title: Insulin glargine 300 units/mL: A new basal insulin product for diabetes mellitus.
abstract: OBJECTIVE
  The pharmacokinetics, efficacy, and safety of U-300 insulin glargine for the management of diabetes are reviewed.
  
  
  CONCLUSIONS
  U-300 (300 units/mL) insulin glargine is a long-acting basal insulin with low within-day variability, high day-to-day reproducibility, longer duration, and constant pharmacokinetic profile compared with U-100 (100 units/mL) insulin glargine. U-300 was evaluated in six randomized, active-comparator, open-label, Phase III clinical studies (EDITION trials) among patients with type 1 or 2 diabetes. The primary endpoint for all EDITION studies was the reduction in glycosylated hemoglobin from baseline to six months. Safety endpoints included confirmed or nocturnal hypoglycemia between week 9 and month 6 and the change in weight from baseline. For hypoglycemic episodes, U-300 insulin glargine was superior to U-100 insulin glargine when comparing the risk of hypoglycemia. U-300 insulin glargine is supplied in a prefilled device (for safety purposes) and packaged in boxes of three or five pens. It is still early to determine the role of U-300 insulin glargine in diabetes management. When compared with U-100 insulin glargine, U-300 insulin glargine appeared to be associated with a lower risk of hypoglycemia and nocturnal hypoglycemia, most likely due to its pharmacokinetics. The wholesale average cost of U-300 insulin glargine is $335.48 per box of three pens.
  
  
  CONCLUSIONS
  The efficacy outcomes of U-300 insulin glargine were similar to those of U-100 insulin glargine, but the constant pharmacokinetic profile and longer duration of action of U-300 insulin glargine may help certain patients with type 1 or type 2 diabetes achieve better glycemic control.
authors.affiliation: Department of Pharmacy Practice, Presbyterian College School of Pharmacy, Clinton, SC. jclements@presby.edu.
authors.forename: Jennifer N
authors.initials: JN
authors.lastname: Clements
authors.affiliation: Presbyterian College School of Pharmacy, Clinton, SC.
authors.forename: Larkin
authors.initials: L
authors.lastname: Bello
mesh_terms: D017326:Clinical Trials, Phase III as Topic / Q000379:methods; D003920:Diabetes Mellitus / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D004304:Dosage Forms; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D000069036:Insulin Glargine / Q000008:administration & dosage* / Q000737:chemistry / Q000493:pharmacokinetics*; D016032:Randomized Controlled Trials as Topic / Q000379:methods
chemical_list: D004304:Dosage Forms; D007004:Hypoglycemic Agents; D000069036:Insulin Glargine