Sitagliptin Cardiovascular Outcome Study (TECOS)
Tracking Information
tart Date ICMJE | December 2008 |
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Estimated Primary Completion Date | December 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 History | Complete 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 ICMJE | Sitagliptin Cardiovascular Outcome Study |
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Official Title ICMJE | 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 |
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 Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study |
Condition ICMJE | Type 2 Diabetes Mellitus |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 14000 | ||||
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Estimated Completion Date | December 2014 | ||||
Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 50 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United 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 ICMJE | NCT00790205 | ||||
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Responsible Party | Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. | ||||
Study ID Numbers ICMJE | 2008_523, MK0431-082 | ||||
Study Sponsor ICMJE | Merck | ||||
Collaborators ICMJE | Duke Clinical Research Institute, Oxford Diabetes Trials Unit | ||||
Investigators ICMJE |
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Information Provided By | Merck |
Source: http://clinicaltrials.gov/