Tehran University of Medical Sciences

Science Communicator Platform

Stay connected! Follow us on X network (Twitter):
Share this content! On (X network) By
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 Publisher



Esteghamati A1 ; Zamanzadeh M2, 3 ; Malek M4 ; Khaledi M5 ; Monavari A6 ; Najafi L7 ; Banazadeh Z8 ; Malboosbaf R9 ; Aghili R7 ; Mahdikhah S10 ; Ganjizadehzavereh H11 ; Kafi H12 ; Hosseinpanah F13 ; Khamseh ME7
Authors
Show Affiliations
Authors Affiliations
  1. 1. Endocrinology and Metabolism Research Center, Tehran University of Medical Sciences, Tehran, Iran
  2. 2. East Tehran Diabetes Association, Tehran, Iran
  3. 3. Iranian Society of Internal Specialist Physicians, Tehran, Iran
  4. 4. Research Center for Prevention of Cardiovascular Disease, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences (IUMS), Tehran, Iran
  5. 5. Iran University of Medical Sciences, Tehran, Iran
  6. 6. Bahar Clinic, Alborz, Karaj, Iran
  7. 7. 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
  8. 8. Endocrine Research Center, Iran University of Medical Sciences, Tehran, Iran
  9. 9. Internal Medicine and Endocrinology, Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences, Tehran, Iran
  10. 10. Firouzgar Endocrine Research Center, Diabetes Clinic, Iran University of Medical Sciences, Tehran, Iran
  11. 11. Dr. Ganjizadeh’s Clinic, Yousefabad, Tehran, Iran
  12. 12. Medical Department, Orchid Pharmed Company, Tehran, Iran
  13. 13. Obesity Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran

Source: Diabetes Therapy Published:2023


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 A1C (HbA1C) 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 HbA1C level with a prespecified margin of 0.4%. The secondary outcomes were the assessment of additional efficacy parameters (including the proportion of patients achieving HbA1C 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 HbA1C 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 HbA1C 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 HbA1C < 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. © 2023, The Author(s).