title: Initiation of human regular U-500 insulin use is associated with improved glycemic control: a real-world US cohort study.
abstract: OBJECTIVE
  Describe the characteristics of patients initiating human regular U-500 insulin (U-500R) and their subsequent glycemic control in a real-world setting.
  
  
  METHODS
  US Humedica electronic health record system data (July 2007-September 2011) were used to identify patients with diabetes aged ≥18 years with ≥1 records for U-500R prescriptions, 6 months of preindex data, 12 months following first use of U-500R, and at least one glycated hemoglobin (HbA1c) value in both preindex and postindex periods. Paired t tests were used to measure the change in HbA1c from preindex to postindex periods (last or most recent values) and hypoglycemia.
  
  
  RESULTS
  Among patients initiating U-500R (N=445), 96.9% had type 2 diabetes with mean age 57 years and mean body mass index 40.4 kg/m(2). Postindex prescriptions were written for U-500R alone (47.0%, group A) and concomitant U-500R/U-100 insulins (53.0%, group B). Concomitant oral antihyperglycemic agents (AHAs) and non-insulin injectable AHAs were used by 43.4% and 14.6% of patients, respectively. Following initiation of U-500R, mean HbA1c improved 0.68% in all patients (p<0.0001 compared with baseline), but the decrease in HbA1c did not differ significantly between groups (A: 0.78%; B: 0.60%). Overall, hypoglycemic events, largely captured in the outpatient setting, increased in incidence from 6.7% to 11.9% (p≤0.0001) and from 0.23 to 0.39 events/patient/year, an increase of 0.16 (p=0.003), from preindex to postindex.
  
  
  CONCLUSIONS
  This real-world outcomes analysis demonstrates that U-500R initiation is associated with a clinically meaningful improvement in glycemic control over the subsequent 12-month period with modest increase in incidence and rate of hypoglycemia.
authors.affiliation: Eli Lilly and Company , Indianapolis, Indiana , USA.
authors.forename: Elizabeth L
authors.initials: EL
authors.lastname: Eby
authors.affiliation: Eli Lilly and Company , Indianapolis, Indiana , USA.
authors.forename: Bradley H
authors.initials: BH
authors.lastname: Curtis
authors.affiliation: Eli Lilly and Company , Indianapolis, Indiana , USA.
authors.forename: Steven C
authors.initials: SC
authors.lastname: Gelwicks
authors.affiliation: Endocrine Clinic of Southeast Texas , Beaumont, Texas , USA.
authors.forename: Robert C
authors.initials: RC
authors.lastname: Hood
authors.affiliation: School of Graduate Entry Medicine, University of Nottingham , Nottingham , UK.
authors.forename: Iskandar
authors.initials: I
authors.lastname: Idris
authors.affiliation: Division of Endocrinology , Keck School of Medicine, University of Southern California , Los Angeles, California , USA.
authors.forename: Anne L
authors.initials: AL
authors.lastname: Peters
authors.affiliation: International Diabetes Center at Park Nicollet , Minneapolis, Minnesota , USA.
authors.forename: Richard M
authors.initials: RM
authors.lastname: Bergenstal
authors.affiliation: Lilly USA, LLC , Indianapolis, Indiana , USA.
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Jackson
keywords: Glycemic Control; Hypoglycemia; Insulin Resistance; Management