title: U300, a novel long-acting insulin formulation.
abstract: BACKGROUND
  Insulin glargine (100 U/ml; U100) was the first long-acting basal insulin analog to be introduced into clinical practice and it remains the most widely used. Although U100 is an effective and safe treatment, research is ongoing to optimize the time-action profile. The focus of this review is insulin glargine [rDNA origin] injection 300 U/ml (U300), a novel formulation that contains a higher concentration of insulin than U100.
  
  
  METHODS
  The clinical efficacy and safety of U300 in patients with type 1 and type 2 diabetes mellitus are discussed, with an emphasis on recently released data from the Phase III EDITION clinical trials.
  
  
  CONCLUSIONS
  The higher concentration of insulin in U300 results in a distinct pharmacokinetic and pharmacodynamic profile. U300 has a longer duration of action than U100 and plasma insulin exposure is less variable. Both insulin formulations exhibit a similar efficacy and safety profile, but importantly, U300 is associated with less body weight gain and a lower incidence of hypoglycaemic events.
authors.affiliation: Institute for Research and Medicine Advancement (IRMEDICA) , Barcelona , Spain.
authors.forename: Gemma
authors.initials: G
authors.lastname: Sutton
authors.forename: Joan
authors.initials: J
authors.lastname: Minguet
authors.forename: Carmen
authors.initials: C
authors.lastname: Ferrero
authors.forename: Peter
authors.initials: P
authors.lastname: Bramlage
mesh_terms: D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D020249:Hormone Replacement Therapy; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000493:pharmacokinetics; D007328:Insulin / Q000008:administration & dosage* / Q000493:pharmacokinetics; D000069036:Insulin Glargine; D049528:Insulin, Long-Acting / Q000008:administration & dosage* / Q000493:pharmacokinetics
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin; D049528:Insulin, Long-Acting; D000069036:Insulin Glargine
keywords: U100; U300; diabetes mellitus; glargine; glycated hemoglobin A1C; hypoglycaemia; insulin