title: Exenatide BID Observational Study (ExOS): results for primary and secondary endpoints of a prospective research study to evaluate the clinical effectiveness of exenatide BID use in patients with type 2 diabetes in a real-world setting.
abstract: OBJECTIVE
  The Exenatide BID Observational Study (ExOS) was designed to evaluate the clinical effectiveness of exenatide BID use in patients with type 2 diabetes (T2D) in a real-world clinical practice setting in the United States.
  
  
  METHODS
  Patients were enrolled from 74 practice sites from 9/2007 through 1/2009 and followed for 12 months. The primary effectiveness endpoint was achieving or maintaining hemoglobin A1C of ≤7.0%, or an absolute drop of 0.5% from baseline. Secondary measures included absolute and percentage change from baseline for a variety of clinical measures (lipid markers, weight, BMI, etc.), and quality of life (QOL) was assessed using the Impact of Weight on Quality of Life (IWQOL)-Lite.
  
  
  RESULTS
  A total of 452 patients were included in the primary study population. At baseline, patients (60% female) had mean (SD) age of 55 (11), T2D duration of 9 (8) years, HbA1c of 8.0 (1.7) %, and body mass index (BMI) of 38.2 (7.4) kg/m(2). Family history of T2D was reported in 73.9% of patients. Hypertension was reported in 61.5% of patients, and 47.1% had hyperlipidemia. The HbA1c goal was achieved in 76.3% of the 118 patients with A1C measurements available at 12 months (P < 0.0001). Patients with available clinical measurements achieved significant improvements in HbA1c, weight, BMI, and QOL measurements at 12 months. A mean improvement of 4.56 was seen in the total IWQOL-Lite score at 12 months (P = 0.001). The single-arm design of this study is a limitation; however, the overall objective of the study was to observe patients on exenatide BID therapy over time, comparing their status at endpoint to baseline, rather than to make comparisons among different drug therapies.
  
  
  CONCLUSIONS
  The Exenatide BID Observational Study supports the clinical effectiveness of exenatide BID observed in previous clinical trials and retrospective database studies.
authors.affiliation: International Diabetes Center at Park Nicollet, Minneapolis, MN 55416, USA. Richard.Bergenstal@ParkNicollet.com
authors.forename: Richard M
authors.initials: RM
authors.lastname: Bergenstal
authors.forename: Louis P
authors.initials: LP
authors.lastname: Garrison
authors.forename: Lesley-Ann
authors.initials: LA
authors.lastname: Miller
authors.forename: Likun
authors.initials: L
authors.lastname: Hou
authors.forename: Amy
authors.initials: A
authors.lastname: Blickensderfer
authors.forename: Anthony
authors.initials: A
authors.lastname: Zagar
authors.forename: Shelley
authors.initials: S
authors.lastname: Stanley
authors.forename: Anuj
authors.initials: A
authors.lastname: Bhargava
authors.forename: Rolin
authors.initials: R
authors.lastname: Wade
authors.forename: William H
authors.initials: WH
authors.lastname: Herman
mesh_terms: D000368:Aged; D015415:Biomarkers / Q000097:blood; D015992:Body Mass Index; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D000077270:Exenatide; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D010455:Peptides / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D011788:Quality of Life; D013997:Time Factors; D014688:Venoms / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D015415:Biomarkers; D000077270:Exenatide; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008055:Lipids; D010455:Peptides; D014688:Venoms; C517652:hemoglobin A1c protein, human