Merck's clinical cardiovascular outcomes study with sitagliptin (JANUVIA), entitled "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 on Mono- or Dual Combination Oral Antihyperglycemic Therapy" (TECOS) began recruiting participants in December 2008 with results expected approximately in 2014.
TECOS is a long-term, event-driven, non-inferiority, cardiovascular outcomes trial evaluating the impact of sitagliptin when added to usual diabetes care in a large, high-risk population across multiple countries and in typical clinical practice environments. The primary objective of TECOS is to determine whether including sitagliptin as part of usual care has any impact upon a composite cardiovascular endpoint (cardiovascular-related death, nonfatal heart attack, nonfatal stroke, or unstable chest pain or discomfort of cardiac origin requiring hospitalization). Secondary objectives include determining whether sitagliptin included as part of usual care has any effect on a secondary composite cardiovascular endpoint (cardiovascular-related death, nonfatal heart attack or nonfatal stroke), or each of the separate components of the primary composite endpoint, all-cause mortality, hospital admissions for congestive heart failure, change from baseline in HbA1c over time, change in renal function and urinary albumin excretion rate over time, time to initiation of chronic insulin therapy, time to addition of first co-interventional agent and medical resource utilization during the trial.
TECOS is a multinational, placebo-controlled, double-blind, randomized, parallel-group clinical trial. Full glycemic and cardiovascular risk factor treatment according to local guidelines for all participants is being emphasized. The study will enroll approximately 14,000 patients over an estimated two years, with an approximate follow-up of four to five years until 1,300 primary cardiovascular events are accumulated. Because this is an event-driven study, the precise duration cannot be determined in advance. Study participants will have type 2 diabetes and pre-existing cardiovascular disease, be at least 50 years of age and have inadequate glycemic control (baseline HbA1c = 6.5 percent and = 8.0 percent) despite monotherapy or dual combination therapy with metformin, pioglitazone or a sulfonylurea.
The Company is working with the academic research organizations University of Oxford Diabetes Trial Unit (DTU) and Duke Clinical Research Institute (DCRI) on this study. TECOS is being managed collaboratively by DTU and DCRI and overseen by principal investigators Professor Rury R. Holman, F.R.C.P. and Robert M. Califf, M.D.; DTU and DCRI will hold and analyze the data. The study protocol was approved by the U.S. Food and Drug Administration (FDA) and the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. Please refer to ClinicalTrials.gov identifier: NCT00790205.
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