Sitagliptin Cardiovascular Outcome Study (0431-082 AM1)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00790205
• Date of registration: 11/11/2008
• Primary sponsor: Merck
• Public title: Sitagliptin Cardiovascular Outcome Study (0431-082 AM1) TECOS
• Scientific 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
• Date of first enrolment: December 2008
• Target sample size: 14000
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00790205
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Estonia, Finland, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patient has Type 2 Diabetes Mellitus

- Patient's HbA1c is between 6.5% (48 mmol/mol) and 8.0% (64 mmol/mol) on stable
dose(s) of antihyperglycemic agent(s), including insulin

- Patient has preexisting cardiovascular disease

Exclusion Criteria:

- Patient has a history of type 1 diabetes mellitus or ketoacidosis.

- Patient is not able to take sitagliptin



Age minimum: 50 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Intervention(s)

Drug: Placebo

Drug: Sitagliptin phosphate

Primary Outcome(s)

Time to first confirmed cardiovascular (CV) event (a composite defined as CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization). [Time Frame: Up to 5 years]

Secondary Outcome(s)

Change in renal function over time. [Time Frame: Up to 5 years]

Time to all-cause mortality. [Time Frame: Up to 5 years]

Time to congestive heart failure. [Time Frame: Up to 5 years]

Time to first confirmed cardiovascular (CV) event (a composite defined as CV-related death, nonfatal MI, or nonfatal stroke). [Time Frame: Up to 5 years]

Secondary ID(s)

0431-082

2008_523

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Duke Clinical Research Institute, Oxford Diabetes Trials Unit