PMID- 25012990
OWN - NLM
STAT- MEDLINE
DCOM- 20150608
LR  - 20221207
IS  - 1873-460X (Electronic)
IS  - 1056-8727 (Linking)
VI  - 28
IP  - 5
DP  - 2014 Sep-Oct
TI  - Equal improvement in glycaemia with lixisenatide given before breakfast or the 
      main meal of the day.
PG  - 735-41
LID - S1056-8727(14)00151-2 [pii]
LID - 10.1016/j.jdiacomp.2014.05.012 [doi]
AB  - AIMS: The aim of this study is to explore whether administration timing affects 
      glycaemic control by lixisenatide once-daily in type 2 diabetes mellitus (T2DM). 
      METHODS: A phase IIIb, open-label, 1:1 randomized, active-controlled, 24-week 
      multicentre study of T2DM patients inadequately controlled on metformin was 
      conducted. Patients were administered lixisenatide before breakfast or the main 
      meal. The primary endpoint was change from baseline at week 24 in glycated 
      haemoglobin (HbA1c). Other endpoints: changes in body weight, fasting plasma 
      glucose (FPG), 7-point self-monitored plasma glucose (SMPG) and Diabetes 
      Treatment Satisfaction Questionnaire status (DTSQs) score. Adverse events (AEs) 
      were monitored. RESULTS: Mean change in HbA1c from baseline at week 24 was -0.65% 
      (-7.1mmol/mol; main meal) and -0.74% (-8.1mmol/mol; breakfast). Mean changes in 
      FPG, body weight and DTSQs score were comparable between groups. The mean change 
      in body weight (kg) was -2.60 (main meal) and -2.80 (breakfast group). The 
      7-point SMPG profiles showed greatest reductions in postprandial glucose after 
      the meal at which lixisenatide was administered, with a residual effect seen on 
      the subsequent meal. AE rates were similar between groups, including 
      gastrointestinal AEs. CONCLUSIONS: Lixisenatide before the main meal was 
      noninferior to lixisenatide before breakfast in patients insufficiently 
      controlled on metformin. Lixisenatide treatment allows flexibility in 
      administration timing.
CI  - Copyright (c) 2014 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Ahren, Bo
AU  - Ahren B
AD  - Department of Clinical Sciences, Lund University, Lund, Sweden. Electronic 
      address: bo.ahren@med.lu.se.
FAU - Vorokhobina, Natalia
AU  - Vorokhobina N
AD  - North-Western State Medical University named after I.I. Mechnikov, Endocrinology 
      Department named after academician V.G. Baranov, St. Petersburg, Russian 
      Federation.
FAU - Souhami, Elisabeth
AU  - Souhami E
AD  - Diabetes Division Clinical Development Department, Sanofi, Paris, France.
FAU - Demil, Nacima
AU  - Demil N
AD  - Diabetes Medical Operation Department, Sanofi, Chilly Mazarin, France.
FAU - Ye, Jenny
AU  - Ye J
AD  - Biostatistics and Programming, Sanofi NJ, USA.
FAU - Aronson, Ronnie
AU  - Aronson R
AD  - LMC Diabetes & Endocrinology, Toronto, Canada.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140605
PL  - United States
TA  - J Diabetes Complications
JT  - Journal of diabetes and its complications
JID - 9204583
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Peptides)
RN  - 0 (hemoglobin A1c protein, human)
RN  - 74O62BB01U (lixisenatide)
SB  - IM
MH  - Aged
MH  - Blood Glucose/*drug effects/metabolism
MH  - *Breakfast/drug effects
MH  - Drug Administration Schedule
MH  - Female
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Hypoglycemic Agents/*administration & dosage/adverse effects
MH  - Male
MH  - *Meals/drug effects
MH  - Middle Aged
MH  - Peptides/*administration & dosage/adverse effects
MH  - Postprandial Period/drug effects
MH  - Time Factors
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Flexibility
OT  - Glycaemic control
OT  - Lixisenatide
OT  - Self-monitored plasma glucose
OT  - Type 2 diabetes mellitus
EDAT- 2014/07/12 06:00
MHDA- 2015/06/09 06:00
CRDT- 2014/07/12 06:00
PHST- 2014/04/04 00:00 [received]
PHST- 2014/05/28 00:00 [revised]
PHST- 2014/05/29 00:00 [accepted]
PHST- 2014/07/12 06:00 [entrez]
PHST- 2014/07/12 06:00 [pubmed]
PHST- 2015/06/09 06:00 [medline]
AID - S1056-8727(14)00151-2 [pii]
AID - 10.1016/j.jdiacomp.2014.05.012 [doi]
PST - ppublish
SO  - J Diabetes Complications. 2014 Sep-Oct;28(5):735-41. doi: 
      10.1016/j.jdiacomp.2014.05.012. Epub 2014 Jun 5.