title: Lixisenatide as add-on to oral anti-diabetic therapy: an effective treatment for glycaemic control with body weight benefits in type 2 diabetes.
abstract: BACKGROUND
  Achieving recommended glycated haemoglobin (HbA1c ) targets in patients with type 2 diabetes mellitus (T2DM) requires effective control of fasting and post-prandial plasma glucose. As T2DM progresses, oral anti-diabetics are no longer sufficient to maintain glycaemic control. Five phase III studies in the GetGoal clinical trial programme assessed the efficacy of lixisenatide, a once-daily prandial glucagon-like peptide-1 receptor agonist, in combination with oral anti-diabetics in patients with T2DM insufficiently controlled using oral anti-diabetics.
  
  
  METHODS
  A meta-analysis was performed of the results of five 24-week clinical trials (comprising 2760 patients) concerning lixisenatide or placebo plus oral anti-diabetic therapy. The primary endpoint of these studies was change in HbA1c at week 24. Changes in fasting and post-prandial plasma glucose, and weight were also established as were the odds ratios for hypoglycaemia and composite safety and efficacy endpoints. Meta-analysis outcomes were assessed using a random effects model. All meta-analyses were performed using RevMan, version 5.1.
  
  
  RESULTS
  Lixisenatide was significantly better than placebo in terms of achieving all endpoints in this meta-analysis, including the primary endpoint change in HbA1c at week 24, with p < 0.0001 for all endpoints. The mean number of symptomatic hypoglycaemic events per patient year was increased for patients in the lixisenatide versus placebo groups (p = 0.04). However, compared with patients in the placebo group, patients treated with lixisenatide were more likely to achieve composite efficacy and safety endpoints.
  
  
  CONCLUSIONS
  This meta-analysis demonstrates that lixisenatide in combination with oral anti-diabetic therapy significantly improves outcomes combining efficacy and safety parameters in patients with T2DM.
authors.affiliation: Department of Diabetology, University Hospital Sainte-Marguerite, Marseille, France.
authors.forename: Denis
authors.initials: D
authors.lastname: Raccah
authors.forename: Pierre
authors.initials: P
authors.lastname: Gourdy
authors.forename: Luc
authors.initials: L
authors.lastname: Sagnard
authors.forename: Antonio
authors.initials: A
authors.lastname: Ceriello
mesh_terms: D000284:Administration, Oral; D017326:Clinical Trials, Phase III as Topic; D003131:Combined Modality Therapy / Q000009:adverse effects; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000150:complications / Q000188:drug therapy* / Q000378:metabolism; D004334:Drug Administration Schedule; D018432:Drug Resistance, Multiple; D004359:Drug Therapy, Combination / Q000009:adverse effects; D000067757:Glucagon-Like Peptide-1 Receptor; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D006943:Hyperglycemia / Q000517:prevention & control*; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008687:Metformin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D015337:Multicenter Studies as Topic; D050177:Overweight / Q000139:chemically induced / Q000150:complications / Q000517:prevention & control*; D010455:Peptides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000077205:Pioglitazone; D016032:Randomized Controlled Trials as Topic; D018027:Receptors, Glucagon / Q000819:agonists* / Q000378:metabolism; D013453:Sulfonylurea Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D045162:Thiazolidinediones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000067758:Glucagon-Like Peptide-2 Receptor
chemical_list: D000067757:Glucagon-Like Peptide-1 Receptor; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D010455:Peptides; D000077205:Pioglitazone; D018027:Receptors, Glucagon; D013453:Sulfonylurea Compounds; D045162:Thiazolidinediones; C000593833:GLP1R protein, human; C517652:hemoglobin A1c protein, human; C479460:lixisenatide; D000067758:Glucagon-Like Peptide-2 Receptor
keywords: glycaemic control; lixisenatide; oral anti-diabetics; prandial; type 2 diabetes mellitus