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Completed

NCT Number: NCT00790205

Sitagliptin Cardiovascular Outcomes Study (MK-0431-082)

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sitagliptin

Drug

Sitagliptin, one 50 mg or one 100 mg tablet (dose dependant on renal function) orally, once daily.

Other names: MK-0431, Januvia®

Placebo

Drug

Placebo tablet matching the 50 mg or 100 mg sitagliptin tablet, orally, once daily.

Primary outcomes

  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 outcomes

  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.)

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Duke Clinical Research Institute, Oxford Diabetes Trials Unit

Registry information

Official study 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

Acronym: TECOS

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Nov 13, 2008
Registry last updated
Nov 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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