title: Exenatide bid observational study (ExOS): baseline population characteristics 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
  To describe the Exenatide Observational Study (ExOS) and patients initiating exenatide therapy in a real-world clinical practice setting.
  
  
  METHODS
  ExOS is a prospective, single-arm, multicenter, observational study to assess the effectiveness of up to 24 months of exenatide therapy in patients with type 2 diabetes (T2D). Patients with T2D ≥18 years of age, who initiated exenatide therapy, were eligible. The primary effectiveness endpoint is achieving or maintaining hemoglobin A1C of ≤7.0%, or an absolute drop of 0.5% from baseline. Secondary objective measures evaluate the absolute and percentage changes from baseline for a variety of clinical measures (lipid markers, weight, BMI, etc.) and quality of life (QOL) is assessed using the Impact of Weight on Quality of Life (IWQOL)-Lite.
  
  
  RESULTS
  On average, the baseline population (n = 531) was aged 55 years, predominantly female (62%), white (79%), educated, obese (mean BMI 39 kg/m(2)), with mean HbA(1c), blood pressure, total cholesterol, and triglyceride values of 8.0%, 129/76 mmHg, 174 mg/dL, and 197 mg/dL, respectively. A total of 28% entered the study with HbA(1c) ≤7.0% and 67% were being treated with oral antihyperglycemic drug(s) (OAD) only [1 (28.4%), 2 (28.4%), >2 (10.2%)], or some form of insulin ±OADs (19%), and ≥50% were on a cholesterol-lowering drug(s) ± antihypertensive medication(s). The single-arm design of this study is a limitation; however, the overall objective of the ongoing study is to observe patients on exenatide therapy over time, comparing their status at endpoint to baseline, rather than to make comparisons among different drug therapies.
  
  
  CONCLUSIONS
  Patients treated with exenatide tended to be obese, middle-aged women on various combinations of OADs and/or insulin who often had hypertension and/or dyslipidemia. Further planned analyses will provide the largest sample of prospective data on outcomes of exenatide therapy for up to 24 months in this usual-care population.
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: Matthew
authors.initials: M
authors.lastname: Wintle
authors.forename: Amy
authors.initials: A
authors.lastname: Blickensderfer
authors.forename: Rolin
authors.initials: R
authors.lastname: Wade
authors.forename: Likun
authors.initials: L
authors.lastname: Hou
authors.forename: Lesley-Ann
authors.initials: LA
authors.lastname: Miller
authors.forename: Jamie
authors.initials: J
authors.lastname: Scism-Bacon
authors.forename: Anthony
authors.initials: A
authors.lastname: Zagar
authors.forename: Derek
authors.initials: D
authors.lastname: Misurski
authors.forename: William H
authors.initials: WH
authors.lastname: Herman
mesh_terms: D000328:Adult; D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000453:epidemiology; D000077270:Exenatide; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D019370:Observation; D010455:Peptides / Q000627:therapeutic use*; D011153:Population; D011320:Primary Health Care / Q000379:methods / Q000706:statistics & numerical data; D011446:Prospective Studies; D012923:Social Class; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014688:Venoms / Q000627:therapeutic use*
chemical_list: D007004:Hypoglycemic Agents; D010455:Peptides; D014688:Venoms; D000077270:Exenatide