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Sponsors and Collaborators: |
Merck Duke Clinical Research Institute, Oxford Diabetes Trials Unit |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00790205 |
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 |
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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 Phase III, 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- and Dual Combination Oral Antihyperglycemic Therapy |
Estimated Enrollment: | 14000 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | January 2015 |
Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Sitagliptin phosphate
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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.
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2: Placebo Comparator
Placebo Comparator
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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.
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Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Toll Free Number | 1-888-577-8839 |
Study Director: | Medical Monitor | Merck |
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2008_523, MK0431-082 |
Study First Received: | November 11, 2008 |
Last Updated: | September 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00790205 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Dipeptidyl-Peptidase IV Inhibitors Hypoglycemic Agents Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Protease Inhibitors Sitagliptin |
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 |