Phase 3 efficacy and safety trial of proposed liraglutide biosimilar for reduction of glycosylated hemoglobin (HbA1c) in patients with Type 2 diabetes mellitus.

Autor: Krishnan K; Kadalmani Krishnan, Levim Biotech, Chennai, India. Electronic address: krishnan@levimbiotech.com., Raman S; Kadalmani Krishnan, Levim Biotech, Chennai, India. Electronic address: srikar@levimbiotech.com., Anand Moses CR; Moses Diabetes and Medical Centre, Chennai, India. Electronic address: cramoses@hotmail.com., Rajesh RP; Aadhavvan Diabetes and Research Centre, Chennai, India. Electronic address: doctorrpr@gmail.com., Gupta A; Atul Gupta, Navitas Life Sciences, Bangalore, India. Electronic address: atul.gupta@navitaslifesciences.com., Mudaliar V; Atul Gupta, Navitas Life Sciences, Bangalore, India. Electronic address: venkatesan.balu@navitaslifesciences.com., Vimal J; Kadalmani Krishnan, Levim Biotech, Chennai, India. Electronic address: jatin@levimbiotech.com.
Jazyk: angličtina
Zdroj: Diabetes research and clinical practice [Diabetes Res Clin Pract] 2024 Jan; Vol. 207, pp. 111034. Date of Electronic Publication: 2023 Dec 05.
DOI: 10.1016/j.diabres.2023.111034
Abstrakt: Liraglutide is indicated for glycaemic control in adults with Type 2 diabetes mellitus (T2DM) as an adjunct to diet and exercise. A proposed biosimilar of liraglutide (Levim Liraglutide) was investigated for efficacy & safety in a phase 3 study against the originator reference liraglutide (Victoza®) manufactured by Novo Nordisk A/S, Denmark. Patients aged 18-65 years of age with glycosylated hemoglobin (HbA1c) between 7 and 10 %, among other criteria, were included in the study. Patients were randomized 1:1 to receive daily doses of either Levim liraglutide or reference liraglutide for 24 weeks. The least square mean (standard error, SE) for the primary efficacy endpoint of reduction in HbA1c% at Week 24 was -1.09 (0.15)% for Levim liraglutide group and -1.04 (0.14)% for reference liraglutide. The upper bound of the confidence interval for treatment difference was less than the non-inferiority margin of 0.4 % at one-sided alpha of 0.025 (P-value = 0.0003). The secondary endpoints for proportion of patients achieving reduction in HbA1c, glycaemic level and weight, changes in cardiovascular parameters and the overall safety profiles of the study drugs were comparable. Levim liraglutide demonstrated non-inferior efficacy and similar safety to reference liraglutide and may be an option in treatment of T2DM (CTRI.nic.in, no. CTRI/2022/02/040261).
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Jatin Vimal, Srikar Raman and Kadalmani Krishnan are employees of Levim Biotech LLP. C.R. Anand Moses and R.P. Rajesh are consultant members for Levim Biotech LLP. Atul Gupta and Venkatesan Mudaliar are employees of Navitas Life Sciences, the contract research organization that conducted the study. This study was funded by Levim Biotech LLP, Chennai, India and BIRAC, DBT, India.
(Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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