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Sitagliptin Cardiovascular Outcomes Study (MK-0431-082) (TECOS)

This study has been completed.
Sponsor:
Collaborator:
Duke Clinical Research Institute, Oxford Diabetes Trials Unit
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00790205
First received: November 11, 2008
Last updated: April 10, 2017
Last verified: April 2017
History of Changes
November 11, 2008
April 10, 2017
December 10, 2008
March 30, 2015   (Final data collection date for primary outcome measure)
  • Percentage of Participants With First Confirmed Cardiovascular (CV) Event of Major Adverse Cardiovascular Event (MACE) Plus (Per Protocol Population) [ Time Frame: Up to 5 years ]
    Primary composite CV endpoint of MACE plus which includes CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization.
  • Percentage of Participants With First Confirmed CV Event of Major Adverse Cardiovascular Event (MACE) Plus (Intent to Treat Population) [ Time Frame: Up to 5 years ]
    Primary composite CV endpoint of MACE plus which includes CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization.
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 ]
Complete list of historical versions of study NCT00790205 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With First Confirmed CV Event of MACE (Per Protocol Population) [ Time Frame: Up to 5 years ]
    CV composite endpoint of MACE which includes CV-related death, nonfatal MI, or nonfatal stroke.
  • Percentage of Participants With First Confirmed CV Event of MACE (Intent to Treat Population) [ Time Frame: Up to 5 years ]
    CV composite endpoint of MACE which includes CV-related death, nonfatal MI, or nonfatal stroke.
  • Percent Incidence of All-cause Mortality (Per Protocol Population) [ Time Frame: Up to 5 years ]
    Percent incidence of all-cause mortality is reported as the percentage of participants who died due to any cause.
  • Percent Incidence of All-cause Mortality (Intent to Treat Population) [ Time Frame: Up to 5 years ]
    Percent incidence of all-cause mortality is reported as the percentage of participants who died due to any cause.
  • Percent Incidence of Congestive Heart Failure (CHF) Requiring Hospitalization (Per Protocol Population) [ Time Frame: Up to 5 years ]
    Percent incidence of CHF requiring hospitalization was reported as the percentage of participants who were admitted to the hospital for CHF.
  • Percent Incidence of CHF Requiring Hospitalization (Intent to Treat Population) [ Time Frame: Up to 5 years ]
    Percent incidence of CHF requiring hospitalization was reported as the percentage of participants who were admitted to the hospital for CHF.
  • Change From Baseline in Renal Function Over Time (Per Protocol Population) [ Time Frame: Baseline and up to 5 years ]
    Change in renal function based on estimated glomerular filtration rate [eGFR] using the Modification of Diet in Renal Disease [MDRD] method.
  • Change From Baseline in Renal Function Over Time (Intent to Treat Population) [ Time Frame: Baseline and up to 5 years ]
    Change in renal function based on eGFR using the MDRD method.
  • Change From Baseline in HbA1c Over Time (Per Protocol Population) [ Time Frame: Baseline and up to 4 years ]
    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.
  • Change From Baseline in HbA1c Over Time (Intent to Treat Population) [ Time Frame: Baseline and up to 4 years ]
    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.
  • Change From Baseline in Urine Albumin:Creatinine Ratio Over Time (Per Protocol Population) [ Time Frame: Baseline and up to 5 years ]
    Change from baseline reflects the difference between the urine albumin:creatinine ratio reported time point and baseline value.
  • Change From Baseline in Urine Albumin:Creatinine Ratio Over Time (Intent to Treat Population) [ Time Frame: Baseline and up to 5 years ]
    Change from baseline reflects the difference between the urine albumin:creatinine ratio reported time point and baseline value.
  • Percentage of Participants Who Initiated Chronic Insulin Therapy (Per Protocol Population) [ Time Frame: Up to 5 years ]
    Chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.
  • Percentage of Participants Who Initiated Chronic Insulin Therapy (Intent to Treat Population) [ Time Frame: Up to 5 years ]
    Chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.
  • Percentage of Participants With Initiation of Co-interventional Agent (Per Protocol Population) [ Time Frame: Up to 5 years ]
    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.)
  • Percentage of Participants With Initiation of Co-interventional Agent (Intent to Treat Population) [ Time Frame: Up to 5 years ]
    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.)
Assess secondary composite cardiovascular endpoint (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) [ Time Frame: Approximately 4-5 years ]
Not Provided
Not Provided
 
Sitagliptin Cardiovascular Outcomes Study (MK-0431-082)
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

This is a clinical trial designed to assess the cardiovascular outcome of long-term treatment with sitagliptin used as part of usual care compared to usual care without sitagliptin in participants with type 2 diabetes mellitus (T2DM) having a history of cardiovascular (CV) disease and a hemoglobin A1c (HbA1c) of 6.5% to 8.0%.

Primary hypothesis A is that sitagliptin, when used as part of usual care, is non-inferior to usual care without sitagliptin with regard to the risk of developing a confirmed event in the primary CV composite endpoint of Major Adverse Cardiovascular Event (MACE) plus. If hypothesis A is satisfied: hypothesis B is that sitagliptin, when used as part of usual care, is superior to usual care without sitagliptin with regard to the risk of developing a confirmed event in the primary CV composite endpoint.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Sitagliptin
    Sitagliptin, one 50 mg or one 100 mg tablet (dose dependant on renal function) orally, once daily.
    Other Names:
    • MK-0431
    • Januvia®
  • Drug: Placebo
    Placebo tablet matching the 50 mg or 100 mg sitagliptin tablet, orally, once daily.
  • Experimental: Sitagliptin
    Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years.
    Intervention: Drug: Sitagliptin
  • Placebo Comparator: Placebo
    Placebo to sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years.
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14671
March 30, 2015
March 30, 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Has T2DM
  • Has HbA1c between 6.5% (48 mmol/mol) and 8.0% (64 mmol/mol) on stable dose(s) of antihyperglycemic agent(s), including insulin
  • Has pre-existing cardiovascular disease

Exclusion Criteria:

  • Has a history of type 1 diabetes mellitus or ketoacidosis.
  • Is not able to take sitagliptin
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
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
 
NCT00790205
0431-082
2008_523 ( Other Identifier: Merck study number )
2008-006719-20 ( EudraCT Number )
Yes
Not Provided
Yes

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Duke Clinical Research Institute, Oxford Diabetes Trials Unit
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP