PMID- 38061446
OWN - NLM
STAT- MEDLINE
DCOM- 20240215
LR  - 20240215
IS  - 1872-8227 (Electronic)
IS  - 0168-8227 (Linking)
VI  - 207
DP  - 2024 Jan
TI  - Phase 3 efficacy and safety trial of proposed liraglutide biosimilar for 
      reduction of glycosylated hemoglobin (HbA1c) in patients with Type 2 diabetes 
      mellitus.
PG  - 111034
LID - S0168-8227(23)00797-0 [pii]
LID - 10.1016/j.diabres.2023.111034 [doi]
AB  - 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(R)) 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).
CI  - Copyright (c) 2023 The Author(s). Published by Elsevier B.V. All rights reserved.
FAU - Krishnan, Kadalmani
AU  - Krishnan K
AD  - Kadalmani Krishnan, Levim Biotech, Chennai, India. Electronic address: 
      krishnan@levimbiotech.com.
FAU - Raman, Srikar
AU  - Raman S
AD  - Kadalmani Krishnan, Levim Biotech, Chennai, India. Electronic address: 
      srikar@levimbiotech.com.
FAU - Anand Moses, C R
AU  - Anand Moses CR
AD  - Moses Diabetes and Medical Centre, Chennai, India. Electronic address: 
      cramoses@hotmail.com.
FAU - Rajesh, R P
AU  - Rajesh RP
AD  - Aadhavvan Diabetes and Research Centre, Chennai, India. Electronic address: 
      doctorrpr@gmail.com.
FAU - Gupta, Atul
AU  - Gupta A
AD  - Atul Gupta, Navitas Life Sciences, Bangalore, India. Electronic address: 
      atul.gupta@navitaslifesciences.com.
FAU - Mudaliar, Venkatesan
AU  - Mudaliar V
AD  - Atul Gupta, Navitas Life Sciences, Bangalore, India. Electronic address: 
      venkatesan.balu@navitaslifesciences.com.
FAU - Vimal, Jatin
AU  - Vimal J
AD  - Kadalmani Krishnan, Levim Biotech, Chennai, India. Electronic address: 
      jatin@levimbiotech.com.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20231205
PL  - Ireland
TA  - Diabetes Res Clin Pract
JT  - Diabetes research and clinical practice
JID - 8508335
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin)
RN  - 0 (Hypoglycemic Agents)
RN  - 839I73S42A (Liraglutide)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Humans
MH  - Middle Aged
MH  - Young Adult
MH  - *Biosimilar Pharmaceuticals/adverse effects
MH  - Blood Glucose/metabolism
MH  - *Diabetes Mellitus, Type 2/drug therapy/chemically induced
MH  - Glycated Hemoglobin
MH  - Hypoglycemic Agents/adverse effects
MH  - Liraglutide/adverse effects
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Biosimilar
OT  - HbA1c reduction
OT  - Liraglutide
OT  - Type 2 diabetes
COIS- 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.
EDAT- 2023/12/08 00:42
MHDA- 2024/02/11 07:42
CRDT- 2023/12/07 19:24
PHST- 2023/09/20 00:00 [received]
PHST- 2023/11/16 00:00 [revised]
PHST- 2023/11/30 00:00 [accepted]
PHST- 2024/02/11 07:42 [medline]
PHST- 2023/12/08 00:42 [pubmed]
PHST- 2023/12/07 19:24 [entrez]
AID - S0168-8227(23)00797-0 [pii]
AID - 10.1016/j.diabres.2023.111034 [doi]
PST - ppublish
SO  - Diabetes Res Clin Pract. 2024 Jan;207:111034. doi: 10.1016/j.diabres.2023.111034. 
      Epub 2023 Dec 5.