Panten

Publikováno v: Diabetes Therapy

Introduction The biosimilar SAR341402 insulin aspart (SAR-Asp) was compared to its originator NovoLog®/NovoRapid® insulin aspart (NN-Asp) in terms of efficacy, safety, and immunogenicity, in adults with type 1 or type 2 diabetes switching from diff

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ee9eb0e08c8d87f3b61825c37dd04ae4
https://doi.org/10.1007/s13300-020-00992-x

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Safety, Immunogenicity, and Glycemic Control of Insulin Aspart Biosimilar SAR341402 Versus Originator Insulin Aspart in People with Diabetes Also Using Insulin Glargine: 12-Month Results from the GEMELLI 1 Trial

Autor: Edward Franek, Marek Wardecki, Travis Monchamp, Daniel Kramer, Satish K. Garg, Karin Wernicke-Panten, Karita Sadeharju, Patrick Miossec, Francois Delalande, Bhaswati Mukherjee, Viral N. Shah

Publikováno v: Diabetes Technology & Therapeutics

Background: SAR341402 (SAR-Asp) is a biosimilar/follow-on of the originator insulin aspart-NovoLog®/NovoRapid® (NN-Asp). This study investigated whether the efficacy, safety, and immunogenicity findings for SAR-Asp versus NN-Asp, observed over 6 mo

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::10d04831f170bc06969d6c37383176ae
http://europepmc.org/articles/PMC7336880

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Autor: S. R. Aravind, Kiran P. Singh, Grace Aquitania, Liliia Mogylnytska, Alsu G. Zalevskaya, Beata Matyjaszek-Matuszek, Karin Wernicke-Panten, My-Liên Nguyên-Pascal, Suzanne Pierre, Baerbel Rotthaeuser, Daniel Kramer, Bhaswati Mukherjee

Publikováno v: Diabetes therapy : research, treatment and education of diabetes and related disorders. 13(5)

This study compared the efficacy, safety, and immunogenicity of biosimilar insulin aspart premix SAR341402 Mix 70/30 (SARThis 26-week, open-label, phase 3 trial enrolled 402 people with T1D (n = 105) or T2D (n = 297) previously treated with premix in

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::bebbeff4fe4b05ba639824f46cddc001
https://pubmed.ncbi.nlm.nih.gov/35420397

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Anti-Insulin Antibodies and Adverse Events with Biosimilar Insulin Lispro Compared with Humalog Insulin Lispro in People with Diabetes

Autor: Philip Home, Karin Wernicke-Panten, Satish K. Garg, Karl-Michael Derwahl, Monika Ziemen, Suzanne Pierre, Yvonne Kirchhein

Publikováno v: Diabetes Technology & Therapeutics

Background: SAR342434 (SAR-Lis) is a biosimilar (follow-on) of insulin lispro (Humalog®; Ly-Lis). Two randomized, controlled, open-label, parallel-group, phase 3 studies were conducted to compare the efficacy and safety of SAR-Lis and Ly-Lis, both i

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7a19651a3ab90d31ee41f9d6b6a5ac33
https://doi.org/10.1089/dia.2017.0373

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Efficacy and Safety of Biosimilar SAR342434 Insulin Lispro in Adults with Type 2 Diabetes, Also Using Insulin Glargine: SORELLA 2 Study

Autor: Suzanne Pierre, Timothy S. Bailey, Lin Ping, Karl-Michael Derwahl, Karin Wernicke-Panten

Publikováno v: Diabetes Technology & Therapeutics

Background: SAR342434 (SAR-Lis) is a biosimilar (follow-on) of insulin lispro (U100; Humalog®; Ly-Lis). This study aimed to show similar efficacy, safety, and immunogenicity of SAR-Lis versus Ly-Lis in adult patients with type 2 diabetes mellitus (T

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d7ed046c94f3b2b3b27c1a5e0b7da2b2
http://europepmc.org/articles/PMC5770084

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Safety of Insulin Lispro and a Biosimilar Insulin Lispro When Administered Through an Insulin Pump

Autor: Satish K. Garg, James Thrasher, Karin Wernicke-Panten, Baerbel Rotthaeuser, Howard Surks, Suzanne Pierre, Irene Nowotny

Publikováno v: Journal of Diabetes Science and Technology

Background: SAR342434 (U100; SAR-Lis; insulin lispro) is a biosimilar/follow-on to insulin lispro (U100; Ly-Lis). Similar pharmacokinetics/pharmacodynamics between the two products has been demonstrated in a hyperinsulinemic euglycemic clamp study. T

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::55144604e5779947526c56264736cb60
http://europepmc.org/articles/PMC6154226

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Efficacy and Safety of Biosimilar SAR342434 Insulin Lispro in Adults with Type 1 Diabetes Also Using Insulin Glargine—SORELLA 1 Study

Autor: Suzanne Pierre, Karin Wernicke-Panten, Satish K. Garg, Maria Rojeski, Krystyna Jedynasty, Yvonne Kirchhein

Publikováno v: Diabetes Technology & Therapeutics. 19:516-526

SAR342434 is a biosimilar follow-on of insulin lispro-HumalogSORELLA-1 was a randomized, open-label phase 3 study (NCT02273180). Patients completing the 6-month main study continued on SAR-Lis or Ly-Lis, as randomized, for a 6-month safety extension.

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6b4b4bcea8a0d5caa742bda74c574962
https://doi.org/10.1089/dia.2017.0117

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Efficacy and Safety of Insulin Aspart Biosimilar SAR341402 Versus Originator Insulin Aspart in People with Diabetes Treated for 26 Weeks with Multiple Daily Injections in Combination with Insulin Glargine: A Randomized Open-Label Trial (GEMELLI 1)

Autor: Marek Wardecki, Travis Monchamp, Viral N. Shah, Karita Sadeharju, Karin Wernicke-Panten, Satish K. Garg, Daniel Kramer, Francois Delalande, Edward Franek, Bhaswati Mukherjee

Publikováno v: Diabetes Technology & Therapeutics

Background: This study compared the efficacy, safety, and immunogenicity of insulin aspart biosimilar/follow-on biologic product SAR341402 (SAR-Asp) with originator insulin aspart-NovoLog®/NovoRapid® (NN-Asp) in people with type 1 diabetes (T1D) or

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0f45f50998c920434fc9716e5f840658
https://pubmed.ncbi.nlm.nih.gov/31804851

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Autor: Daniel Kramer, Travis Monchamp, Karita Sadeharju, Marek Wardecki, Satish K. Garg, Karin Wernicke-Panten, Francois Delalande, Edward Franek, Viral N. Shah

Publikováno v: Diabetes. 68

SAR341402 (SAR-Asp) was developed as a biosimilar/follow-on product to rapid-acting insulin NovoLog®/NovoRapid® (NN-Asp). This 6-month randomized, controlled, open-label, phase 3 study compared efficacy and safety of SAR-Asp and NN-Asp in adults wi

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::37e8074f50c05f867173920cbefc797c
https://doi.org/10.2337/db19-129-lb

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