title: Equal improvement in glycaemia with lixisenatide given before breakfast or the main meal of the day.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Clinical Sciences, Lund University, Lund, Sweden. Electronic address: bo.ahren@med.lu.se.
authors.forename: Bo
authors.initials: B
authors.lastname: Ahrén
authors.affiliation: North-Western State Medical University named after I.I. Mechnikov, Endocrinology Department named after academician V.G. Baranov, St. Petersburg, Russian Federation.
authors.forename: Natalia
authors.initials: N
authors.lastname: Vorokhobina
authors.affiliation: Diabetes Division Clinical Development Department, Sanofi, Paris, France.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Souhami
authors.affiliation: Diabetes Medical Operation Department, Sanofi, Chilly Mazarin, France.
authors.forename: Nacima
authors.initials: N
authors.lastname: Demil
authors.affiliation: Biostatistics and Programming, Sanofi NJ, USA.
authors.forename: Jenny
authors.initials: J
authors.lastname: Ye
authors.affiliation: LMC Diabetes & Endocrinology, Toronto, Canada.
authors.forename: Ronnie
authors.initials: R
authors.lastname: Aronson
mesh_terms: D000368:Aged; D001786:Blood Glucose / Q000187:drug effects* / Q000378:metabolism; D062408:Breakfast / Q000187:drug effects; D004334:Drug Administration Schedule; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D062407:Meals / Q000187:drug effects; D008875:Middle Aged; D010455:Peptides / Q000008:administration & dosage* / Q000009:adverse effects; D019518:Postprandial Period / Q000187:drug effects; D013997:Time Factors; D016896:Treatment Outcome; D000067758:Glucagon-Like Peptide-2 Receptor
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D010455:Peptides; C517652:hemoglobin A1c protein, human; C479460:lixisenatide; D000067758:Glucagon-Like Peptide-2 Receptor
keywords: Flexibility; Glycaemic control; Lixisenatide; Self-monitored plasma glucose; Type 2 diabetes mellitus