Sitagliptin Cardiovascular Outcome Study (0431-082 AM1) - Full Text View

Sponsor:	Merck
Collaborator:	Duke Clinical Research Institute, Oxford Diabetes Trials Unit
Information provided by (Responsible Party):	Merck
ClinicalTrials.gov Identifier:	NCT00790205

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 III

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Sitagliptin Sitagliptin phosphate

U.S. FDA Resources

Further study details as provided by Merck:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790205

Contacts

Contact: Toll Free Number

1-888-577-8839

Show 38 Study Locations

Sponsors and Collaborators

Merck

Duke Clinical Research Institute, Oxford Diabetes Trials Unit

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT00790205 History of Changes
Other Study ID Numbers:	2008_523, MK-0431-082
Study First Received:	November 11, 2008
Last Updated:	December 2, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors

Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012