Sitagliptin Cardiovascular Outcome Study - Full Text View

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

Purpose

Large, simple trial designed to assess 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 and a history of cardiovascular disease with an HbA1c of 6.5 - 8.0% on single agent or dual combination antihyperglycemic therapy.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Official Title:	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 on Mono- or Dual Combination Oral Antihyperglycemic Therapy

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Heart Attack

Drug Information available for: Sitagliptin Sitagliptin phosphate

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Assess the impact of sitagliptin as part of usual care vs usual care without sitagliptin on primary composite cardiovascular (CV) endpoint (CV-related death, non-fatal myocardial infarction, non-fatal stroke, or unstable angina requiring hospitalization) [ Time Frame: Approximately 4-5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess the impact of sitagliptin as part of usual care vs usual care without sitagliptin on secondary composite cardiovascular endpoint (CV-related death, non-fatal myocardial infarction, or non-fatal stroke or each of the primary endpoint components) [ Time Frame: Approximately 4-5 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
1: Experimental Sitagliptin phosphate	Drug: Sitagliptin phosphate Sitagliptin phosphate (one 100 mg tablet once daily for patients with normal or mildly impaired renal function as defined by estimated glomerular filtration rate [eGFR] or one 50 mg tablet once daily for patients with moderately impaired renal function as defined by eGFR). Treatment period of approximately 4-5 years.
2: Placebo Comparator Placebo Comparator	Drug: Comparator: Placebo Sitagliptin phosphate placebo (one 100 mg placebo tablet once daily for patients with normal or mildly impaired renal function as defined by estimated glomerular filtration rate [eGFR] or one 50 mg placebo tablet once daily for patients with moderately impaired renal function as defined by eGFR). Treatment period of approximately 4-5 years.

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 - 8.0% on stable dose(s) of oral antihyperglycemic therapy
Patient has preexisting cardiovascular disease

Exclusion Criteria:

Patient has a history of type 1 diabetes mellitus, ketoacidosis or is currently taking insulin
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 50 Study Locations

Sponsors and Collaborators

Merck

Duke Clinical Research Institute, Oxford Diabetes Trials Unit

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

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

PhRMA Clinical Study Results Database - web-based repository for clinical study results 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 Sharp & Dohme Corp ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_523, MK0431-082
Study First Received:	November 11, 2008
Last Updated:	January 27, 2010
ClinicalTrials.gov Identifier:	NCT00790205 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Dipeptidyl-Peptidase IV Inhibitors
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Enzyme Inhibitors
Glucose Metabolism Disorders
Pharmacologic Actions
Protease Inhibitors
Sitagliptin

ClinicalTrials.gov processed this record on February 08, 2010