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

Objectives:

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/m²), 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.

Key words::

• Diabetes
• Exenatide
• HbA_1c
• Obesity
• Observational
• Weight

Transparency

Declaration of funding

This study was funded by Eli Lilly and Company, Indianapolis, IN, USA.

Declaration of financial/other relationships

R.B. has disclosed that he receives research grant support and/or is a member of scientific advisory boards for the following companies: Abbott Diabetes Care, Amylin, Bayer, Eli Lilly and Company, Intuity Medical, Hygieia Medical, LifeScan, Mannkind, Medtronic-Minimed, National Institutes of Health, Novo Nordisk, ResMed, Roche, Sanofi Aventis, UnitedHealth Group, and Valeritas. He also has disclosed that he owns Merck stock, a family inheritance. All research activity, advisory/consultancy work, and educational services are performed under contract with the non-profit Park Nicollet Institute and the International Diabetes Center, and R.B. has disclosed that he receives no personal compensation for these activities. L.G. has disclosed that he has received consulting fees from Lilly for serving as a member of the Scientific Steering Committee for the ExOS trial. M.W. and A.B. have disclosed that they are employees of Amylin Pharmaceuticals, Inc., and own stock in Amylin. R.W. and L.H. have disclosed that they are employees of HealthCore, Inc., a research organization contracted by Eli Lilly and Company to conduct the ExOS trial. L-A.M. and A.Z. have disclosed that they are employed by, and own stock in, Lilly. D.M. and J.S-B. have disclosed that they were previously employed by, and owned stock in, Lilly. W.H. has disclosed that he has received consulting fees from Lilly for serving as a member of the Scientific Steering Committee for the ExOS trial.

Acknowledgment

The authors thank Dr Alan Ogelsby and Dr Rosalind Fabunmi for their contributions to the design of ExOS; Dr John Holcombe and Dr Manjiri Pawaskar for their scientific review of the manuscript; and Dr Michael Stensland for his assistance with the execution of ExOS and development of the manuscript.

Data in this paper were previously presented at the American Diabetes Association 70th Scientific Sessions, Orlando, FL, USA, June 25–29, 2010.