At a glance
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TECOS: A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes After Treatment With Sitagliptin in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control
In Brief
A Phase 3 clinical trial evaluating Sitagliptin and Placebo for Type 2 Diabetes Mellitus. Completed, enrolled 14,671 participants.
Detailed Summary
This is a clinical trial designed to assess the cardiovascular outcome of long-term treatment with sitagliptin used as part of usual care compared to usual care without sitagliptin in participants with type 2 diabetes mellitus (T2DM) having a history of cardiovascular (CV) disease and a hemoglobin A1c (HbA1c) of 6.5% to 8.0%. Primary hypothesis A is that sitagliptin, when used as part of usual care, is non-inferior to usual care without sitagliptin with regard to the risk of developing a confirmed event in the primary CV composite endpoint of Major Adverse Cardiovascular Event (MACE) plus. If hypothesis A is satisfied: hypothesis B is that sitagliptin, when used as part of usual care, is superior to usual care without sitagliptin with regard to the risk of developing a confirmed event in the primary CV composite endpoint.
Study Details
Timeline
Interventions
Sitagliptin, one 50 mg or one 100 mg tablet (dose dependant on renal function) orally, once daily.
Placebo tablet matching the 50 mg or 100 mg sitagliptin tablet, orally, once daily.