Sitagliptin Cardiovascular Outcomes Study (MK-0431-082)

Phase 3 Completed 14671 enrolled Merck Sharp & Dohme LLC Duke Clinical Research Institute, Oxford Diabetes Trials Unit · collab

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2008-12-10
Primary completion: 2015-03-30
Completion: 2015-03-30

Outcome

Met primary endpoint

paper Sitagliptin was noninferior to placebo for the primary composite cardiovascular outcome (hazard ratio, 0.98; 95% CI, 0.88 to 1.09; P<0.001). reads as unknown PMID 26052984 ↗

release “Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) of Merck’s DPP-4 inhibitor, JANUVIA ® (sitagliptin), achieved its primary endpoint of non-inferiority” reads as met primary endpoint merck.com ↗

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sitagliptin	Small molecule	50 mg	Oral
Subject	Sitagliptin	Small molecule	100 mg	Oral