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: March 15, 2016
Last verified: March 2016

November 11, 2008
March 15, 2016
December 2008
March 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 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00790205 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With First Confirmed CV Event of MACE [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    CV composite endpoint of MACE which includes CV-related death, nonfatal MI, or nonfatal stroke.
  • Percent Incidence of All-cause Mortality [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    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 Requiring Hospitalization [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    Percent incidence of congestive heart failure requiring hospitalization was reported as the percentage of participants who were admitted to the hospital for congestive heart failure.
  • Change From Baseline in HbA1c Over Time [ Time Frame: Baseline and up to 4 years ] [ Designated as safety issue: No ]
    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 Renal Function Over Time [ Time Frame: Baseline and up to 5 years ] [ Designated as safety issue: No ]
    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 Urine Albumin:Creatinine Ratio Over Time [ Time Frame: Baseline and up to 5 years ] [ Designated as safety issue: No ]
    Change from baseline reflects the difference between the urine albumin:creatinine ratio reported time point and baseline value.
  • Percent of Participants Who Initiated Chronic Insulin Therapy [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.
  • Percent Participants With Initiation of Co-interventional Agent [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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.)
Assess secondary composite cardiovascular endpoint (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) [ Time Frame: Approximately 4-5 years ] [ Designated as safety issue: No ]
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 outcomes 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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 2015
March 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
Both
50 Years and older
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, 2008-006719-20
Yes
Not Provided
Not Provided
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.
March 2016

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