Sitagliptin Cardiovascular Outcome Study (TECOS)


Tracking Information

tart Date  ICMJEDecember 2008
Estimated Primary Completion DateDecember 2014   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: October 29, 2009)		Assess the impact of sitagliptin as part of usual care vs usual care without sitagliptin on primary composite cardiovascular (CV) endpoint (CV-related death, non-fatal myocardial infarction, non-fatal stroke, or unstable angina requiring hospitalization) [ Time Frame: Approximately 4-5 years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJE 
 (submitted: November 11, 2008)		Assess primary composite cardiovascular endpoint (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or unstable angina requiring hospitalization [ Time Frame: Approximately 4-5 years ] [ Designated as safety issue: No ]
Change HistoryComplete list of historical versions of study NCT00790205 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: October 29, 2009)		Assess the impact of sitagliptin as part of usual care vs usual care without sitagliptin on secondary composite cardiovascular endpoint (CV-related death, non-fatal myocardial infarction, or non-fatal stroke or each of the primary endpoint components) [ Time Frame: Approximately 4-5 years ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: November 11, 2008)		Assess secondary composite cardiovascular endpoint (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) [ Time Frame: Approximately 4-5 years ] [ Designated as safety issue: No ]

Descriptive Information

Brief Title  ICMJESitagliptin Cardiovascular Outcome Study
Official Title  ICMJEA 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
Brief Summary

Large, simple trial designed to assess cardiovascular outcome of long-term treatment with sitagliptin used as part of usual care compared to usual care without sitagliptin in patients with Type 2 Diabetes Mellitus and a history of cardiovascular disease with an HbA1c of 6.5 - 8.0% on single agent or dual combination antihyperglycemic therapy.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Condition  ICMJEType 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Sitagliptin phosphate
    Sitagliptin phosphate (one 100 mg tablet once daily for patients with normal or mildly impaired renal function as defined by estimated glomerular filtration rate [eGFR] or one 50 mg tablet once daily for patients with moderately impaired renal function as defined by eGFR). Treatment period of approximately 4-5 years.
    Other Name: Januvia®
  • Drug: Comparator: Placebo
    Sitagliptin phosphate placebo (one 100 mg placebo tablet once daily for patients with normal or mildly impaired renal function as defined by estimated glomerular filtration rate [eGFR] or one 50 mg placebo tablet once daily for patients with moderately impaired renal function as defined by eGFR). Treatment period of approximately 4-5 years.
Study Arms / Comparison Groups
  • 1: Experimental
    Sitagliptin phosphate
    Intervention: Drug: Sitagliptin phosphate
  • 2: Placebo Comparator
    Placebo Comparator
    Intervention: Drug: Comparator: Placebo

Recruitment Information

Estimated Enrollment  ICMJE14000
Estimated Completion DateDecember 2014
Estimated Primary Completion DateDecember 2014   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient has type 2 diabetes mellitus
  • Patient's HbA1c is between 6.5 - 8.0% on stable dose(s) of oral antihyperglycemic therapy
  • Patient has preexisting cardiovascular disease

Exclusion Criteria:

  • Patient has a history of type 1 diabetes mellitus, ketoacidosis or is currently taking insulin
  • Patient is not able to take sitagliptin
GenderBoth
Ages50 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Toll Free Number1-888-577-8839
Location Countries  ICMJEUnited States,   Australia,   Bulgaria,   Canada,   Chile,   Colombia,   Czech Republic,   Germany,   Hong Kong,   Hungary,   India,   Israel,   Korea, Republic of,   Latvia,   Lithuania,   Malaysia,   Netherlands,   New Zealand,   Poland,   Russian Federation,   Slovakia,   South Africa,   Spain,   Taiwan,   Ukraine,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00790205
Responsible PartyExecutive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Study ID Numbers  ICMJE2008_523, MK0431-082
Study Sponsor  ICMJEMerck
Collaborators  ICMJEDuke Clinical Research Institute, Oxford Diabetes Trials Unit
Investigators  ICMJE
Study Director:Medical MonitorMerck
Information Provided ByMerck