Efficacy, Safety, and Immunogenicity of Biosimilar Insulin Aspart Premix SAR341402 Mix 70/30 Compared with Originator Insulin Aspart Mix 70/30 in Adults with Diabetes (GEMELLI M): A Subgroup Analysis by Prior Type of Premix Insulin-Reference-Cited by-同舟云学术

Efficacy, Safety, and Immunogenicity of Biosimilar Insulin Aspart Premix SAR341402 Mix 70/30 Compared with Originator Insulin Aspart Mix 70/30 in Adults with Diabetes (GEMELLI M): A Subgroup Analysis by Prior Type of Premix Insulin

Published:2022-06-01 Issue:7 Volume:13 Page:1299-1310
ISSN:1869-6953
Container-title:Diabetes Therapy
language:en
Short-container-title:Diabetes Ther

Author:

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

Funder

Sanofi

Publisher

Springer Science and Business Media LLC

Subject

Endocrinology, Diabetes and Metabolism,Internal Medicine

Link

https://link.springer.com/content/pdf/10.1007/s13300-022-01279-z.pdf

Reference9 articles.

1. European Medicines Agency. Truvelog Mix 30. https://www.ema.europa.eu/en/medicines/human/summaries-opinion/truvelog-mix-30. Accessed Mar 9, 2022.

2. European Medicines Agency: Insulin aspart Sanofi: summary of product characteristics, updated 27 January 2022. https://www.ema.europa.eu/en/documents/product-information/insulin-aspart-sanofi-epar-product-information_en.pdf. Accessed Apr 15, 2022.

3. European Medicines Agency: NovoMix 30 (30% insulin aspart and 70% insulin aspart protamine): summary of product characteristics, updated 12 November 2020. https://www.ema.europa.eu/en/documents/product-information/novomix-epar-product-information_en.pdf. Accessed Sept 1, 2021.

4. Kapitza C, Nosek L, Schmider W, Teichert L, Mukherjee B, Nowotny I. A single-dose euglycaemic clamp study in two cohorts to compare the exposure of SAR341402 (insulin aspart) Mix 70/30 with US- and European-approved versions of insulin aspart Mix 70/30 and SAR341402 rapid-acting solution in subjects with type 1 diabetes. Diabetes Obes Metab. 2021;23:674–81.

5. Aravind SR, Singh KP, Aquitania G, et al. Biosimilar insulin aspart premix SAR341402 Mix 70/30 versus originator insulin aspart Mix 70/30 (NovoMix 30) in people with diabetes: a 26-week, randomized, open-label trial (GEMELLI M). Diabetes Ther. 2022;13:1053–71.

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