生物仿制药利拉鲁肽 (Melitide®) 与参考利拉鲁肽 (Victoza®) 在 2 型糖尿病患者中的疗效和安全性：一项随机、双盲、非劣效性临床试验,Diabetes Therapy

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生物仿制药利拉鲁肽 (Melitide®) 与参考利拉鲁肽 (Victoza®) 在 2 型糖尿病患者中的疗效和安全性：一项随机、双盲、非劣效性临床试验
Diabetes Therapy ( IF 2.8 ) Pub Date : 2023-09-14 , DOI: 10.1007/s13300-023-01462-w
Alireza Esteghamati ₁ , Mehran Zamanzadeh _{2,

3} , Mojtaba Malek ₄ , Mohammad Khaledi ₅ , Arezoo Monavari ₆ , Laily Najafi ₇ , Zahra Banazadeh ₈ , Ramin Malboosbaf ₉ , Rokhsareh Aghili ₇ , Sedigheh Mahdikhah ₁₀ , Hasan Ganjizadeh-Zavereh ₁₁ , Hamidreza Kafi ₁₂ , Farhad Hosseinpanah ₁₃ , Mohammad Ebrahim Khamseh ₇

Affiliation

Endocrinology and Metabolism Research Center, Tehran University of Medical Sciences, Tehran, Iran.
East Tehran Diabetes Association, Tehran, Iran.
Iranian Society of Internal Specialist Physicians, Tehran, Iran.
Research Center for Prevention of Cardiovascular Disease, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences (IUMS), Tehran, Iran.
Iran University of Medical Sciences, Tehran, Iran.
Bahar Clinic, Karaj, Alborz, Iran.
Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences (IUMS), No. 10, Firoozeh St, Vali-asr Ave, Vali-asr Sq, Tehran, 1593716615, Iran.
Endocrine Research Center, Iran University of Medical Sciences, Tehran, Iran.
Internal Medicine and Endocrinology, Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences, Tehran, Iran.
Firouzgar Endocrine Research Center, Diabetes Clinic, Iran University of Medical Sciences, Tehran, Iran.
Dr. Ganjizadeh's Clinic, Yousefabad, Tehran, Iran.
Medical Department, Orchid Pharmed Company, Tehran, Iran.
Obesity Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

介绍

利拉鲁肽有效控制血糖水平并减轻体重。本研究的目的是比较生物仿制药利拉鲁肽（Melitide ^®；CinnaGen，德黑兰，伊朗）与参比利拉鲁肽（Victoza ^®；诺和诺德，Bagsvaerd，丹麦）对 2 型糖尿病 (T2DM) 患者的疗效和安全性）。

方法

在这项 3 期临床非劣效性试验中，T2DM 控制不充分且血红蛋白 A _1C (HbA _1C ) 水平为 7-10.5% 且服用至少两种剂量稳定的口服降糖药物至少 3 个月的成年患者被随机分组接受治疗Melitide ^® ( n = 150) 或 Victoza ^® ( n = 150) 1.8 mg/天，持续 26 周。主要结果是评估 Melitide ^®相对于 Victoza ^®在 HbA _1C水平变化方面的非劣效性，预设裕度为 0.4%。_{次要结局是对其他疗效参数的评估（包括实现 HbA 1C}水平 < 7%的患者比例）、不良事件发生率和免疫原性。

结果

在参与这项研究的 300 名参与者中，有 235 名参加了符合方案分析（Melitide ^®组有 112 名，Victoza ^®组有 123 名）。^{Melitide ®组的 HbA}_1C平均（标准差）变化为 − 1.76% (1.22) ，Victoza ^®组为 − 1.59% (1.31) 。^{Melitide ®}和 Victoza ^®在降低 HbA _1C方面的平均差异的 95% 单侧置信区间 (CI) 上限低于预定范围（平均差异 − 0.18，95% CI − 0.5 至 0.15）。意向治疗分析也得到了类似的结果。_{两个研究组之间在实现 HbA 1C} < 7%的患者比例( p = 0.210)、其他疗效参数 ( p > 0.05) 和报告的不良事件 ( p = 0.916) 方面没有观察到统计学上的显着差异。此外，没有患者产生抗利拉鲁肽抗体。

结论

与参比利拉鲁肽相比，生物仿制药利拉鲁肽 (Melitide ^{® ) 的疗效并不逊色，且安全性相当。}

试用注册

NCT03421119。

"点击查看英文标题和摘要"

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

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.