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)

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
Rok vydání: 2022
Předmět:
Zdroj: Diabetes therapy : research, treatment and education of diabetes and related disorders. 13(5)
ISSN: 1869-6953
Popis: 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 insulin, who were randomized (1:1) to SARAfter 26 weeks, the least squares (LS) mean [median] change in HbA1c from baseline was similar in both treatment groups (SARThe totality of evidence indicates that SAREudraCT number 2017-000092-84.
Databáze: OpenAIRE