title: The efficacy and safety of imeglimin as add-on therapy in patients with type 2 diabetes inadequately controlled with metformin monotherapy.
abstract: OBJECTIVE
  A 12-week study assessed the efficacy and safety of a new oral antidiabetic agent, imeglimin, as add-on therapy in type 2 diabetes patients inadequately controlled with metformin alone.
  
  
  METHODS
  A total of 156 patients were randomized 1:1 to receive imeglimin (1,500 mg twice a day) or placebo added to a stable dose of metformin (1,500-2,000 mg/day). Change in A1C from baseline was the primary efficacy outcome; secondary outcomes included fasting plasma glucose (FPG) and proinsulin/insulin ratio.
  
  
  RESULTS
  After 12 weeks, the placebo-subtracted decrease in A1C with metformin-imeglimin was -0.44% (P < 0.001). Metformin-imeglimin also significantly improved FPG and the proinsulin/insulin ratio from baseline (-0.91 mg/dL and -7.5, respectively) compared with metformin-placebo (0.36 mg/dL and 11.81). Metformin-imeglimin therapy was generally well-tolerated with a comparable safety profile to metformin-placebo.
  
  
  CONCLUSIONS
  Addition of imeglimin to metformin improved glycemic control and offers potential as a new treatment for type 2 diabetes.
authors.affiliation: Poxel SA, Lyon, France. pascale.fouqueray@poxelpharma.com
authors.forename: Pascale
authors.initials: P
authors.lastname: Fouqueray
authors.forename: Valdis
authors.initials: V
authors.lastname: Pirags
authors.forename: Silvio E
authors.initials: SE
authors.lastname: Inzucchi
authors.forename: Clifford J
authors.initials: CJ
authors.lastname: Bailey
authors.forename: Guntram
authors.initials: G
authors.lastname: Schernthaner
authors.forename: Michaela
authors.initials: M
authors.lastname: Diamant
authors.forename: Harold E
authors.initials: HE
authors.lastname: Lebovitz
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D008297:Male; D008687:Metformin / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D016896:Treatment Outcome; D014227:Triazines / Q000008:administration & dosage / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D007004:Hypoglycemic Agents; D014227:Triazines; D008687:Metformin; C575881:imeglimin