Dataset Information

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 noninferiority of Melitide^® to Victoza^® in terms of change in HbA_1C level with a prespecified margin of 0.4%. The secondary outcomes were the assessment of additional efficacy parameters (including the proportion of patients achieving HbA_1C levels of < 7%), the incidence of adverse events, and immunogenicity.

Results

Of the 300 participants enrolled in this study, 235 were included in the per-protocol analysis (112 in the Melitide^® group and 123 in the Victoza^® group). The mean (standard deviation) changes in HbA_1C were - 1.76% (1.22) in the Melitide^® group and - 1.59% (1.31) in the Victoza^® group. The upper limit of the 95% one-sided confidence interval (CI) of the mean difference between Melitide^® and Victoza^® in lowering HbA_1C was lower than the predefined margin (mean difference - 0.18, 95% CI - 0.5 to 0.15). Similar findings were obtained with the intention-to-treat analysis. No statistically significant differences were observed between the two study arms regarding the proportion of patients achieving HbA_1C < 7% (p = 0.210), other efficacy parameters (p > 0.05), and reported adverse events (p = 0.916). Furthermore, none of the patients developed anti-liraglutide antibodies.

Conclusion

The biosimilar liraglutide (Melitide^®) was noninferior in efficacy and comparable in safety when compared with the reference liraglutide.

Trial registration

NCT03421119.

SUBMITTER: Esteghamati A

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

REPOSITORIES: biostudies-literature

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Publications

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

Esteghamati Alireza A Zamanzadeh Mehran M Malek Mojtaba M Khaledi Mohammad M Monavari Arezoo A Najafi Laily L Banazadeh Zahra Z Malboosbaf Ramin R Aghili Rokhsareh R Mahdikhah Sedigheh S Ganjizadeh-Zavereh Hasan H Kafi Hamidreza H Hosseinpanah Farhad F Khamseh Mohammad Ebrahim ME

Diabetes therapy : research, treatment and education of diabetes and related disorders 20230914 11

<h4>Introduction</h4>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<sup>®</sup>; CinnaGen, Tehran, Iran) to the reference liraglutide (Victoza<sup>®</sup>; Novo Nordisk, Bagsvaerd, Denmark) in people with type 2 diabetes mellitus (T2DM).<h4>Methods</h4>In this phase 3 clinical noninferiority trial, adult patients with inadequately controlled T2DM and with hemoglobin A ...[more]

PMID: 37707701

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Dataset Information

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.

Introduction

Methods

Results

Conclusion

Trial registration

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Dataset Information

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.

Introduction

Methods

Results

Conclusion

Trial registration

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

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.