Study Design
Green et al, 20151
TECOS (Trial Evaluating Cardiovascular Outcomes With Sitagliptin) is a randomised double blind controlled CV safety trial, comparing JANUVIA and placebo when added to usual care in 14,671 patients with type 2 diabetes and established cardiovascular disease. Median follow-up was 3.0 years (interquartile range, 2.3 to 3.8, maximum, 5.7).
Enrolled 14,735 patients aged >50 years with type 2 diabetes and a history of cardiovascular disease
Both groups treated to individually appropriate HbA1c targets with the aim of no difference in the glycaemic control between arms**
•Prior antihyperglycaemic monotherapy or dual therapy† was continued after randomisation.
• Additional diabetes medications,† including insulin (excluding other DPP-4 inhibitors and GLP-1 receptor agonists), could have been added based on usual care to target individualised HbA1c goals according to local guidelines.
* Starting dose of once-daily sitagliptin was 100 mg or 50 mg for patients with eGFR 30–50 mL/min/1.73m²; if eGFR fell to <30 mL/min/1.73m², the dose was reduced to once-daily sitagliptin 25 mg; if eGFR showed sustained recovery, dose was up-titrated.
**During the study there was a small difference of HbA1c (least-square mean difference for sitagliptin vs. placebo. -0.29%; 95% confidence CI, -0.32 to -0.27, p<0.001).
† Antihyperglycaemic medication could have included metformin, sulphonylurea, pioglitazone, or insulin with or without metformin, excluding other DPP-4 inhibitors and GLP-1 RAs.
