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: September 26, 2014
Last verified: September 2014
  Purpose

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%.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Sitagliptin phosphate
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 14000
Study Start Date: December 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sitagliptin phosphate 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®
Placebo Comparator: Placebo Comparator Drug: Placebo
Placebo tablet matching the 50 mg or 100 mg sitagliptin phosphate tablet, orally, once daily

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Additional Information:
No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00790205     History of Changes
Other Study ID Numbers: 0431-082, 2008_523
Study First Received: November 11, 2008
Last Updated: September 26, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on October 21, 2014