TECOS: Trial Evaluating Cardiovascular Outcomes with Sitagliptin
International trial of patients with type 2 diabetes
|Funding:||Merck and Co Inc|
|Collaborators:||Center for Clinical and Genetic Economics (CCGE), Duke Clinical Research Institute; Diabetes Trial 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. TECOS is a large clinical trial that evaluates the impact on CV outcomes in patients with T2DM of including sitagliptin as part of usual care compared to usual care without sitagliptin. The study aims to recruit around 14,000 patients from 425 clinical sites in Australasia, Asia, Europe, North America, South America, India and South Africa. It is expected that patients will be followed on average for 5 years.
HERC is leading the economic evaluation alongside this trial. The analysis plan involves conducting a trial-based economic evaluation and a long term cost-effectiveness model using the UKPDS Outcomes Model. In addition, an investigators survey that collects information on site characteristics, practice patterns and other potentially useful information is currently on-going. The latter will be used later when conducting the statistical analysis to estimate more precise country-specific cost-effectiveness estimates.
The first patient of TECOS was randomized in December 2008.