title: Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, parallel-treatment trial.
abstract: BACKGROUND
  New treatments for type 2 diabetes mellitus are needed to retain insulin-glucose coupling and lower the risk of weight gain and hypoglycaemia. We aimed to investigate the safety and efficacy of liraglutide as monotherapy for this disorder.
  
  
  METHODS
  In a double-blind, double-dummy, active-control, parallel-group study, 746 patients with early type 2 diabetes were randomly assigned to once daily liraglutide (1.2 mg [n=251] or 1.8 mg [n=247]) or glimepiride 8 mg (n=248) for 52 weeks. The primary outcome was change in proportion of glycosylated haemoglobin (HbA(1c)). Analysis was done by intention-to-treat. This trial is registered with ClinicalTrials.gov, number NTC00294723.
  
  
  RESULTS
  At 52 weeks, HbA(1c) decreased by 0.51% (SD 1.20%) with glimepiride, compared with 0.84% (1.23%) with liraglutide 1.2 mg (difference -0.33%; 95% CI -0.53 to -0.13, p=0.0014) and 1.14% (1.24%) with liraglutide 1.8 mg (-0.62; -0.83 to -0.42, p<0.0001). Five patients in the liraglutide 1.2 mg, and one in 1.8 mg groups discontinued treatment because of vomiting, whereas none in the glimepiride group did so.
  
  
  CONCLUSIONS
  Liraglutide is safe and effective as initial pharmacological therapy for type 2 diabetes mellitus and leads to greater reductions in HbA(1c), weight, hypoglycaemia, and blood pressure than does glimepiride.
authors.affiliation: Baylor College of Medicine, Houston, TX, USA.
authors.forename: Alan
authors.initials: A
authors.lastname: Garber
authors.forename: Robert
authors.initials: R
authors.lastname: Henry
authors.forename: Robert
authors.initials: R
authors.lastname: Ratner
authors.forename: Pedro A
authors.initials: PA
authors.lastname: Garcia-Hernandez
authors.forename: Hiromi
authors.initials: H
authors.lastname: Rodriguez-Pattzi
authors.forename: Israel
authors.initials: I
authors.lastname: Olvera-Alvarez
authors.forename: Paula M
authors.initials: PM
authors.lastname: Hale
authors.forename: Milan
authors.initials: M
authors.lastname: Zdravkovic
authors.forename: Bruce
authors.initials: B
authors.lastname: Bode
mesh_terms: D001786:Blood Glucose / Q000187:drug effects; D001794:Blood Pressure / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D052216:Glucagon-Like Peptide 1 / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D006442:Glycated Hemoglobin / Q000187:drug effects; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D000069450:Liraglutide; D008297:Male; D008875:Middle Aged; D013453:Sulfonylurea Compounds / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*
chemical_list: D001786:Blood Glucose; D052216:Glucagon-Like Peptide 1; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000069450:Liraglutide; D013453:Sulfonylurea Compounds; C057619:glimepiride