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Trial record 1 of 2 for:    TECOS
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Sitagliptin Cardiovascular Outcomes Study (MK-0431-082) (TECOS)

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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.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Sitagliptin Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14671 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 10, 2008
Actual Primary Completion Date : March 30, 2015
Actual Study Completion Date : March 30, 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Sitagliptin
Sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years.
 Drug: Sitagliptin
Sitagliptin, one 50 mg or one 100 mg tablet (dose dependant on renal function) orally, once daily.
Other Names:
  • MK-0431
  • Januvia®
Placebo Comparator: Placebo
Placebo to sitagliptin tablet taken orally once daily in the morning for up to approximately 5 years.
 Drug: Placebo
Placebo tablet matching the 50 mg or 100 mg sitagliptin tablet, orally, once daily.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.)

  16. 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.)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00790205


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Duke Clinical Research Institute, Oxford Diabetes Trials Unit
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00790205    
Other Study ID Numbers: 0431-082
2008_523 ( Other Identifier: Merck study number )
2008-006719-20 ( EudraCT Number )
First Posted: November 13, 2008    Key Record Dates
Results First Posted: April 15, 2016
Last Update Posted: August 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
 Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action