PMID- 29923298
OWN - NLM
STAT- MEDLINE
DCOM- 20190415
LR  - 20240403
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Print)
IS  - 1462-8902 (Linking)
VI  - 20
IP  - 11
DP  - 2018 Nov
TI  - Low incidence of gastrointestinal adverse events over time with a fixed-ratio 
      combination of insulin glargine and lixisenatide versus lixisenatide alone.
PG  - 2690-2694
LID - 10.1111/dom.13444 [doi]
AB  - This post hoc analysis of gastrointestinal (GI) adverse events (AEs) from the 
      phase 3 LixiLan-L (NCT02058160) and LixiLan-O (NCT02058147) trials aimed to 
      determine the frequency and timing of nausea, vomiting, and diarrhoea for 
      iGlarLixi, a titratable, fixed-ratio combination of insulin glargine 100 units/mL 
      (iGlar) and lixisenatide, versus iGlar alone or iGlar and lixisenatide alone, in 
      patients with type 2 diabetes uncontrolled with oral antidiabetes drugs (OADs) or 
      basal insulin +/- OADs. In iGlarLixi-treated patients, the rate of GI AEs during 
      the initial weeks of treatment was lower versus patients treated with 
      lixisenatide alone (9.6% and 11.7% of iGlarLixi-treated patients in LixiLan-L and 
      LixiLan-O, respectively, vs. 27.5% of lixisenatide-treated patients in 
      LixiLan-O). Beyond day 60, these rates were generally low and similar to those of 
      lixisenatide. These lower rates are likely due to the gradual titration of 
      lixisenatide in iGlarLixi. Median durations of intermittent GI AEs in the 
      iGlarLixi arms were 6.0, 2.0 and 2.5 days (LixiLan-L), and 5.0, 1.0 and 3.5 days 
      (LixiLan-O), respectively. iGlarLixi-associated GI AEs were transient, mostly 
      mild or moderate in severity, and occurred mainly during initial titration.
CI  - (c) 2018 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & 
      Sons Ltd.
FAU - Trujillo, Jennifer M
AU  - Trujillo JM
AUID- ORCID: 0000-0001-7898-8029
AD  - Department of Clinical Pharmacy, Skaggs School of Pharmacy and Pharmaceutical 
      Sciences, University of Colorado, Aurora, Colorado.
FAU - Roberts, Michelle
AU  - Roberts M
AD  - Sanofi US, Inc., Bridgewater, New Jersey.
FAU - Dex, Terry
AU  - Dex T
AD  - Sanofi US, Inc., Bridgewater, New Jersey.
FAU - Chao, Jason
AU  - Chao J
AD  - Xinyi, Inc., Bridgewater, New Jersey.
FAU - White, John
AU  - White J
AD  - Department of Pharmacy, Washington State University, Spokane, Washington.
FAU - LaSalle, James
AU  - LaSalle J
AD  - Excelsior Springs Clinic, Excelsior Springs, Missouri.
LA  - eng
SI  - ClinicalTrials.gov/NCT02058160
SI  - ClinicalTrials.gov/NCT02058147
GR  - Sanofi US Inc./International
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20180821
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Drug Combinations)
RN  - 0 (Peptides)
RN  - 2ZM8CX04RZ (Insulin Glargine)
RN  - 74O62BB01U (lixisenatide)
SB  - IM
MH  - Adult
MH  - Diabetes Mellitus, Type 2/complications/*drug therapy/*epidemiology/metabolism
MH  - Drug Combinations
MH  - Female
MH  - Gastrointestinal Diseases/chemically induced/*epidemiology
MH  - Humans
MH  - Incidence
MH  - Insulin Glargine/*administration & dosage/*adverse effects
MH  - Male
MH  - Peptides/*administration & dosage/*adverse effects
MH  - Postprandial Period
MH  - Retrospective Studies
PMC - PMC6221077
OTO - NOTNLM
OT  - fixed-ratio combination
OT  - gastrointestinal adverse events
OT  - insulin glargine
OT  - lixisenatide
COIS- J. M. T. reports past participation in advisory boards and being a consultant for 
      Sanofi Inc. M. R. reports being an employee of Sanofi US, Inc. T. D. reports 
      being an employee and stock/shareholder of Sanofi US, Inc. J. C. reports being an 
      employee of Xinyi, Inc., which is under contract with Sanofi US, Inc. J. W. 
      reports past participation in advisory boards for Novo Nordisk, Inc. and Sanofi 
      Inc. J. L. reports past participation in advisory boards for Eli Lilly and 
      Company, Novo Nordisk, Inc., and Sanofi Inc., and being a member of the speakers 
      bureau for Novo Nordisk, Inc. AUTHOR CONTRIBUTIONS: J. M. T., M. R., T. D., J. W. 
      and J. L. co-developed the concept of the study, interpreted the data, critically 
      reviewed the manuscript drafts, and provided final approval of the version of the 
      manuscript to be submitted. J. C. collected the data, performed the analyses and 
      provided the data tables, interpreted the data, critically reviewed the 
      manuscript drafts, and provided final approval of the version of the manuscript 
      to be submitted. J. M. T. is the guarantor of this work and, as such, had full 
      access to the data in the study and takes responsibility for the integrity of the 
      data and the accuracy of the data analysis.
EDAT- 2018/06/21 06:00
MHDA- 2019/04/16 06:00
PMCR- 2018/11/07
CRDT- 2018/06/21 06:00
PHST- 2017/12/19 00:00 [received]
PHST- 2018/06/08 00:00 [revised]
PHST- 2018/06/16 00:00 [accepted]
PHST- 2018/06/21 06:00 [pubmed]
PHST- 2019/04/16 06:00 [medline]
PHST- 2018/06/21 06:00 [entrez]
PHST- 2018/11/07 00:00 [pmc-release]
AID - DOM13444 [pii]
AID - 10.1111/dom.13444 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2018 Nov;20(11):2690-2694. doi: 10.1111/dom.13444. Epub 2018 
      Aug 21.