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Trial NCT00813995

Resource URI: http://static.linkedct.org/resource/trials/NCT00813995
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/10225>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/20576>
linkedct:brief_title A Study to Test the Safety and Efficacy of Adding Sitagliptin in Patients With Type 2 Diabetes Mellitus
linkedct:condition <http://static.linkedct.org/resource/condition/13331>
linkedct:criteria Inclusion Criteria: - 18 - 78 years of age - Currently on metformin monotherapy Exclusion Criteria: - History of Type 1 diabetes mellitus or ketoacidosis - Currently on a weight loss program and not in the maintenance phase or has started on a weight loss medication within the last 8 weeks - Have undergone surgery requiring general anesthesia within the past 4 weeks or has planned major surgery - Currently participating in a study or have participated in a study with or without an investigational compound or device within the past 12 weeks - History of active liver disease such as chronic active hepatitis B or C, cirrhosis or symptomatic gallbladder disease - HIV positive - Pregnant, breast-feeding or planning to become pregnant during the study - User of recreational or illicit drugs or have a recent history (within the past year) of drug or alcohol abuse or dependence
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 78 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date July 2010
linkedct:enrollment 400 (xsd:int)
linkedct:firstreceived_date December 19, 2008
linkedct:id NCT00813995
linkedct:intervention <http://static.linkedct.org/resource/intervention/76124>
linkedct:intervention <http://static.linkedct.org/resource/intervention/76310>
rdfs:label Trial NCT00813995
linkedct:lastchanged_date December 2, 2009
linkedct:lead_sponsor_agency Merck
linkedct:location <http://static.linkedct.org/resource/location/24801>
linkedct:nct_id NCT00813995
linkedct:number_of_arms 2 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin 100 mg Once Daily in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy
linkedct:org_study_id 2008_601
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/39955>
linkedct:overall_status Recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/534>
foaf:page <http://clinicaltrials.gov/show/NCT00813995>
linkedct:phase Phase 3
linkedct:primary_completion_date July 2010
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/38693>
linkedct:secondary_id MK0431-074
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/10288>
linkedct:source Merck
linkedct:start_date December 2008
linkedct:study_design Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
linkedct:study_type Interventional
linkedct:summary A study to assess the safety and efficacy of the addition of sitagliptin compared to placebo in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin.
rdf:type linkedct:trials
linkedct:verification_date December 2009