title: Addition of once daily prandial lixisenatide to basal insulin therapy in patients with type-2 diabetes results in a reduction of HbA1c as an effect of postprandial glucose lowering.
abstract: OBJECTIVE
  Basal insulin has been shown to effectively reduce fasting blood glucose (FBG), but postprandial plasma glucose (PPG) excursions may remain higher than normal. Glucagon-like peptide (GLP)-1 receptor agonists such as the short-acting lixisenatide are able to control such excursions by slowing gastric emptying. However, data regarding its use in a real world clinical setting are scarce.
  
  
  METHODS
  24 week, prospective, multicentre, non-interventional study in 1437 patients with type-2 diabetes receiving 20μg lixisenatide once daily in combination with basal insulin. The per-protocol set (PPS) comprised 540 patients.
  
  
  RESULTS
  HbA1clevels were found to decrease significantly over 24 weeks of treatment in the PPS (0.94±0.99% [7.9±8.5]; p≤0.001). An HbA1cof <7% (53mmol/mol) was achieved in 26.9% of patients, with 9.8% reaching <6.5% (48mmol/mol) and 30.0% reaching their individual treatment goal. There was a slight decrease in FBG (2.84±30.4mg/dl; p≤0.001), and a significant reduction in PPG, with levels decreasing by between 35mg/dl (1.9mmol/l) and 38mg/dl (2.1mmol/l), respectively on average after all main meals in basal optimised patients (PPS; ≤140mg/dl). Body weight decreased from 101 to 98kg with a mean difference of 3.10±4.10kg (p≤0.001). There were few reports of hypoglycaemia and no reports of serious hypoglycaemia and need for external help. AEs were infrequent, and were in line with previous studies.
  
  
  CONCLUSIONS
  Lixisenatide in combination with basal insulin was shown to be an effective treatment strategy for patients with type 2 diabetes, controlling HbA1clevels by reduction of PPG excursions during the whole day.
authors.affiliation: Medical Department, Sanofi Aventis Deutschland GmbH, Berlin, Germany. Electronic address: holger.fleischmann@sanofi.com.
authors.forename: Holger
authors.initials: H
authors.lastname: Fleischmann
authors.affiliation: Diabetes Schwerpunktpraxis, Kirchhain, Marburg, Germany. Electronic address: rbg@gmx.org.
authors.forename: Rüdiger
authors.initials: R
authors.lastname: Göke
authors.affiliation: Institut für Pharmakologie und Präventive Medizin, Mahlow, Germany. Electronic address: peter.bramlage@ippmed.de.
authors.forename: Peter
authors.initials: P
authors.lastname: Bramlage
mesh_terms: D001786:Blood Glucose / Q000378:metabolism*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000378:metabolism; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006442:Glycated Hemoglobin / Q000032:analysis*; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010455:Peptides / Q000008:administration & dosage*; D019518:Postprandial Period; D011379:Prognosis; D011446:Prospective Studies; D000067758:Glucagon-Like Peptide-2 Receptor
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D010455:Peptides; C517652:hemoglobin A1c protein, human; C479460:lixisenatide; D000067758:Glucagon-Like Peptide-2 Receptor
keywords: Basal insulin; Body weight; Glucagon-like peptide-1 receptor agonists; Hypoglycaemia; Postprandial glucose