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

This study is ongoing, but not recruiting participants.
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 22, 2014
Last verified: April 2014

November 11, 2008
April 22, 2014
December 2008
December 2014   (final data collection date for primary outcome measure)
Time to first confirmed cardiovascular (CV) event (a composite defined as CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization). [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
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
  • Time to first confirmed cardiovascular (CV) event (a composite defined as CV-related death, nonfatal MI, or nonfatal stroke). [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Time to all-cause mortality. [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Time to congestive heart failure. [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Change in renal function over time. [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
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 Outcome 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 patients with Type 2 Diabetes Mellitus having a history of cardiovascular disease and a hemoglobin A1c (HbA1c) of 6.5% to 8.0%.

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 phosphate
    sitagliptin phosphate, 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 phosphate tablet, orally, once daily
  • Experimental: Sitagliptin phosphate
    Intervention: Drug: Sitagliptin phosphate
  • Placebo Comparator: Placebo Comparator
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
14000
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient has Type 2 Diabetes Mellitus
  • Patient's HbA1c is between 6.5% (48 mmol/mol) and 8.0% (64 mmol/mol) on stable dose(s) of antihyperglycemic agent(s), including insulin
  • Patient has preexisting cardiovascular disease

Exclusion Criteria:

  • Patient has a history of type 1 diabetes mellitus or ketoacidosis.
  • Patient 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
 
NCT00790205
0431-082, 2008_523
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Duke Clinical Research Institute, Oxford Diabetes Trials Unit
Not Provided
Merck Sharp & Dohme Corp.
April 2014

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