title: Pharmacokinetics and pharmacodynamics of insulin glargine 300 U/mL in the treatment of diabetes and their clinical relevance.
abstract: BACKGROUND
  A more concentrated insulin glargine formulation, containing 300 U/mL (Gla-300) was approved in 2015 in the US and Europe for the treatment of diabetes mellitus in adults.
  
  
  METHODS
  This drug evaluation focuses on the pharmacokinetics (PK) and pharmacodynamics (PD) of Gla-300 from studies published up to May 2016. The clinical relevance of this new formulation will be addressed.
  
  
  CONCLUSIONS
  Gla-300 was developed to produce a flatter and more prolonged PK/PD profile compared with insulin glargine 100 U/mL (Gla-100) in order to maintain effective glycemic control and reduce the risk of hypoglycemia. Compared to Gla-100, Gla-300 achieves lower and delayed peak concentrations with a PK exposure that is more stable and evenly distributed across a 24-h dosing interval. As a consequence, Gla-300 results in a consistent glucose-lowering effect with less variability over a 24-h dosing interval, which translates to a reduction in the rate of hypoglycemia (particularly nocturnal events).
authors.affiliation: a Diabetes Research Group , Swansea University , Swansea , UK.
authors.forename: David R
authors.initials: DR
authors.lastname: Owens
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000187:drug effects; D003920:Diabetes Mellitus / Q000188:drug therapy*; D004334:Drug Administration Schedule; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced / Q000453:epidemiology; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000493:pharmacokinetics / Q000494:pharmacology; D000069036:Insulin Glargine / Q000008:administration & dosage* / Q000493:pharmacokinetics / Q000494:pharmacology
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D000069036:Insulin Glargine
keywords: Euglycemic glucose clamp; insulin glargine 100 U/ml; insulin glargine 300 U/ml; pharmacodynamics; pharmacokinetics; type 1 diabetes; type 2 diabetes