Initiation of human regular U-500 insulin use is associated with improved glycemic control: a real-world US cohort study

Elizabeth L Eby; Bradley H Curtis; Steven C Gelwicks; Robert C Hood; Iskandar Idris; Anne L Peters; Richard M Bergenstal; Jeffrey A Jackson

doi:10.1136/bmjdrc-2014-000074

Initiation of human regular U-500 insulin use is associated with improved glycemic control: a real-world US cohort study

BMJ Open Diabetes Res Care. 2015 Apr 30;3(1):e000074. doi: 10.1136/bmjdrc-2014-000074. eCollection 2015.

Authors

Elizabeth L Eby¹, Bradley H Curtis¹, Steven C Gelwicks¹, Robert C Hood², Iskandar Idris³, Anne L Peters⁴, Richard M Bergenstal⁵, Jeffrey A Jackson⁶

Affiliations

¹ Eli Lilly and Company , Indianapolis, Indiana , USA.
² Endocrine Clinic of Southeast Texas , Beaumont, Texas , USA.
³ School of Graduate Entry Medicine, University of Nottingham , Nottingham , UK.
⁴ Division of Endocrinology , Keck School of Medicine, University of Southern California , Los Angeles, California , USA.
⁵ International Diabetes Center at Park Nicollet , Minneapolis, Minnesota , USA.
⁶ Lilly USA, LLC , Indianapolis, Indiana , USA.

Abstract

Aim: 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.

Keywords: Glycemic Control; Hypoglycemia; Insulin Resistance; Management.