Trial Evaluating Cardiovascular Outcomes With Sitagliptin
The Trial to Evaluate Cardiovascular Outcomes after Treatment with Sitagliptin (TECOS) clinical trial will find out if giving people with type 2 diabetes a drug called sitagliptin alongside their usual diabetes care regime can reduce their risk of heart attacks and strokes.
TECOS is a phase III multinational trial, being conducted in 38 countries across Australasia, Asia, Europe, North America, South America, India and South Africa.
Coordinated by DTU and Duke Clinical Research Institute (DCRI), and sponsored by Merck & Co. Inc, the TECOS trial began in 2008 and recruitment is now complete. Over 14,700 people with type 2 diabetes aged 50 years or older, who have heart and circulatory disease and whose blood glucose is not being controlled well, are taking part. Each participant will receive either sitagliptin or a placebo (dummy drug) and will be followed for three to five years.
We expect that results of this event-driven trial (where a certain number of events, in this case 1300 confirmed cardiovascular events, must occur to prove if a particular treatment is effective) will be available in 2015. TECOS is also an example of a pragmatic trial, which aims to measure how beneficial a treatment would be in real clinical practice.