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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00790205
Recruitment Status : Completed
First Posted : November 13, 2008
Results First Posted : April 15, 2016
Last Update Posted : August 17, 2018
Sponsor:
Collaborator:
Duke Clinical Research Institute, Oxford Diabetes Trials Unit
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE November 11, 2008
First Posted Date  ICMJE November 13, 2008
Results First Submitted Date  ICMJE March 15, 2016
Results First Posted Date  ICMJE April 15, 2016
Last Update Posted Date August 17, 2018
Actual Study Start Date  ICMJE December 10, 2008
Actual Primary Completion Date March 30, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2016)
  • 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.
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2016)
  • 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.)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sitagliptin Cardiovascular Outcomes Study (MK-0431-082)
Official Title  ICMJE 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
Brief Summary

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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 15, 2016)		 14671
Original Estimated Enrollment  ICMJE
 (submitted: November 11, 2008)		 14000
Actual Study Completion Date  ICMJE March 30, 2015
Actual Primary Completion Date March 30, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries 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
 
Administrative Information
NCT Number  ICMJE NCT00790205
Other Study ID Numbers  ICMJE 0431-082
2008_523 ( Other Identifier: Merck study number )
2008-006719-20 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Duke Clinical Research Institute, Oxford Diabetes Trials Unit
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date July 2018

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