Efficacy and Safety of a Biosimilar Liraglutide (Melitide^®) Versus the Reference Liraglutide (Victoza^®) in People with Type 2 Diabetes Mellitus: A Randomized, Double-Blind, Noninferiority Clinical Trial.

ABSTRACT:

Introduction

Liraglutide effectively controls blood glucose level and reduces body weight. The aim of this study was to compare the efficacy and safety of a biosimilar liraglutide (Melitide^®; CinnaGen, Tehran, Iran) to the reference liraglutide (Victoza^®; Novo Nordisk, Bagsvaerd, Denmark) in people with type 2 diabetes mellitus (T2DM).

Methods

In this phase 3 clinical noninferiority trial, adult patients with inadequately controlled T2DM and with hemoglobin A_1C (HbA_1C) levels of 7-10.5% on at least two oral glucose-lowering drugs with stable doses for at least 3 months were randomized to receive Melitide^® (n = 150) or Victoza^® (n = 150) 1.8 mg/day for 26 weeks. The primary outcome was assessment of the noninfe

SUBMITTER: Esteghamati A 

PROVIDER: S-EPMC10570258 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature