EXSCEL: EXenatide Study of Cardiovascular Event Lowering
Glycemic control in patients with type 2 diabetes
|Funding:||Amylin Pharmaceuticals Inc|
|Collaborators:||Center for Clinical and Genetic Economics (CCGE), Duke Clinical Research Institute; Diabetes Trials Unit (DTU), University of Oxford|
Type 2 diabetes mellitus (T2DM) is a serious public health concern and the fourth leading cause of death in developed countries. People with T2DM are at higher risk of dying from cardiovascular disease (CVD) and a number of clinical trials have shown that CVD risks can be reduced by lowering LDL cholesterol, blood pressure and glycated haemoglobin. Exenatide is a GLP-1 receptor agonist that has been shown in a randomized clinical trial to improve glycemic controls, improve insulin secretion, reduce blood pressure and improve weight loss. When compared to exenatide twice daily, exenatide once weekly (EWQ) has shown improvements in glycemic control and therefore could potentially reduce CVD risks. EXSCEL (EXenatide Study of Cardiovascular Event Lowering) is a pragmatic, long-term, placebo-controlled, double blinded trial that compares exenatide once weekly as part of usual care compared with usual care without exenatide in patients with T2DM.
HERC, in collaboration with the Center for Clinical and Genetic Economics (CCGE) at Duke Clinical Research Institute and the Diabetes Trial Unit (DTU) at the University of Oxford, is leading the economic evaluation alongside this important trial. The analysis plan involves conducting the economic evaluation of the within-trial analysis up to five and a half years follow-up and a long-term extrapolation of these results using the UKPDS Outcomes model. Resource use and quality of life data using the EQ-5D 5 level data is being collected alongside this study. Quality of life data will be combined with survival times to estimate quality adjusted time in the trial per patient. Cost-effectiveness will report the incremental cost per major cardiovascular outcome averted, cardiovascular related death averted, life-year and quality-adjusted life year gained of including exenatide once weekly as part of usual care versus usual care without exenatide.
The first patient of EXSCEL was randomized in June 2010.