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

Autor:	S. R. Aravind, Kiran P. Singh, Liliia Mogylnytska, Alsu G. Zalevskaya, Beata Matyjaszek-Matuszek, Karin Wernicke-Panten, My-Liên Nguyên-Pascal, Suzanne Pierre, Baerbel Rotthaeuser, Daniel Kramer, Bhaswati Mukherjee
Rok vydání:	2022
Předmět:	Endocrinology Diabetes and Metabolism Internal Medicine
Zdroj:	Diabetes Therapy. 13:1299-1310
ISSN:	1869-6961 1869-6953
DOI:	10.1007/s13300-022-01279-z
Popis:	We compared the efficacy, safety, and immunogenicity of biosimilar insulin aspart premix SAR341402 Mix 70/30 (70% intermediate SAR341402 protamine and 30% rapid SAR341402 solution) (SARThis phase 3, randomized, open-label, multinational, 26-week trial (GEMELLI M) enrolled 402 participants with type 1 or type 2 diabetes. At randomization, participants switched from their prestudy premix insulin NovoMix 30 (n = 341) or Humalog Mix 25/Liprolog Mix 25 (n = 61) to equivalent (1:1) doses of either SARAt week 26, change from baseline in HbA1c (primary efficacy endpoint) was similar between SAREfficacy, safety, and immunogenicity profiles of SAREudraCT number 2017-000092-84.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0caa3cbb19b79639d8e3fe739120f26b https://doi.org/10.1007/s13300-022-01279-z Zobrazit plný text záznamu Plný text ve formátu PDF Plný text ve formátu HTML
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