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/m². 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.

Key words::

• Body weight
• Diabetes mellitus
• Exenatide
• HbA1c
• Observational

Transparency

Declaration of funding

This study was funded by Eli Lilly and Company, Indianapolis, IN, USA and Amylin Pharmaceuticals, Inc., San Diego, CA, USA.

Declaration of financial/other relationships

R.M.B. receives research grant support from 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 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, for which he receives no personal compensation. L.P.G. has received consulting fees from Eli Lilly and Company for serving as a member of the Scientific Steering Committee for the ExOS trial. A.Bl. is an employee of Amylin Pharmaceuticals, Inc., and owns stock in Amylin Pharmaceuticals. R.W. and L.H. 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. are employed by Eli Lilly and Company and own stock in Eli Lilly and Company. W.H.H. has received consulting fees from Eli Lilly and Company for serving as a member of the Scientific Steering Committee for the ExOS trial.

Acknowledgments

The authors thank Dr Alan Ogelsby, Dr Matthew Wintle, and Dr Rosalind Fabunmi for their contributions to the design of ExOS, Dr Michael Stensland for his assistance with the execution of ExOS, and Rebecca McCracken, MSPH, for her contributions to the writing of the manuscript. This study was funded by Eli Lilly and Company, Indianapolis, IN, USA and Amylin Pharmaceuticals, Inc., San Diego, CA, USA.

Previous presentation: Academy of Managed Care Pharmacy 23rd Annual Meeting and Showcase, Minneapolis, MN, USA, April 27–29, 2011.