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Clinical Trial Details

Trial ID: L6879
Source ID: NCT00790205
Associated Drug: Sitagliptin
Title: Sitagliptin Cardiovascular Outcomes Study (MK-0431-082)
Acronym: TECOS
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00790205/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Sitagliptin|DRUG: Placebo
Outcome Measures: Primary: Percentage of Participants With First Confirmed Cardiovascular (CV) Event of Major Adverse Cardiovascular Event (MACE) Plus (Per Protocol Population), Primary composite CV endpoint of MACE plus which includes CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization., Up to 5 years|Percentage of Participants With First Confirmed CV Event of Major Adverse Cardiovascular Event (MACE) Plus (Intent to Treat Population), Primary composite CV endpoint of MACE plus which includes CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization., Up to 5 years | Secondary: Percentage of Participants With First Confirmed CV Event of MACE (Per Protocol Population), CV composite endpoint of MACE which includes CV-related death, nonfatal MI, or nonfatal stroke., Up to 5 years|Percentage of Participants With First Confirmed CV Event of MACE (Intent to Treat Population), CV composite endpoint of MACE which includes CV-related death, nonfatal MI, or nonfatal stroke., Up to 5 years|Percent Incidence of All-cause Mortality (Per Protocol Population), Percent incidence of all-cause mortality is reported as the percentage of participants who died due to any cause., Up to 5 years|Percent Incidence of All-cause Mortality (Intent to Treat Population), Percent incidence of all-cause mortality is reported as the percentage of participants who died due to any cause., Up to 5 years|Percent Incidence of Congestive Heart Failure (CHF) Requiring Hospitalization (Per Protocol Population), Percent incidence of CHF requiring hospitalization was reported as the percentage of participants who were admitted to the hospital for CHF., Up to 5 years|Percent Incidence of CHF Requiring Hospitalization (Intent to Treat Population), Percent incidence of CHF requiring hospitalization was reported as the percentage of participants who were admitted to the hospital for CHF., Up to 5 years|Change From Baseline in Renal Function Over Time (Per Protocol Population), Change in renal function based on estimated glomerular filtration rate \[eGFR\] using the Modification of Diet in Renal Disease \[MDRD\] method., Baseline and up to 5 years|Change From Baseline in Renal Function Over Time (Intent to Treat Population), Change in renal function based on eGFR using the MDRD method., Baseline and up to 5 years|Change From Baseline in HbA1c Over Time (Per Protocol Population), HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Estimated mean difference between sitagliptin and placebo controlling for baseline HbA1c and region., Baseline and up to 4 years|Change From Baseline in HbA1c Over Time (Intent to Treat Population), HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Estimated mean difference between sitagliptin and placebo controlling for baseline HbA1c and region., Baseline and up to 4 years|Change From Baseline in Urine Albumin:Creatinine Ratio Over Time (Per Protocol Population), Change from baseline reflects the difference between the urine albumin:creatinine ratio reported time point and baseline value., Baseline and up to 5 years|Change From Baseline in Urine Albumin:Creatinine Ratio Over Time (Intent to Treat Population), Change from baseline reflects the difference between the urine albumin:creatinine ratio reported time point and baseline value., Baseline and up to 5 years|Percentage of Participants Who Initiated Chronic Insulin Therapy (Per Protocol Population), Chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months., Up to 5 years|Percentage of Participants Who Initiated Chronic Insulin Therapy (Intent to Treat Population), Chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months., Up to 5 years|Percentage of Participants With Initiation of Co-interventional Agent (Per Protocol Population), In participants not receiving insulin at baseline, time to addition of first co-interventional agent (i.e., next oral antihyperglycemic agent \[AHA\] or chronic insulin, where chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.), Up to 5 years|Percentage of Participants With Initiation of Co-interventional Agent (Intent to Treat Population), In participants not receiving insulin at baseline, time to addition of first co-interventional agent (i.e., next oral AHA or chronic insulin, where chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.), Up to 5 years
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC | Collaborators: Duke Clinical Research Institute, Oxford Diabetes Trials Unit
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 14671
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2008-12-10
Completion Date: 2015-03-30
Results First Posted: 2016-04-15
Last Update Posted: 2021-11-23
Locations:
URL: https://clinicaltrials.gov/show/NCT00790205