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.

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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. Condition or disease Intervention/treatment Phase Type 2 Diabetes Mellitus Drug: Sitagliptin Drug: Placebo Phase 3. Layout table for study information Study Type: Interventional (Clinical Trial) Actual Enrollment: 14671 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment Official Title: 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 Actual Study Start Date: December 10, 2008 Actual Primary Completion Date: March 30, 2015 Actual Study Completion Date: March 30, 2015. Layout table for additonal information Responsible Party: Merck Sharp & Dohme Corp. ClinicalTrials.gov Identifier: Other Study ID Numbers: 0431-082 2008_523 ( Other Identifier: Merck study number ) 2008-006719-20 ( EudraCT Number ) First Posted: November 13, 2008 Results First Posted: April 15, 2016 Last Update Posted: August 17, 2018 Last Verified: July 2018 Individual Participant Data (IPD) Sharing Statement: Plan to Share IPD: Yes Plan Description: URL: Additional relevant MeSH terms.

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