PMID- 36787044
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230403
IS  - 1869-6953 (Print)
IS  - 1869-6961 (Electronic)
IS  - 1869-6961 (Linking)
VI  - 14
IP  - 4
DP  - 2023 Apr
TI  - Effectiveness and Safety of iGlarLixi (Insulin Glargine 100 U/mL Plus 
      Lixisenatide) in Type 2 Diabetes According to the Timing of Daily Administration: 
      Data from the REALI Pooled Analysis.
PG  - 639-652
LID - 10.1007/s13300-023-01375-8 [doi]
AB  - INTRODUCTION: iGlarLixi (insulin glargine 100 U/mL plus lixisenatide) has 
      demonstrated glycaemic efficacy and safety in adults with inadequately controlled 
      type 2 diabetes mellitus (T2DM). Per the European Medicines Agency's product 
      label, iGlarLixi should be injected once a day within 1 h prior to a meal, 
      preferably the same meal every day when the most convenient meal has been chosen. 
      It is however unknown whether iGlarLixi administration timing affects glycaemic 
      control and safety, as clinical trial evidence is mainly based on pre-breakfast 
      iGlarLixi administration. Therefore, we assessed the effectiveness and safety of 
      iGlarLixi in clinical practice, according to its administration timing. METHODS: 
      Data were pooled from two prospective observational studies including 1303 
      European participants with T2DM inadequately controlled on oral antidiabetic 
      drugs with or without basal insulin who initiated iGlarLixi therapy for 24 weeks. 
      Participants were classified into four subgroups based on daily timing of 
      iGlarLixi injection: pre-breakfast (N = 436), pre-lunch (N = 262), pre-dinner 
      (N = 399), and those who switched iGlarLixi injection time during the study 
      (N = 206). RESULTS: No meaningful differences in baseline characteristics were 
      observed between the study groups. Least-squares mean reductions in 
      haemoglobin A1c (HbA1c) from baseline to week 24 were substantial in all groups, 
      with the numerically largest decrease observed in the pre-breakfast group (1.57%) 
      compared with the pre-lunch (1.27%), pre-dinner (1.42%), or changed injection 
      time (1.33%) groups. Pre-breakfast iGlarLixi injection also resulted in a 
      numerically greater proportion of participants achieving HbA1c < 7.0% at week 24 
      (33.7% versus 19.0% for pre-lunch, 25.6% pre-dinner, and 23.2% changed injection 
      time). iGlarLixi was well tolerated across all groups, with low rates of 
      gastrointestinal disorders and hypoglycaemia. Mean body weight decreased 
      similarly in all groups (by 1.3-2.3 kg). CONCLUSION: iGlarLixi was effective and 
      safe regardless of its daily administration time. However, pre-breakfast 
      iGlarLixi injection resulted in a more effective glycaemic control.
CI  - (c) 2023. The Author(s).
FAU - Haluzik, Martin
AU  - Haluzik M
AD  - Institute for Clinical and Experimental Medicine and Charles University, Prague, 
      Czech Republic.
FAU - Seufert, Jochen
AU  - Seufert J
AD  - Division of Endocrinology and Diabetology, Department of Medicine II, Medical 
      Centre-Faculty of Medicine, University of Freiburg, Freiburg, Germany.
FAU - Guja, Cristian
AU  - Guja C
AD  - Department of Diabetes, Nutrition and Metabolic Diseases, Carol Davila University 
      of Medicine and Pharmacy, Bucharest, Romania.
FAU - Bonnemaire, Mireille
AU  - Bonnemaire M
AD  - General Medicines, Sanofi, Paris, France. mireille.bonnemaire@sanofi.com.
FAU - Bigot, Gregory
AU  - Bigot G
AD  - IVIDATA Group, Paris, France.
FAU - Tournay, Mathilde
AU  - Tournay M
AD  - International Drug Development Institute (IDDI), Louvain-la-Neuve, Belgium.
FAU - Kis, Janos Tibor
AU  - Kis JT
AD  - Department of Internal Medicine Centrum, Szent Janos Hospital, Budapest, Hungary.
FAU - Freemantle, Nick
AU  - Freemantle N
AD  - Institute of Clinical Trials and Methodology, University College London, London, 
      UK.
LA  - eng
PT  - Journal Article
DEP - 20230214
PL  - United States
TA  - Diabetes Ther
JT  - Diabetes therapy : research, treatment and education of diabetes and related 
      disorders
JID - 101539025
PMC - PMC10064361
OTO - NOTNLM
OT  - Fixed-ratio combination
OT  - Insulin glargine
OT  - Lixisenatide
OT  - Time of administration
OT  - Type 2 diabetes
EDAT- 2023/02/15 06:00
MHDA- 2023/02/15 06:01
PMCR- 2023/02/14
CRDT- 2023/02/14 11:23
PHST- 2022/12/16 00:00 [received]
PHST- 2023/01/23 00:00 [accepted]
PHST- 2023/02/15 06:01 [medline]
PHST- 2023/02/15 06:00 [pubmed]
PHST- 2023/02/14 11:23 [entrez]
PHST- 2023/02/14 00:00 [pmc-release]
AID - 10.1007/s13300-023-01375-8 [pii]
AID - 1375 [pii]
AID - 10.1007/s13300-023-01375-8 [doi]
PST - ppublish
SO  - Diabetes Ther. 2023 Apr;14(4):639-652. doi: 10.1007/s13300-023-01375-8. Epub 2023 
      Feb 14.